| CTRI Number |
CTRI/2025/07/090890 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
14/07/2025 |
| 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
|
Comparison of 2 techniques to release thumb muscles to reduce pain and improve strength. |
|
Scientific Title of Study
|
Comparative study of Graston technique versus Cyriax technique along with exercise in management of trigger thumb in panchakarma Practitioners |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ketaki Belekar |
| Designation |
Post Graduate Student |
| Affiliation |
Dr. D Y Patil College of Physiotherapy, Dr. D Y Patil Vidyapeeth. Pimpri, Pune 18. |
| Address |
Department of Musculoskeletal,Dr. D Y patil college of physiotherapy, 4th floor, Sant tukaram Nagar, Pimpri, Pune.
Pune
MAHARASHTRA
411018
India |
| Phone |
9130743186 |
| Fax |
|
| Email |
ketakiab28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tushar Palekar |
| Designation |
Principal |
| Affiliation |
Dr.D Y Patil College of Physiotherapy |
| Address |
Department of Musculoskeletal,Dr. D Y patil college of physiotherapy, 4th floor, Sant tukaram Nagar, Pimpri, Pune.
Pune
MAHARASHTRA
411018
India |
| Phone |
09822606869 |
| Fax |
|
| Email |
principal.physio@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Ketaki Belekar |
| Designation |
Post Graduate Student |
| Affiliation |
Dr. D Y Patil College of Physiotherapy, Dr. D Y Patil Vidyapeeth. Pimpri, Pune 18. |
| Address |
Department of Musculoskeletal,Dr. D Y patil college of physiotherapy, 4th floor, Sant tukaram Nagar, Pimpri, Pune.
Pune
MAHARASHTRA
411018
India |
| Phone |
9130743186 |
| Fax |
|
| Email |
ketakiab28@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Musculoskeletal, Dr. D Y patil college of physiotherapy, 4th floor,Department of musculoskeletal, Sant tukaram Nagar, Pimpri, Pune, 411018 India |
|
|
Primary Sponsor
|
| Name |
Dr D Y Patil College of physiotherapy |
| Address |
Department of Musculoskeletal,Dr. D Y patil college of physiotherapy, 4th floor, Sant tukaram Nagar, Pimpri, Pune 411018 India |
| 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 Tushar Palekar |
Dr D Y Patil College of Physiotherapy |
Department of Musculoskeletal, 4th floor, Sant tukaram Nagar, Pimpri, Pune.
Pune
MAHARASHTRA |
09822606869
principal.physio@dpu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. DY Patil College of Physiotherapy, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Panchakarma practioners with trigger thumb |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cyriax technique with exercises |
Cyriax technique with exercises will be given for trigger thumb in panchkarma practitioners for 4 weeks 3 days in each week for 12 sessions |
| Intervention |
Graston technique with exercises . |
Graston technique with exercises will be given for trigger thumb in panchkarma practitioners for 4 weeks 3 days in each week for 12 sessions. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Panchakarma practitioner practicing for minimum 1 year
2. Both gender
3. Age group 30 – 60 years
4. Working for maximum 6 hrs |
|
| ExclusionCriteria |
| Details |
1. Not having neurological, cardiorespiratory and systemic disorder
2. Recent fracture on thumb or wrist.
3. Recent surgery. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Pinch Gauge
2.Kapandji score
3.Numerical Pain Rating Scale |
Baseline pre and post 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 1 |
|
Date of First Enrollment (India)
|
31/07/2025 |
| 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
|
Participants will be recruited in the study according to the eligibility criteria. A written informed consent will be obtained from the participants .Patient will be allocated to Group A and Group B by using Chit method as it was simple random sampling. The purpose of the study will be explained in detail to all the patients, any doubts regarding the same will be answered by the therapist. Pre Assessment will be done on day 1 before the treatment and Post assessment will be done after the 12 session by using following outcome measure pinch gauze ,Kapandji score and Numerating pain rating scale. |