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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
SLCTR
Registry ID
SLCTR/2024/021
Enrollment
Unknown
Registered
2024-06-17
Start date
2024-06-17
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic knee osteoarthritis

Interventions

Study setting: Department of Rheumatology and Rehabilitation (special unit) at the National Hospital of Sri Lanka (NHSL), Colombo and Clinical Medicine and Research Centre (ClinMARC), NHSL. The pai
pleasant activity scheduling Discuss week 2 homework Education on pacing and over activity cycle Exploring pleasant activities Learning on benefits of pleasant acti

Sponsors

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 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).

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. 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.

Design outcomes

Primary

MeasureTime frame
The Visual Analogue Scale (VAS) - change in mean pain intensity scores from baseline to post-intervention and 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)] 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)]

Secondary

MeasureTime frame
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)] The World Health Organization Quality of Life Questionnaire (WHOQOL-BREF) - changes 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)]

Countries

Sri Lanka

Contacts

Public ContactMedhavi Gunasekara

Clinical Psychologist

medhavi.gunasekara@gmail.com+94 77 100 2321

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026