Myofascial Pain SyndromesMPSNCT01742546
Effectiveness of Ultrasound Combine TENS in Treatment of Upper Trapezius Myofascial Pain
A study testing Therapeutic ultrasound combine TENS in people with Myofascial Pain Syndromes, run by Sirindhorn National Medical Rehabilitation Centre at 1 site in Thailand.
Trial summary
To assess the effectiveness of therapeutic ultrasound combine transcutaneous electrical nerve stimulation (TENS) and therapeutic ultrasound in treatment of myofascial pain syndrome in upper trapezius muscle measured by mean change between pre and post treatment of pressure pain threshold (PPT), patient's complaint in… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Myofascial Pain Syndromes
- What is being tested?
- Therapeutic ultrasound combine TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- Jun 2012to Jan 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 20 years old
- Clinical diagnosis of myofascial trigger point pain at upper trapezius muscle(s) persisted more than 1 week but less than 6 months before recruitment time, first or recurrence episodes
- Baseline VAS more than or equal 4 at upper trapezius muscle
Who cannot join
- During the past 2 weeks had received injection or physical therapy at upper trapezius muscle or shoulder area
- Had experience of ultrasound combine transcutaneous electrical nerve stimulation (TENS)
- Had history of accidence or severe trauma to shoulder region
- Had serious musculoskeletal condition that need surgical intervention such as acute shoulder subluxation, abnormal neurological examination
- Insensate skin or sensory impairment around shoulder area
- Skin infection at shoulder area
Show all 9Show fewer
- Had contraindication for U/S such as cardiac pacemaker, implantation, malignancy in relevant area, bleeding disorder, acute inflammatory musculoskeletal disease, pregnancy, lactation
- Unable to communication
- Unable to complete treatment session and follow protocol
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Sirindhorn National Medical Rehabilitation Centre
Muang, Changwat Nonthaburi, 11000
About this study
Official title: Effectiveness of Ultrasound Combine Transcutaneous Electrical Nerve Stimulation (TENS) in Treatment of Upper Trapezius Myofascial Pain: a Randomized Controlled Trial
To assess the effectiveness of therapeutic ultrasound combine transcutaneous electrical nerve stimulation (TENS) and therapeutic ultrasound in treatment of myofascial pain syndrome in upper trapezius muscle measured by mean change between pre and post treatment of pressure pain threshold (PPT), patient's complaint in pain intensity and the number of total tablet usage of acetaminophen in both groups.
Read the detailed description
Myofascial pain syndrome (MPS) is one of the most common causes of musculoskeletal pain and can affect any skeletal muscles in the body.Myofascial pain is not fatal condition but it can significant reduced quality of life and is a major cause of time lost from work. There are various treatments, which divided into invasive and non-invasive therapies. In the recent clinical practice, there is a new type of combine treatment unit which composes of electrotherapy and ultrasound therapy in one unit. However, there is no conclusive evidence for supports the effectiveness of this combine therapy compare with the conventional ultrasound in treatment of myofascial pain especially in aspect of pain relief.
- Conditions
- Myofascial Pain Syndromes
- Being tested
- Therapeutic ultrasound combine TENS
- Keywords
- myofascial pain syndrome, therapeutic ultrasound, combine therapy
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic ultrasound combine TENSDevice
Also called Therapeutic ultrasound combine simultaneous electrotherapy
Use ultrasound treatment parameters as continuous mode, 1 MHz in frequency and 1 w/cm2 for intensity and circular stroking of sound head over affected upper trapezius muscle throughout treatment period. For simultaneous TENS parameters as pulse frequency 100-150 pps, pulse duration 50- 80 µs and adjust amplitude as produce tingling for 10 minutes. The skin electrode should be placed near the active trigger in area of trapezius muscle. And the control group received sham TENS by turn-off electrical current.
The therapeutic ultrasound machine in this study was Sonopuls 492 TM (Enraf-Nonius).
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic ultrasound combine TENS | Experimental | Use therapeutic ultrasound with simultaneous TENS for 10 minutes/session for 10 sessions/course.
The therapeutic ultrasound machine in this study was Sonopuls 492 TM (Enraf-Nonius), this device has treatment head described by the manufacturers as having surface area as 5.8 cm2, ERA (Effective Radiating Area) of 5.0 cm2 and BNR (Beam Non-uniform Ratio) as max. 5.0. For electrotherapy unit which composes of 2 channels, output characteristics are constant current (CC) or constant voltage (CV), resolution of output signal is in steps of 0.2 mA and timer is limited to 30 minutes during ultrasound and combination therapy are operated. Receives: Device: Therapeutic ultrasound combine TENS |
| Therapeutic ultrasound with sham TENS | Sham comparator | Use the same therapeutic ultrasound machine and place the electrode as experimental group but turn-off electrical current during treatment period Receives: Device: Therapeutic ultrasound combine TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of pain relief by measured mean change between pre and post treatment of pressure pain threshold (PPT)
pressure pain threshold (PPT) was measured with calibrated mechanical pressure algometer
Measured: within two weeks or 10 times treatment-course
Secondary outcomes (1)
Evidence of pain relief by visual analogue scale(VAS)
the patient's complaint in pain intensity which represent by mean change between pre and post treatment of visual analog scale
Measured: within two weeks or 10 times treatment- course
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2012 (estimated)
- Study startJun 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Pain SyndromesStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sirindhorn National Medical Rehabilitation Centre
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Bootsakorn Loharjun, MD, Sirindhorn National Medical Rehabilitation Centre
- Investigators
- Bootsakorn Loharjun, Medical Doctor, Principal investigator, Sirindhorn National Medical Rehabilitation Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01742546
- Sponsor's protocol ID
- SNMRC001
- Acronym
- MPS
- Status last verified
- Feb 2013
- First submitted
- 8 Nov 2012
- Last updated
- 25 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Ultrasound Combine Transcutaneous Electrical Nerve Stimulation (TENS) in Treatment of Upper Trapezius Myofascial Pain: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01742546
- Acronym / sponsor ID
- MPS / SNMRC001
- Conditions
- Myofascial Pain Syndromes
- Keywords
- myofascial pain syndrome, therapeutic ultrasound, combine therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sirindhorn National Medical Rehabilitation CentreOther government
- Study start
- Jun 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 5 Dec 2012 (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.
