Open-Label, Randomized Controlled Trial to Investigate the outcome of a Cognitive Behavior Therapy based - Pain Coping Skills Psychological Intervention in Relieving Pain and Psychological Distress in Sinhala-conversant Patients with Chronic Knee Osteoarthritis’
- Conditions
- Chronic knee osteoarthritis
Recruitment & Eligibility
- Status
- Complete: follow up continuing
- Sex
- Not specified
- Target Recruitment
- Not specified
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)
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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)]<br>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)<br>]<br>
- Secondary Outcome Measures
Name Time Method 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)<br>]<br>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)<br>]<br>