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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03197207
Enrollment
60
Registered
2017-06-23
Start date
2016-06-03
Completion date
2016-12-30
Last updated
2017-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Pain

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.

Interventions

PROCEDUREDragon 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.

PROCEDUREDragon 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.

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to 55 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Numerical rating scale (NRS) during needle manipulationThrough study completion, an average of 5 minutes.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

MeasureTime frameDescription
Change in Pain pressure algometer (PA) during needle manipulationThrough study completion, an average of 5 minutes.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 manipulationThrough study completion, an average of 5 minutes.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)Through study completion, an average of 10 minutes.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)

Other

MeasureTime frameDescription
Change in Acusensor2, Needle manipulation parametersThrough study completion, an average of 5 minutes.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 )

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026