Effectiveness of Ultrasound Combine TENS in Treatment of Upper Trapezius Myofascial Pain (MPS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bootsakorn Loharjun, MD, Sirindhorn National Medical Rehabilitation Centre
ClinicalTrials.gov Identifier:
NCT01742546
First received: November 8, 2012
Last updated: February 21, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Myofascial Pain Syndromes
Device: Therapeutic ultrasound combine TENS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Ultrasound Combine Transcutaneous Electrical Nerve Stimulation (TENS) in Treatment of Upper Trapezius Myofascial Pain: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Sirindhorn National Medical Rehabilitation Centre:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    pressure pain threshold (PPT) was measured with calibrated mechanical pressure algometer


Secondary Outcome Measures:
  • Evidence of pain relief by visual analogue scale(VAS) [ Time Frame: within two weeks or 10 times treatment- course ] [ Designated as safety issue: Yes ]
    the patient's complaint in pain intensity which represent by mean change between pre and post treatment of visual analog scale


Other Outcome Measures:
  • Evidence of analgesic drug usage [ Time Frame: within two weeks or 10 times treatment-course ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: June 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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 Name: Therapeutic ultrasound combine simultaneous electrotherapy
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

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 Name: Therapeutic ultrasound combine simultaneous electrotherapy

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01742546

Locations
Thailand
Sirindhorn National Medical Rehabilitation Centre
Muang, Nonthaburi, Thailand, 11000
Sponsors and Collaborators
Sirindhorn National Medical Rehabilitation Centre
Investigators
Principal Investigator: Bootsakorn Loharjun, Medical Doctor Sirindhorn National Medical Rehabilitation Centre
  More Information

No publications provided

Responsible Party: Bootsakorn Loharjun, MD, Dr.Bootsakorn Loharjun, MD, Sirindhorn National Medical Rehabilitation Centre
ClinicalTrials.gov Identifier: NCT01742546     History of Changes
Other Study ID Numbers: SNMRC001
Study First Received: November 8, 2012
Last Updated: February 21, 2013
Health Authority: Thailand: Ministry of Public Health

Keywords provided by Sirindhorn National Medical Rehabilitation Centre:
myofascial pain syndrome
therapeutic ultrasound
combine therapy

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Fibromyalgia
Somatoform Disorders
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on April 16, 2014