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CompletedNCT03197207Updated Jun 23, 2017

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

An interventional study of "Dragon and Tiger warring" in lifting and thrusting and "Dragon and Tiger warring" in twisting-rotating in Shoulder Pain, sponsored by Chang Gung Memorial Hospital. Completed. Open to participants aged 20 Years to 55 Years. Per ClinicalTrials.gov, last updated 2017-06-23.

Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Jun 2016, registered May 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
20 Years to 55 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Shoulder Pain

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03

In context

Shoulder Pain

707 studies on the registry are indexed under Shoulder Pain; 152 are open to participants now.

This study's enrollment of 60 is close to the median of 60 across 561 interventional studies indexed under Shoulder Pain.

Browse Shoulder Pain studies →

Lead sponsor

Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 55 Years
Sexes eligible
All
Accepts 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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    lifting and thrusting

    "Dragon and Tiger warring" in lifting and thrusting

    Procedure: "Dragon and Tiger warring" in lifting and thrusting

  • Experimental
    twisting and rotating

    "Dragon and Tiger warring" in twisting-rotating

    Procedure: "Dragon and Tiger warring" in twisting-rotating

Interventions

  • 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.

  • Procedure"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.

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: Through study completion, an average of 5 minutes.

Secondary outcomes

  1. 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)

    Time frame: Through study completion, an average of 5 minutes.

  2. 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" )

    Time frame: Through study completion, an average of 5 minutes.

  3. 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)

    Time frame: Through study completion, an average of 10 minutes.

Other outcomes

  1. 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" )

    Time frame: Through study completion, an average of 5 minutes.

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 24298773 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 23, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03197207
Lead sponsor
Chang Gung Memorial Hospital
Responsible party
Sponsor
First posted
Jun 23, 2017
Start date
Jun 3, 2016
Primary completion
Aug 25, 2016
Completion
Dec 30, 2016
Last update
Jun 23, 2017

Study contacts

Horng-Sheng Shiue, Dr.
principal investigator · Chang Gung Memorial Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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