Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-26 @ 3:57 AM
Study NCT ID:
NCT04350918
Status:
COMPLETED
Last Update Posted:
2020-04-20
First Post:
2020-04-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Muscle Energy Technique and Static Stretching on Pain Intensity and Functional Disability in Patients With Mechanical Neck Pain
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D052580', 'term': 'Muscle Stretching Exercises'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D015444', 'term': 'Exercise'}, {'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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Subjects for this study were patients diagnosed of mechanical neck pain in Physiotherapy Outpatient Department of Obafemi Awolowo University Teaching Hospital Complex (OAUTHC), Ile-Ife. Individuals who meet the inclusion criteria were randomly allocated to Muscle Energy Techniques Group and Static Stretching Group using the simple random assignment method without replacement (Fish Bowl).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-01-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-16', 'studyFirstSubmitDate': '2020-04-15', 'studyFirstSubmitQcDate': '2020-04-15', 'lastUpdatePostDateStruct': {'date': '2020-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analogue Scale', 'timeFrame': 'From March 2019 to November 2019, The treatment for each patient was for 6 weeks', 'description': 'VAS is a one-dimensional measure of pain intensity, which has been widely used in diverse adult populations, including those with rheumatic diseases (Mc Cormack et al, 1988). pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm) (Aun et al, 1986)'}], 'secondaryOutcomes': [{'measure': 'Neck Disability Index (NDI)', 'timeFrame': 'From March 2019 to November 2019, The treatment for each patient was for 6 weeks', 'description': "The NDI can be scored as a raw score or doubled and expressed as a percent (Vernon, 1991). Each session is scored on a 0 to 5 rating scale, in which zero means 'No Pain' and 5 means 'Worst Imaginable Pain'. All the points can be summarized as a total score. The test can be interpreted as a raw score with a maximum score of 50 or as a percentage."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Static stretching, ,', 'neck pain,', 'muscle energy techniques', 'visual analogue scale,', 'neck disability index'], 'conditions': ['Neck Pain']}, 'descriptionModule': {'briefSummary': "Neck pain is becoming increasingly common throughout the world with a considerable impact on individuals, communities, health-care systems and businesses (Hoy et al, 2011).Neck pain is a common problem within our society affecting individual's physical and social functioning considerably and interfering with the patient's daily activities. There is lack of evidence to allow conclusions to be drawn about the effectiveness of MET when compared with stretching exercises for relieving mechanical neck pain. Therefore, this study is designed to examine the effect of MET, static stretching and to compare their effects on pain intensity and functional disability in patient with mechanical neck pain.", 'detailedDescription': 'This experimental study purposively recruited 24 subjects (male: n=10, female: n = 14) with mechanical neck pain from the Outpatient Physiotherapy Department of the Obafemi Awolowo University Teaching Hospitals Complex, Ile-Ife. Subjects were randomly allocated into the MET and SS groups. Subjects in MET group received 6 treatment sessions of Muscle Energy Technique in addition to conventional physiotherapy treatments. Patients in SS group received 6 treatment sessions of Static Stretching in addition to conventional physiotherapy treatments. All subjects were treated twice a week for six weeks. Visual Analogue Scale (VAS) and Neck Disability Index (NDI) were used to assess the pain intensity and functional disability at baseline, 3rd week and 6th week of treatment sessions respectively. Descriptive and Inferential statistics were used to analyse the data. Alpha level was set at \\< 0.05.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:i. Male and female patients with history of mechanical neck pain of more than 3 months\n\nExclusion Criteria:\n\n* Patients with acute neck pain\n* Subjects were excluded if they have neck pain associated with an underlying pathology such as fracture of the cervical spine, neck pain radiating into the arms or upper extremity or associated with headaches or facial pain, malignancy, infections, inflammatory disorders, osteoporosis or cases of disc prolapse.\n* Patients with history of surgery of the cervical spine during the previous 12months'}, 'identificationModule': {'nctId': 'NCT04350918', 'acronym': 'MET&SSinNckp', 'briefTitle': 'Muscle Energy Technique and Static Stretching on Pain Intensity and Functional Disability in Patients With Mechanical Neck Pain', 'organization': {'class': 'OTHER', 'fullName': 'Obafemi Awolowo University'}, 'officialTitle': 'Effects Muscle Energy Technique and Static Stretching on Pain Intensity and Functional Disability in Patients With Mechanical Neck Pain: A Randomized Control Study', 'orgStudyIdInfo': {'id': 'OJO/2020/01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Muscle Energy Technique (MET)', 'description': 'MET Group received 12 treatment sessions of MET (Nagrale et al, 2010) two times a week in addition to conventional physiotherapy. The procedures employ voluntary muscle contractions by the patient in a precisely controlled direction and intensity against a counterforce applied by the Physiotherapist. The technique requires the therapist to provide stabilization to the segment on which the distal aspect of the muscle attaches. A command for anisometric contraction of the muscle is given that causes accessory movement of the joint. Several specific muscle energy techniques are described for the subcranial region of the cervical spine.', 'interventionNames': ['Device: Muscle Enery Techniques']}, {'type': 'EXPERIMENTAL', 'label': 'Static stretching (SS)', 'description': 'Subjects in SS Group received 12 treatment sessions of static stretching (Dutton et al, 2008) two times a week in addition to conventional physiotherapy.\n\nStretching involves the application of manual or mechanical force to elongate structures that have adaptively shortened and are hypo-mobile (Sullivan, 2007) Static stretching involves stretching a muscle to a point of discomfort and holding the stretch for a length of time, followed by a return to normal resting muscle length (Andrews et al, 2004). Muscles of the neck were stretched in especially in side flexion, extension, flexion and side rotation for 10 seconds and was repeated 10 times for a session.', 'interventionNames': ['Device: Static Stretching']}], 'interventions': [{'name': 'Muscle Enery Techniques', 'type': 'DEVICE', 'otherNames': ['MET'], 'description': 'Group of patients that underwent muscle energy technique as a mean of treatment for the complaint', 'armGroupLabels': ['Muscle Energy Technique (MET)']}, {'name': 'Static Stretching', 'type': 'DEVICE', 'otherNames': ['SS'], 'description': 'Set of patients that had static stretching technique for the treatment for the complaint', 'armGroupLabels': ['Static stretching (SS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '220005', 'city': 'Ile-Ife', 'state': 'Osun State', 'country': 'Nigeria', 'facility': 'Obafemi Awolowo University', 'geoPoint': {'lat': 7.4824, 'lon': 4.56032}}], 'overallOfficials': [{'name': 'Adesola O Ojoawo PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Head, Department of Medical Rehabilitation, Obafemi Awolowo University Ile Ife'}, {'name': 'Kayode Ijaduola', 'role': 'STUDY_CHAIR', 'affiliation': 'Provost, College of Health Sciences, Obafemi Awolowo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Obafemi Awolowo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr and Head of Department', 'investigatorFullName': 'Adesola Ojo Ojoawo', 'investigatorAffiliation': 'Obafemi Awolowo University'}}}}