Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 10:04 PM
Study NCT ID:
NCT01855958
Status:
COMPLETED
Last Update Posted:
2017-09-15
First Post:
2013-05-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Motor Cortex Plasticity and the Effect of Deep Intramuscular Needling Stimulation Therapy (DIMST) in Osteoarthritis Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'caumo@cpovo.net', 'phone': '+555133598430', 'title': 'Wolnei Caumo, MD,PhD.', 'organization': 'Hospital de Clínicas de Porto Alegre'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'DIMST, Deep Intramuscular Stimulation Therapy', 'description': 'The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterioris; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.', 'otherNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo-sham, Rubber Electrodes With Electrostimulation', 'description': 'The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.', 'otherNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Intracortical Inhibition (ICI) After Intervention.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DIMST, Deep Intramuscular Stimulation Therapy', 'description': 'The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterioris; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.'}, {'id': 'OG001', 'title': 'Placebo-sham, Rubber Electrodes With Electrostimulation', 'description': 'The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.75', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '0.57', 'spread': '0.30', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Evaluated in one day. The cortical excitability before and within an hour after intervention.', 'description': 'ICI was evaluated using inter-stimuli intervals (ISIs) of 2 ms with paired-pulse stimulation. The subthreshold stimulus was set at 80% of rMT (conditioning stimulus) , and the suprathreshold test stimulus was set at 130% of rMT. After a randomized protocol, thirty stimuli were assessed using a 2ms interval (ICI), a 12ms interval (ICF) and test-only trials (MEPs). The resulting MEP amplitude was converted into the mean amplitude, and paired-pulse parameters were expressed as the amount of inhibition or facilitation. The calculation result of ICI was done by the ratio of the mean ICI by the mean MEP.\n\n\\# Below the data after intervention.', 'unitOfMeasure': 'ratio of amplitude (mV).', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Intensity After Intervention.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DIMST, Deep Intramuscular Stimulation Therapy', 'description': 'The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterioris; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.'}, {'id': 'OG001', 'title': 'Placebo-sham, Rubber Electrodes With Electrostimulation', 'description': 'The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.88', 'spread': '1.58', 'groupId': 'OG000'}, {'value': '3.36', 'spread': '3.32', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Evaluated within twenty four hours before and within one hour after the intervention.', 'description': 'The intensity of pain was measured by a 10-cm VAS. VAS scores ranged from no pain (zero) to the worst possible pain possible (10 cm). The pain score on VAS during the last 24 hours was used to classify the subjects into two groups: (1) absence of pain or mild pain (scores equal to or lower than 4 cm) and (2) moderate, intense, or worst possible pain (scores higher than 4 cm).\n\n\\# Below the data after intervention.', 'unitOfMeasure': 'cm ( mean).', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Pain Pressure Threshold (PPT) After Intervention..', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DIMST, Deep Intramuscular Stimulation Therapy', 'description': 'The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterioris; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.'}, {'id': 'OG001', 'title': 'Placebo-sham, Rubber Electrodes With Electrostimulation', 'description': 'The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.82', 'spread': '3.00', 'groupId': 'OG000'}, {'value': '6.66', 'spread': '1.67', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before and within one hour after intervention.', 'description': 'PPT (alone): The patient was instructed to verbally report the perception of pain onset. The investigator assessed PPT using an electronic algometer (J Tech Medical Industries, USA). The device had a 1-cm2 hard-rubber probe, which was applied over structures at L1- L5 dermatome at the knee and at the contralateral forearm. The average values of PPT in kgf/cm2 for three successive readings taken at intervals of 3-5 min were used as the outcomes.\n\n\\# Below, the data after intervention.', 'unitOfMeasure': 'Kgf / cm2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Motor Evoked Potential (MEP) After Intervention.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DIMST, Deep Intramuscular Stimulation Therapy', 'description': 'The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterioris; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.'