The evaluation of the effects of adding dry needling of scapular and shoulder muscles myofascial trigger points to routine physiotherapy on pain and function of patients with CTS
Design
This clinical trial has a control group, with parallel groups, double-blinded and randomized by block randomization method with block size 4. The sample size is 20 persons in each group.
Settings and conduct
Patients (n: 40) referred to medical centers of SUMS who suffer from carpal tunnel syndrome, enter the study according to the inclusion and exclusion criteria and after signing the informed consent. They are randomly assigned to intervention group (routine physiotherapy with dry needling) and control group (routine physiotherapy). Treatment will be done by a physiotherapist. assessments will be performed by another physiotherapist and statistical analysis by a statistician who are unaware of group assignment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with mild to moderate carpal tunnel syndrome; age between 30-60 years; pain and paresthesia in the hand; positive phalen's test and tinel's sign; myofascial painful points around the scapula and shoulder.
Exclusion criteria: cervical disc herniation; cervical radiculopathy; cervical vertebrae degeneration; upper limb fractures; diabetes and rheumatoid arthritis.
Intervention groups
The control group undergoes routine physiotherapy including ultrasound, TENS, hot pack and nerve mobilization techniques in 10 sessions for 2 weeks on the wrist area. The intervention group undergoes dry needling in the muscles around the shoulder and scapula in addition to the interventions of the control group.
Main outcome variables
Pain; Grip power; Function; Two point discrimination
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220530055032N1
Registration date:2022-07-27, 1401/05/05
Registration timing:prospective
Last update:2022-07-27, 1401/05/05
Update count:0
Registration date
2022-07-27, 1401/05/05
Registrant information
Name
Sedighe Rezaeyan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3631 7233
Email address
sedigherezaeyan73@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-06, 1401/05/15
Expected recruitment end date
2023-02-04, 1401/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of dry needling on painful myofascial points of scapular and shoulder muscles on pain and function of patients with carpal tunnel syndrome
Public title
Evaluation of the effect of dry needling of scapular and shoulder muscles painful points on pain and function of patients with carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with mild to moderate carpal tunnel syndrome
Aged between 30 and 60 years
Pain and paresthesia in hand (especially thumb, index and middle fingers)
Having symptoms for more than one month
Positive Phalen’s test
Positive Tinel’s test
Painful myofascial points at least in two muscles around scapula (Upper Trapezius, Supraspinatus, Infraspinatus, Subscapularis, Teres minor and major) and at least in one muscle around shoulder (Biceps and Deltoid)
Normal BMI to overweight
Exclusion criteria:
Cervical disc protrusion
Cervical radiculopathy
Cervical vertebral degeneration
Double crush syndrome
Upper limb fracture
Sensory or motor defects of the ulnar or radial nerves
History of wrist or cervical spine severe injury
Previous wrist, upper limb or cervical vertebrae surgeries
History of steroid injection into the wrist
History of systemic disease causing carpal tunnel syndrome such as diabetes, rheumatoid arthritis and fibromyalgia
Pregnancy
Thenar muscles atrophy
Use of blood thinner drugs
Tumor
Epilepsy
Age
From 30 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly divided into two equal groups of routine physical therapy and routine physical therapy plus dry needling via Block randomization method, with a block size of 4 by using of random allocation software.
