BEhaviour change for People with clinically diagnosed Knee Osteoarthritis: A pragmatic trial (BEPKO-3)
Knee osteoarthritis
Participants will then be randomly assigned to one of two groups. This assignment is done using a process called randomisation, which is similar to flipping a coin. It ensures that each participant has an equal chance of being placed in either group. This helps make the results fair and unbiased. The randomisation is done by a computer programme, not by the researchers, so no one can influence which group a participant goes into. The process also considers which hospital or clinic the participant is attending, to make sure both groups are balanced across different locations. Participants will be told which group they are in, after the randomisation is complete. The researchers collecting follow-up data will not know which group each participant is in, to help keep the results as objective as possible. Group 1 will receive CMT which involves seven one-hour sessions with a trained physiotherapist over 7–9 weeks. The treatment includes education about pain, relaxation techniques, and exercises to reduce muscle overactivity. Participants will also be given online or paper materials (dependent on preference) to support home practice. Group 2will be advised to continue with their current NHS care as if there were not in the trial. All participants, regardless of group, will be asked to complete follow-up questionnaires at 6 months and 12 months, after starting the study. These questionnaires will measure pain, function, quality of life, and healthcare use. Participants may complete these online, by post, or over the phone. Researchers will follow a reminder schedule when contacting participants about questionnaire completion. Some participants and physiotherapists will also be invited to take part in interviews or focus groups to share their experiences of the treatment and the study. Participants can withdraw at any time. If they stop the treatment, they will still be invited to complete the follow-up questionnaires.
1. Aged 45 years or older. (KOA is most common in people over 45 and used in NICE criteria for knee osteoarthritis) 2. Activity-related joint pain (These are typical clinical signs of knee osteoarthritis and help confirm the diagnosis without needing an X-ray) 3. Morning stiffness lasting less than 30 minutes. (These are typical clinical signs of knee osteoarthritis and help confirm the diagnosis without needing an X-ray) 4. Score 4 or more (out of 20) on the WOMAC pain scale. (This ensures participants have a minimum level of pain, making it possible to detect meaningful improvements from the intervention) 5. Knee pain lasting more than 6 months. (This ensures participants have a long-term condition and are not experiencing temporary or acute symptoms) 6. Have tried therapeutic exercise and are dissatisfied with the outcome. (CMT is designed as a second-line treatment for people who have not responded well to exercise therapy, which is the first recommended treatment for knee OA) 7. Able to stand for 5 minutes and walk independently with no more than one walking stick or elbow crutch. (The intervention involves physical tasks such as standing, walking, and stair climbing. Participants need a basic level of mobility to safely take part) 8. Able to attend for seven hour-long intervention sessions with a physiotherapist (to receive the intervention)
1. Body Mass Index (BMI) over 33 kg/m². (Excess body fat can interfere with the equipment used to measure muscle activity (electromyography), which is essential for the treatment) 2. Systemic inflammatory arthritis (e.g. rheumatoid arthritis). (This is a different type of joint condition that requires other forms of treatment and may respond differently to the intervention) 3. Diagnosis of a widespread pain condition (e.g. fibromyalgia). (These conditions involve pain throughout the body and may not benefit from a treatment focused specifically on the knee) 4. Neurological disorders. (These conditions may affect movement and safety during the physical parts of the treatment) 5. Diagnosis of dementia and score > 17 on the Telephone-Mini mental state examination (T-MMSE). (Participants need be able to understand intervention materials to benefit. If dementia is diagnosed, we will assess severity using the T-MMSE and include those with mild impairment) 6. Unable to speak English well enough to understand the treatment and complete study tasks (The treatment involves detailed explanations and guided exercises. Participants need to understand instructions clearly to benefit and stay safe. We have no budget to translate intervention materials or pay translators)