Quantitative Analysis of Different Acupuncture Needle Manipulation to Treat Chronic Shoulder Pain
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
The plan " Quantitative analysis of different acupuncture needle manipulation to treat chronic shoulder pain "includes an objective observation of acupuncture operation (movement in the form of acupuncture needles, intensity, etc.) and the body (acupoints) reactions. Patients during 20-55 years old suffered shoulder pain more than six weeks with numerical rating scale (NRS) pain intensity more than 5 points, and the previous month were not taking medicine or Western medicine were included. Then use of distal acupoints GB34 and GB39, giving once acupuncture manipulation therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2016
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 3, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 25, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2016
CompletedFirst Submitted
Initial submission to the registry
May 11, 2017
CompletedFirst Posted
Study publicly available on registry
June 23, 2017
CompletedJune 23, 2017
May 1, 2017
3 months
May 11, 2017
June 22, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Numerical rating scale (NRS) during needle manipulation
Pain scale, smaller score, less pain. NRS in T0(before needle manipulation), T1(after GB34 "de-qi" ), T2(after GB34 "Dragon and Tiger warring" ), T3(after GB39 "de-qi" ), T4(after GB39 "Dragon and Tiger warring" ), T5(after Retaining Needle 20 minutes), T6(Telephone access, 24 hours later)
Through study completion, an average of 5 minutes.
Secondary Outcomes (3)
Change in Pain pressure algometer (PA) during needle manipulation
Through study completion, an average of 5 minutes.
Change in Massachusetts General Hospital Acupuncture Sensation Scale (MASS) during needle manipulation
Through study completion, an average of 5 minutes.
Change in Shoulder Pain & Disability Index (SPADI)
Through study completion, an average of 10 minutes.
Other Outcomes (1)
Change in Acusensor2, Needle manipulation parameters
Through study completion, an average of 5 minutes.
Study Arms (2)
lifting and thrusting
EXPERIMENTAL"Dragon and Tiger warring" in lifting and thrusting
twisting and rotating
EXPERIMENTAL"Dragon and Tiger warring" in twisting-rotating
Interventions
"Tight press" slow insert in each acupoint through the superficial,intermediate, deep layer, then "tight lifting" slow withdraw needle through the deep, intermediate, superficial layer . Two acupoints (GB34, GB39) are manipulation in the process three times each during one minute, then let patients lift shoulder up and down for three times, then draw out the needle 20 minutes later.
When needle insert in each acupoint through the superficial,intermediate, deep layer, within each layer twisting thumb forward nine times, then twisting backward six times. Two acupoints (GB34, GB39) are manipulation in the process during one minute, then let patients lift shoulder up and down for three times, then draw out the needle 20 minutes later.
Eligibility Criteria
You may qualify if:
- (A) have agreed to participate in the trial and signed by the Chang Geng Memorial Hospital Human Body Test Committee approved the human test consent.
- (B) suffering from chronic shoulder pain (including frozen shoulder, or rotator cuff injury, or subclavian bursitis, Or biceps tendonitis or nonspecific shoulder pain).
- (C) at least six weeks before the screening period of shoulder pain, digital grading scale measurement of pain intensity of 5 points or more.
You may not qualify if:
- (A) shoulder fracture
- (B) intra-articular infection
- (C) stroke hemiplegia
- (D) spinal cord injury
- (E) postoperative shoulder surgery
- (F) pregnant woman,
- (G) took traditional Chinese medicine or Western medicine, less than one month before the screening period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Xue HS, Zhang J. [Manipulation and comprehensive application of reinforcing-reducing methods according to numbers and directions of rotation]. Zhongguo Zhen Jiu. 2013 Sep;33(9):809-13. Chinese.
PMID: 24298773BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Horng-Sheng Shiue, Dr.
Chang Gung Memorial Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2017
First Posted
June 23, 2017
Study Start
June 3, 2016
Primary Completion
August 25, 2016
Study Completion
December 30, 2016
Last Updated
June 23, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share