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

Not Applicable

Completed

• Conditions: Myofascial Pain Syndromes
• Interventions: Device: Therapeutic ultrasound combine TENS

• Registration Number: NCT01742546
• Lead Sponsor: Sirindhorn National Medical Rehabilitation Centre

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.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-11-08
• Study First Submitted QC: 2012-12-02
• Study First Posted: 2012-12-05
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-21
• Last Update Posted: 2013-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Therapeutic ultrasound combine TENS	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.
Therapeutic ultrasound with sham TENS	Therapeutic ultrasound combine TENS	Use the same therapeutic ultrasound machine and place the electrode as experimental group but turn-off electrical current during treatment period

Primary Outcome Measures

Name	Time	Method
Evidence of pain relief by measured mean change between pre and post treatment of pressure pain threshold (PPT)	within two weeks or 10 times treatment-course	pressure pain threshold (PPT) was measured with calibrated mechanical pressure algometer

Secondary Outcome Measures

Name	Time	Method
Evidence of pain relief by visual analogue scale(VAS)	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

Trial Locations

Locations (1)

Sirindhorn National Medical Rehabilitation Centre; 🇹🇭 Muang, Nonthaburi, Thailand