| CTRI Number |
CTRI/2024/02/063120 [Registered on: 23/02/2024] Trial Registered Prospectively |
| Last Modified On: |
19/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effect of laser therapy and
strengthening exercises
on carpal tunnel
syndrome with rheumatoid Arthritis |
|
Scientific Title of Study
|
Effect of laser therapy and
strengthening exercises on hand
function in patients of carpal tunnel
syndrome with rheumatoid arthritis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Zafar Mohammad |
| Designation |
PG Student |
| Affiliation |
College of Physiotherapy, Pt. B. D. Sharma University of Health Sciences, PGIMS, Rohtak |
| Address |
College of Physiotherapy, room no. 4, E-block, Pt. B. D. Sharma
University of Health Sciences, PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9991112206 |
| Fax |
|
| Email |
zafarali015@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dimple Choudhry |
| Designation |
Assistant Professor |
| Affiliation |
College of Physiotherapy, Pt. B. D. Sharma University of Health Sciences, PGIMS, Rohtak |
| Address |
College of Physiotherapy, room no. 4, E-block, Pt. B. D. Sharma
University of Health Sciences, PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9416666445 |
| Fax |
|
| Email |
dimplephysio80@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Zafar Mohammad |
| Designation |
PG Student |
| Affiliation |
College of Physiotherapy, Pt. B. D. Sharma University of Health Sciences, PGIMS, Rohtak |
| Address |
College of Physiotherapy, room no. 4, E-block, Pt. B. D. Sharma
University of Health Sciences, PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9991112206 |
| Fax |
|
| Email |
zafarali015@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt. B. D. Sharma University of Health Sciences, PGIMS, Rohtak |
|
|
Primary Sponsor
|
| Name |
Zafar Mohammad |
| Address |
College of Physiotherapy, room no. 4, E-block, Pt. B. D. Sharma
University of Health Sciences, PGIMS, Rohtak |
| 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 Anubha Garg |
Pt. B. D. Sharma , PGIMS, Rohtak |
Ch. Ranbir Singh OPD, Department of Medicine, room no. 136, PGIMS, Rohtak Rohtak HARYANA
Rohtak
HARYANA |
9812223053
anubhag741@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee Pt. B. D. Sharma Post Graduate Institute of Medical Sciences, UHS, Rohtak |
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 |
Group A ( Experimental Group )
Laser therapy and
Strengthening Exercises |
Laser therapy shall be applied using Ga-As laser diode (Electronica Pagani, Mod: HPL 1.6, Made in Italy) with IR source 808 nm and effective power 1200 mW. The area of treatment
will be cleaned with alcohol. The patient shall be in sitting position. The probe of laser shall
be applied with direct contact perpendicularly over the median nerve course where
it passes superficially on the wrist volar for 10 minutes . The laser therapy sessions will be given 5 times
a week for 2 weeks.
The patients will also be asked to perform exercise at least 5 times a week with each of the
task repeated 10 times with the position of maximum effort held for 3-5 seconds with a 20
seconds rest between the repetitions, with 10-15 repetition in a progressive manner. The
exercises shall be performed in sitting position with shoulder in neutral position, elbow flexed
to 90 degree and forearm rest on arm rest of chair with hand free from any support. Subjects will be asked to use therapeutic putty (85g) for finger resistance exercise. Soft, medium or
firm variety of therapeutic putty based on the strength of hand muscles will be used |
| Comparator Agent |
Group B (Control group) Strengthening Exercises |
Patients will be asked to perform exercise at least 5 times a week with each of the task
repeated 10 times with the position of maximum effort held for 3-5 second with a 20 seconds
rest between the repetitions, with 10-15 repetition in a progressive manner. The exercises shall
be performed in sitting position with shoulder in neutral position, elbow flexed to 90 degree
and forearm rest on arm rest of chair with hand free from any support. Subjects will be asked
to use therapeutic putty (85g) for finger resistance exercise. Soft, medium or firm variety of
therapeutic putty based on the strength of hand muscles will be used. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients diagnosed for RA with CTS by physician
2) Both male and female patients of age ≥ 30 years |
|
| ExclusionCriteria |
| Details |
1) Underlying metabolic disorder such as diabetes mellitus and thyroid
disorders, acromegaly
2) Cervical radiculopathy, Peripheral neuropathies 3) Pregnancy
4) Intractable pain due to CTS
5) History of :Steroid injection, laser therapy at wrist in previous 3 months, carpal tunnel wrist surgery, recent wrist trauma and fractures |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
NPRS, DAS-28, NCV, FSS, SSS and
dynamometer |
Day 0 and Day 42 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Grip strength, symptoms severity,hand function,nerve conduction, disease activation of RA, intensity of pain |
Day 0 and Day 42 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 3 |
|
Date of First Enrollment (India)
|
29/02/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Carpal tunnel syndrome (CTS) is an entrapment neuropathy in which median nerve is
compressed or squeezed at the wrist level in the carpal tunnel. Recently, trials of laser therapy without any side effects have demonstrated benefits on clinical
and electrophysiological parameters. Laser therapy, also called as photobiomodulation, can
reduce pain, inflammation, swelling and synovitis. Studies also indicated tissue remodeling
and regeneration effects of laser therapy. Photons produced by laser therapy are absorbed in
the cells which increased ATP production, induce cellular events such as DNA synthesis and
replication, cell proliferation, cell differentiation and protein synthesis. Low-intensity lasers
has non-thermal and non-invasive effect on biological systems. The dexterity and
functionality of the hands improved through hand and wrist stretching and strengthening
exercises. Although there are many studies which have reported efficacy of laser therapy on carpal
tunnel syndrome. But only a few studies have studied the effect of laser therapy on patients of
CTS with RA. To our knowledge, no study has observed the effect of laser therapy with
strengthening exercises in patients of CTS with RA till now. |