The Effectiveness of Tecar Therapy on Improving Pain and Functional Disability of Neck and Shoulder in Patients with Myofascial Pain Syndrome in Upper Trapezius
Determination of the effect of TECAR therpy on reducing pain and improving neck and shoulder function in patients with myofacial pain syndrome in upper trapezius
Design
The study will be conducted as a randomized clinical trial.The patients will be divided to 2 groups of intervention and control using block randomization method.The control group will be under stretching exercises of upper trapezius and taking acetaminophen tablets with Tizanidine tablets.The intervention group will also undergo TECAR therapy, upper trapezius stretching exercises and acetaminophen tablets with Tizanidine tablets.
Settings and conduct
The study will be conducted as a randomized clinical trial including all patients aged 18-60 years with upper trapezius muscle myofascial pain syndrom who have pain for at least one month and VAS score greater than 3 and refer to physical medicine and rehabilitation clinic at the specified time.The diagnostic method is based on physical examination.The patients will be divided to 2 groups of intervention and control. All patients will be evaluated for pain and disability through VAS, NDI and SPADI.
Participants/Inclusion and exclusion criteria
The study population consisted of all patients 18-60 years old with upper trapezius muscle myofascial pain who had pain for at least one month and VAS score greater than 3 and referred to physical medicine and rehabilitation clinic at the specified time. Exclusion criteria: diseases or conditions that interfere with the desired treatment.
Intervention groups
The control group will be under stretching exercises of upper trapezius and taking acetaminophen tablets with Tizanidine tablets.The intervention group will also undergo TECAR therapy, upper trapezius stretching exercises and acetaminophen tablets with Tizanidine tablets.
Main outcome variables
Improving Pain and Functional Disability of Neck and Shoulder
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210623051688N1
Registration date:2021-07-22, 1400/04/31
Registration timing:prospective
Last update:2021-07-22, 1400/04/31
Update count:0
Registration date
2021-07-22, 1400/04/31
Registrant information
Name
Soroush Sadri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3778 9307
Email address
soroushsadri@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-23, 1400/05/01
Expected recruitment end date
2022-05-22, 1401/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Tecar Therapy on Improving Pain and Functional Disability of Neck and Shoulder in Patients with Myofascial Pain Syndrome in Upper Trapezius
Public title
The Effectiveness of Tecar Therapy on Improving Pain and Functional Disability of Neck and Shoulder in Patients with Myofascial Pain Syndrome in Upper Trapezius
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Myofascial pain in superior trapezius muscle diagnosed by clinical examination and presence of point trigger and band taut
Consent for being included in the study
No therapeutic intervention in the recent 30 days
Pain for at least 1 month and VAS score higher than 3
Age between 18 to 60
Referral at the appointed time to the Physical Medicine and Rehabilitation clinic
Exclusion criteria:
Surgery or Cervical Fracture in past 2 years
Pregnancy-Lactation
Infection
Coagulation disorders
Using oral or parenteral corticosteroids
Using oral or parenteral narcotics
Cervical Myelopathy or Radiculopathy
Psychologic disorders or Cognitive Impairments
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Diagnosis will be done by clinical examination and presence of trigger point and taut band. The patients will be divided to 2 groups of intervention(TECAR THERAPY, drug, exercise) and control (drug and exercise) using block randomization method.
After admission of patients to the Physical Medicine and Rehabilitation clinic , The Physiatrist will examine the patient and refer him to the practitioner. The practitioner divided the patients into two groups.(randomization will be done by the practitioner and the examiner is blinded)
After intervention, the patient will be examined by the specialist (who is blided) for the second time.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Building No. 4, Vice Chancellor for Research and Technology, Isfahan University of Medical Sciences, Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
7346181746
Approval date
2021-06-21, 1400/03/31
Ethics committee reference number
IR.MUI.MED.REC.1400.219
Health conditions studied
1
Description of health condition studied
Myofascial Pain Syndrome in Upper Trapezius
ICD-10 code
M79.1
ICD-10 code description
Myalgia
Primary outcomes
1
Description
Pain and Functional Disability of Neck and Shoulder
Timepoint
Before the intervention, immediately after the end of the intervention and one month after the end of the intervention
Method of measurement
Visual Analogue Scale(VAS)-Neck Disability Index(NDI)-Shoulder Pain and Disability Index(SPADI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: TECAR therapy is a long-wave diathermy that is performed for 6 sessions, 2 sessions per week for 3 weeks, for 20 minutes per session.
Category
Treatment - Devices
2
Description
Intervention group: Upper Trapezius stretching exercises 9 times a day (3 times in the morning-3 times noon-3 times at night) and 30 seconds each time
Category
Rehabilitation
3
Description
Intervention group: Taking acetaminophen 325 mg tablets daily with 4 mg tizanidine tablets in the form of taking a quarter tablet in the first 3 nights and then a second tablet every night
Category
Treatment - Drugs
4
Description
Control group: Upper Trapezius stretching exercises 9 times a day (3 times in the morning-3 times noon-3 times at night) and 30 seconds each time
Category
Rehabilitation
5
Description
Control group: Taking acetaminophen 325 mg tablets daily with 4 mg tizanidine tablets in the form of taking a quarter tablet in the first 3 nights and then a second tablet every night
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan University of Medical Sciences
Full name of responsible person
Soroush Sadri
Street address
Isfahan University of Medical Sciences, Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooy Javanmard
Street address
Building No. 4, Vice Chancellor for Research and Technology, Isfahan University of Medical Sciences, Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Soroush Sadri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Isfahan University of Medical Sciences, Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8138
Email
sadrisoroush@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Parisa Taheri
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Isfahan University of Medical Sciences, Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8138
Email
prs_taheri@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Soroush Sadri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Isfahan University of Medical Sciences, Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8138
Email
sadrisoroush@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available