Does a pain coping skills psychological intervention delivered by physiotherapists and occupational therapists offer greater relief from pain and psychological distress (Depression, Anxiety and Stress) compared to standard care in Sinhala-conversant patients with chronic knee osteoarthritis?

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 pain coping skills group intervention (PCSGI) involves six-weekly (one per week) group sessions, approximately 50-60 minutes each, delivered by a either occupational therapists (OT) or physiotherapists (PT) who are trained by a licensed clinical psychologist one to one. The PCSGI therapist manual provides a session-by-session plan for a cognitive behaviour therapy-based psychological intervention. Participants are provided with handouts to facilitate each session, along with an audio recording to guide relaxation techniques.

Session title, tasks and skills learned in each session, and time duration for each task of the pain coping skills intervention.

Week 01 :Pre-group planning and orientation to the pain coping skills intervention
Chronic pain education - provide a brief overview of the cognitive behavior chronic pain model Goal setting and homework
Obtaining participants feedback and answer their questions (Q & A session)

Week 02 Relaxation techniques
Discuss week 1 homework
Pre-preparation instructions for relaxation techniques Discuss benefits of relaxation
Practicing relaxation techniques
Homework, Q & A session

Week 03 Exercise and Pacing; pleasant activity scheduling Discuss week 2 homework
Education on pacing and over activity cycle
Exploring pleasant activities Learning on benefits of pleasant activities
Preparing a pleasant activity schedule
Homework, Q & A session

Week 04 Identify Negative Automatic Thoughts
Discuss week 3 homework
Teaching relationship between thoughts, emotions and chronic pain
Training on identifying negative automatic thoughts (provide examples)
Homework, Q & A session

Week 05 Cognitive coping and calming self-statements
Discuss week 4 homework
Challenging negative automatic thoughts
Learning self-statements
Homework, Q & A session
Early preparation for the termination

Week 06 Termination of Pain Coping Skills Intervention
Discuss week 5 homework
Review of progress
Education on coping with flare-ups
Termination, Q & A session

The Q & A session will be a brief 5 to 10-minute discussion between patients and the PT/OT regarding the session they conducted.

Randomization and Group Allocation: Patients will be randomly assigned into one of three groups using a computer-generated random number table with a 1:1:1 allocation ratio:

Group 1 - PT Delivered PCSGI This group will receive PCSGI by PT alongside standard Treatment as Usual (TAU).

Group 2 – OT Delivered PCSGI This group will receive PCSGI by OT alongside standard Treatment as Usual.

Group 3 - Waitlist Control Group This group will receive standard TAU only. Once the trial is over, they will be offered the PCSGI.

Standard Treatment as Usual (TAU): TAU includes pharmacological treatments, physiotherapy, occupational therapy, and other medical treatments by the consultant rheumatologist and clinic staff. The principal investigator will not influence TAU.

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.