Protocol summary

Study aim
Comparison of the effectiveness of high-power laser versus corticosteroid injection in improving the function and symptoms of patients with mild and moderate carpal tunnel syndrome
Design
The study is a randomized, controlled, parallel-group, single-blind trial involving 40 patients. Block randomization with blocks of four was used, and Excel software was employed for randomization.
Settings and conduct
Patients with mild and moderate carpal tunnel syndrome who visit the physical medicine clinics of Imam Khomeini and Sina hospitals during the study period and meet the inclusion criteria will be enrolled in the study. They will be randomly assigned to either the intervention or control group using block randomization method with block size of 4. This study will be conducted in a single -blind manner, such that physicians, and data analysts will be unaware of the type of intervention.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Age > 18, Mild to moderate CTS (based on nerve conduction study) Exclusion Criteria: Surgical indication, Neurological disorders, pregnancy, infection, malignancy, Allergy or contraindication to corticosteroids, Prior CTS surgery or corticosteroid injection in the last 6 months
Intervention groups
Intervention: Six sessions of high-power laser therapy were applied to the flexor retinaculum of the affected wrist. The patient sat comfortably with the forearm on the table. Both patient and physician wore protective goggles. The scanner probe was moved back and forth over the area for five minutes. Treatment followed a specific carpal tunnel protocol (30 Hz, 1.5 W, 30 J/cm²), conducted over three weeks, every other day. Control: Standard treatment with a 1 ml injection of 40 mg triamcinolone at the distal wrist crease
Main outcome variables
Boston Questionnaire Score, Pain and Numbness Severity, Patient Satisfaction, Median Nerve Conduction Study (NCS) Findings

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20241228064194N1
Registration date: 2025-04-20, 1404/01/31
Registration timing: prospective

Last update: 2025-04-20, 1404/01/31
Update count: 0
Registration date
2025-04-20, 1404/01/31
Registrant information
Name
Fateme Khosravipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 936 038 5602
Email address
khosravifahime35@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-05-05, 1404/02/15
Expected recruitment end date
2025-06-05, 1404/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Evaluation of High-power Laser versus Anti-Inflammatory Effects of Corticosteroid Injection on Symptoms and Function in Patients with Mild to Moderate Carpal Tunnel Syndrome
Public title
High power Laser in carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years mild to moderate carpal tunnel syndrome (CTS) based on nerve conduction study (NCS) findings
Exclusion criteria:
Patients who have surgical indications, such as severe weakness, thenar muscle atrophy, or lack of response to treatment. Concurrent neurological disorders based on electromyography observations, such as polyneuropathy, ulnar neuropathy, proximal median neuropathy, plexopathy, mononeuritis multiplex, cervical radiculopathy. pregnancy infection malignancy patients who have received corticosteroid injections in the past six months. patients with a history of wrist surgery for CTS treatment, allergy to corticosteroids contraindications for corticosteroids
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
randomized (block randomization method with the block size 4 using Excel software), phase 4 on 40 patients
Blinding (investigator's opinion)
Single blinded
Blinding description
This was a single-blind study. A physician (specialist in physical medicine and rehabilitation), who was unaware of the treatment group of each patient, was responsible for the initial electrodiagnostic assessment and for collecting data from all patients (including demographic data, pain intensity [VAS], Boston questionnaire, grip strength, and electrodiagnostic findings). Another physician performed high-power laser therapy, and a therapist administered the cortisone injections, both of whom were blinded to the patients’ group assignments. The patients themselves were not blinded to the treatment they received.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Emam Khomeini complex Hospital
Street address
No.5.Gharib St,Keshavarz Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2023-08-29, 1402/06/07
Ethics committee reference number
IR.TUMS.IKHC.REC.1402.210

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
Boston Questionnaire Score
Timepoint
Before the intervention, 2 weeks, 1 month, and 3 months after the completion of the intervention.
Method of measurement
Boston Questionnaire

2

Description
Patient Satisfaction level
Timepoint
Before the intervention, 2 weeks, 1 month, and 3 months after the completion of the intervention.
Method of measurement
Patient Satisfaction Questionnaire

3

Description
Visual Analog Scale for pain and numbness score
Timepoint
Before the intervention, 2 weeks, 1 month, and 3 months after the completion of the intervention.
Method of measurement
Visual Analog Scale for pain and numbness

4

Description
Median Nerve Conduction Study (NCS) Findings
Timepoint
Before the intervention and 3 months after the completion of the intervention.
Method of measurement
Nerve Conduction Study (NCS) device.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients will receive six sessions of high-power laser therapy over three weeks, with a two-day interval between each session, each lasting five minutes, according to the predefined protocol on the Novin high-power laser device (30 Hz frequency, 1.5 W power, and 30 J/cm² dose). The device is calibrated before use and is the same for all patients. Due to the lack of consistency in laser parameters across studies using high-power lasers, we used the preset program for carpal tunnel syndrome (CTS) provided by the device. The session begins with the patient seated in a relaxed position, with the forearm resting on the treatment table. In the main unit of the device, the therapist selects the CTS treatment program. Then, after providing protective glasses for both the patient and therapist, the treatment begins, and the scanner probe is moved back and forth over the flexor retinaculum of the wrist (3 cm proximal and distal to the wrist crease) for five minutes, simultaneously with pedal pressure, which activates the laser. The pedal pressure corresponds to the laser exposure. All these steps are performed by one physician for all patients.
Category
Treatment - Devices

2

Description
Control group: For this group of patients, routine and standard treatment for carpal tunnel syndrome is performed. This treatment includes an injection of 1 mL of triamcinolone (40 mg) in the distal wrist crease.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Khomeini complex hospital
Full name of responsible person
Dr Fateme Khosravipour
Street address
Number 21, Gharib St. Keshavarz Blvd, Vali-e Asr Ave., Tehran , Iran
City
Tehran
Province
Tehran
Postal code
1416643491
Phone
+98 21 6119 2291
Fax
+98 21 6658 1625
Email
Imamhospital@tums.ac.ir
Web page address
https://ikhc.tums.ac.ir

2

Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Fateme Khosravi pour
Street address
No.5,Hasan Abad Ave, Emam Khomeini .Blvd,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
4691111367
Phone
+98 21 6634 8500
Email
hosp_sina@sina.tums.ac.ir
Web page address
https://sinahospital.tums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Ramin Kordi
Street address
Number 21, Qods St., Keshavarz Blvd., Tehran 1416753955 Iran
City
Tehran
Province
Tehran
Postal code
1417935840
Phone
+98 21 8898 7381
Fax
+98 21 8898 9664
Email
pajoheshi-ece@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Fateme Khosravipour
Position
physical medicine and rehabilitation resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
No.5.Gharib St,Keshavarz Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2291
Fax
+98 86 4623 2503
Email
khosravifahime35@gmail.com
Web page address
https://ikhc.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohadese Azadvari
Position
Associated professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
No.5.Gharib St,Keshavarz Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1416643491
Phone
+98 912 634 2982
Email
drazadvari@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fateme Khosravipour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
No.5.Gharib St,Keshavarz Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 936 038 5602
Email
khosravifahime35@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 more information available.”
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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