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CompletedNCT01742546MPSUpdated Feb 25, 2013

Effectiveness of Ultrasound Combine TENS in Treatment of Upper Trapezius Myofascial Pain

An interventional study of Therapeutic ultrasound combine TENS in Myofascial Pain Syndromes, sponsored by Sirindhorn National Medical Rehabilitation Centre. Completed at 1 site in Thailand. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2013-02-25.

Sponsored by Sirindhorn National Medical Rehabilitation Centre · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Myofascial Pain Syndromes

Keywords

  • myofascial pain syndrome
  • therapeutic ultrasound
  • combine therapy
03

In context

Myofascial Pain Syndromes

1,136 studies on the registry are indexed under Myofascial Pain Syndromes; 137 are open to participants now.

This study's enrollment of 40 is below the median of 60 across 931 interventional studies indexed under Myofascial Pain Syndromes.

Browse Myofascial Pain Syndromes studies →

Lead sponsor

This is the only study on the registry with Sirindhorn National Medical Rehabilitation Centre as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Therapeutic ultrasound combine TENS

    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.

    Device: Therapeutic ultrasound combine TENS

  • Sham comparator
    Therapeutic ultrasound with sham TENS

    Use the same therapeutic ultrasound machine and place the electrode as experimental group but turn-off electrical current during treatment period

    Device: Therapeutic ultrasound combine TENS

Interventions

  • DeviceTherapeutic ultrasound combine TENS

    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).

    Also known as: Therapeutic ultrasound combine simultaneous electrotherapy

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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

    Time frame: within two weeks or 10 times treatment- course

Other outcomes

  1. Evidence of analgesic drug usage

    Time frame: within two weeks or 10 times treatment-course

07

Study locations

1 site
  • Sirindhorn National Medical Rehabilitation Centre
    Muang, Nonthaburi 11000, Thailand
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01742546
Lead sponsor
Sirindhorn National Medical Rehabilitation Centre
Responsible party
Bootsakorn Loharjun, MD (Dr.Bootsakorn Loharjun, MD, Sirindhorn National Medical Rehabilitation Centre) — Principal investigator
First posted
Dec 5, 2012
Start date
Jun 2012
Primary completion
Jan 2013
Completion
Jan 2013
Last update
Feb 25, 2013

Study contacts

Bootsakorn Loharjun, Medical Doctor
principal investigator · Sirindhorn National Medical Rehabilitation Centre

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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