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

Primary Purpose

Shoulder Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
"Dragon and Tiger warring" in lifting and thrusting
"Dragon and Tiger warring" in twisting-rotating
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    lifting and thrusting

    twisting and rotating

    Arm Description

    "Dragon and Tiger warring" in lifting and thrusting

    "Dragon and Tiger warring" in twisting-rotating

    Outcomes

    Primary Outcome Measures

    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)

    Secondary Outcome Measures

    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)
    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" )
    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)

    Full Information

    First Posted
    May 11, 2017
    Last Updated
    June 22, 2017
    Sponsor
    Chang Gung Memorial Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03197207
    Brief Title
    Quantitative Analysis of Different Acupuncture Needle Manipulation to Treat Chronic Shoulder Pain
    Official Title
    Quantitative Analysis of Different Acupuncture Needle Manipulation to Treat Chronic Shoulder Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 3, 2016 (Actual)
    Primary Completion Date
    August 25, 2016 (Actual)
    Study Completion Date
    December 30, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Chang Gung Memorial Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Shoulder Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    lifting and thrusting
    Arm Type
    Experimental
    Arm Description
    "Dragon and Tiger warring" in lifting and thrusting
    Arm Title
    twisting and rotating
    Arm Type
    Experimental
    Arm Description
    "Dragon and Tiger warring" in twisting-rotating
    Intervention Type
    Procedure
    Intervention Name(s)
    "Dragon and Tiger warring" in lifting and thrusting
    Intervention Description
    "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
    Intervention Name(s)
    "Dragon and Tiger warring" in twisting-rotating
    Intervention Description
    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 Outcome Measure Information:
    Title
    Change in Numerical rating scale (NRS) during needle manipulation
    Description
    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 Outcome Measure Information:
    Title
    Change in Pain pressure algometer (PA) during needle manipulation
    Description
    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.
    Title
    Change in Massachusetts General Hospital Acupuncture Sensation Scale (MASS) during needle manipulation
    Description
    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.
    Title
    Change in Shoulder Pain & Disability Index (SPADI)
    Description
    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 Pre-specified Outcome Measures:
    Title
    Change in Acusensor2, Needle manipulation parameters
    Description
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Horng-Sheng Shiue, Dr.
    Organizational Affiliation
    Chang Gung Memorial Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    24298773
    Citation
    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.
    Results Reference
    background

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

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