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

NCT01742546 | Completed DMC

• 1 other identifier: SNMRC001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myofascial Pain Syndromes

Keywords

myofascial pain syndrome; therapeutic ultrasound; combine therapy

Outcome Measures

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

  within two weeks or 10 times treatment-course

Secondary Outcomes (1)

• Evidence of pain relief by visual analogue scale(VAS)

  within two weeks or 10 times treatment- course

Other Outcomes (1)

• Evidence of analgesic drug usage

  within two weeks or 10 times treatment-course

Study Arms (2)

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.

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

Device: Therapeutic ultrasound combine TENS

Interventions

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).

Also known as: Therapeutic ultrasound combine simultaneous electrotherapy

Therapeutic ultrasound combine TENS; Therapeutic ultrasound with sham TENS

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sirindhorn National Medical Rehabilitation Centre: lead

Study Sites (1)

Sirindhorn National Medical Rehabilitation Centre

Muang, Changwat Nonthaburi, 11000, Thailand

Location

MeSH Terms

Conditions

Myofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases

Study Officials

• Bootsakorn Loharjun, Medical Doctor

  Sirindhorn National Medical Rehabilitation Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.Bootsakorn Loharjun, MD

Study Record Dates

• First Submitted: November 8, 2012
• First Posted: December 5, 2012
• Study Start: June 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: February 25, 2013

Record last verified: 2013-02

Locations

TH (1)