Home » Trials » SLCTR/2013/014
Effectiveness of transcutaneous electrical nerve stimulation (TENS) and interferential therapy (IFT) on myofascial pain syndrome patients with myofascial trigger points in the upper trapezius and influence of pain catastrophysing on treatment response.
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SLCTR Registration Number
SLCTR/2013/014
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
Effectiveness of transcutaneous electrical nerve stimulation (TENS) and interferential therapy (IFT) on myofascial pain syndrome patients with myofascial trigger points in the upper trapezius and influence of pain catastrophysing on treatment response.
Public Title of Trial
A study of the effectiveness of two methods of electrotherapy treatment for painful areas in the upper shoulder.
Disease or Health Condition(s) Studied
Myofascial pain syndrome with upper trapezius trigger points
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
2012/EC/39 (Ethics Review Committee, Faculty of Medicine, University of Peradeniya)
What is the research question being addressed?
What is the effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS) and Interferential therapy (IFT) used in combination with standard treatment in treating myofascial pain syndrome patients with upper trapezius trigger points? What is the influence of pain catastrophysing on the treatment response?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Available
Intervention(s) planned
Participants will be recruited from the orthopedic and sports medicine clinics at the Teaching Hospital, Peradeniya. The study will be conducted at the Physiotherapy Service Unit, Department of Physiotherapy, Faculty of Allied Health Sciences, University of Peradeniya.
Following recruitment, all participants will be examined to determine the number and location of myofascial trigger points (MTP). The MTPs will be marked and pre-treatment pain intensity will be recorded using a Visual Analogue Scale (VAS). Cervical ROM, including flexion and extension, right- and left-side bending, and the right and left rotation will be evaluated using a universal goniometer of 360 degrees. The Pain Catastrophizing Scale will be administered to the participants at this visit
The participants will then be randomized using an envelope method to three treatment arms. Standard therapy will include hot pack (20min), active range of motion exercise (5repitions), myofascial release technique (10min) Arm 1 will receive TENS (20 mins) in addition to standard therapy, Arm 2 will receive IFT (20 mins) in addition to standard therapy while Arm 3C will receive standard therapy alone. Treatment will take place twice a week for a period of 4 weeks (8 sessions per participant).
The effect of pain catastrophysing will be assessed in all 3 arms.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
|
[ At baseline, within 5min after the first session, before eighth session and one week after eighth session ] |
Secondary outcome(s)
|
1.
Effect of pain catastrophysing on the treatment outcome |
[ At the end of the study period ] |
Target number/sample size
105
Countries of recruitment
Sri Lanka
Anticipated start date
2013-04-01
Anticipated end date
2014-06-25
Date of first enrollment
2013-04-04
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2012-11-15
Approval number
2012/EC/39
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Peradeniya |
| Institutional Address: | Galaha Road, Kandy, Sri Lanka |
| Telephone: | +94-812396361 |
| Email: | chairpersonierc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Thusharika Dilrukshi Dissanayaka
Lecturer(Probationary)
Department of Physiotherapy,
Faculty of Allied Health Sciences,
University of Peradeniya
071-6305852
thushfhs@yahoo.com
Contact Person for Public Queries
Dr. Anula Kariyawasam . ,
Senior Lecturer
Department of Physiology, Faculty of Medicine, University of Peradeniya
0812396296
0718667836
thushfhs@yahoo.com
Primary study sponsor/organization
Department of Physiotherapy
Faculty of Allied Health Sciences, University of Peradeniya
081-3999623
081-2387394
www.pdn.ac.lk/ahs/index.html
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
