Back to resultsEffectiveness of Ultrasound Combine TENS in Treatment of Upper Trapezius Myofascial Pain (MPS)
Primary Purpose
Myofascial Pain Syndromes
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Therapeutic ultrasound combine TENS
Sponsored by
About this trial
This is an interventional treatment trial for Myofascial Pain Syndromes focused on measuring myofascial pain syndrome, therapeutic ultrasound, combine therapy
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
Sites / Locations
- Sirindhorn National Medical Rehabilitation Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Therapeutic ultrasound combine TENS
Therapeutic ultrasound with sham TENS
Arm 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.
Use the same therapeutic ultrasound machine and place the electrode as experimental group but turn-off electrical current during treatment period
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01742546
First Posted
November 8, 2012
Last Updated
February 21, 2013
Sponsor
Sirindhorn National Medical Rehabilitation Centre
1. Study Identification
Unique Protocol Identification Number
NCT01742546
Brief Title
Effectiveness of Ultrasound Combine TENS in Treatment of Upper Trapezius Myofascial Pain
Acronym
MPS
Official Title
Effectiveness of Ultrasound Combine Transcutaneous Electrical Nerve Stimulation (TENS) in Treatment of Upper Trapezius Myofascial Pain: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sirindhorn National Medical Rehabilitation Centre
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain Syndromes
Keywords
myofascial pain syndrome, therapeutic ultrasound, combine therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Therapeutic ultrasound combine TENS
Arm Type
Experimental
Arm 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.
Arm Title
Therapeutic ultrasound with sham TENS
Arm Type
Sham Comparator
Arm Description
Use the same therapeutic ultrasound machine and place the electrode as experimental group but turn-off electrical current during treatment period
Intervention Type
Device
Intervention Name(s)
Therapeutic ultrasound combine TENS
Other Intervention Name(s)
Therapeutic ultrasound combine simultaneous electrotherapy
Intervention Description
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).
Primary Outcome Measure Information:
Title
Evidence of pain relief by measured mean change between pre and post treatment of pressure pain threshold (PPT)
Description
pressure pain threshold (PPT) was measured with calibrated mechanical pressure algometer
Time Frame
within two weeks or 10 times treatment-course
Secondary Outcome Measure Information:
Title
Evidence of pain relief by visual analogue scale(VAS)
Description
the patient's complaint in pain intensity which represent by mean change between pre and post treatment of visual analog scale
Time Frame
within two weeks or 10 times treatment- course
Other Pre-specified Outcome Measures:
Title
Evidence of analgesic drug usage
Time Frame
within two weeks or 10 times treatment-course
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bootsakorn Loharjun, Medical Doctor
Organizational Affiliation
Sirindhorn National Medical Rehabilitation Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sirindhorn National Medical Rehabilitation Centre
City
Muang
State/Province
Nonthaburi
ZIP/Postal Code
11000
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Ultrasound Combine TENS in Treatment of Upper Trapezius Myofascial Pain
We'll reach out to this number within 24 hrs