Quantitative Analysis of Different Acupuncture Needle Manipulation to Treat Chronic Shoulder Pain

Shoulder Pain Clinical Trial

Official title:

Quantitative Analysis of Different Acupuncture Needle Manipulation to Treat Chronic Shoulder Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03197207
• Other study ID #: 105-0313C
• Status: Completed
• Phase: N/A
• First received: May 11, 2017
• Last updated: June 22, 2017
• Start date: June 3, 2016
• Est. completion date: December 30, 2016

Study information

• Verified date: May 2017
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 30, 2016
• Est. primary completion date: August 25, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Shoulder Pain

Intervention

Procedure:
• "Dragon and Tiger warring" in lifting and thrusting
"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.
• "Dragon and Tiger warring" in twisting-rotating
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Acusensor2, Needle manipulation parameters	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" )	Through study completion, an average of 5 minutes.
Primary	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	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)	Through study completion, an average of 5 minutes.
Secondary	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" )	Through study completion, an average of 5 minutes.
Secondary	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)	Through study completion, an average of 10 minutes.