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Evaluation of the comparative effect of high-power and low-power laser and drug therapy in improving the symptoms, function and sonographic findings in patients with mild to moderate carpal tunnel syndrome

Protocol summary

Study aim
Determining and comparing the effect of high-power and low-power laser and drug therapy in improving the symptoms, function, and sonographic findings in patients with carpal tunnel syndrome
Design
A randomized, double-blind clinical trial with the parallel groups; on 66 patients. Randomization by lottery
Settings and conduct
In this randomized double-blind clinical trial study, 66 eligible patients referred to Amin Hospital in Isfahan will be included in the study and randomly divided into three groups. For patients in the first group, splints, gabapentin, and vitamin B1, in the second and third groups, in addition to the mentioned treatment, low-power laser and high-power laser are performed, respectively. The intervention will be performed in such a way that the patient and the investigator, outcome assessor, and data analyzer will have no knowledge of the type of intervention. Then the symptoms, function and sonographic findings will be compared between the three groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria include patients with mild to moderate degrees of carpal tunnel syndrome in the age group over 18 years and no history of carpal tunnel injection in a recent month and consent to participate in the study. Exclusion criteria include having neuropathic diseases, having systemic diseases that affect treatment, having a history of carpal tunnel surgery, and pregnancy.
Intervention groups
Control group: For patients in this group, splints, gabapentin, and vitamin B1 are prescribed. Intervention group 1: In this group, in addition to splint administration, gabapentin, and vitamin B1, patients undergo low-power laser. Second intervention group: In this group, in addition to prescribing splints, gabapentin, and vitamin B1, patients undergo high-power laser.
Main outcome variables
Symptoms; Functional status; Pain; Nerve and muscle strip findings; Ultrasound findings

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220423054620N1
Registration date: 2022-06-08, 1401/03/18
Registration timing: prospective

Last update: 2022-06-08, 1401/03/18
Update count: 0
Registration date
2022-06-08, 1401/03/18
Registrant information
Name
parisa monzavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3778 8275
Email address
parisamonzavi@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-22, 1401/04/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the comparative effect of high-power and low-power laser and drug therapy in improving the symptoms, function and sonographic findings in patients with mild to moderate carpal tunnel syndrome
Public title
Comparison of the effect of high-power and low-power laser and drug therapy in improving the symptoms, function and sonographic findings in patients with carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with mild to moderate carpal tunnel syndrome Age category over 18 years No history of injection in the carpal tunnel in a recent month Consent to participate in the study
Exclusion criteria:
Having neuropathic diseases Having systemic diseases that affect treatment (such as hypothyroidism, diabetes, rheumatism) Having a history of carpal tunnel surgery Pregnancy
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 66
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 66 eligible patients are randomly selected. For this, the letter A is written on 22 sheets, the letter B is written on 22 sheets, and the letter C is written on 22sheets, and each of them is placed in an envelope. Each patient is then asked to choose one of the envelopes. Depending on the selected envelope, the patient is assigned to one of three groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, all three groups will be prescribed drug treatment, and in addition, two groups will be under low-power or high-power laser. Due to the difference in the laser power intensity, the Care provider is aware of the type of intervention in each group, but the patient will not be aware of the laser power used. In addition, the investigator, outcome assessor, and data analyzer will not know the type of intervention in the three groups.
Placebo
Not used
Assignment
Parallel
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
Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq
City
Isfahan
Province
Isfehan
Postal code
8179964167
Approval date
2022-02-13, 1400/11/24
Ethics committee reference number
IR.MUI.MED.REC.1400.803

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
Symptoms
Timepoint
Before treatment, one month and three months after treatment
Method of measurement
Boston Questionnaire

2

Description
Functional status
Timepoint
Before treatment, one month and three months after treatment
Method of measurement
Boston Questionnaire

3

Description
Pain
Timepoint
Before treatment, one month and three months after treatment
Method of measurement
Visual Analog Scale (VAS)

4

Description
Nerve Conduction Velocity (NCV) across wrist
Timepoint
Before treatment and three months after treatment
Method of measurement
Nerve and muscle strip

5

Description
Sensory nerve action potential (SNAP) across wrist
Timepoint
Before treatment and three months after treatment
Method of measurement
Nerve and muscle strip

6

Description
Compound Muscle Action Potential (CMAP) across wrist
Timepoint
Before treatment and three months after treatment
Method of measurement
Nerve and muscle strip

7

Description
Cross-sectional area (CSA) carpal tunnel
Timepoint
Before treatment and three months after treatment
Method of measurement
Sonography

Secondary outcomes

empty

Intervention groups

1

Description
Control group: In this group, patients have routinely prescribed wrist splints, in addition to vitamin B1 and gabapentin 100 mg for two weeks.
Category
Treatment - Drugs

2

Description
Intervention group 1: In this group, patients are prescribed routine treatment including a wrist splint, vitamin B1, and gabapentin 100 mg for two weeks. In addition, patients are treated with a low-power laser (New Vision device) five days a week (for two weeks) with a wavelength of 808 nm and a frequency of 1000 Hz, and an energy of 4 J/cm2 five days a week (for two weeks). The device is placed on the pulse settings and in the area of the carpal tunnel and the palm area in the path of the median nerve branches, the median nerve of fingers 1, 2, 3, and 4 will be fast manual scanning.
Category
Treatment - Devices

3

Description
Intervention group 2: In this group, patients are prescribed routine treatment including wrist splint, vitamin B1 and gabapentin 100 mg for two weeks. In addition, patients are treated with a high-power laser (Fisioline device) five days a week (for two weeks) with a wavelength of 1064-910 nm and a frequency of 1000 Hz and an energy of 4 J/cm2. The device is placed on the pulse settings and in the area of the carpal tunnel and the palm area in the path of the median nerve branches, the median nerve of fingers 1, 2, 3 and 4 will be fast manual scanning.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Amin Hospital
Full name of responsible person
Raziye Maghroori
Street address
Ibn Sina Street
City
Isfahan
Province
Isfehan
Postal code
5314181486
Phone
+98 31 3445 5051
Email
maghroori@mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mansour Siavash Dastjerdi
Street address
Vice Chancellor for Research, School of Medicine, Hezar Jarib Street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan 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
Raziye Maghroori
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Physical Medicine and Rehabilitation Department, Kashani Hospital, Kashani Street.
City
Isfahan
Province
Isfehan
Postal code
8183983434
Phone
+98 31 3233 0091
Email
maghroori@mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Raziye Maghroori
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Physical Medicine and Rehabilitation Department, Kashani Hospital, Kashani Street.
City
Isfahan
Province
Isfehan
Postal code
8183983434
Phone
+98 31 3233 0091
Email
maghroori@mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Parisa Monzavi
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Physical Medicine and Rehabilitation Department, Kashani Hospital, Kashani Street.
City
Isfahan
Province
Isfehan
Postal code
8183983434
Phone
+98 31 3233 0091
Email
parisamonzavi@resident.mui.ac.ir

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
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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