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Radial Shock Wave and Acupuncture for Myofascial Pain

Primary Purpose

Myofascial Pain

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Radial shock wave
Acupuncture
Sponsored by
Shin Kong Wu Ho-Su Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myofascial Pain focused on measuring Radial shock wave, Acupuncture

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:Physical examination showed

  • unilateral upper back pain,
  • palpable intramuscular taut band,
  • normal neurological examination
  • presence of trigger points

Exclusion Criteria:

  • bilateral neck pain
  • pregnancy
  • coagulopathy
  • patients with pacemaker
  • open wound at treatment area
  • cervical spine fracture or previous operation around neck
  • cervical myelopathy
  • rheumatoid arthritis
  • severe systemic disease

Sites / Locations

  • Shin Kong Wu Ho-Su Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Radial shock wave, Acupuncture

radial shock wave& no treatment

Arm Description

Radial shock wave: 2 Hz with 2000 shock waves, and the energy level of 0.056mJ/mm2 in the trapezius muscle. It will be done once per week for 3 weeks. Acupuncture: performed at Fenfchi (GB20) point over upper back. It will be performed once per week for 3 weeks .

No treatment: patients recieved no intervention.

Outcomes

Primary Outcome Measures

VAS for pain
horizontal lines of 100 mm, with 0 indicating no pain on the left and 100 indicating very severe pain on the right
Pain threshold
A pressure algometer, the pressure threshold meter, was applied onto the affected and unaffected sides of upper trapezius, with the metal rod perpendicular to the surface of the skin. The pressure of compression was increased gradually until the subject began to feel pain or any discomfort. Three repetitive measurements at an interval of 20-60 s were performed. The average values of the three readings were used for data analysis of the pain threshold measurement.

Secondary Outcome Measures

neck disability index
It consists of 10 items referring to various activities (personal care, lifting, driving, work, sleeping, concentrating, reading, recreation) and pain (pain intensity, headache) with six possible answers for each item, only one answer to be chosen by the patient for each item. Scores for each item ranged from 0 (no pain and functional limitation) to 5 (worst pain and maximal limitation), resulting in a total score of 0 (not disabled) to 50 (totally disabled).
cervical active range of motion
neck flexion, extension, rotation and side bending

