A Clinical Study of Acupuncture Comprehensive Therapy on Common Orthopedic Pain Syndromes
NCT ID: NCT02983201
Last Updated: 2016-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2015-03-31
2018-03-31
Brief Summary
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Detailed Description
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Filiform needle is the most common needle used for acupuncture, and it is commonly accepted as the primary tool to perform acupuncture. Traditional Acupuncture (using filiform needle)is proven to be effective in pain management. In 2003, World Health Organization(WHO) confirmed that "There is significant neurophysiological evidence that supports the the notion that acupuncture is capable of modulating pain sensation". Relatively fewer research and study has been done on efficacy of Intra-dermal needle in pain management.
The objective of this trial is to further confirm and assess the efficacy of filiform needle therapy on the common orthopedic pain syndromes and investigate whether or not thumbtack needle therapy could further enhance the clinical efficacy and pain healing effect of the filiform needle therapy.
150 outpatients diagnosed with common orthopedic pain syndromes (Coracoiditis, External humeral epicondylitis, Radial styloid process stenosing tenosynovitis, Flexor tendon stenosing tenosynovitis, Costochondritis and Supraspinal ligament injury) will be recruited. The recruited patient will be divided randomly into (i)Filiform Needle Group (75 cases) and (ii)Filiform Needle supplemented by Thumbtack Intra-dermal Needle Group (75cases) by using computer generated random number.
During the study period, a maximum of two courses of acupuncture therapy, consisting of 7 sessions each, will be administered. Treatment will be given twice per week. After completing the first course of 7 sessions, there will be a break of one week, at the end of which the second course will commence. Treatment will come to a halt as soon as the pain has totally subsided. The aim of treatment is to relieve the pain associated with the common orthopedic syndrome within the shortest period of time.
Questionnaire incorporating The Short-form McGill Pain Form and selected life efficacy questions will be used in this study to quantify the level of pain. Traditional Chinese Medicine(TCM) Syndrome Diagnostic Efficacy Standards and The Guiding Rules of Clinical Research of New Chinese Medicine will be adopted as the standard to observe and evaluate the efficacy of treatment. Patients will be observed and evaluate before and after each treatment and each treatment course. The subjects' level and intensity of pain will be recorded together with the improvement of body mobility and symptoms related to the pain. Follow up will take place 3 months, 6 months and 12 months after treatment completed through phone interview.
Data collected will be analysed by Statistical Product and Service Solutions(SPSS) statistical software, The efficacy of Filiform Needle Therapy and Thumbtack Needle Therapy on Common Orthopedic Pain Syndromes will be objectively assessed and compared.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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filiform needle
Patients will receive filiform needle treatment only.During the study period, a maximum of two courses of acupuncture therapy, consisting of 7 sessions each, will be administered. Treatment will be given twice per week. After completing the first course of 7 sessions, there will be a break of one week, at the end of which the second course will commence. Treatment will come to a halt as soon as the pain has totally subsided.
filiform needle
Patients will receive filiform needle treatment only.During the study period, a maximum of two courses of acupuncture therapy, consisting of 7 sessions each, will be administered. Treatment will be given twice per week. After completing the first course of 7 sessions, there will be a break of one week, at the end of which the second course will commence. Treatment will come to a halt as soon as the pain has totally subsided.
thumbtack needle+filiform needle
Thumbtack intra-dermal needle will be applied to selected acupuncture points after filiform needle treatment. The thumbtack needle will remain embedded in the patient's dermal part for 2-3 days as per instruction.During the study period, a maximum of two courses of acupuncture therapy, consisting of 7 sessions each, will be administered. Treatment will be given twice per week. After completing the first course of 7 sessions, there will be a break of one week, at the end of which the second course will commence. Treatment will come to a halt as soon as the pain has totally subsided.
filiform needle
Patients will receive filiform needle treatment only.During the study period, a maximum of two courses of acupuncture therapy, consisting of 7 sessions each, will be administered. Treatment will be given twice per week. After completing the first course of 7 sessions, there will be a break of one week, at the end of which the second course will commence. Treatment will come to a halt as soon as the pain has totally subsided.
thumbtack needle
Thumbtack intra-dermal needle will be applied to selected acupuncture points after filiform needle treatment. The thumbtack needle will remain embedded in the patient's dermal part for 2-3 days as per instruction.During the study period, a maximum of two courses of acupuncture therapy, consisting of 7 sessions each, will be administered. Treatment will be given twice per week. After completing the first course of 7 sessions, there will be a break of one week, at the end of which the second course will commence. Treatment will come to a halt as soon as the pain has totally subsided.
Interventions
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filiform needle
Patients will receive filiform needle treatment only.During the study period, a maximum of two courses of acupuncture therapy, consisting of 7 sessions each, will be administered. Treatment will be given twice per week. After completing the first course of 7 sessions, there will be a break of one week, at the end of which the second course will commence. Treatment will come to a halt as soon as the pain has totally subsided.
thumbtack needle
Thumbtack intra-dermal needle will be applied to selected acupuncture points after filiform needle treatment. The thumbtack needle will remain embedded in the patient's dermal part for 2-3 days as per instruction.During the study period, a maximum of two courses of acupuncture therapy, consisting of 7 sessions each, will be administered. Treatment will be given twice per week. After completing the first course of 7 sessions, there will be a break of one week, at the end of which the second course will commence. Treatment will come to a halt as soon as the pain has totally subsided.
Eligibility Criteria
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Inclusion Criteria
* b. Gender: male or female
* c. Duration: not restricted
* d. Comply with Western medicine diagnostic criteria.
* e. Signed the Patient/Subject Consent Form for this study.
Exclusion Criteria
* b. The disease is outside the range of this study.
* c. Acute disease activity phase.
* d. Skin swelling, skin infection, skin active ulcer disease, or local purpura and scar.
* e. Patients with skin allergies, bleeding disorders
* f. Pregnancy, lactating women.
* g. Application of other therapy, the disease has been or is gradually improving.
* h. Chronic wasting disease.
* i. Severe primary diseases of the liver, kidney, hematopoietic system and -endocrine system,
* j. Mental illness.
* k. With other severe diseases, it is difficult to exact evaluate the efficacy and safety of acupuncture.
* l. Not signed the Patient/Subject Consent Form for this study.
18 Years
ALL
No
Sponsors
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The University of Hong Kong
OTHER
Responsible Party
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Principal Investigators
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Lei Li
Role: PRINCIPAL_INVESTIGATOR
The University of Hong Kong
Locations
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School of Chinese Medicine, The University of Hong Kong
Hong Kong, Hong Kong, China
Countries
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Central Contacts
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Facility Contacts
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Clara Chan
Role: primary
Other Identifiers
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UW13-348
Identifier Type: -
Identifier Source: org_study_id