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

NCT ID: NCT03197207

Last Updated: 2017-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-03

Study Completion Date

2016-12-30

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.

Conditions

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Shoulder Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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lifting and thrusting

"Dragon and Tiger warring" in lifting and thrusting

Group Type EXPERIMENTAL

"Dragon and Tiger warring" in lifting and thrusting

Intervention Type 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.

twisting and rotating

"Dragon and Tiger warring" in twisting-rotating

Group Type EXPERIMENTAL

"Dragon and Tiger warring" in twisting-rotating

Intervention Type 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.

Interventions

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"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.

Intervention Type 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.

Intervention Type PROCEDURE

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Horng-Sheng Shiue, Dr.

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

References

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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.

Reference Type BACKGROUND
PMID: 24298773 (View on PubMed)

Other Identifiers

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105-0313C

Identifier Type: -

Identifier Source: org_study_id

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