Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2025-12-28 @ 11:34 AM
Study NCT ID:
NCT06158568
Status:
COMPLETED
Last Update Posted:
2024-04-30
First Post:
2023-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Percutaneous Electrical Nerve Stimulation and Exercise for Shoulder Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020069', 'term': 'Shoulder Pain'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D018771', 'term': 'Arthralgia'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004561', 'term': 'Transcutaneous Electric Nerve Stimulation'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-04-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-27', 'studyFirstSubmitDate': '2023-11-27', 'studyFirstSubmitQcDate': '2023-11-27', 'lastUpdatePostDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in disability between baseline and follow-up periods', 'timeFrame': 'Baseline, one week after the last intervention and 1 and 3 months after the intervention', 'description': 'The Disabilities of the Arm, Shoulder and Hand (DASH) will be used to determine the disability induced by shoulder pain'}], 'secondaryOutcomes': [{'measure': 'Changes in shoulder pain between baseline and follow-up periods', 'timeFrame': 'Baseline, one week after the last intervention and 1 and 3 months after the intervention', 'description': "A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' mean level of shoulder pain experienced in the preceding week in the shoulder area."}, {'measure': 'Changes in sleep quality between baseline and follow-up periods', 'timeFrame': 'Baseline, one week after the last intervention and 1 and 3 months after the intervention', 'description': 'The Pittsburgh Sleep Quality Index (PSQI) will be used to evaluate the quality of sleep'}, {'measure': 'Changes in anxiety/depressive symptoms between baseline and follow-up periods', 'timeFrame': 'Baseline, one week after the last intervention and 1 and 3 months after the intervention', 'description': 'The Hospital Anxiety and Depression Scale (HADS, A: Anxiety; D: Depression) will be used to evaluate the presence of anxiety/depressive symptoms'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neuromodulation', 'Percutaneous Nerve Stimulation', 'Exercise'], 'conditions': ['Shoulder Pain']}, 'descriptionModule': {'briefSummary': 'Based on the available literature, application of percutaneous electrical nerve stimulation interventions targeting peripheral nerves (also called percutaneous neuromodulation) has shown positive effects for improving pain-related and functional outcomes in musculoskeletal chronic pain. Studies investigating the use of this intervention for the shoulder are lacking.', 'detailedDescription': 'Based on the available literature, application of percutaneous electrical nerve stimulation interventions targeting peripheral nerves (also called percutaneous neuromodulation) has shown positive effects for improving pain-related and functional outcomes in musculoskeletal chronic pain. Studies investigating the use of this intervention for the shoulder are lacking.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unilateral non-traumatic shoulder pain (positive painful arc during shoulder abduction and a positive Hawkins test on clinical examination)\n* Shoulder pain from at least 3 months\n* Shoulder pain of more than 3/10 points on a NPRS\n\nExclusion Criteria:\n\n* Bilateral shoulder symptoms\n* Younger than 18 or older than 65 years\n* History of shoulder traumatisms, fractures or dislocation\n* Diagnosis of cervical radiculopathy or myelopathy\n* Previous interventions with steroid injections in the shoulder area\n* Comorbid medical conditions, e.g., fibromyalgia syndrome\n* Previous history of shoulder or neck surgery\n* Any type of intervention for the neck-shoulder area during the previous year\n* Fear to needles'}, 'identificationModule': {'nctId': 'NCT06158568', 'briefTitle': 'Percutaneous Electrical Nerve Stimulation and Exercise for Shoulder Pain', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Rey Juan Carlos'}, 'officialTitle': 'Effects of Percutaneous Electrical Nerve Stimulation and Exercise for Patients With Subacromial Pain Syndrome', 'orgStudyIdInfo': {'id': 'URJC0609202218622'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Percutaneous Electrical Nerve Stimulation', 'description': 'Participants assigned to this group will received four sessions (once per week) of ultrasound guided percutaneous electrical nerve stimulation targeting the axillar and suprascapular nerves for 30 minutes. We will apply a biphasic compensated electrical current at a frequency of 2 Hz, a pulse width of 250 μs and intensity allowed over a pain-free motor threshold (muscle contraction). In addition, they will receive a program of exercises for the shoulder musculature for 3 weeks.', 'interventionNames': ['Other: Percutaneous Electrical Nerve Stimulation', 'Other: Exercise']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Percutaneous Nerve Stimulation', 'description': 'Participants assigned to this group will received four sessions (once per week) of placebo ultrasound guided percutaneous electrical nerve stimulation targeting the axillar and suprascapular nerve. The electrical current will be off and no electrical current will be provided to the patient. In addition, they will receive the same program of exercises for the shoulder than the experimental group for three weeks.', 'interventionNames': ['Other: Placebo Percutaneous Electrical Nerve Stimulation', 'Other: Exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Exercise', 'description': 'Participants assigned to this group will receive the same program of exercises for the shoulder than the remaining groups for three weeks.', 'interventionNames': ['Other: Exercise']}], 'interventions': [{'name': 'Percutaneous Electrical Nerve Stimulation', 'type': 'OTHER', 'description': 'Application of a electrical current percutaneously (at the motor response intensity) targeting the suprascapular and axillar nerves', 'armGroupLabels': ['Percutaneous Electrical Nerve Stimulation']}, {'name': 'Placebo Percutaneous Electrical Nerve Stimulation', 'type': 'OTHER', 'description': 'Application of sham electrical current (no intensity) percutaneously targeting the suprascapular and axillar nerves', 'armGroupLabels': ['Placebo Percutaneous Nerve Stimulation']}, {'name': 'Exercise', 'type': 'OTHER', 'description': 'Application of three weeks of progressive exercises targeting the shoulder musculature', 'armGroupLabels': ['Exercise', 'Percutaneous Electrical Nerve Stimulation', 'Placebo Percutaneous Nerve Stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28922', 'city': 'Madrid', 'state': 'Rest of the World', 'country': 'Spain', 'facility': 'César Fernández-de-las-Peñas', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'César Fernández-de-las-Peñas, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad Rey Juan Carlos'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'César Fernández-de-las-Peñas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'César Fernández-de-las-Peñas', 'investigatorAffiliation': 'Universidad Rey Juan Carlos'}}}}