| CTRI Number |
CTRI/2024/07/070547 [Registered on: 13/07/2024] Trial Registered Prospectively |
| Last Modified On: |
23/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The Efficacy of Laser Therapy and Radial Shock Wave Therapy in Carpal Tunnel Syndrome patients |
|
Scientific Title of Study
|
Comparison Between Efficacy of Laser Therapy and Radial Shock Wave Therapy on Pain, Grip Strength and Function in Patient with Carpal Tunnel Syndrome: A Randomized Clinical Trial
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yadul Saikh |
| Designation |
Post Graduate Student |
| Affiliation |
National Institute for Locomotor Disabilities(Divyangjan) |
| Address |
Room Number 117,Department of Physiotherapy National Institute for Locomotor Disabilities(Divyangjan)BT Road,Bonhoogly,Kolkata
North Twentyfour Parganas
WEST BENGAL
700090
India |
| Phone |
9064369810 |
| Fax |
|
| Email |
yadsaikh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pravin Kumar |
| Designation |
Assistant Professor |
| Affiliation |
National Institute for Locomotor Disabilities (Divyangjan) |
| Address |
Room Number 117,Department of Physiotherapy National Institute for Locomotor Disabilities(Divyangjan)BT Road,Bonhoogly,Kolkata
North Twentyfour Parganas
WEST BENGAL
700090
India |
| Phone |
9815365870 |
| Fax |
|
| Email |
drpravinkumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Yadul Saikh |
| Designation |
Post Graduate Student |
| Affiliation |
National Institute for Locomotor Disabilities (Divyangjan) |
| Address |
Room Number 117,Department of Physiotherapy National Institute for Locomotor Disabilities(Divyangjan)BT Road,Bonhoogly,Kolkata
North Twentyfour Parganas
WEST BENGAL
700090
India |
| Phone |
9064369810 |
| Fax |
|
| Email |
yadsaikh@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute for Locomotor Disabilities (Divyangjan) |
|
|
Primary Sponsor
|
| Name |
Yadul Saikh |
| Address |
National Institute for Locomotor Disabilities(Divyangjan)BT Road,Bonhoogly,Kolkata West Bengal Pin Code-700090 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Yadul Saikh |
National Institute For Locomotor Disabilities (Divyangjan) |
Room Number 117,Department of Physiotherapy BT Road, Bonhooghly, Kolkata West Bengal Pin code-700090 North Twentyfour Parganas WEST BENGAL
North Twentyfour Parganas
WEST BENGAL |
9064369810
yadsaikh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G560||Carpal tunnel syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
LASER Therapy |
LASER Therapy 10 sessions (5 sessions per week for 2 weeks) along with Standardized Exercise Program and Home Exercise Program (5 sessions per week for 2 weeks) |
| Comparator Agent |
Radial Shock Wave Therapy |
Radial Shock Wave Therapy 4 sessions [in 2 weeks (on 1st, 4th, 7th and 10th day)] along with Standardized Exercise Program and Home Exercise Program (5 sessions per week for 2 weeks) |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Both male and female patients.
2.Age group between 30 to 60 years.
3.Clinical symptoms, such as night pain, numbness, and tingling sensation on the median nerve distribution over the hand or both hand that have persisted for more than 1 months.
4.VAS score between 3 cm to 7 cm.
5.Any one of following special test should be positive;
a.Phalens test
b.Tinel sign
c.Carpal compression test
6.Carpal Tunnel Syndrome confirmed by Nerve conduction velocity (NCV).
|
|
| ExclusionCriteria |
| Details |
1.Musculoskeletal conditions like rheumatoid arthritis, upper limb fracture, hand deformity etc.
2.Disorders that mimic CTS, such as cervical radiculopathy, polyneuropathy, and thoracic outlet syndrome etc.
3.Metabolic disorders like acromegaly.
4.History of corticosteroid injections in last 3 months or oral steroids in last 1months.
5.Surgical history involving the wrist.
6.Neurological conditions like Stroke, Complex regional pain syndrome (CRPS), Parkinson’s disease etc.
7.Pregnancy.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Pain intensity by VAS
2.Maximum Grip strength by Hand-Held Dynamometer
3.Hand Function by BCTS Questionnaire
|
2 times -on day 0 and after 10 days of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
23/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
23/07/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
PURPOSE OF THE STUDY There are many studies available which showed the individual efficacy of
LASER Therapy and Radial Shock Wave Therapy in Carpal Tunnel Syndrome. However,
to the best of our knowledge, no such studies has been performed comparing
between the efficacy of LASER Therapy and Radial Shock Wave Therapy in Carpal
Tunnel Syndrome in Indian population. Thus,
the purpose of this study is to compare between efficacy of LASER Therapy and
Radial Shock Wave Therapy on Pain, Grip strength and Function in Patients with
Carpal Tunnel Syndrome. AIM AND OBJECTIVES
AIM:
To compare between the efficacy of LASER Therapy and Radial Shock Wave Therapy
on Pain, Grip strength and Function in patient with Carpal Tunnel Syndrome.
OBJECTIVES:
1.
To find out the efficacy of
LASER Therapy with standardized exercise on Pain, Grip strength and Function in patient with Carpal Tunnel Syndrome.
2.
To find out the
efficacy of Radial Shock Wave Therapy with standardized exercise on Pain, Grip
strength and Function in patient with Carpal Tunnel Syndrome
3.
To compare
between the efficacy of LASER Therapy and Radial Shock Wave Therapy on Pain, Grip
strength and Function in patient with Carpal Tunnel Syndrome. HYPOTHESES NULL HYPOTHESIS (H0) There
is no statistically significant difference between the efficacy of LASER
Therapy and Radial Shock Therapy on Pain, Grip strength and Function in patient
with Carpal Tunnel Syndrome. ALTERNATIVE
HYPOTHESIS (H1)
There
is statistically significant difference between the efficacy of LASER Therapy
and Radial Shock Wave Therapy on Pain, Grip strength and Function in patient
with Carpal Tunnel Syndrome. PROCEDURE Approval
from the Institutional Ethical Committee (IEC) will be taken prior to the
commencement of the study. All patients diagnosed with Carpal Tunnel Syndrome
referred to the Department of Physiotherapy from the assessment clinic of
National Institute for Locomotor Disabilities (Divyangjan) will be approached
with the proposal of the study. They will be evaluated and screened according
to inclusion and exclusion criteria. Patients meeting the exclusion criteria
will not be included in the study. Those fulfilling the inclusion criteria will
be explained in details about the study in their preferred language. Informed
consent written in their preferred language will be obtained from the patients
agreeing to participate. Then the patients will be randomly divided into two
groups with a minimum of 17 patients in each group by block randomization
method. The
demographic data and the baseline data for Pain intensity using VAS, Maximum Grip
strength using Hand-Held Dynamometer and Functional status using Boston CTS
Questionnaire will be collected from each patient before treatment. All the patients
in “Group A†(n =17) will receive LASER Therapy 10 sessions (5 sessions per
week for 2 weeks) along with Standardized Exercise Program and Home Exercise
Program (5 sessions per week for 2 weeks), whereas patients in “Group B†(n=17)
will receive Radial Shock Wave Therapy 4 sessions [in 2 weeks (on 1st,
4th, 7th and 10th day)] along with Standardized
Exercise Program and Home Exercise Program (5 sessions per week for 2 weeks).
The patients will be evaluated after 10th session of treatment and
the data for Pain intensity, Grip Strength and Functional Status will be taken.
Data will be analysed at the baseline and after 2 weeks.
Rescue
medications duly prescribed by the physician will be continued along with the
physiotherapeutic approach in both groups in the study. |