Blinding (investigator's opinion)
Double blinded
Blinding description
The treatment will be performed by a physiotherapist and the variables will be measured by another physiotherapist who is unaware of the allocated groups, and the data will be analyzed by a statistician who is unaware of the group assignments.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Shiraz University of Medical Sciences
Street address
School of Rehabilitation, Abiverdi 1 St., Chamran Blvd., Shiraz, Fars, Iran
City
Shiraz
Province
Fars
Postal code
7194733669
Approval date
2022-05-11, 1401/02/21
Ethics committee reference number
IR.SUMS.REHAB.REC.1401.006
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
Before treatment, after the last treatment session, 1 month after the last treatment sessions
Method of measurement
Visual analogue scale
2
Description
Grip power
Timepoint
Before treatment, after the last treatment session, 1 month after the last treatment sessions
Method of measurement
Hand-held dynamometer
3
Description
Functional disability
Timepoint
Before treatment, after the last treatment session, 1 month after the last treatment sessions
Method of measurement
DASH questionnaire
4
Description
Severity and functional ability
Timepoint
Before treatment, after the last treatment session, 1 month after the last treatment sessions
Method of measurement
Boston questioner
5
Description
Two point discrimination
Timepoint
Before treatment, after the last treatment session, 1 month after the last treatment sessions
Method of measurement
Two point discriminator
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients will receive 10 sessions of routine physical therapy at the wrist area: therapeutic continuous ultrasound (for 5 min with 3.0 MHz applicator, ERA = 5 cm2, intensity= 1.5 W/cm2); Burst TENS on median nerve (frequency 100Hz, pulse width 80 ms, electrode size 4* 6 for 20 min); hot pack on wrist area; median nerve mobilization technique; Dry needling technique in the muscles around the scapula and shoulder.
Category
Rehabilitation
2
Description
Control group: patients will receive 10 sessions of routine physical therapy at the wrist area: therapeutic continuous ultrasound (for 5 min with 3.0 MHz applicator, ERA = 5 cm2, intensity= 1.5 W/cm2); Burst TENS on median nerve (frequency 100Hz, pulse width 80 ms, electrode size 4* 6 for 20 min); hot pack on wrist area; median nerve mobilization technique.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Medical centers affiliated to Shiraz University of Medical Sciences
Full name of responsible person
Dr Samaneh Ebrahimi
Street address
School of Rehabilitation, Abiverdi 1 St., Chamran Blvd., Shiraz, Fars, Iran
City
Shiraz
Province
Fars
Postal code
7194733669
Phone
+98 71 3627 1551
Fax
+98 71 3627 2495
Email
ebrahimis@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Mahtab Memarpour
Street address
Vice Chancellor for Research and Technology, Zand St. Shiraz, Fars The central building of Shiraz University of Medical Sciences, seventh floor
City
Shiraz
Province
Fars
Postal code
7194733669
Phone
+98 71 3235 7282
Email
memarpour@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Sedighe Rezaeyan
Position
Master of Science Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Abiverdi 1 St., Chamran Blvd., Shiraz, Fars, Iran
City
Shiraz
Province
Fars
Postal code
7194733669
Phone
+98 71 3631 7233
Email
sedigherezaeyan73@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sedighe Rezaeyan
Position
Master of Science Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Abiverdi 1 St., Chamran Blvd., Shiraz, Fars, Iran
City
Shiraz
Province
Fars
Postal code
71947-33669
Phone
+98 71 3631 7233
Email
sedigherezaeyan73@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sedighe Rezaeyan
Position
Master of Science Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Abiverdi 1 St., Chamran Blvd., Shiraz, Fars, Iran
City
Shiraz
Province
Fars
Postal code
71947-33669
Phone
+98 71 3631 7233
Email
sedigherezaeyan73@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not 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
After coordination with the Research Ethics Committee for approval of the ethics committee, participants data file will be provided In complete secrecy and for research purposes only.
When the data will become available and for how long
6-12 month after acceptance of the article by the journal.
To whom data/document is available
In addition to the principal researcher and the supervisor of the project, upon request, access to information can be reviewed by the Ethics Committee.
Under which criteria data/document could be used
Preferably it is only used for the subject of my research, but if research is to be done in order to use the statistical population, the main project executor and the student's main collaborator will make a decision with the permission of the ethics committee.
From where data/document is obtainable
Executors of the project can first be referred to through Dr. Zahra Rojhani Shirazi (09171127108), and the main colleague and student collaborator Ms Fatemeh Panahi (09183571646).
What processes are involved for a request to access data/document
6 months after article publication, referring the request to the executor of the project, an official letter from the ethics committee will be commented on in order to obtain a license, and if the ethics committee approves, emphasizing the confidentiality of the information, the requested information will be provided to the applicant.