}, {'id': 'OG001', 'title': 'Placebo-sham, Rubber Electrodes With Electrostimulation', 'description': 'The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.14', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '1.12', 'spread': '1.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before and within one hour after intervention.', 'description': 'Cortical excitability was assessed using a MagPro X100 (MagVenture Company, Lucernemarken, Denmark) and a figure-of-8 coil centered over the left motor cortex (M1). Subjects were seated in a comfortable reclining chair with their arms and hands lying relaxed on the armrests. The investigators measured the resting motor threshold (rMT) of the right first dorsal interosseous (FDI) muscle. The MEPs were recorded by surface electromyography (EMG) using Ag-AgCl cup electrodes in a belly tendon montage. Resting motor threshold (rMT) was defined as the stimulus intensity at which peak-to-peak MEP amplitude of 50 µV (microvolts) was obtained in at least 5 of 10 consecutive trials.\n\nMEP was defined as approximately 130% of the rMT or the stimulus intensity at which peak-to-peak MEP amplitude of at least 1 mV was obtained in 10 consecutive trials. The result of the MEP was the average of 10 curves (unconditioned MEP).\n\n\\# Below the data after intervention.', 'unitOfMeasure': 'mV (millivolts).', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Intracortical Facilitation (ICF) After Intervention.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DIMST, Deep Intramuscular Stimulation Therapy', 'description': 'The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterioris; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.'}, {'id': 'OG001', 'title': 'Placebo-sham, Rubber Electrodes With Electrostimulation', 'description': 'The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.20', 'spread': '0.98', 'groupId': 'OG000'}, {'value': '0.78', 'spread': '0.57', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before and within one hour after intervention.', 'description': 'ICF was evaluated using an inter-stimuli intervals (ISIs) of 12 ms with paired-pulse and similar parameters for the conditioning and test stimuli. After a randomized protocol, thirty stimuli were assessed using a 2ms interval (ICI), a 12ms interval (ICF) and test-only trials (MEP). The resulting MEP amplitude was converted into the mean amplitude, and paired-pulse parameters were expressed as the amount of inhibition or facilitation. The calculation result of ICF was done by the ratio of the mean ICF by the mean MEP.\n\n\\# Below the data after intervention.', 'unitOfMeasure': 'ratio of amplitude (mV).', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cortical Silent Period (CSP) After Intervention.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DIMST, Deep Intramuscular Stimulation Therapy', 'description': 'The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterioris; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.'}, {'id': 'OG001', 'title': 'Placebo-sham, Rubber Electrodes With Electrostimulation', 'description': 'The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.93', 'spread': '24.48', 'groupId': 'OG000'}, {'value': '48.92', 'spread': '22.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Evaluated before and within one hour after intervention.', 'description': 'To determine the cortical silent period (CSP), subjects were instructed to squeeze the dynamometer using their fingers at 20% of maximal force when a single pulse stimulus (130% rMT) was applied. The result was the average of five consecutive measurements. The CSP was determined by the interval between the stimulus and the motor response elicited in the subject.\n\n\\# Below the data after intervention.', 'unitOfMeasure': 'ms (milliseconds).', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Conditioned Pain Modulation (CPM) After Intervention.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DIMST', 'description': 'The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterior; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.\n\nDIMST: The investigators used electro acupuncture of 2 Hz during 30 minutes.'}, {'id': 'OG001', 'title': 'Placebo-sham', 'description': 'The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.\n\nPlacebo-sham: Electro acupuncture with rubber electrodes, without current passing.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.62', 'spread': '3.47', 'groupId': 'OG000'}, {'value': '9.15', 'spread': '2.17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before and within one hour after intervention.', 'description': 'PPT during cold water immersion (PPT+CPM): By measuring PPT during cold water immersion, we evaluated the degree to which pain perception is modulated by conditioned pain modulation (CPM) following the presentation of an initial heterotopic noxious stimulus. Subjects immersed their left hands into cold water (zero to 1°C) for 1 minute. During the last 30 seconds of cold-water immersion, the PPT procedure was administered at the right forearm. The temperature was held constant across during the experiment for each subject.