Investigating the effect of concurrent myofascial release of the shoulder girdle and hand compared to myofascial release of the hand on functional and electrodiagnostic parameters of patients with mild and moderate carpal tunnel syndrome
Studying the effect of simultaneous shoulder and hand myofascial release compared to hand myofascial release
Design
Individuals will be divided into three groups by simple randomization method, which is done with a dice: 1) simultaneous MFR of the hand and shoulder, 2) MFR of the hand, 3) control group . This study is single-blinded.
Each group will include 15 samples and a total of three groups will include 45 samples.
To compare the effect of treatment before and after the intervention, ANOVA statistical analysis will be used with SPSS software.
Settings and conduct
Individuals with symptoms of CTS will be referred to the clinic of the Neuromuscular Research Center of Semnan University of Medical Sciences and an initial electrodiagnostic study will be performed. Pain and function will also be assessed with the Visual Pain Scale and the Boston Questionnaire. The evaluator and the therapist are two separate individuals, so this study is single-blind. Myofascial release will be performed in the hand and shoulder girdle area.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 18 to 50 years and VAS above 3.
Patients with other confounding diagnoses, such as cervical radiculopathy, other mononeuropathies, or polyneuropathies, were excluded from this study. Patients with a positive history of other diseases that may cause secondary CTS or whose disease is associated with secondary CTS, were also excluded from this study if they were pregnant or lactating, or had a history of fracture or surgery.
Intervention groups
Individuals will be randomly divided into three groups using a simple randomization method: 1) simultaneous hand and shoulder myofascial release, 2) hand myofascial release, and 3) control group
Investigating the effect of concurrent myofascial release of the shoulder girdle and hand compared to myofascial release of the hand on functional and electrodiagnostic parameters of patients with mild and moderate carpal tunnel syndrome
Public title
Investigating the effect of concurrent myofascial release of the shoulder girdle and hand compared to myofascial release of the hand on functional and electrodiagnostic parameters of patients with mild and moderate carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age: 18-50 years old
Mild & moderate idiopathic CTS
VAS above 3
Exclusion criteria:
Cervical radiculopathypoly
Polyneuropathy
Diabetes mellitus
Hypothyroidism
Chronic kidney failure
Chronic alcoholism
Acromegaly
Connective tissue disease
Inflammatory diseases
Pregnant
Breast feeding
History of fracture or surgery in the hand
More than 20% absence in practice sessions
Unwillingness to continue
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, randomization is done by a dice, so that in this 3-group study, numbers 1 and 2 are considered for the first group, numbers 3 and 4 for the second group, and numbers 5 and 6 for the third group.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the evaluator and the therapist are two separate individuals, and the evaluator is blind, so the present study will be single-blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd.
City
Semnan
Province
Semnan
Postal code
3519899946
Approval date
2025-02-26, 1403/12/08
Ethics committee reference number
IR.SEMUMS.REC.1403.284
Health conditions studied
1
Description of health condition studied
Carpal Tunnel Syndrome
ICD-10 code
G56.0
ICD-10 code description
Carpal tunnel syndrome
Primary outcomes
1
Description
Pain
Timepoint
After the initial evaluation, individuals in all three groups will undergo 10 treatment sessions, 3 sessions per week for 4 weeks. Four weeks after the last treatment session, the evaluations will be repeated and the results will be reviewed
Method of measurement
Visual Analog Scale(VAS)
2
Description
Function
Timepoint
After the initial evaluation, individuals in all three groups will undergo 10 treatment sessions, 3 sessions per week for 4 weeks. Four weeks after the last treatment session, the evaluations will be repeated and the results will be reviewed
Method of measurement
Boston CTS questionnaire
3
Description
Myofascial Release
Timepoint
After the initial evaluation, individuals in all three groups will undergo 10 treatment sessions, 3 sessions per week for 4 weeks. Four weeks after the last treatment session, the evaluations will be repeated and the results will be reviewed
Method of measurement
Manual
4
Description
Nerve Conduction Velocity
Timepoint
