Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
Study NCT ID:
NCT05540093
Status:
COMPLETED
Last Update Posted:
2023-01-25
First Post:
2022-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Influence of Adding High Power Pain Threshold Ultrasound to Traditional Therapy on Axioappendicular Muscles Amplitude and Fatigue in Mechanical Neck Pain Randomized Clinical Trials
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019547', 'term': 'Neck Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'permuted block randomization'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'high power pain threshold ultrasound and traditional therapy'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-23', 'studyFirstSubmitDate': '2022-09-12', 'studyFirstSubmitQcDate': '2022-09-12', 'lastUpdatePostDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain intensity', 'timeFrame': 'up to four weeks', 'description': 'pain will be measured by visual analogue scale'}, {'measure': 'pressure pain threshold', 'timeFrame': 'up to four weeks', 'description': 'commander algometer device will be used to measure pressure pain threshold'}], 'secondaryOutcomes': [{'measure': 'neck disability', 'timeFrame': 'up to four weeks', 'description': 'neck disability index will be used to measure neck disability.'}, {'measure': 'muscle amplitude and fatigue', 'timeFrame': 'up to four weeks', 'description': 'electromyography will be used to measure muscle amplitude and fatigue'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['high power pain threshold ultrasound', 'mechanical neck pain'], 'conditions': ['Neck Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study will investigate the effect of adding high power pain threshold ultrasound to traditional therapy on axioappendicular muscles amplitude and fatigue in neck pain', 'detailedDescription': 'Myofascial pain syndrome is a common musculoskeletal pain disorder affecting almost 95% of people with chronic pain disorders and is a common finding in especially pain management centres.It is characterized by trigger points, defined as hyperirritable spots within taut bands of skeletal muscle fibers. The syndrome is associated with tenderness in the muscle, referred pain, spasm and restriction of motion. Patients with MPS begin with one active MTrP (called the primary MTrP) in the affected muscles due to chronic repetitive minor muscle strain, poor posture, systemic diseases, or neuro-musculoskeletal lesions. When not treated correctly, expansion of the pain region and additional active MTrPs (called secondary or satellite MTrPs) will develop one of the most appropriate treatments for trigger points ultrasound therapy. The high-power pain threshold ultrasound (HPPTUS) technique is one of the ultrasound modifications used to treat trigger points In 2004, Majlesi et al. performed the first clinical study to compare this technique with the traditional ultrasound technique in patients with myofascial trigger points. The results showed that HPPTUS was much more effective than the traditional technique, and pain reduction and improved range of motion (ROM) were significant in a smaller number of sessions.sixty patients with mechanical neck pain will be assigned randomly to two equal group. one group will receive high power pain threshold ultrasound and traditional therapy and the other receive traditional therapy alone for four weeks.\n\n.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '38 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with mechanical neck pain from both genders.\n* age between 19 and 38 years\n* patients will be required to have active TrPs in the upper trapezius and levator muscle and neck pain\n\nExclusion Criteria:\n\n* Patients will be excluded if they have History of whiplash injury,\n* History of cervical spine surgery,\n* Cervical radiculopathy or myelopathy,\n* Having undergone physical therapy within the past 3 months before the study\n* Non- rheumatologic diseases as multiple sclerosis,\n* thyroid dysfunction and chronic infection and Rheumatologic condition as mild systemic lupus erythematosus, poly-articular osteoarthritis, rheumatoid arthritis and advanced cervical spine degenerative diseases.'}, 'identificationModule': {'nctId': 'NCT05540093', 'acronym': 'MNP', 'briefTitle': 'Influence of Adding High Power Pain Threshold Ultrasound to Traditional Therapy on Axioappendicular Muscles Amplitude and Fatigue in Mechanical Neck Pain Randomized Clinical Trials', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Influence of Adding High Power Pain Threshold Ultrasound to Traditional Therapy on Axioappendicular Muscles Amplitude and Fatigue in Mechanical Neck Pain Randomized Clinical Trials', 'orgStudyIdInfo': {'id': 'p.t.REC/012/003619'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'high power pain threshold ultrasound', 'description': 'the patients will receive high power pain threshold ultrasound and traditional therapy twice a week for four weeks', 'interventionNames': ['Other: high power pain threshold ultrasound', 'Other: traditional therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'traditional therapy', 'description': 'the patients will receive traditional therapy twice a week for four weeks', 'interventionNames': ['Other: traditional therapy']}], 'interventions': [{'name': 'high power pain threshold ultrasound', 'type': 'OTHER', 'description': 'After explaining the procedure, and the trigger points will be marked by a physical therapist that . Then, the hand placed next to the prone position with the head in the neutral position, and the hands placed next to the body. The frequency was set to 1 MHz, and the intensity increased from 0.5 to 2 until the patient reported an unpleasant sensation. The probe will be held there for 4 s; then, the intensity was reduced by 50%, and the probe was moved over and around the trigger point. This process is done several times for three minutes.', 'armGroupLabels': ['high power pain threshold ultrasound']}, {'name': 'traditional therapy', 'type': 'OTHER', 'description': 'the patients will receive traditional therapy in the form of postural correction exercise, active range of motion and stretching exercise for cervical muscles', 'armGroupLabels': ['high power pain threshold ultrasound', 'traditional therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12511', 'city': 'Giza', 'country': 'Egypt', 'facility': 'Al Shaymaa Shaaban Abd El Azeim', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principle investigator', 'investigatorFullName': 'Al Shaymaa Shaaban Abd El Azeim', 'investigatorAffiliation': 'Cairo University'}}}}