SLCTR/2024/021尚未招募Unknown
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
未提供0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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).
排除标准
- •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
- •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.
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