Full Information

First Posted
December 3, 2013
Last Updated
February 3, 2016
Sponsor
Shin Kong Wu Ho-Su Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02024451
Brief Title
Radial Shock Wave and Acupuncture for Myofascial Pain
Official Title
Comparison of the Effect of Radial Shock Wave and Acupuncture in the Treatment of Myofascial Pain Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shin Kong Wu Ho-Su Memorial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Myofascial pain syndrome is common in Rehabilitation clinic. The pain occurs asymmetrically in isolated or regional muscles, and is associated with acute muscle strain or chronic muscle overuse. Myofascial pain is characteristics with localized muscle tenderness, palpable intramuscular taut band, typical referred pain, and local twitch response. Treatment of myofascial pain syndrome includes physical therapy, stretch exercise, dry needle insertion and trigger point injection. Acupuncture originated from ancient Chinese medicine which involves the insertion of fine needle to stimulate specific points of the body along the 12 meridians. The mechanism of pain relief may be initiated by activation of both spinal segmental and supraspinal centers. Acupuncture is commonly used for pain relief. Recently, radial shock wave has been shown to be effective in the treatment of chronic musculoskeletal pain, including calcific tendinitis, epicondylitis, and plantar fasciitis. The energy and pressure produced by radial shock wave is focused on the treated musculoskeletal tissue. The mechanism of action has been hypothesized that the energy could result in analgesic effect and stimulation of angiogenesis and healing response and then relief of the symptoms. The effectiveness of radial shock wave on treatment of myofascial pain was reported by Jeon and colleagues in 2012. The aim of this study is to compare the efficacy of acupuncture and radial shock wave therapy in patients with myofascial pain syndrome.
Detailed Description
80 participants diagnosed with myofascial pain syndrome in trapezius muscle will be enrolled from the outpatient clinic of Department of Physical Medicine and Rehabilitation in Shin Kong Wu Ho-Su Memorial Hospital . The patients will be randomized to either treatment groups: group 1, radial extracorporeal shock wave therapy (RSWT group) and group 2, acupuncture group (AC group). All treatments will be given in the Department of Physical Medicine and Rehabilitation, and will be handled by a physiatrist who is familiar with both kinds of therapy. The RSWT is delivered at 2 Hz with 2000 shock waves and the energy level of 0.056 mJ / mm2 in the trapezius muscle. Treatment point is the origin attachment of upper trapezius at the external occipital protuberance. RSWT will be performed once per week, and will be continued for 3 weeks. Acupuncture is performed at Fenfchi (GB20) point over upper back. This acupoint is a common local point for treating upper back pain. Acupuncture therapy will be provided by the same physiatrist to all patients. The primary outcome measures are VAS for pain and pain threshold. The secondary outcome measures are neck disability index, and patients' satisfaction. All subjects will be assessed by an independent, blinded investigator at baseline, post treatment and at 1-month after the treatments are completed. Demographic data, including age, sex, employment status, and sleep quality, history of head or neck surgery, or other psychiatric and medical disorders will be recorded at baseline. A history will be taken concerning the duration of complaints (months), previous treatments (injections, physical therapy), and current pain medications. Concomitant diseases and the use of medications will be registered.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain
Keywords
Radial shock wave, Acupuncture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radial shock wave, Acupuncture
Arm Type
Active Comparator
Arm Description
Radial shock wave: 2 Hz with 2000 shock waves, and the energy level of 0.056mJ/mm2 in the trapezius muscle. It will be done once per week for 3 weeks. Acupuncture: performed at Fenfchi (GB20) point over upper back. It will be performed once per week for 3 weeks .
Arm Title
radial shock wave& no treatment
Arm Type
No Intervention
Arm Description
No treatment: patients recieved no intervention.
Intervention Type
Device
Intervention Name(s)
Radial shock wave
Other Intervention Name(s)
Dolorclast
Intervention Description
radial shock wave: Treatment point is the origin attachment of upper trapezius at the external occipital protuberance. Radial shock wave therapy will be performed once per week, and will be continued for 3 weeks. Acetaminophen will be prescribed as rescue medication, and the amount given will be recorded at the end of the study.
Intervention Type
Device
Intervention Name(s)
Acupuncture
Intervention Description
Acupuncture is performed at Fenfchi (GB20) point over upper back by the same physiatrist to all patients.
Primary Outcome Measure Information:
Title
VAS for pain
Description
horizontal lines of 100 mm, with 0 indicating no pain on the left and 100 indicating very severe pain on the right
Time Frame
up to 1 week before treatment, on the day treatment is completed, 1 month after treatment completed
Title
Pain threshold
Description
A pressure algometer, the pressure threshold meter, was applied onto the affected and unaffected sides of upper trapezius, with the metal rod perpendicular to the surface of the skin. The pressure of compression was increased gradually until the subject began to feel pain or any discomfort. Three repetitive measurements at an interval of 20-60 s were performed. The average values of the three readings were used for data analysis of the pain threshold measurement.
Time Frame
up to 1 week before treatment, on the day treatment is completed, 1 month after treatment completed
Secondary Outcome Measure Information:
Title
neck disability index
Description
It consists of 10 items referring to various activities (personal care, lifting, driving, work, sleeping, concentrating, reading, recreation) and pain (pain intensity, headache) with six possible answers for each item, only one answer to be chosen by the patient for each item. Scores for each item ranged from 0 (no pain and functional limitation) to 5 (worst pain and maximal limitation), resulting in a total score of 0 (not disabled) to 50 (totally disabled).
Time Frame
up to 1 week before treatment, on the day treatment is completed, 1 month after treatment completed
Title
cervical active range of motion
Description
neck flexion, extension, rotation and side bending
Time Frame
up to 1 week before treatment, on the day treatment is completed, 1 month after treatment completed

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:Physical examination showed unilateral upper back pain, palpable intramuscular taut band, normal neurological examination presence of trigger points Exclusion Criteria: bilateral neck pain pregnancy coagulopathy patients with pacemaker open wound at treatment area cervical spine fracture or previous operation around neck cervical myelopathy rheumatoid arthritis severe systemic disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen-Ling Chen, MD
Organizational Affiliation
Shin Kong Hospital,No. 95, Wen Chang Road, Shih Lin District, Taipei City, Twiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shin Kong Wu Ho-Su Memorial Hospital
City
Taipei,
State/Province
Taipei city
ZIP/Postal Code
111
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
23185731
Citation
Jeon JH, Jung YJ, Lee JY, Choi JS, Mun JH, Park WY, Seo CH, Jang KU. The effect of extracorporeal shock wave therapy on myofascial pain syndrome. Ann Rehabil Med. 2012 Oct;36(5):665-74. doi: 10.5535/arm.2012.36.5.665. Epub 2012 Oct 31.
Results Reference
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Radial Shock Wave and Acupuncture for Myofascial Pain

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