A study to compare the efficacy of topical Ayurvedic oil preparation against placebo in symptomatic knee osteoarthritis

Not Applicable

Conditions: Knee Osteoarthritis

Registration Number: SLCTR/2017/039

Lead Sponsor: niversity Grants Commission, Sri Lanka

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: Not specified

Inclusion Criteria

1. Diagnosis of symptomatic knee osteoarthritis (KOA) according to the American College of Rheumatology (ACR) radiological and clinical criteria, with a functional scale between i – iii.

2. Radiographic evidence of knee osteoarthritis (osteophytes, joint space narrowing)

3. Knee pain (3-4 pain flares per month) along with three out of the following six

a. Age >50 years and <70 years

b. Joint stiffness lasting for less than 30 minutes

c. Joint crepitus

d. Bony tenderness

e. Bony enlargement

f. No palpable warmth

4. Ability to identify a predominantly painful (index) knee with moderate pain in the index knee, defined by pain on walking on a flat surface, pain at rest and climbing upstairs rated as 4 or 5 for questions of the the Western Ontario and McMaster Universities Arthritis Index [WOMAC - 11 point numerical rating scale (NRS), v. 3.1] and a total average WOMAC pain sub scale score of <7 at the first (B1) and second (B2) baseline visits five days apart.

Exclusion Criteria

1. Inflammatory diseases
2. History of total knee replacement
3. Long term use of non-steroidal anti-inflammatory drugs (Patients will be required to withdraw from topical non-steroidal anti-inflammatory drugs for 48 hours prior to recruitment)
4. Serious co-morbidities (e.g. any form of debility that restricts independent movement, stroke, chronic renal failure and inadequate mental capacity to participate in the study)
5. Difference in pain rating (determined from questions of WOMAC) or the difference in the total average pain score between the B1 and B2 over 2.
6. Skin lesions or dermatological diseases in the treatment area
7. Symptomatic ipsilateral hip osteoarthritis or predominant patello-femoral knee osteoarthritis
8. Non-index knee pain, or any other pain condition requiring the chronic use of pain medication
9. Intra-articular injections of hyaluronic acid within 3 months before or during the study
10. Use of oral, inhaled, parenteral corticosteroids within 2 months before or during the study
11. Intra-articular injections of corticosteroids within one month from the study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction of pain [At baseline, at the end of the 2nd week and 4th week, at the beginning of 8th week, at the end of the 10th week and 12th week after commencement of the intervention.]<br> Reduction of functional limitation [ At baseline, at the end of the 2nd week and 4th week, at the beginning of 8th week, at the end of the 10th week and 12th week after commencement of the intervention.]<br>Reduction in stiffness <br><br>The outcomes will be assessed using the Western Ontario and McMaster Universities (WOMAC) composite index. [ At baseline, at the end of the 2nd week and 4th week, at the beginning of 8th week, at the end of the 10th week and 12th week after commencement of the intervention.]<br>

Secondary Outcome Measures