MedPath

To study the importance of causation (trauma) rubric in traumatic osteoarthritis of knee.

Phase 1
Completed
Conditions
Health Condition 1: M172- Bilateral post-traumatic osteoarthritis of knee
Registration Number
CTRI/2023/06/054561
Lead Sponsor
CLINICAL RESEARCH UNIT FOR HOMOEOPATHY. RANCHI
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
75
Inclusion Criteria

1. Age: 50-70 years

2. Both sexes

3. Diagnosed knee osteoarthritis as per American College of Rheumatology (ACR) clinical/radiographic classification criteria, 30 (sensitivity 91%; specificity 86%) - history of trauma over knee, knee pain, stiffness less than 30 min, and crepitus on knee motion, osteophytes on a knee x-ray

4. Patients already undergoing regular oral or topical analgesics or NSAID therapy for painful episodes of osteoarthritis, provided the medications are stopped at least 2 weeks prior to study entry entirely

5. Literate patients; can able to read Hindi or English

6. Providing written informed consent

Exclusion Criteria

1. Severe degeneration of the knee joint with marked joint narrowing, varus or valgus deformity of the knee ( >12°), evidenced by imaging or other evidence and requiring surgical intervention

2.Non-ambulant patients

3. Self-reported joint disorders other than osteoarthritis (e.g., inflammatory joint disease, specific arthropathy, hyperuricaemia and/or gout, severe axis deviations or instabilities, joint or skin infections, joint prostheses of the lower limbs)

4. Intra-articular injections within 2 weeks before study entry

5. Transplanted knees

6. Recent significant knee surgery within the last 6 months

7. Patients who are too sick for consultation

8. Unwilling to take part and not giving consent to join the study

9. Unable to read the patient information sheet

10 Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting the quality of life

11. Pregnancy and lactation

12. Substance abuse and or dependence

13. Self-reported immune-compromised state, and

14. Undergoing homoeopathic treatment for any chronic disease within the last 6 months

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To evaluate group differences in Knee Injury and Osteoarthritis Outcome Score (KOOS) between the two groups over 3 months of intervention;Timepoint: Monthly Follow-up up to 3 months
Secondary Outcome Measures
NameTimeMethod
To evaluate group differences in quality of life measured in terms of EQ-5D-5L measures between the two groups over 3 months of intervention.Timepoint: Monthly Follow-up up to 3 months
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