Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2026-01-29 @ 5:27 PM
Study NCT ID:
NCT02834702
Status:
UNKNOWN
Last Update Posted:
2017-11-06
First Post:
2016-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sinew Acupuncture for Neck Pain: Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019547', 'term': 'Neck Pain'}, {'id': 'D059350', 'term': 'Chronic 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': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-10-31', 'studyFirstSubmitDate': '2016-07-13', 'studyFirstSubmitQcDate': '2016-07-14', 'lastUpdatePostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'week 1, 2, 3 & 6', 'description': 'Adverse events at week 1, 2, 3 \\& 6'}], 'primaryOutcomes': [{'measure': 'Visual Analog Scale (VAS)', 'timeFrame': 'week 3', 'description': 'VAS at week 3'}], 'secondaryOutcomes': [{'measure': 'VAS', 'timeFrame': 'week 1, 2 & 6', 'description': 'VAS at week 1, 2 \\& 6'}, {'measure': 'Northwick Park Neck Pain Questionnaire (NPQ)', 'timeFrame': 'week 1, 2, 3 & 6', 'description': 'NPQ at week 1, 2, 3 \\& 6'}, {'measure': 'Short Form-36 (SF-36)', 'timeFrame': 'week 1, 2, 3 & 6', 'description': 'SF-36 at week 1, 2, 3 \\& 6'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sinew acupuncture', 'neck pain', 'chronic pain'], 'conditions': ['Neck Pain']}, 'descriptionModule': {'briefSummary': 'The study aims to examine the efficacy and safety of sinew acupuncture for chronic mechanical neck pain (CMNP).', 'detailedDescription': "Objectives:\n\nSinew acupuncture is a superficial needling technique with the advantage of minimal pain, feasible manipulation, and no apparent adverse effects. The proposal aims to examine the efficacy and safety of sinew acupuncture for chronic mechanical neck pain (CMNP).\n\nHypothesis to be tested:\n\nSinew acupuncture can reduce pain intensity, and improve neck pain disability and health-related quality of life without significant side effects for CMNP subjects compared to a sham acupuncture treatment.\n\nDesign:\n\nA randomized, subject- and assessor-blind, sham acupuncture-controlled clinical trial\n\nParticipants:\n\nSubjects (N=130) will be randomized into sinew acupuncture or sham acupuncture group (in 1:1 ratio).\n\nStudy instrument:\n\nVisual Analog Scale (VAS), Northwick Park Neck Pain Questionnaire (NPQ) and Short Form-36 (SF-36)\n\nIntervention:\n\nSinew acupuncture group will receive five sessions of needling in two weeks. Sham group will receive the non-invasive treatment with the same procedures. All subjects are followed up for 4 weeks.\n\nMain outcome measures:\n\nVAS for neck pain intensity at week 3 serves as the primary outcome. VAS at other time points, NPQ score and SF-36 at week 1, 2, 3, and 6, and adverse events are analyzed as the secondary outcomes.\n\nData analysis:\n\nAnalysis will be on the 'intention to treat' principle. T-test and mixed-effect model analysis will be used to measure primary and secondary outcomes respectively.\n\nExpected results:\n\nFive sessions of sinew acupuncture treatment can significantly reduce neck pain intensity, and improve neck pain disability and quality of life without obvious side effects."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (1) aged 18 years or above; (2) able to read and write Chinese; (3) the pain is located between the neck and shoulder regions and movement or palpation of the cervical region provokes the symptoms (18); (4) the pain has persisted for more than 3 months; (5) VAS (0 to 100 mm) pain score is ≥30 mm at baseline assessment; (6) no treatments (Chinese medicine, acupuncture, moxibustion, physiotherapies, medications, etc) intended for pain management have been received within the preceding two weeks.\n\nExclusion Criteria:\n\n* (1) a history of fracture or surgery to the neck; (2) malignant tumor; (3) cervical congenital abnormality; (4) a severe psychiatric illness; (5) needle phobia; (6) acupuncture treatment in the preceding 3 months, and (7) other acupuncture contraindications as indicated in Hospital Authority Guideline on Safety in Acupuncture for Chinese Medicine Practitioners (Quality and Risk Sub-Committee, Hospital Authority, 2010).'}, 'identificationModule': {'nctId': 'NCT02834702', 'briefTitle': 'Sinew Acupuncture for Neck Pain: Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Sinew Acupuncture for Chronic Mechanical Neck Pain: a Randomized Assessor-blind Sham-controlled Trial', 'orgStudyIdInfo': {'id': 'UHongKong-UW 15-456'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sinew acupuncture', 'description': 'Sinew acupuncture', 'interventionNames': ['Device: Sinew acupuncture']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham acupuncture', 'description': 'Sham acupuncture', 'interventionNames': ['Device: Sham acupuncture']}], 'interventions': [{'name': 'Sinew acupuncture', 'type': 'DEVICE', 'description': 'The subject is asked to be on sitting posture. The skin around the needling points is disinfected with a 75% alcohol swap. A tube-guided, sterilized, disposal needle is then inserted (at a small angle to the skin) into the acupoint at 0.5-1 cun (depending on point location and body size of the subject). No needle sensation (deqi sensation) is required. A piece of surgical adhesive tape will be applied to the needle immediately after insertion.', 'armGroupLabels': ['Sinew acupuncture']}, {'name': 'Sham acupuncture', 'type': 'DEVICE', 'description': 'The procedure in the sham acupuncture group will be as similar to that of the acupuncture group as possible. In the sham acupuncture group, however, a mock plastic needle guiding tube is tapped on the surface of each acupoint (Ashi point and traditional acupoints) to produce some discernible sensation. A piece of adhesive tape is immediately applied to fix the needle on the dermal surface tapped, without needle insertion. In addition, a plastic tube-guided needle is superficially inserted at the sham point at less than 5mm in depth.', 'armGroupLabels': ['Sham acupuncture']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Haiyong Chen, PhD', 'role': 'CONTACT', 'email': 'haiyong@hku.hk', 'phone': '39176413'}], 'overallOfficials': [{'name': 'Haiyong Chen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}