| CTRI Number |
CTRI/2024/10/075939 [Registered on: 25/10/2024] Trial Registered Prospectively |
| Last Modified On: |
21/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Taping in wrist Pain |
|
Scientific Title of Study
|
Effects of dynamic taping on pain, disability and grip strength among patients with de-quervains tenosynovitis :A Pilot Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHIKHA MALIK |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
GALGOTIAS UNIVERSITY |
| Address |
PHYSIOTHERAPY OPD E-BLOCK GALGOTIAS UNIVERSITY SECTOR 17A GREATER NOIDA UTTAR PRADESH
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9779761606 |
| Fax |
|
| Email |
shinny00720@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
KARAN SINGH |
| Designation |
MPT STUDENT |
| Affiliation |
galgotias university |
| Address |
PHYSIOTHERAPY OPD E-BLOCK GALGOTIAS UNIVERSITY SECTOR 17A GREATER NOIDA UTTAR PRADESH
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
8840270132 |
| Fax |
|
| Email |
singhkaran02312@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
TARUNA VERMA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
galgotias university |
| Address |
PHYSIOTHERAPY OPD E-BLOCK GALGOTIAS UNIVERSITY SECTOR 17A GREATER NOIDA UTTAR PRADESH
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
07678268531 |
| Fax |
|
| Email |
taruna.verma@galgotiasuniversity.edu.in |
|
|
Source of Monetary or Material Support
|
| Research and Development Cell, Galgotias University Plot No 2, Sector 17A, Opposite Buddha International Circuit, Greater Noida Uttar Pradesh India, 203201 |
|
|
Primary Sponsor
|
| Name |
Galgotias University |
| Address |
Plot No 2, Sector 17A, Opposite Buddha International Circuit, Greater Noida Uttar Pradesh India, 203201 |
| Type of Sponsor |
Research institution |
|
|
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 Shikha Malik |
Galgotias University |
Room no. E003 ,Department of Physiotherapy ,School of Allied Sciences
Gautam Buddha Nagar
UTTAR PRADESH |
9779761606
shinny00720@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental research committee, Department of physiotherapy, School of allied health sciences, galgotias university |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M659||Synovitis and tenosynovitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
physiotherapy group |
cryotherapy for 10-15 minutes for 3 times in a week for 4 weeks, therapeutic ultrasound applied frequency-1.0 Hz intensity-1.2 watt/cm2 duration-7 min for 3 times in a week for 4 weeks. Active exercises of wrist, thumb, and tendon gliding 3 times in a week till 4 weeks.
active ROM exercises 10 reps of 3 sets.
strengthening with weights or rubber bands 10 reps for 3 sets.
active stretching 4-5 reps for 3 sets.
|
| Intervention |
taping group |
Before applying tape, the treated area will be wet and hair will be trimmed. The skin will kept dry and free of oils, lotions, or sweat. The tape cut into three pieces, two in Y shape and rounded to prevent peeling. The patient will be instructed to place their affected wrist on a table, first strip is applied to offload the extensor pollicis brevis (EPB) tendon, the second strip applied at the styloid process to offload EPB &APL tendons, and third strip is applied to offload abductor pollicis longus (APL) tendon. At last light massage will be given at all of the strips and advised against using water for at least six hours. The physiotherapist trained in DT and repeated these taping procedures three times in a week for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1) Age group 25-45 years
2) Both males and females
3) Pain over styloid process
4) Pain with movement
5) Swelling and tenderness over first extensor compartment of wrist
|
|
| ExclusionCriteria |
| Details |
1) Recent dislocation
2) Surgery of wrist
3) Osteoarthritis of wrist
4) Wrist injection in last 3 months
5) Acute trauma
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
pain.
grip strength |
Baseline and Immediate after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| disability |
Baseline & immediate after 4 weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2024 |
| 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="1"
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
|
This pilot study aims to evaluate the effect of dynamic
taping on pain, disability, and grip strength among patients with De Quervain’s
tenosynovitis. De Quervain’s tenosynovitis is a common condition that results
in pain and functional limitation in the wrist and thumb, impacting the quality
of life and productivity. While various treatments such as splinting and
physiotherapy are available, dynamic taping presents a promising, non-invasive
intervention. However, its effectiveness remains under-explored. The study will
employ a pilot feasibility trial design involving 30 participants diagnosed
with De Quervain’s tenosynovitis. Participants will be randomly assigned to
either the intervention group receiving dynamic taping or the control group
receiving standard care. The study will be conducted over 1 month, with
assessments taken at baseline, post-intervention. Primary outcome measures will
include pain intensity (measured using the Visual Analogue Scale), grip
strength (measured by Jamar dynamometer) and secondary outcome measures will
include disability (Patient-rated wrist/hand evaluation or PRWHE). These
outcomes will be compared between the two groups to determine the efficacy of
dynamic taping. The anticipated findings will provide preliminary evidence on
whether dynamic taping can offer significant improvements in pain reduction,
disability, and grip strength, potentially establishing it as a viable
treatment option for De Quervain’s tenosynovitis. This study could serve as a
foundation for larger trials and contribute to the development of clinical
guidelines for the condition. all participants will provide informed consent.
This pilot study has the potential to inform future research and improve
clinical outcomes for individuals with De Quervain’s tenosynovitis. |