Radial Shock Wave and Acupuncture for Myofascial Pain

NCT ID: NCT02024451

Last Updated: 2016-02-04

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

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Myofascial Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Radial shock wave, Acupuncture

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 .

Group Type ACTIVE_COMPARATOR

Radial shock wave

Intervention Type DEVICE

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.

Acupuncture

Intervention Type DEVICE

Acupuncture is performed at Fenfchi (GB20) point over upper back by the same physiatrist to all patients.

radial shock wave& no treatment

No treatment: patients recieved no intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Radial shock wave

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

Acupuncture

Acupuncture is performed at Fenfchi (GB20) point over upper back by the same physiatrist to all patients.

Intervention Type DEVICE

Other Intervention Names

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Dolorclast

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shin Kong Wu Ho-Su Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wen-Ling Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Shin Kong Hospital,No. 95, Wen Chang Road, Shih Lin District, Taipei City, Twiwan

Locations

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Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taipei city, Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type RESULT
PMID: 23185731 (View on PubMed)

Other Identifiers

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20130712R

Identifier Type: -

Identifier Source: org_study_id

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