Investigating the effect of physical therapy combined with dry needling compared to physical therapy alone on hand muscle strength in people with carpal tunnel syndrome: a randomized clinical trial
Comparison of the effect of physiotherapy treatment alone and physiotherapy combined with dry needling on the components of pain, strength gain, functional status, severity of symptoms and effectiveness of treatment in patients with carpal tunnel syndrome.
Design
Participants in this study will be treated for 12 sessions, 3 sessions per week. In the control group, the standard rehabilitation program includes electrotherapy, ultrasound modality, median nerve mobilization techniques and gliding flexor tendons, and exercises that will be placed in the form of brochures to be performed at the patient's home. In the treatment group, in addition to the standard rehabilitation program that is also performed in the control group, dry needling will be applied in the wrist area by the physiotherapist.
Settings and conduct
Physiotherapy Department of Ghaem Mashhad Hospital
Participants/Inclusion and exclusion criteria
Entry requirements:
65-20 years
Clinical diagnosis of CTS based on the presence of at least two criteria proposed by Chang in 2008
Presence of symptoms for at least 4 weeks
Confirmation of mild to moderate severity of CTS based on electrodiagnostic findings
Non-entry conditions:
Clinical conditions that can mimic CTS
diabetes
Rheumatoid arthritis
Hypothyroidism and hyperthyroidism
Intervention groups
In the intervention group, in addition to the standard rehabilitation program that is performed in the control group, at the end of the fifth treatment session, dry needling will be applied based on the FCDN technique. The standard rehabilitation program includes electrotherapy, ultrasound modality, median nerve mobilization techniques and gliding flexor tendons, and exercises that will be available in the form of brochures to be performed at the patient's home. The main outcome evaluated in this study will be pain.
Main outcome variables
Grip strength
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221030056342N3
Registration date:2024-10-24, 1403/08/03
Registration timing:prospective
Last update:2024-10-24, 1403/08/03
Update count:0
Registration date
2024-10-24, 1403/08/03
Registrant information
Name
Afsaneh Zeinalzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3884 6710
Email address
zeinalzadehaf@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-12-02, 1403/09/12
Expected recruitment end date
2025-12-03, 1404/09/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of physical therapy combined with dry needling compared to physical therapy alone on hand muscle strength in people with carpal tunnel syndrome: a randomized clinical trial
Public title
The effect of physical therapy combined with dry needling compared to physical therapy alone on hand muscle strength in people with carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Clinical diagnosis of CTS based on at least two criteria proposed by Chang
Presence of symptoms for at least 4 weeks
Confirmation of mild to moderate severity of CTS based on electrodiagnostic findings
Exclusion criteria:
Clinical conditions that can mimic CTS include cervical radiculopathy, brachial plexus injury, proximal median neuropathy, or significant polyneuropathy.
Severe CTS with visible muscle atrophy
Diabetes
Rheumatoid arthritis
Hypothyroidism and hyperthyroidism
Pregnancy and breastfeeding
Alcohol abuse
Taking medicine
Malignancy
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
In the present study, the quadruple randomization block method will be used for randomization. For this method, the volume of each block must be determined first (for example, a quadruple block). Then write the list of blocks and assign numbers to them (AABB(1)- ABAB(2)-ABBA(3)-BBAA(4)- BABA(5)- BAAB(6)) then choose random numbers between 1 and 6 (for example, 1, 4, 5, etc.) and finally specifying the treatment allocation list based on the previous random numbers (...AABB-BBAA-BABA-).}. The website www.sealedenvelope.com will be used to generate the assigned sequences.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are randomly assigned to two groups of physical therapy alone (control group) and physical therapy with dry needling (treatment group) by the method of quadruple random blocks by a person who is not involved in any of the intervention and evaluation stages.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Central Organization of Mashhad University of Medical Sciences, Knowledge and Health City, End of Shahid Fakuri Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Approval date
2024-02-24, 1402/12/05
Ethics committee reference number
IR.MUMS.REC.1403.005
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
Hand grip
Timepoint
Before, immediately after and six weeks after the end of treatment
Method of measurement
Grip strength will be measured in kilograms using a hand-held dynamometer. First, patients are taught how to work with the device. They are then asked to maintain maximum grip strength and press the handle 3 times with 10 seconds of rest between each test, and the average score of the three presses of the machine will be calculated.
Secondary outcomes
1
Description
Pain severity
Timepoint
Before, immediately after and six weeks after completion
Method of measurement
Visual analog scale (VAS) will be used to evaluate pain intensity at rest (8). VAS is a 10-point scale from 0 to 10, where 0 represents "no pain" and 10 represents "worst possible pain". All participants are instructed to rate pain intensity based on the past 7 days.
2
Description
Functional status and symptom severity
Timepoint
Before, immediately after and six weeks after completion
Method of measurement
Functional status and severity of self-reported symptoms will be measured using the self-reported Boston Carpal Tunnel Questionnaire (BCTQ). This is a CTS-specific questionnaire that refers to a typical 24-hour period in the past two weeks. It consists of two different scales: Symptom Severity Scale (SSS) and Functional Status Scale (FSS). The SSS consists of 11 questions about symptom severity, while the FSS consists of 8 daily activities that are rated by severity. These two scales will be rated on a 5-point scale, where greater impairment is indicated by higher scores, and finally, the average of each section is calculated, and the higher the average, the greater the severity of the patient's symptoms and disability. The BCTQ is responsive to clinically relevant changes and is therefore an appropriate measure of treatment outcome. This questionnaire was Persianized by Mashhad University of Medical Sciences and its reliability and validity have been reported before.
