Open-Label, Randomized Controlled Trial to Investigate Physiotherapist and Occupational Therapist Delivered Pain Coping Skills Psychological Intervention Versus Standard Care in Relieving Pain and Psychological Distress in Sinhala-conversant Patients with Chronic Knee Osteoarthritis
- Conditions
- Chronic knee osteoarthritis
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- Not specified
i.Males and Females with an age greater than or equal to 50 years
ii.Diagnosis of knee osteoarthritis, verified by the consultant rheumatologist, adhering to criteria
established by the American College of Rheumatology (presence of crepitus and morning stiffness
lasting more than 30 minutes, accompanied by bony enlargement; or presence of crepitus and
morning stiffness lasting 30 minutes or less; or absence of crepitus and presence of bony
enlargement).
[Note: As the principal investigator's expertise lies in clinical psychology, diagnosis confirmation for
study recruitment will be conducted by a Consultant Rheumatologist (co-investigator).
iii.Knee pain for greater than or equal to three months (IASP Task Force on Taxonomy, 1994)
iv.Overall average knee pain in the last week of greater than 40 on a 100 mm Visual Analogue Scale
[Note: Stratified sampling by pain severity will be incorporated during participant recruitment to
ensure baseline comparability of pain severity among the three study groups].
v.Participants must be conversant in Sinhala and confirm their ability to read, write, and understand the
Sinhala language. This is essential for completing study measures and comprehending the delivered
through the intervention sessions, which will be conducted in Sinhala.
vi.Participants must have access to a telephone or mobile phone to receive reminders related to
session attendance and follow-up assessments
vii.Participants must possess the ability to read and write, understand, and follow given instructions,
equivalent to 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. However, patients with mild, unrelated neurological issues,
such as carpal tunnel syndrome, are not excluded
viii.Patients with cancer pain
ix.Utilizing alternative therapy modalities such as Ayurveda medicine, native medicine, homeopathic
medication, acupuncture treatment, or exercises designed specifically for the knee learned from non-
professional sources, such as family, friends, or online videos over the past six months and currently.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The Visual Analogue Scale (VAS) - change in mean pain intensity scores from baseline to post-intervention and follow-up assessments. <br> [The primary outcomes will be measured at 3-time points: Baseline (before 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>The Depression, Anxiety and Stress Scale (DASS-21) - changes in mean depression, anxiety, and stress levels by calculating the difference in total scores between baseline and post-intervention/follow-up assessments. [ The primary outcomes will be measured at 3-time points: Baseline (before 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>
- Secondary Outcome Measures
Name Time Method The Coping Strategies Questionnaire (CSQ) - change in mean scores from baseline to post-intervention/follow-up assessments. [The secondary outcomes will be measured at 3-time points: Baseline (before 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> The World Health Organization Quality of Life Questionnaire (WHOQOL-BREF) -<br>changes in mean scores from baseline to post-intervention/follow-up assessments<br> [ The secondary outcomes will be measured at 3-time points: Baseline (before 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>