Trial of 2 conservative therapies for knee arthritis patients

Phase 3

Completed

• Conditions: mild and moderate grade of Knee osteoarthritis

• Registration Number: CTRI/2014/01/004270
• Lead Sponsor: not applicable

Brief Summary

Knee osteoarthritis (KOA) is one of the common cause of disability after fourth decade of life. In India, its prevalence has been reported to be in the range of 17-61% among people aged above 50 years. Intractable pain is the most common symptom of KOA. Quality of life (QOL) of KOA patients significantly deteriorates with pain and loss of mobility causing dependence and disability. There is no permanent cure for KOA. However, long-term effects of early to moderate KOA can be managed through non surgical interventions. This includes use of non-pharmacological interventions (NPIs) comprising of patient education, a set of exercises and weight reduction etc.These are often used in conjunction with a pharmacological regimen.

In contrast to the situation in western countries, where research has been regularly conducted to evaluate the relative impact of combining a variety of non pharmacological interventions on KOA, there has not been any systematic effort in India on these lines.

**Objectives:**

Primary:

i)       To compare the impact of two non pharmacological intervention packages on quality of life in KOA patients reporting at PGIMER Chandigarh.

Secondary:

i)           To enlist and compare the components of various NPIs being prescribed to KOA patients in India.

ii)            To explore the opinion of clinicians regarding the potential effectiveness of various NPIs being used for KOA patients including that of the package developed for this study

iii)           To document the difficulties/problems faced by KOA patients in complying with the instructions pertaining to the NPIs given in the hospital.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-10
• Study Completion: 2015-02-02
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• 1.Self-reported knee pain 2.Radiological /clinical grade 1, 2, 3 as per Kellgren Lawrence scale (table.
• ) certified by clinician. 3.Demonstrated minimal knee OA related dysfunction as per WOMAC score 4.Motivated and willing to alter their lifestyle and able to comply with the planned schedule for follow up.

Exclusion Criteria

• 1.Candidates for surgery due to deformity or intra –articular pathology 2.Excessive obesity (BMI>40)or any co-morbidity not allowing proper exercise protocol 3.Unresolved balance disorder 4.Unresolved neurological disorder 5.History of knee surgery or knee trauma 6.Hip or ankle instability, excessive weakness 7.Hip or knee replacement 8.Intra-articular joint injection within 4 weeks of the study 9.Inadequate communication skills in Hindi /Punjabi 10.Illiterate (nor have any literate caregivers) 11.Unable to comply with exercise protocol.
• Participants will also be excluded if they have a significant medical condition that will increase their risk of a significant adverse health event during physical activity (eg, myocardial infarction in the previous 6 months, abnormal blood pressure response to exercise, etc.); have any other known organic disease that would contraindicate safe participation in the study (eg, cancer); have a non-OA inflammatory arthropathy or another arthritic disorder (eg, rheumatoid arthritis); use oral corticosteroids regularly.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•Quality of life	visit 0- visit 26
• 50-Foot Timed Walk,	visit 0- visit 26
•Measure of function	visit 0- visit 26
•Visual analogue scale	visit 0- visit 26
•30-second Chair Stand Test	visit 0- visit 26
•Timed up and go test	visit 0- visit 26
•BMI	visit 0- visit 26

Secondary Outcome Measures

Name	Time	Method
1.Difficulties faced by participants in complying with the intervention package.	2.Impact of KOA on daily routine, treatment taken by different agencies

Trial Locations

Locations (1)

ORTHOPAEDICS OPD PGIMER CHANDIGARH; 🇮🇳 Chandigarh, CHANDIGARH, India

ORTHOPAEDICS OPD PGIMER CHANDIGARH

🇮🇳Chandigarh, CHANDIGARH, India

Dr Meenakshi

Principal investigator

9463595993

MNXMPH@GMAIL.COM