Radial Shock Wave and Acupuncture for Myofascial Pain

NCT02024451 | Completed DMC

• 1 other identifier: 20130712R
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Myofascial Pain

Keywords

Radial shock wave; Acupuncture

Outcome Measures

Primary Outcomes (2)

• 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

  up to 1 week before treatment, on the day treatment is completed, 1 month after treatment completed

• 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.

  up to 1 week before treatment, on the day treatment is completed, 1 month after treatment completed

Secondary Outcomes (2)

• neck disability index

  up to 1 week before treatment, on the day treatment is completed, 1 month after treatment completed

• cervical active range of motion

  up to 1 week before treatment, on the day treatment is completed, 1 month after treatment completed

Study Arms (2)

Radial shock wave, Acupuncture

ACTIVE COMPARATOR

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 .

Device: Radial shock wave; Device: Acupuncture

radial shock wave& no treatment

NO INTERVENTION

No treatment: patients recieved no intervention.

Interventions

Radial shock wave 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.

Also known as: Dolorclast

Radial shock wave, Acupuncture

Acupuncture DEVICE

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

Radial shock wave, Acupuncture

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shin Kong Wu Ho-Su Memorial Hospital: lead

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taipei city, 111, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 23185731 RESULT

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Wen-Ling Chen, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2013
• First Posted: December 31, 2013
• Study Start: January 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: February 4, 2016

Record last verified: 2016-02

Locations

TW (1)