Myofascial PainNCT02024451
Radial Shock Wave and Acupuncture for Myofascial Pain
A study testing Radial shock wave and Acupuncture in people with Myofascial Pain, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Myofascial Pain
- What is being tested?
- Radial shock wave and Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- unilateral upper back pain,
- palpable intramuscular taut band,
- normal neurological examination
- presence of trigger points
Who cannot join
- bilateral neck pain
- pregnancy
- coagulopathy
- patients with pacemaker
- open wound at treatment area
- cervical spine fracture or previous operation around neck
Show all 9Show fewer
- cervical myelopathy
- rheumatoid arthritis
- severe systemic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effect of Radial Shock Wave and Acupuncture in the Treatment of Myofascial Pain Syndrome
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.
Read more
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.
Read the 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.
- Conditions
- Myofascial Pain
- Being tested
- Radial shock wave, Acupuncture
- Keywords
- Radial shock wave, Acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radial shock waveDevice
Also called Dolorclast
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.
AcupunctureDevice
Acupuncture is performed at Fenfchi (GB20) point over upper back by the same physiatrist to all patients.
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: Device: Radial shock wave; Device: Acupuncture |
| radial shock wave& no treatment | No intervention | No treatment: patients recieved no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: up to 1 week before treatment, on the day treatment is completed, 1 month after treatment completed
Secondary outcomes (2)
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).
Measured: up to 1 week before treatment, on the day treatment is completed, 1 month after treatment completed
cervical active range of motion
neck flexion, extension, rotation and side bending
Measured: up to 1 week before treatment, on the day treatment is completed, 1 month after treatment completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionDec 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myofascial PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wen-Ling Chen, MD, Principal investigator, Shin Kong Hospital,No. 95, Wen Chang Road, Shih Lin District, Taipei City, Twiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02024451
- Sponsor's protocol ID
- 20130712R
- Status last verified
- Feb 2016
- First submitted
- 3 Dec 2013
- Last updated
- 4 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23185731
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Radial Shock Wave and Acupuncture in the Treatment of Myofascial Pain Syndrome
- ClinicalTrials.gov ID
- NCT02024451
- Acronym / sponsor ID
- 20130712R
- Conditions
- Myofascial Pain
- Keywords
- Radial shock wave, Acupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 31 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radial shock wave, Acupuncture | Active comparator | Device: Radial shock wave, Device: AcupunctureRadial 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 . |
| radial shock wave& no treatment | No intervention | –No treatment: patients recieved no intervention. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- unilateral upper back pain,
- palpable intramuscular taut band,
- normal neurological examination
- presence of trigger points
Key exclusion criteria (9 listed)
- bilateral neck pain
- pregnancy
- coagulopathy
- patients with pacemaker
- open wound at treatment area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radial shock waveAlso: Dolorclastradial 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. | Device | Radial shock wave, Acupuncture |
| AcupunctureAcupuncture is performed at Fenfchi (GB20) point over upper back by the same physiatrist to all patients. | Device | Radial shock wave, Acupuncture |
Primary outcome
VAS for pain
Time frame: up to 1 week before treatment, on the day treatment is completed, 1 month after treatment completed
horizontal lines of 100 mm, with 0 indicating no pain on the left and 100 indicating very severe pain on the right
Pain threshold
Time frame: up to 1 week before treatment, on the day treatment is completed, 1 month after treatment completed
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.
2 secondary outcomes
neck disability index
Time frame: up to 1 week before treatment, on the day treatment is completed, 1 month after treatment completed
cervical active range of motion
Time frame: up to 1 week before treatment, on the day treatment is completed, 1 month after treatment completed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2016.
- Results publication: PubMed 23185731Jeon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wen-Ling Chen, MD principal investigator
Shin Kong Hospital,No. 95, Wen Chang Road, Shih Lin District, Taipei City, Twiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radial shock wave and Acupuncture in people with Myofascial Pain, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS for pain (time frame: up to 1 week before treatment, on the day treatment is completed, 1 month after treatment completed). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02024451, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2016.