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

NCT ID: NCT01742546

Last Updated: 2013-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2013-01-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Therapeutic ultrasound combine TENS

Intervention Type: 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).

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

Group Type: SHAM_COMPARATOR

Therapeutic ultrasound combine TENS

Intervention Type: 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).

Interventions

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).

Intervention Type: DEVICE

Other Intervention Names

Therapeutic ultrasound combine simultaneous electrotherapy

Eligibility 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sirindhorn National Medical Rehabilitation Centre

OTHER_GOV

Sponsor Role: lead

Responsible Party

Bootsakorn Loharjun, MD

Dr.Bootsakorn Loharjun, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bootsakorn Loharjun, Medical Doctor

Role: PRINCIPAL_INVESTIGATOR

Sirindhorn National Medical Rehabilitation Centre

Locations

Sirindhorn National Medical Rehabilitation Centre

Muang, Changwat Nonthaburi, Thailand

Countries

Thailand

Other Identifiers

SNMRC001

Identifier Type: -

Identifier Source: org_study_id