Clinical trial NCT02024451: 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
Overall status: COMPLETED
Phase: NA
Conditions: Myofascial Pain
Keywords: Radial shock wave
Acupuncture
Lead sponsor: Shin Kong Wu Ho-Su Memorial Hospital
Sponsor class: OTHER
First posted: 2013-12-31
Enrollment: 68
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: VAS for pain
timeFrame: up to 1 week before treatment, on the day treatment is completed, 1 month after treatment completed
measure: Pain threshold
timeFrame: up to 1 week before treatment, on the day treatment is completed, 1 month after treatment completed
Secondary outcomes:
measure: neck disability index
timeFrame: up to 1 week before treatment, on the day treatment is completed, 1 month after treatment completed
measure: cervical active range of motion
timeFrame: up to 1 week before treatment, on the day treatment is completed, 1 month after treatment completed
Other outcomes:
Locations:
city: Taipei,
country: Taiwan
facility: Shin Kong Wu Ho-Su Memorial Hospital
state: Taipei city
Study officials:
affiliation: Shin Kong Hospital,No. 95, Wen Chang Road, Shih Lin District, Taipei City, Twiwan
name: Wen-Ling Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.