| CTRI Number |
CTRI/2025/11/098220 [Registered on: 28/11/2025] Trial Registered Prospectively |
| Last Modified On: |
27/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A prospective study of use of Low Dose Radiation Therapy for pain relief in patients with osteoarthritis of hands which is not controlled by routine medications |
|
Scientific Title of Study
|
A Prospective Study of Low Dose Radiation Therapy in Osteoarthritis of Hands |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mayur Mayank |
| Designation |
Senior Consultant |
| Affiliation |
Medanta The Medicity |
| Address |
Division of Radiation Oncology,
Medanta Cancer Institute,
Medanta The Medicity,
Sector 38, Gurugram
Gurgaon HARYANA 122001 India |
| Phone |
9560250562 |
| Fax |
|
| Email |
mayank.rch@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Mayur Mayank |
| Designation |
Senior Consultant |
| Affiliation |
Medanta The Medicity |
| Address |
Division of Radiation Oncology,
Medanta Cancer Institute,
Medanta The Medicity,
Sector 38, Gurugram
HARYANA 122001 India |
| Phone |
9560250562 |
| Fax |
|
| Email |
mayank.rch@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Mayur Mayank |
| Designation |
Senior Consultant |
| Affiliation |
Medanta The Medicity |
| Address |
Division of Radiation Oncology,
Medanta Cancer Institute,
Medanta The Medicity,
Sector 38, Gurugram
HARYANA 122001 India |
| Phone |
9560250562 |
| Fax |
|
| Email |
mayank.rch@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Medanta The Medicity |
| Address |
Sector 38, Gurugram, Haryana |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Mayur Mayank |
Medanta The Medicity |
Division of Radiation Oncology
Medanta Cancer Institute
Medanta The Medicity
Sector 38 Gurgaon HARYANA |
9560250562
mayank.rch@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medanta Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M190||Primary osteoarthritis of other joints, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Low Dose Radiation Therapy |
Low Dose Radiation Therapy (300 cGy in 6 fractions over 3 weeks (50 cGy/fraction delivered twice weekly) for pain control in Osteoarthritis of Hands |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
- Diagnosed to have Osteoarthritis of the hands
- Patients refractory to conventional NSAIDs to full tolerance dose
- Patients needing more than two NSAIDs
- Patients consenting to be a part of the study |
|
| ExclusionCriteria |
| Details |
- Patients with diagnosis other than Osteoarthritis
- Patients who have received Radiation Therapy to the affected area earlier due to any reason
- Patients not consenting to be a part of the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The reduction in the pain score of the patients with Osteoarthritis of the hands after low dose Radiation Therapy |
3 & 6 months after the completion of Low Dose Radiation Therapy and then 6 monthly thereafter |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The reduction in use of NSAIDs in patients with Osteoarthritis of the hands after low dose Radiation Therapy |
3 & 6 months after the completion of Low Dose Radiation Therapy and then 6 monthly thereafter |
| Radiographic changes observed in the Hands in patients with Osteoarthritis after low dose Radiation Therapy |
3 & 6 months after the completion of Low Dose Radiation Therapy and then 6 monthly thereafter |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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 2 |
|
Date of First Enrollment (India)
|
15/12/2025 |
| 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="1" Months="11" 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
|
Osteoarthritis (OA) is the most common form of arthritis in the world. In India, around 23.46 million individuals had OA in 1990 which increased to 62.35 million in 2019. OA was the 20th most common cause disability in India in 2019, increasing from 23rd most common cause in 1990. Knee OA is the most common form of OA in India, followed by hand OA. Radiation therapy (RT) has been used to treat benign conditions for over a century. Conventional and hypofractionated RT have anti-proliferative principles that are used in the treatment of malignant disorders. Alternatively, at doses of less than 1 Gray (Gy) per fraction, RT has been shown to have strong anti-inflammatory effects. By using anti-inflammatory properties, low dose radiation therapy (LDRT) has been used to successfully treat painful musculoskeletal conditions such as plantar fasciitis, trochanteric bursitis, medial and lateral epicondylitis, tendinopathies of various joints, and osteoarthritis (OA) of both large and small joints have been shown to benefit from LDRT. This study will try to assess the role of Low Dose Radiation Therapy for pain management in patients with OA of the hands which is refractory to pain medications and/or needs too many pain medications for management. |