\n\n\\# Below the data after intervention.', 'unitOfMeasure': 'Kgf / cm2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DIMST, Deep Intramuscular Stimulation Therapy', 'description': 'The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterioris; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.'}, {'id': 'FG001', 'title': 'Placebo-sham, Rubber Electrodes With Electrostimulation', 'description': 'The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited through a call list generated by public means of mass communication in January 2012, and announcements of research in the Department of Pain and Palliative Medicine, Hospital de Clinicas, before and during the study. Throughout the study the members of the list were selected through a telephone interview.', 'preAssignmentDetails': 'Eighty-five subjects were screened. Five refused to participate, fifty-four were not enrolled for the following reasons:\n\nPrevious experience with acupuncture. Inability to walk a certain distance. Live distant of center. Twenty-six were recruited in the study and randomized further to active(n = 13) or placebo (n = 13)groups.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'DIMST, Deep Intramuscular Stimulation Therapy', 'description': 'The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterioris; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.'}, {'id': 'BG001', 'title': 'Placebo-sham, Rubber Electrodes With Electrostimulation', 'description': 'The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.85', 'spread': '7.53', 'groupId': 'BG000'}, {'value': '63.55', 'spread': '7.54', 'groupId': 'BG001'}, {'value': '64.50', 'spread': '7.72', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Brazil', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-17', 'studyFirstSubmitDate': '2013-05-08', 'resultsFirstSubmitDate': '2013-07-03', 'studyFirstSubmitQcDate': '2013-05-16', 'lastUpdatePostDateStruct': {'date': '2017-09-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-08-19', 'studyFirstPostDateStruct': {'date': '2013-05-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Pressure Threshold (PPT) After Intervention..', 'timeFrame': 'Before and within one hour after intervention.', 'description': 'PPT (alone): The patient was instructed to verbally report the perception of pain onset. The investigator assessed PPT using an electronic algometer (J Tech Medical Industries, USA). The device had a 1-cm2 hard-rubber probe, which was applied over structures at L1- L5 dermatome at the knee and at the contralateral forearm. The average values of PPT in kgf/cm2 for three successive readings taken at intervals of 3-5 min were used as the outcomes.\n\n\\# Below, the data after intervention.'}, {'measure': 'Motor Evoked Potential (MEP) After Intervention.', 'timeFrame': 'Before and within one hour after intervention.', 'description': 'Cortical excitability was assessed using a MagPro X100 (MagVenture Company, Lucernemarken, Denmark) and a figure-of-8 coil centered over the left motor cortex (M1). Subjects were seated in a comfortable reclining chair with their arms and hands lying relaxed on the armrests. The investigators measured the resting motor threshold (rMT) of the right first dorsal interosseous (FDI) muscle. The MEPs were recorded by surface electromyography (EMG) using Ag-AgCl cup electrodes in a belly tendon montage. Resting motor threshold (rMT) was defined as the stimulus intensity at which peak-to-peak MEP amplitude of 50 µV (microvolts) was obtained in at least 5 of 10 consecutive trials.\n\nMEP was defined as approximately 130% of the rMT or the stimulus intensity at which peak-to-peak MEP amplitude of at least 1 mV was obtained in 10 consecutive trials. The result of the MEP was the average of 10 curves (unconditioned MEP).\n\n\\# Below the data after intervention.'}, {'measure': 'Conditioned Pain Modulation (CPM) After Intervention.', 'timeFrame': 'Before and within one hour after intervention.', 'description': 'PPT during cold water immersion (PPT+CPM): By measuring PPT during cold water immersion, we evaluated the degree to which pain perception is modulated by conditioned pain modulation (CPM) following the presentation of an initial heterotopic noxious stimulus. Subjects immersed their left hands into cold water (zero to 1°C) for 1 minute. During the last 30 seconds of cold-water immersion, the PPT procedure was administered at the right forearm. The temperature was held constant across during the experiment for each subject.\n\n\\# Below the data after intervention.'