| CTRI Number |
CTRI/2023/06/054169 [Registered on: 20/06/2023] Trial Registered Prospectively |
| Last Modified On: |
19/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Screening
Dentistry
Physiotherapy (Not Including YOGA)
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
"A Comparative Study of Shock Wave Therapy & Laser Therapy in the Management of Hand Pain in Dental Population" |
|
Scientific Title of Study
|
"A Comparative Study of Shock Wave Therapy & Low-Level Laser Therapy in the management of De-Quervains Disease in Dental Professionals" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neha Bhagdewani |
| Designation |
M.P.T |
| Affiliation |
Dr. DY Patil College of Physiotherapy |
| Address |
Dr. D.Y. Patil College of Physiotherapy, 3rd Floor Electrotherapy & Electrodiagnosis Department, Dr. D.Y. Patil Vidyapeeth, Sant Tukaram Nagar, Pimpri, Pune.
Pune
MAHARASHTRA
411018
India |
| Phone |
9168497673 |
| Fax |
|
| Email |
nbhagdevani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Soumik Basu |
| Designation |
Associate Professor |
| Affiliation |
Dr. D.Y. Patil College of Physiotherapy |
| Address |
Dr. D.Y. Patil College of Physiotherapy, 3rd Floor Electrotherapy & Electrodiagnosis Department, Dr. D.Y. Patil Vidyapeeth, Sant Tukaram Nagar, Pimpri, Pune.
Pune
MAHARASHTRA
411018
India |
| Phone |
9762165015 |
| Fax |
|
| Email |
soumikphysio24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Soumik Basu |
| Designation |
Associate Professor |
| Affiliation |
Dr. D.Y. Patil College of Physiotherapy |
| Address |
Dr. D.Y. Patil College of Physiotherapy, 3rd Floor Electrotherapy & Electrodiagnosis Department, Dr. D.Y. Patil Vidyapeeth, Sant Tukaram Nagar, Pimpri, Pune.
Pune
MAHARASHTRA
411018
India |
| Phone |
9762165015 |
| Fax |
|
| Email |
soumikphysio24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D.Y. Patil College of Physiotherapy, 3rd Floor Electrotherapy & Electrodiagnosis Department, Dr. D.Y. Patil Vidyapeeth, Sant Tukaram Nagar, Pimpri, Pune. |
|
|
Primary Sponsor
|
| Name |
Neha Bhagdewani |
| Address |
Dr. D.Y. Patil College of Physiotherapy, Dr. D.Y. Patil Vidyapeeth, Sant Tukaram Nagar, Pimpri, Pune. |
| 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 |
| Neha Bhagdewani |
Dr. D.Y. Patil College Of Physiotherapy |
3rd Floor Electrotherapy & Electrodiagnosis Department, Dr. D.Y. Patil Vidyapeeth, Sant Tukaram Nagar, Pimpri, Pune.
Pune
MAHARASHTRA |
9168497673
nbhagdevani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe, Dr. D.Y. Patil College of Physiotherapy, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
De-Quervains Disease |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Low-Level Laser Therapy |
Low-level Laser therapy (LLLT) used as a treatment method for eliminating pain and increasing skin resistance. The analgesic effect of laser is by means of mechanism or combination of various mechanism as follows: increasing blood perfusion, collagen proliferation, peripheral nerve stimulation, anti-inflammatory and direct analgesic effect. A non-invasive light source treatment called LASER (light amplification by stimulated emission of radiation) produces light at a single wavelength. There are no known contraindications for this particular treatment |
| Intervention |
Shock Wave Therapy |
Shock wave therapy (SWT) works by means of electromagnetic induction mechanism and producing low energy wave which may be effective on increasing blood flow in the treated area. Orthopedic conditions include, lateral epicondylitis, calcific shoulder tendonitis,de-quervain’s, and carpal tunnel syndrome have all been treated using this technique. According to several studies, this approach has a success rate for treating these diseases that ranges between 65% and 91%, and it has few complications that can be neglected |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Those who are having positive Finkelstein Test
2.Those who have been in the dental field for at least 6 months to 1Â year and are treating at least 5 patients per day
3.Those who are having NPRS scores 5 and above
|
|
| ExclusionCriteria |
| Details |
1. Those who have other rheumatologic diseases causing wrist pain, pregnancy, history of fracture, severe trauma, and coagulation disorders.
2. Those who have any previous history of surgery and metal implants.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Hand Held Dynamometer
2.Pinch Gauge
3.Numeric Pain Rating Scale
4.QuickDASH Score
|
Pre & Post
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| QuickDASH Score |
Pre & Post |
|
|
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)
|
30/06/2023 |
| 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)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None |
|
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 is a painful, inflammatory condition caused by tendons on the side of the wrist at the base of the thumb. The main complaint, pain, worsens with thumb abduction, hand grasping, and ulnar deviation of the wrist. Thickening and swelling may also be present. Due to overuse injuries, this condition is most frequently observed in dentistry. In Dental practitioners, the proportion of shoulder pain is more common than wrist pain. Shoulder pain is correlated with wrist pain since the wrist is continually used during dental practice. The prevalence rate of shoulder pain occurs 52% of the time, whereas wrist and hand pain occurs 37% and 21% of the time, respectively. Therefore, we can aid in the reduction of the prevalence of shoulder pain by managing wrist pain. Shock wave therapy and laser therapy are used to treat De-Quervain’s disease-related wrist pain. However, no such study has been done till date to compare the effectiveness of Shock wave therapy and Low-level laser therapy in dentistry professionals. It is, therefore, necessary to conduct the study to determine which modality is more successful in treating De-Quervains in Dental professionals. |