Clinical trial NCT03197207: 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
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Pain
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2017-06-23
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Numerical rating scale (NRS) during needle manipulation
timeFrame: Through study completion, an average of 5 minutes.
Secondary outcomes:
measure: Change in Pain pressure algometer (PA) during needle manipulation
timeFrame: Through study completion, an average of 5 minutes.
measure: Change in Massachusetts General Hospital Acupuncture Sensation Scale (MASS) during needle manipulation
timeFrame: Through study completion, an average of 5 minutes.
measure: Change in Shoulder Pain & Disability Index (SPADI)
timeFrame: Through study completion, an average of 10 minutes.
Other outcomes:
measure: Change in Acusensor2, Needle manipulation parameters
timeFrame: Through study completion, an average of 5 minutes.
Locations:
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Horng-Sheng Shiue, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.