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

Myofascial Pain Syndromes Clinical Trial

— MPS  

Official title:

Effectiveness of Ultrasound Combine Transcutaneous Electrical Nerve Stimulation (TENS) in Treatment of Upper Trapezius Myofascial Pain: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01742546
• Other study ID #: SNMRC001
• Status: Completed
• Phase: N/A
• First received: November 8, 2012
• Last updated: February 21, 2013
• Start date: June 2012
• Est. completion date: January 2013

Study information

• Verified date: February 2013
• Source: Sirindhorn National Medical Rehabilitation Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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).

Locations

Country	Name	City	State
Thailand	Sirindhorn National Medical Rehabilitation Centre	Muang	Nonthaburi

Sponsors (1)

Lead Sponsor	Collaborator
Sirindhorn National Medical Rehabilitation Centre

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evidence of analgesic drug usage		within two weeks or 10 times treatment-course	Yes
Primary	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	Yes
Secondary	Evidence of pain relief by visual analogue scale(VAS)	the patient's complaint in pain intensity which represent by mean change between pre and post treatment of visual analog scale	within two weeks or 10 times treatment- course	Yes