To assess the effectiveness of therapeutic ultrasound combine transcutaneous electrical nerve stimulation (TENS) and therapeutic ultrasound in treatment of myofascial pain syndrome in upper trapezius muscle measured by mean change between pre and post treatment of pressure pain threshold (PPT), patient's complaint in pain intensity and the number of total tablet usage of acetaminophen in both groups.
Detailed description
Myofascial pain syndrome (MPS) is one of the most common causes of musculoskeletal pain and can affect any skeletal muscles in the body.Myofascial pain is not fatal condition but it can significant reduced quality of life and is a major cause of time lost from work. There are various treatments, which divided into invasive and non-invasive therapies. In the recent clinical practice, there is a new type of combine treatment unit which composes of electrotherapy and ultrasound therapy in one unit. However, there is no conclusive evidence for supports the effectiveness of this combine therapy compare with the conventional ultrasound in treatment of myofascial pain especially in aspect of pain relief.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic ultrasound combine TENS | Experimental | Device: Therapeutic ultrasound combine TENSUse therapeutic ultrasound with simultaneous TENS for 10 minutes/session for 10 sessions/course. The therapeutic ultrasound machine in this study was Sonopuls 492 TM (Enraf-Nonius), this device has treatment head described by the manufacturers as having surface area as 5.8 cm2, ERA (Effective Radiating Area) of 5.0 cm2 and BNR (Beam Non-uniform Ratio) as max. 5.0. For electrotherapy unit which composes of 2 channels, output characteristics are constant current (CC) or constant voltage (CV), resolution of output signal is in steps of 0.2 mA and timer is limited to 30 minutes during ultrasound and combination therapy are operated. |
| Therapeutic ultrasound with sham TENS | Sham comparator | Device: Therapeutic ultrasound combine TENSUse the same therapeutic ultrasound machine and place the electrode as experimental group but turn-off electrical current during treatment period |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 20 years old
- Clinical diagnosis of myofascial trigger point pain at upper trapezius muscle(s) persisted more than 1 week but less than 6 months before recruitment time, first or recurrence episodes
- Baseline VAS more than or equal 4 at upper trapezius muscle
Key exclusion criteria (9 listed)
- During the past 2 weeks had received injection or physical therapy at upper trapezius muscle or shoulder area
- Had experience of ultrasound combine transcutaneous electrical nerve stimulation (TENS)
- Had history of accidence or severe trauma to shoulder region
- Had serious musculoskeletal condition that need surgical intervention such as acute shoulder subluxation, abnormal neurological examination
- Insensate skin or sensory impairment around shoulder 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 |
|---|---|---|
| Therapeutic ultrasound combine TENSAlso: Therapeutic ultrasound combine simultaneous electrotherapyUse ultrasound treatment parameters as continuous mode, 1 MHz in frequency and 1 w/cm2 for intensity and circular stroking of sound head over affected upper trapezius muscle throughout treatment period. For simultaneous TENS parameters as pulse frequency 100-150 pps, pulse duration 50- 80 µs and adjust amplitude as produce tingling for 10 minutes. The skin electrode should be placed near the active trigger in area of trapezius muscle. And the control group received sham TENS by turn-off electrical current. The therapeutic ultrasound machine in this study was Sonopuls 492 TM (Enraf-Nonius). | Device | Therapeutic ultrasound combine TENS, Therapeutic ultrasound with sham TENS |
Primary outcome
Evidence of pain relief by measured mean change between pre and post treatment of pressure pain threshold (PPT)
Time frame: within two weeks or 10 times treatment-course
pressure pain threshold (PPT) was measured with calibrated mechanical pressure algometer
1 secondary outcome
Evidence of pain relief by visual analogue scale(VAS)
Time frame: within two weeks or 10 times treatment- course
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 25 Feb 2013.
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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.
Bootsakorn Loharjun, Medical Doctor principal investigator
Sirindhorn National Medical Rehabilitation Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic ultrasound combine TENS in people with Myofascial Pain Syndromes, run by Sirindhorn National Medical Rehabilitation Centre at 1 site in Thailand.
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 3 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 25 Feb 2013. 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 Thailand. 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. Some participants in this study may receive a placebo. 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?
Evidence of pain relief by measured mean change between pre and post treatment of pressure pain threshold (PPT) (time frame: within two weeks or 10 times treatment-course). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2013.