Quantitative Analysis of Different Acupuncture Needle Manipulation to Treat Chronic Shoulder Pain
Primary Purpose
Shoulder Pain
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
"Dragon and Tiger warring" in lifting and thrusting
"Dragon and Tiger warring" in twisting-rotating
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Pain
Eligibility Criteria
Inclusion Criteria:
- (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.
Exclusion Criteria:
- (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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
lifting and thrusting
twisting and rotating
Arm Description
"Dragon and Tiger warring" in lifting and thrusting
"Dragon and Tiger warring" in twisting-rotating
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Change in Pain pressure algometer (PA) during needle manipulation
The higher the score, the greater the strength that can be tolerated. PA 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)
Change in Massachusetts General Hospital Acupuncture Sensation Scale (MASS) during needle manipulation
objectively measure sensation associated with 'de qi' sensation. MASS in T1(after GB34 "de-qi" ), T2(after GB34 "Dragon and Tiger warring" ), T3(after GB39 "de-qi" ), T4(after GB39 "Dragon and Tiger warring" )
Change in Shoulder Pain & Disability Index (SPADI)
13 items that assess two domains, 5-item subscale that measures pain, 8-item subscale that measures disability. T0(before needle manipulation), T5(after Retaining Needle 20 minutes), T6(Telephone access, 24 hours later)
Full Information
NCT ID
NCT03197207
First Posted
May 11, 2017
Last Updated
June 22, 2017
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03197207
Brief Title
Quantitative Analysis of Different Acupuncture Needle Manipulation to Treat Chronic Shoulder Pain
Official Title
Quantitative Analysis of Different Acupuncture Needle Manipulation to Treat Chronic Shoulder Pain
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
June 3, 2016 (Actual)
Primary Completion Date
August 25, 2016 (Actual)
Study Completion Date
December 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Numerical rating scale (NRS) and pain pressure algometer were used to objective and quantitative assessment of the patient's pain. And shoulder pain and disability index-SPADI was used to objectively assess the functional changes of acupuncture treatment in patients with chronic shoulder pain. Massachusetts General Hospital Acupuncture Sensation Scale - MASS was used to get objectively record of de-qi when needle manipulation for the the body (acupoints) reactions. Acusensor2 was used to get objective observation reaction during needling manipulation, the sensor provided measurement parameters such as the lift and thrust, twisting, strength and torque during needle manipulation. Investigators will study and analysis associated clinical outcome with needling process, the needle manipulation by lifting-thrusting or twisting-rotating during the process of reinforce method or reducing method to study its dynamics and kinematics.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
lifting and thrusting
Arm Type
Experimental
Arm Description
"Dragon and Tiger warring" in lifting and thrusting
Arm Title
twisting and rotating
Arm Type
Experimental
Arm Description
"Dragon and Tiger warring" in twisting-rotating
Intervention Type
Procedure
Intervention Name(s)
"Dragon and Tiger warring" in lifting and thrusting
Intervention Description
"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.
Intervention Type
Procedure
Intervention Name(s)
"Dragon and Tiger warring" in twisting-rotating
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Numerical rating scale (NRS) during needle manipulation
Description
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)
Time Frame
Through study completion, an average of 5 minutes.
Secondary Outcome Measure Information:
Title
Change in Pain pressure algometer (PA) during needle manipulation
Description
The higher the score, the greater the strength that can be tolerated. PA 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)
Time Frame
Through study completion, an average of 5 minutes.
Title
Change in Massachusetts General Hospital Acupuncture Sensation Scale (MASS) during needle manipulation
Description
objectively measure sensation associated with 'de qi' sensation. MASS in T1(after GB34 "de-qi" ), T2(after GB34 "Dragon and Tiger warring" ), T3(after GB39 "de-qi" ), T4(after GB39 "Dragon and Tiger warring" )
Time Frame
Through study completion, an average of 5 minutes.
Title
Change in Shoulder Pain & Disability Index (SPADI)
Description
13 items that assess two domains, 5-item subscale that measures pain, 8-item subscale that measures disability. T0(before needle manipulation), T5(after Retaining Needle 20 minutes), T6(Telephone access, 24 hours later)
Time Frame
Through study completion, an average of 10 minutes.
Other Pre-specified Outcome Measures:
Title
Change in Acusensor2, Needle manipulation parameters
Description
Measurement of lift and thrust, twisting, strength and torque during needle manipulation. The real-time motion and force tracings records created during needle manipulation will be combined to report needling motion and force profiles pictures. Displacement (mm), Rotation (rev), Force (mN), Torque (microNm). Ta(during GB34 "Dragon and Tiger warring" ), Tb(during GB39 "Dragon and Tiger warring" )
Time Frame
Through study completion, an average of 5 minutes.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
(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.
Exclusion Criteria:
(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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Horng-Sheng Shiue, Dr.
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24298773
Citation
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.
Results Reference
background
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Quantitative Analysis of Different Acupuncture Needle Manipulation to Treat Chronic Shoulder Pain
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