Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
40 participants
INTERVENTIONAL
2023-12-01
2024-03-01
Brief Summary
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* What are the effects of a combined iCBT and standardized exercise program on pain and function in chronic knee pain patients with psychological distress
* What are the effects of a combined iCBT and standardized exercise program on depression, psychological distress, physical function, quality of life, and quadriceps muscle strength in chronic knee pain patients with psychological distress
* Do a combined iCBT and standardized exercise program significantly improve pain and function in chronic knee pain patients with psychological distress compared to a control group?
* Do a combined iCBT and standardized exercise program significantly improve depression, psychological distress, physical function, QoL, and quadriceps muscles strength in chronic knee pain patients with psychological distress compared to a control group?
Participants will be allocated randomly to either intervention group or control group.
Intervention group will be given iCBT, exercise and educational program, while the control group will be given exercise and educational program only.
Researchers will compare both groups to see if the intervention group improves much better in terms of pain, function and other outcome measures compared to the study group.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intervention Group
Participants in this group will be given 8 sessions of a standardized exercise program, a link to access online educational sessions, in addition to internet based cognitive behavioural therapy sessions.
Standardized Exercise Program
Participants will be asked to attend to the department for 8 supervised physiotherapy sessions designed to strengthen lower limb muscles. Eight sessions were chosen as this number should be able to achieve improvements in pain and function. Standardized exercises sessions will be held once weekly in the health center and will be supervised by the researcher. In addition, participants will be requested to perform the prescribed exercises 3 times per week at home, with 1-2 days rest interval between the exercise's sessions.
The program is comprised of a minimum of 4 and a maximum of 6 individualized lower limb exercises to be performed 4 times per week (once in the health center and 3 times at home). All exercise programs will include at least 2 knee extensor strengthening exercises, 1 hip abductor strengthening exercise, 1 hamstring strengthening exercise, 1 calf strengthening exercise, and 1 other exercise will be chosen based on assessment findings.
Internet based Cognitive Behavioral Therapy
This intervention will be given to participants in intervention group. This is a link to access pre-recorded online sessions of CBT.
The iCBT link contained eight 35- to 45-minute sessions, designed to be completed weekly, each provided an explanation of a cognitive or behavioural pain coping skill. Session 1 provided an overview, including a therapeutic rationale of CBT, followed by training in progressive muscle relaxation. Sessions 2 through 7 taught brief relaxation skills, activity-rest cycling, pleasant activity scheduling, cognitive restructuring, pleasant imagery, and problem-solving. Session 8 consolidated the learnt and taught strategies for long-term skill use. Each session has to be completed within the same week where the physiotherapy session is given.
The researcher has developed a website that contained all the CBT materials.
Educational Materials
All participants will receive a link to access online educational material about chronic knee pain. This is a YouTube link that consists of 5 sessions, with each lasting for 5-7 minutes, and is comprised of general information about the following: healthy eating, osteoarthritis and X-Ray, physical activity, the full pain experience, and proper footwear. Participants will be encouraged to access the educational material at their own leisure and pace.
Control Group
Participants in this group will be given 8 sessions of a standardized exercise program and a link to access online educational sessions.
Standardized Exercise Program
Participants will be asked to attend to the department for 8 supervised physiotherapy sessions designed to strengthen lower limb muscles. Eight sessions were chosen as this number should be able to achieve improvements in pain and function. Standardized exercises sessions will be held once weekly in the health center and will be supervised by the researcher. In addition, participants will be requested to perform the prescribed exercises 3 times per week at home, with 1-2 days rest interval between the exercise's sessions.
The program is comprised of a minimum of 4 and a maximum of 6 individualized lower limb exercises to be performed 4 times per week (once in the health center and 3 times at home). All exercise programs will include at least 2 knee extensor strengthening exercises, 1 hip abductor strengthening exercise, 1 hamstring strengthening exercise, 1 calf strengthening exercise, and 1 other exercise will be chosen based on assessment findings.
Educational Materials
All participants will receive a link to access online educational material about chronic knee pain. This is a YouTube link that consists of 5 sessions, with each lasting for 5-7 minutes, and is comprised of general information about the following: healthy eating, osteoarthritis and X-Ray, physical activity, the full pain experience, and proper footwear. Participants will be encouraged to access the educational material at their own leisure and pace.
