Chronic knee osteoarthritis
Conditions
Interventions
Study setting(s)
Clinical Medicine Academic & Research Centre- National hospital of Sri Lanka.
Randomization
a. Method of randomization - block randomization (1:1 allocation ratio)
b. Unit of rand
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: i. Age 50 or more than 50 years ii. Consultant rheumatologist-confirmed diagnosis of knee osteoarthritis iii. Knee pain for three months or more iv. Overall average knee pain in the last week 40 or more on a 100 mm Visual Analogue Scale v. Participants who are conversant in Sinhala and confirm their ability to read, write, and understand the Sinhala language in order to complete the study measures and understand the content and material delivered through the developed PCSGI sessions, which will be conducted in Sinhala. vi. Access to a telephone or mobile phone to send reminders regarding session attendance and follow- up assessment vii. Participants who are able to read and write, understand and follow the given instructions (e.g., junior secondary education in Sri Lanka - grade 9 or lower in local and international education syllabus)
Exclusion criteria
Exclusion criteria: i. Knee surgery including arthroscopy within the past 6 months ii. Awaiting or planning any back or lower limb surgery within the next 12 months iii. Current or past (within 3 months) oral or intra-articular corticosteroid use iv. Systemic arthritis conditions such as rheumatoid arthritis v. Participation in a psychologically based training program for pain-coping abilities within the previous two years vi. Identified mild cognitive impairment using the Montreal Cognitive Assessment-Sinhala version test score of less than 26 vii. Have received a confirmed diagnosis of a mental illness and any underlying neurological issues from a consultant psychiatrist or a neurologist viii. Patients with cancer pain ix. Utilizing alternative therapy modalities such as Ayurveda medicine, native medicine, homoeopathic medication, acupuncture treatment, or exercises designed specifically for the knee over the past six months and currently.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Decreased levels of perceived Pain as indicated through the Visual Analogue Scale (VAS) [The primary outcomes will be measured at 3-time points: Baseline (prior to the commencement of the intervention), post-intervention (just after termination of the six sessions of the intervention) and follow-up (after 3-months of the termination of the intervention)] 2. Decreased levels of psychological distress in intervention group participants as indicated through decreased sub-scale scores of depression, anxiety and stress as assessed through the Depression, Anxiety and Stress Scale (DASS-21) [The primary outcomes will be measured at 3-time points: Baseline (prior to the commencement of the intervention), post-intervention (just after termination of the six sessions of the intervention) and follow-up (after 3-months of the termination of the intervention) ] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Increase levels of cognitive and behavioral coping strategies will be measured using the Coping Strategies Questionnaire (CSQ) [The secondary outcomes will be measured at 3-time points: Baseline (prior to the commencement of the intervention), post-intervention (just after termination of the six sessions of the intervention) and follow-up (after 3-months of the termination of the intervention) ] 2. Increased levels of Quality of Life will be measured through the World Health Organization Quality of Life Questionnaire [The secondary outcomes will be measured at 3-time points: Baseline (prior to the commencement of the intervention), post-intervention (just after termination of the six sessions of the intervention) and follow-up (after 3-months of the termination of the intervention) ] | — |
Countries
Sri Lanka
Contacts
Public ContactMedhavi Gunasekara
Clinical Psychologist
Outcome results
None listed