After the initial evaluation, individuals in all three groups will undergo 10 treatment sessions, 3 sessions per week for 4 weeks. Four weeks after the last treatment session, the evaluations will be repeated and the results will be reviewed
Method of measurement
Electrodiagnostic studies with an EMG device
5
Description
Latency
Timepoint
After the initial evaluation, individuals in all three groups will undergo 10 treatment sessions, 3 sessions per week for 4 weeks. Four weeks after the last treatment session, the evaluations will be repeated and the results will be reviewed
Method of measurement
Electrodiagnostic studies with an EMG device
6
Description
Amplitude
Timepoint
After the initial evaluation, individuals in all three groups will undergo 10 treatment sessions, 3 sessions per week for 4 weeks. Four weeks after the last treatment session, the evaluations will be repeated and the results will be reviewed
Method of measurement
Electrodiagnostic studies with an EMG device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: concurrent myofascial release of the shoulder girdle and hand Myofascial release of the shoulder girdle area is performed on the upper terapezius, pectoralis major, supraspinatus, and subscapularis. The same hand release will be performed on the carpal ligament area of the wrist. The release will last 90 to 120 seconds, followed by a ten-second rest, and this technique will be repeated 5 times per session.The group will undergo 10 treatment sessions, 3 sessions per week for 4 weeks.
Category
Treatment - Other
2
Description
Intervention group: Intervention group2: Hand Myofascial Release Myofascial release will be performed on the carpal ligament area of the wrist. The release will last for 90 to 120 seconds, followed by a ten-second rest, and this technique will be repeated 5 times per session.The group will undergo 10 treatment sessions, 3 sessions per week for 4 weeks.
Category
Treatment - Other
3
Description
Control group: In the control group, only routine physiotherapy is performed. Routine physiotherapy is performed in the form of applying a high-frequency TENS current for fifteen minutes with a frequency of 100 HZ and a diurnance of 100 with an amplitude of 15 mA and 5 minutes with a frequency of 1 HZ and a diurnance of 200 with an amplitude of 5 mA in a two-channel manner on the wrist and palm area.Then, pulsed ultrasound current with a frequency of 1 MHz and an intensity of 0.8 watts/square centimeter will be used for 3 minutes on the carpal ligament area of the wrist. After that, infrared will be used for 15 minutes at a distance of 50 cm.The group will undergo 10 treatment sessions, 3 sessions per week for 4 weeks.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Neuromuscular Research Center, Semnan University of Medical Sciences
Full name of responsible person
Azadeh Mokhtari
Street address
Neuromuscular Rehabilitation Research Center, Tabatabaei Clinic, Qods Boulevard
City
Semnan
Province
Semnan
Postal code
9837535196
Phone
+98 23 3332 8502
Email
azadehmokhtari27@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Abbasali Vafaei
Street address
Headquarters of Semnan University of Medical Sciences, Basij Boulevard
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3344 1022
Email
aavafaei@semums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Azadeh Mokhtari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Neuromuscular Rehabilitation Research Center, Tabatabaei Clinic, Qods Boulevard
City
Semnan
Province
Semnan
Postal code
9837535196
Phone
+98 23 3365 4180
Email
azadehmokhtari27@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Azadeh Mokhtari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Neuromuscular Rehabilitation Research Center, Tabatabaei Clinic, Qods Boulevard
City
Semnan
Province
Semnan
Postal code
9837535196
Phone
+98 23 3332 8502
Email
azadehmokhtari27@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Azadeh Mokhtari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Neuromuscular Rehabilitation Research Center, Tabatabaei Clinic, Qods Boulevard
City
Semnan
Province
Semnan
Postal code
9837535196
Phone
+98 23 3332 8502
Email
azadehmokhtari27@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
"There is no further information."
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals.
When the data will become available and for how long
"Access period begins 6 months after results are published."
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
There are no other conditions.
From where data/document is obtainable
azadehmokhtari27@gmail.com
What processes are involved for a request to access data/document
Two weeks after submitting the request, an email will be sent to the applicant and the individual's academic identity will be verified.