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

S

Sirindhorn National Medical Rehabilitation Centre

Status

Completed

Conditions

Myofascial Pain Syndromes

Treatments

Device: Therapeutic ultrasound combine TENS

Study type

Interventional

Funder types

Other

Identifiers

NCT01742546
SNMRC001

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups

Therapeutic ultrasound combine TENS
Experimental group
Description:
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.
Treatment:
Device: Therapeutic ultrasound combine TENS
Therapeutic ultrasound with sham TENS
Sham Comparator group
Description:
Use the same therapeutic ultrasound machine and place the electrode as experimental group but turn-off electrical current during treatment period
Treatment:
Device: Therapeutic ultrasound combine TENS

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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