}], 'secondaryOutcomes': [{'measure': 'Intracortical Inhibition (ICI) After Intervention.', 'timeFrame': 'Evaluated in one day. The cortical excitability before and within an hour after intervention.', 'description': 'ICI was evaluated using inter-stimuli intervals (ISIs) of 2 ms with paired-pulse stimulation. The subthreshold stimulus was set at 80% of rMT (conditioning stimulus) , and the suprathreshold test stimulus was set at 130% of rMT. After a randomized protocol, thirty stimuli were assessed using a 2ms interval (ICI), a 12ms interval (ICF) and test-only trials (MEPs). The resulting MEP amplitude was converted into the mean amplitude, and paired-pulse parameters were expressed as the amount of inhibition or facilitation. The calculation result of ICI was done by the ratio of the mean ICI by the mean MEP.\n\n\\# Below the data after intervention.'}, {'measure': 'Pain Intensity After Intervention.', 'timeFrame': 'Evaluated within twenty four hours before and within one hour after the intervention.', 'description': 'The intensity of pain was measured by a 10-cm VAS. VAS scores ranged from no pain (zero) to the worst possible pain possible (10 cm). The pain score on VAS during the last 24 hours was used to classify the subjects into two groups: (1) absence of pain or mild pain (scores equal to or lower than 4 cm) and (2) moderate, intense, or worst possible pain (scores higher than 4 cm).\n\n\\# Below the data after intervention.'}, {'measure': 'Intracortical Facilitation (ICF) After Intervention.', 'timeFrame': 'Before and within one hour after intervention.', 'description': 'ICF was evaluated using an inter-stimuli intervals (ISIs) of 12 ms with paired-pulse and similar parameters for the conditioning and test stimuli. After a randomized protocol, thirty stimuli were assessed using a 2ms interval (ICI), a 12ms interval (ICF) and test-only trials (MEP). The resulting MEP amplitude was converted into the mean amplitude, and paired-pulse parameters were expressed as the amount of inhibition or facilitation. The calculation result of ICF was done by the ratio of the mean ICF by the mean MEP.\n\n\\# Below the data after intervention.'}, {'measure': 'Cortical Silent Period (CSP) After Intervention.', 'timeFrame': 'Evaluated before and within one hour after intervention.', 'description': 'To determine the cortical silent period (CSP), subjects were instructed to squeeze the dynamometer using their fingers at 20% of maximal force when a single pulse stimulus (130% rMT) was applied. The result was the average of five consecutive measurements. The CSP was determined by the interval between the stimulus and the motor response elicited in the subject.\n\n\\# Below the data after intervention.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Osteoarthritis', 'Electro acupuncture', 'Deep intramuscular stimulation', 'Transcranial Magnetic Stimulation', 'Pain pressure threshold', 'Conditioned pain modulation', 'Clinical trial'], 'conditions': ['Knee Osteoarthritis', 'Chronic Pain']}, 'referencesModule': {'references': [{'pmid': '17101886', 'type': 'BACKGROUND', 'citation': 'Lefaucheur JP, Drouot X, Menard-Lefaucheur I, Keravel Y, Nguyen JP. Motor cortex rTMS restores defective intracortical inhibition in chronic neuropathic pain. Neurology. 2006 Nov 14;67(9):1568-74. doi: 10.1212/01.wnl.0000242731.10074.3c.'}, {'pmid': '22632870', 'type': 'BACKGROUND', 'citation': 'Zunhammer M, Eichhammer P, Franz J, Hajak G, Busch V. Effects of acupuncture needle penetration on motor system excitability. Neurophysiol Clin. 2012 Jun;42(4):225-30. doi: 10.1016/j.neucli.2012.02.134. Epub 2012 Mar 6.'}, {'pmid': '12824765', 'type': 'BACKGROUND', 'citation': 'Lo YL, Cui SL. Acupuncture and the modulation of cortical excitability. Neuroreport. 2003 Jul 1;14(9):1229-31. doi: 10.1097/00001756-200307010-00008.'}, {'pmid': '18821657', 'type': 'BACKGROUND', 'citation': 'Imamura M, Imamura ST, Kaziyama HH, Targino RA, Hsing WT, de Souza LP, Cutait MM, Fregni F, Camanho GL. Impact of nervous system hyperalgesia on pain, disability, and quality of life in patients with knee osteoarthritis: a controlled analysis. Arthritis Rheum. 2008 Oct 15;59(10):1424-31. doi: 10.1002/art.24120.'}, {'pmid': '20540759', 'type': 'BACKGROUND', 'citation': 'Schwenkreis P, Scherens A, Ronnau AK, Hoffken O, Tegenthoff M, Maier C. Cortical disinhibition occurs in chronic neuropathic, but not in chronic nociceptive pain. BMC Neurosci. 2010 Jun 11;11:73. doi: 10.1186/1471-2202-11-73.'}, {'pmid': '22752510', 'type': 'BACKGROUND', 'citation': 'Laste G, Caumo W, Adachi LN, Rozisky JR, de Macedo IC, Filho PR, Partata WA, Fregni F, Torres IL. After-effects of consecutive sessions of transcranial direct current stimulation (tDCS) in a rat model of chronic inflammation. Exp Brain Res. 2012 Aug;221(1):75-83. doi: 10.1007/s00221-012-3149-x. Epub 2012 Jul 3.'}, {'pmid': '460936', 'type': 'BACKGROUND', 'citation': 'Le Bars D, Dickenson AH, Besson JM. Diffuse noxious inhibitory controls (DNIC). II. Lack of effect on non-convergent neurones, supraspinal involvement and theoretical implications. Pain. 1979 Jun;6(3):305-327. doi: 10.1016/0304-3959(79)90050-2.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the cortical excitability in pain of knee osteoarthritis (OA), as well as the effect of one session of a kind of electroacupuncture (deep needling intramuscular stimulation therapy - DIMST) in this pain and the cortical excitability after the intervention.