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Completed

NCT Number: NCT01742546

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

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sirindhorn National Medical Rehabilitation Centre

Muang, Changwat Nonthaburi, 11000, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Therapeutic ultrasound combine TENS

Device

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).

Other names: Therapeutic ultrasound combine simultaneous electrotherapy

Primary outcomes

  1. 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

Secondary outcomes

  1. Evidence of pain relief by visual analogue scale(VAS)

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

    the patient's complaint in pain intensity which represent by mean change between pre and post treatment of visual analog scale

Other outcomes

  1. Evidence of analgesic drug usage

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

Sponsors and collaborators

Lead sponsor

Sirindhorn National Medical Rehabilitation Centre

Other Gov

Registry information

Official study title

Effectiveness of Ultrasound Combine Transcutaneous Electrical Nerve Stimulation (TENS) in Treatment of Upper Trapezius Myofascial Pain: a Randomized Controlled Trial

Acronym: MPS

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 5, 2012
Registry last updated
Feb 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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