| CTRI Number |
CTRI/2023/01/049052 [Registered on: 17/01/2023] Trial Registered Prospectively |
| Last Modified On: |
18/01/2023 |
| 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
|
To Compare the Effectiveness of Kinesio taping and Thumb Spica Splint on Pain,Muscle strength and Function in De Quervains Tenosynovitis |
|
Scientific Title of Study
|
Comparative Effectiveness of Kinesio taping and Thumb Spica Splint on Pain,Muscle strength and Function in De Quervains Tenosynovitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vrinda Sachdeva |
| Designation |
Student |
| Affiliation |
Indian Spinal Injury Center- Institute of Rehabilitation Sciences |
| Address |
Indian spinal injury center- Institute of Rehabilitation sciences,Second floor,Department of Physiotherapy
Sector C,Vasant Kunj,New Delhi
Same as Address 1
South
DELHI
110070
India |
| Phone |
9810125272 |
| Fax |
|
| Email |
vrindasachdeva98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Megha Nijhawan |
| Designation |
Assistant Professor |
| Affiliation |
ISIC Institute of Rehabilitation Sciences |
| Address |
Indian Spinal Injuries Center- Institute of rehabilitation sciences, Second Floor, Musculoskeletal Lab, Department of Physiotherapy
Same as Address 1
South
DELHI
110070
India |
| Phone |
8802021752 |
| Fax |
|
| Email |
physiomegha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Megha Nijhawan |
| Designation |
Assistant Professor |
| Affiliation |
ISIC Institute of Rehabilitation Sciences |
| Address |
Indian Spinal Injuries Center- Institute of rehabilitation sciences, Second Floor, Musculoskeletal Lab, Department of Physiotherapy
Same as Address 1
South
DELHI
110070
India |
| Phone |
8802021752 |
| Fax |
|
| Email |
physiomegha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Spinal Injuries Center,Vasant Kunj, New Delhi,110070 |
|
|
Primary Sponsor
|
| Name |
Vrinda Sachdeva |
| Address |
Indian Spinal Injuries Center- Institute of rehabilitation sciences, Second Floor
Vasant Kunj, New Delhi |
| 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 |
| Megha Nijhawan |
Indian spinal injuries center |
Department of Physiotherapy
Second Floor, Musculoskeletal Lab
South
DELHI |
8802021752
-
physiomegha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutonal Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
De Quervains Tenosynovitis |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kinesio taping |
Kinesio taping along with conventional treatment
Total duration of intervention- 2 weeks (3 sessions per week) |
| Comparator Agent |
Thumb spica splint |
Thumb spica splint along with conventional treatment
Total duration of intervention- 2 weeks (3 sessions per week) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with De Quervains Tenosynovitis |
|
| ExclusionCriteria |
| Details |
Pregnancy
Diagnosed with any of the following:
-Degenerative arthritis like wrist OA
-Inflammatory arthritis like RA
-Recent trauma/surgery to upper limb
Patient taking corticosteroid injection
Contraindications of KT:
-Open wounds
-Psoriasis
-Skin infections / Allergy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain(VAS)
Muscle strength(MMT)
Function (PRWE) |
2 weeks(3 days/week) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Muscle strength (Pinch meter) |
Treatment time-2 weeks(3 days/week) |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
N/A |
|
Date of First Enrollment (India)
|
19/01/2023 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
De quervain’s tenosynovitis (DQT) is
a disorder characterized by pain, tenderness and edema over the lateral side of
the wrist caused by mechanical impingement between the tendons of Abductor
pollicis longus and extensor pollicis brevis. DQT results
in impairment of wrist, hand and thumb function with activities of daily living
like lifting and gripping. Therapeutic tools like Kinesio taping (KT) and
splints like Thumb spica splint, are used for the management of musculoskeletal
injuries. KT supports the inflamed and damaged tissue without immobilizing the
structures. The comparative effectiveness of KT
and splint has not been clinically evaluated in DQT. Aim of the study is to compare effectiveness of KT and
Thumb spica splint on Pain, muscle strength and function in DQT. Based on the
inclusion and exclusion criteria, patients will be allocated in 2 groups. Group
1 will be given KT along with conventional treatment (Ultrasonic therapy+
Rehabilitation exercises) and Group 2 with Thumb spica splint along with
conventional treatment. Outcome variables used pre and post intervention are
Pain (VAS), Muscle strength and Function (PRWE Scale). Duration of
treatment in both the groups will be for 2 weeks (3 days/week). The results can
provide an evidence to which treatment is more effective in DQT. |