| CTRI Number |
CTRI/2025/12/099278 [Registered on: 17/12/2025] Trial Registered Prospectively |
| Last Modified On: |
16/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Platelet-rich plasma versus Methylprednisolone acetate in hip osteoarthritis: which one is better for your hip ? |
|
Scientific Title of Study
|
Effectiveness of ultrasound guided intra-articular injection of platelet-rich plasma (PRP) in comparison with methylprednisolone acetate in reducing pain and improving function in hip osteoarthritis: A randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bidyabati Yumnam |
| Designation |
Post graduate trainee |
| Affiliation |
Regional Institute of Medical Sciences, Imphal, Manipur |
| Address |
Department of Physical Medicine and Rehabilitation, Regional Institute of Medical Sciences, Imphal, Manipur
Imphal West
MANIPUR
795004
India |
| Phone |
7005264509 |
| Fax |
|
| Email |
bidyabatiyumnam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Longjam Nilachandra Singh |
| Designation |
Professor |
| Affiliation |
Regional Institute of Medical Sciences, Imphal, Manipur |
| Address |
Department of Physical Medicine and Rehabilitation, Regional Institute of Medical Sciences, Imphal, Manipur
Imphal West
MANIPUR
795004
India |
| Phone |
7005019045 |
| Fax |
|
| Email |
drnilalong@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bidyabati Yumnam |
| Designation |
Post graduate trainee |
| Affiliation |
Regional Institute of Medical Sciences, Imphal, Manipur |
| Address |
Department of Physical Medicine and Rehabilitation, Regional Institute of Medical Sciences, Imphal, Manipur
Imphal West
MANIPUR
795004
India |
| Phone |
7005264509 |
| Fax |
|
| Email |
bidyabatiyumnam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physical Medicine and Rehabilitation, Regional Institute of Medical Sciences, Imphal, Manipur, India, 795004 |
|
|
Primary Sponsor
|
| Name |
No Primary Sponsor |
| Address |
Not applicable |
| Type of Sponsor |
Other [Not applicable] |
|
|
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 Bidyabati Yumnam |
Regional Institute of Medical Sciences, Imphal |
Department of Physical Medicine and Rehabilitation, RIMS, Imphal, Manipur
Imphal West
MANIPUR |
7005264509
bidyabatiyumnam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Board RIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M169||Osteoarthritis of hip, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Methylprednisolone acetate |
80 mg Methylprednisolone acetate, will be given once, route of administration intraarticularly into hip joint under ultrasound, guidance, total duration 30 minutes |
| Intervention |
Platelet-rich plasma |
4ml platelet-rich plasma, will be given once, route of administration intraarticularly into hip joint under ultrasound, guidance, total duration 30 minutes |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients fulfilling 1991 American College of
Rheumatology criteria for hip osteoarthritis
2. Duration of symptoms of more than 3 months
3. KL Grade 2 and 3
4. Age group 40 to 70 years
5. People who are willing to comply with the
study and follow up assessments
|
|
| ExclusionCriteria |
| Details |
1. Infection of hip joint
2. Platelet count less than 180×1000/microliter
3. Acute and chronic systemic infections
4.Coagulopathy and Bleeding disorders
5. Impaired cognition
6. Immunosuppressed patients (eg., HIV)
7. Systemic disorders such as uncontrolled diabetes
8. Malignancy |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain by VAS score |
Baseline, 1 week, 4 week, 12 week and 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Physical function by WOMAC score |
Baseline, 1 week, 4 week, 12 week and 24 weeks |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
27/12/2025 |
| 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="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
|
Osteoarthritis (OA) of hip is a chronic disease with loss of articular cartilage resulting in pain, stiffness and dysfunction of joint affecting day to day activities. It is the 2nd largest joint that is commonly affected by OA. The prevalence of hip OA increases with age and weight. Various treatment modalities of hip OA includes lifestyle modification, exercise, physical therapy, pharmacological treatment such as NSAIDs, intra-articular injection and surgery in advance conditions. Intra-articular steroid injection in hip is commonly practiced. But these treatments are not very effective in preventing the destructive process nor in facilitating reconstruction. Therefore, one of the recent interventions that has gained popularity towards biological treatment is platelet-rich plasma in hip OA. PRP is a biological treatment with great prospective but there is lacking of standardization on the effect of intra-articular PRP injection for the management of hip OA. Due to the limited number of studies available for intra-articular PRP in the management of hip OA, there is still need to study effects of PRP in the management of hip OA. Thus, a randomized controlled trial shall be conducted in the Department of Physical Medicine and Rehabilitation, RIMS, Imphal to determine the effectiveness of ultrasound guided intra-articular injection of PRP in comparison with methylprednisolone acetate in reducing pain and improving function in hip osteoarthritis. The outcome variables which are VAS and WOMAC will be measured before starting intervention at baseline and at 1st week, 4th week, 12th week, 24th week post intervention follow up by using VAS for pain scale and WOMAC for quality of life. To represent the descriptive statistics, mean, standard deviation and percentage will be used. For comparing categorical data, chi square test will be used. Independent t-test will be used for comparison between the groups and the mean changes from baseline within each group will be compared by repeated measures ANOVA test. A p-value < 0.05 will be considered statistically significant. |