Interventions
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Standardized Exercise Program
Participants will be asked to attend to the department for 8 supervised physiotherapy sessions designed to strengthen lower limb muscles. Eight sessions were chosen as this number should be able to achieve improvements in pain and function. Standardized exercises sessions will be held once weekly in the health center and will be supervised by the researcher. In addition, participants will be requested to perform the prescribed exercises 3 times per week at home, with 1-2 days rest interval between the exercise's sessions.
The program is comprised of a minimum of 4 and a maximum of 6 individualized lower limb exercises to be performed 4 times per week (once in the health center and 3 times at home). All exercise programs will include at least 2 knee extensor strengthening exercises, 1 hip abductor strengthening exercise, 1 hamstring strengthening exercise, 1 calf strengthening exercise, and 1 other exercise will be chosen based on assessment findings.
Internet based Cognitive Behavioral Therapy
This intervention will be given to participants in intervention group. This is a link to access pre-recorded online sessions of CBT.
The iCBT link contained eight 35- to 45-minute sessions, designed to be completed weekly, each provided an explanation of a cognitive or behavioural pain coping skill. Session 1 provided an overview, including a therapeutic rationale of CBT, followed by training in progressive muscle relaxation. Sessions 2 through 7 taught brief relaxation skills, activity-rest cycling, pleasant activity scheduling, cognitive restructuring, pleasant imagery, and problem-solving. Session 8 consolidated the learnt and taught strategies for long-term skill use. Each session has to be completed within the same week where the physiotherapy session is given.
The researcher has developed a website that contained all the CBT materials.
Educational Materials
All participants will receive a link to access online educational material about chronic knee pain. This is a YouTube link that consists of 5 sessions, with each lasting for 5-7 minutes, and is comprised of general information about the following: healthy eating, osteoarthritis and X-Ray, physical activity, the full pain experience, and proper footwear. Participants will be encouraged to access the educational material at their own leisure and pace.
Eligibility Criteria
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Inclusion Criteria
2. Depression level of at least 2 out 6 on the PHQ-2 questionnaire and/or psychological distress level (K-6) of at least 7 out of 24
3. Knee pain for more than 3 months and for most days of the previous month
4. A minimum average knee pain intensity of 4 on an 11-point numeric rating scale in the previous week
5. Mild to moderate difficulty with physical activities on KOOS-PS questionnaire, at least 6 out of 24
6. Has a smartphone with internet access.
Exclusion Criteria
2. Awaiting or planning any back or lower limb surgery within the next 12 months
3. Current or past (within 3 months) oral or intra-articular corticosteroid use
4. Current long-term use of analgesics or drugs that cause analgesic effects such as the drugs used for epilepsy and bipolar disorders
5. Systemic arthritic conditions such as rheumatoid arthritis
6. Physiotherapy, chiropractic or acupuncture treatment or exercises specifically for the knee within the past 6 months
7. Walking \>30 min continuously daily or participating in a regular (more than twice a week) exercise program
8. Past participation in a CBT program
9. Inability to walk unaided as this is necessary for some of the physical testing
10. Grade IV on Kellgren and Lawrence grading system for Osteoarthritis classification
11. Medical condition precluding safe exercise such as uncontrolled hypertension or heart condition
12. Major joint pain (e.g., back, hip or ankle) to a greater extent than the knee pain that could limit the ability to exercise
13. Self-reported psychiatric history such as schizophrenia, epilepsy, and bipolar disorders
14. Self-reported diagnosis of current clinical depression
15. Neurological condition such as Parkinson's disease, Multiple sclerosis, or stroke
16. Inadequate written and spoken Arabic
17. Unable to comply with the protocol such as the inability to attend therapy sessions or attend assessment appointments at the health center.
45 Years
70 Years
ALL
No
Sponsors
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University of Bahrain
OTHER
Responsible Party
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Amal Alaradi
Senior Physiotherapist
Principal Investigators
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Amal Alaradi
Role: PRINCIPAL_INVESTIGATOR
Primary Healthcare Centers- Kingdom of Bahrain
Central Contacts
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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iCBTExCKP
Identifier Type: -
Identifier Source: org_study_id
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