3
Description
The effectiveness of treatment
Timepoint
Before, immediately after and six weeks after completion
Method of measurement
Global rating of change (GRC) will be used to evaluate the effectiveness of the treatment, which evaluates the patient's current health status compared to the patient's status at the beginning of the treatment. It is an 11-point Likert scale ranging from +5 (much better) to -5 (much worse).
Intervention groups
1
Description
Intervention group: In the treatment group, in addition to the standard rehabilitation program that is also performed in the control group, dry needling will be applied in the wrist region based on the Four Pole Carpal Dry Needling technique by the physiotherapist. In this method, needles with dimensions of 25*0.30 mm are placed in their position in all patients according to anatomical references. The highest needles are at the scaphoid (proximal-radial: P-R) and pisiform (proximal-ulnar: P-U) bones, while the lowest ones are at the level of the trapezium (distal-radial: D-R) and hamate (distal-ulnar: D-U) bones. ) are placed. 4 oblique directional needles (45 degrees in both cranio-caudal and internal-external directions), slightly inclined to the back and at the same time follow the midline. Each needle is inserted into the tissue until an elastic state is felt, which in the absence of ultrasound confirmation is attributed to the transverse carpal ligament. Fascial winding technique (FWT) is then applied to each needle, which involves twisting them in one direction until reaching the final threshold of "Needle grasp". The rotation of the needles is limited due to their adhesion to the tissue, which means that by applying force to remove the needles, the tissue will be exposed to tension. This force is along the longitudinal axis of the needles, but it is not enough to pull them out of the tissue and it must be done simultaneously on each pair of opposite needles that are two by two miles together (i.e. P-R with D-U and P-U with D-R). At this moment, we consider the FWT complete. This method leads to continuous tension on the transverse carpal ligament, which is stronger and more effective. In the treatment group, dry needling will be performed at the beginning of the first, fifth and ninth sessions before routine physiotherapy, and patients will be advised to refrain from taking NSAIDs 24 hours before and after the dry needling treatment.
Category
Rehabilitation
2
Description
Control group: In the control group, the standard rehabilitation program includes electrotherapy, ultrasound modality, median nerve mobilization techniques and gliding flexor tendons, and exercises that will be placed in the form of brochures to be performed at the patient's home. The mobilization technique of the median nerve, which is performed by the physiotherapist, and the gliding of the flexor tendons will be explained in detail, and the patient will be taught how to do the exercise at home. The treatment duration of the standard rehabilitation program is 45 to 60 minutes per session. And it is as follows: 20 minutes of electrotherapy in the form of tennis with a frequency of 80 Hz and a pulse width of 60 microseconds - 5 minutes of interrupted ultrasound on the carpal tunnel area of the wrist with a frequency of 1 MHz and an intensity of 1 watt per square centimeter - mobilization of the median nerve in 3 sets with 15 repetitions in Each session - Glide the flexor tendons of the hand so that each exercise is repeated 1 to 3 times for 10 times and each position is maintained for 5 seconds. Teaching exercises to stretch the transverse carpal ligament and glide the median nerve and flexor tendons to be done at home as follows: 1) Stretching the transverse carpal ligament by the patient: the patient is asked to bend his wrist upwards at a 90 degree angle. and connect his palm to the opposite wall, and with his opposite hand, slowly pull the thenar ridge towards him so that the transverse carpal ligament is stretched. Participants are asked to hold each stretch for 30 seconds and do it 4 times a day during their treatment period. Participants in this study will be treated for 12 sessions, 3 sessions per week.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Special clinic of physical therapy of Ghaem Hospital
Full name of responsible person
Mohammad Javad Zarandi
Street address
Narjes building, first floor, Physiotherapy Department, Qaem Hospital, Nurse Street.
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3841 1538
Email
zarandiMJ1@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Taphaghodi
Street address
Research and Technology Vice-Chancellor, Qureshi Building, next to Howezeh Cinema, Daneshgah St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1535
Email
vcresarch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Shayeste Jan Alizadeh
Position
MSc Colleague
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Paramedical and Rehabilitation Sciences, Kharazmi Building, University Campus, East Door of Mashhad University of Medical Sciences, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Phone
+98 51 3884 6710
Email
Janalizadehs4002@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Afsaneh Zeinalzadeh
Position
Associate Professor of Mashhad University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Paramedical and Rehabilitation Sciences, Kharazmi Building, University Campus, East Door of Mashhad University of Medical Sciences, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Phone
+98 51 3884 6710
Email
zeinalzadehAF@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Afsaneh Zeinalzadeh
Position
Associate Professor, Department of Physiotherapy, Mashhad University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Paramedical and Rehabilitation Sciences, Kharazmi Building, University Campus, East Door of Mashhad University of Medical Sciences, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Phone
+98 51 3884 6710
Email
zeinalzadehAF@mums.ac.ir
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
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data will be reported in the form of a research article. Raw data will be delivered to researchers for meta analysis.
When the data will become available and for how long
6 months after publication
To whom data/document is available
For researchers only
Under which criteria data/document could be used
For meta-analysis Only
From where data/document is obtainable
zeinalzadehAF@mums.ac.ir
What processes are involved for a request to access data/document
The response will be sent 3 within months after considering the researcher's request.