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Completed

NCT Number: NCT03197207

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

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.

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Key information

Conditions

Shoulder Pain Arthralgia Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

"Dragon and Tiger warring" in lifting and thrusting

Procedure

"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

Procedure

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 outcomes

  1. Change in Numerical rating scale (NRS) during needle manipulation

    Time frame: Through 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 outcomes

  1. Change in Pain pressure algometer (PA) during needle manipulation

    Time frame: Through 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)

  2. Change in Massachusetts General Hospital Acupuncture Sensation Scale (MASS) during needle manipulation

    Time frame: Through 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" )

  3. Change in Shoulder Pain & Disability Index (SPADI)

    Time frame: 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 outcomes

  1. Change in Acusensor2, Needle manipulation parameters

    Time frame: Through 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" )

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 23, 2017
Registry last updated
Jun 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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