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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Shoulder Pain

Intervention / Treatment
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* Procedure: Dragon and Tiger warring in lifting and thrusting
* Procedure: Dragon and Tiger warring in twisting-rotating


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lifting and thrusting<br>Dragon and Tiger warring in lifting and thrusting | Procedure: Dragon and Tiger warring in lifting and thrusting<br>* 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.<br>|
| Experimental: twisting and rotating<br>Dragon and Tiger warring in twisting-rotating | Procedure: Dragon and Tiger warring in twisting-rotating<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. |