\n\nThe hypothesis is that cortical excitability is altered in this condition, confirming the findings already described in other chronic pain conditions. The investigators also believe that a session DIMST can reduce pain and alter cortical excitability, restoring its previous activity will occur from chronic pain.', 'detailedDescription': 'Recent developments in the treatment of chronic pain have shown that the primary motor cortex (M1) is an effective target for neural brain stimulation techniques, such as transcranial magnetic stimulation (TMS). Due to these promising initial results, the plasticity of M1 has also been investigated as a potential marker for chronic pain. TMS studies using single or paired pulse shown changes in M1 plasticity in neuropathic pain and fibromyalgia pain compared to healthy subjects. Thus, there is a decrease in the inhibitory activity of chronic pain that can take a state as shown uninhibited by measuring TMS indexed intracortical inhibition (ICI) and cortical silent period (CSP). Based on these experimental data and clinical studies have been focused on the effects of neuromodulation techniques in M1 excitability. The techniques used to stimulate the peripheral nervous system was investigated using different approaches. The DIMST is a therapy applied to treat peripheral chronic syndromes that may have central components such as myofascial pain. During DIMST, the needles are applied to the spinal segment associated with nerve roots dermatome corresponding to the pathology. This treatment can also be effective in the treatment of diseases that have major peripheral components such as OA. OA is a major cause of suffering and disability in the elderly, having an inflammatory component, such as a factor that contributes to the symptoms and progression of the disease. There is evidence that OA could lead to sensitization central and segmental, but these effects on M1 plasticity and other central components are not completely known.\n\nTherefore, researchers proposed to evaluate the plasticity of M1 in this chronic pain condition and also the effect of bottom-up DIMST in pain and cortical excitability.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with over 18 years old, with chronic pain because of primary osteoarthritis of the knee.\n* Pain stable for at least three months. Score greater than or equal to 3 cm (0 cm = "no pain" and "worst possible pain" = 10cm) on VAS for pain perception at baseline.\n* No contraindications to electro acupuncture or transcranial magnetic stimulation.\n* Naive in acupuncture treatment.\n\nExclusion Criteria:\n\n* Clinically significant or unstable disorder, medical or psychiatric.\n* Presence of neurological or rheumatic comorbidity.\n* Pregnancy.\n* Having performed surgery in the knee to be treated in the last 6 months, or be planning surgery for the next semester.\n* Having performed with corticosteroid infiltration in the last six weeks or are using this.\n* Having performed with hyaluronic acid infiltration.'}, 'identificationModule': {'nctId': 'NCT01855958', 'briefTitle': 'Motor Cortex Plasticity and the Effect of Deep Intramuscular Needling Stimulation Therapy (DIMST) in Osteoarthritis Pain', 'organization': {'class': 'OTHER', 'fullName': 'Hospital de Clinicas de Porto Alegre'}, 'officialTitle': 'Primary Motor Cortex Plasticity and the Bottom up Effect of Deep Intramuscular Needling Stimulation Therapy (DIMST)in Osteoarthritis Chronic Pain', 'orgStudyIdInfo': {'id': '11-0013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DIMST', 'description': 'The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterior; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.', 'interventionNames': ['Procedure: DIMST']}, {'type': 'SHAM_COMPARATOR', 'label': 'Placebo-sham', 'description': 'The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.', 'interventionNames': ['Procedure: Placebo-sham']}], 'interventions': [{'name': 'DIMST', 'type': 'PROCEDURE', 'otherNames': ['Paraspinal electro acupuncture.'], 'description': 'The investigators used electro acupuncture of 2 Hz during 30 minutes.', 'armGroupLabels': ['DIMST']}, {'name': 'Placebo-sham', 'type': 'PROCEDURE', 'otherNames': ['Electrostimulation with rubber electrodes.'], 'description': 'Electro acupuncture with rubber electrodes, without current passing.', 'armGroupLabels': ['Placebo-sham']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90035903', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital de Clínicas de Porto Alegre.', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}], 'overallOfficials': [{'name': 'Wolnei Caumo, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Federal University of Rio Grande do Sul'}, {'name': 'Maria L Tarragó, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of Rio Grande do Sul'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital de Clinicas de Porto Alegre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Associação Fundo de Incentivo à Pesquisa', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}