Chronic Knee PainiCBTNCT06133738
Effects of iCBT and Exercise for Chronic Knee Patients
A study testing Standardized Exercise Program, Internet based Cognitive Behavioral Therapy and Educational Materials in people with Chronic Knee Pain, run by University of Bahrain.
Trial summary
The goal of this clinical trial is to study the effects of using an internet-based cognitive behavioural therapy (iCBT) program and exercise in chronic knee patients with psychological distress. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Chronic Knee Pain
- What is being tested?
- Standardized Exercise Program, Internet based Cognitive Behavioral Therapy and Educational Materials
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 45 years
- 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
- Knee pain for more than 3 months and for most days of the previous month
- A minimum average knee pain intensity of 4 on an 11-point numeric rating scale in the previous week
- Mild to moderate difficulty with physical activities on KOOS-PS questionnaire, at least 6 out of 24
- Has a smartphone with internet access.
Who cannot join
- Knee surgery including arthroscopy within the past 6 months
- Awaiting or planning any back or lower limb surgery within the next 12 months
- Current or past (within 3 months) oral or intra-articular corticosteroid use
- Current long-term use of analgesics or drugs that cause analgesic effects such as the drugs used for epilepsy and bipolar disorders
- Systemic arthritic conditions such as rheumatoid arthritis
- Physiotherapy, chiropractic or acupuncture treatment or exercises specifically for the knee within the past 6 months
Show all 17Show fewer
- Walking >30 min continuously daily or participating in a regular (more than twice a week) exercise program
- Past participation in a CBT program
- Inability to walk unaided as this is necessary for some of the physical testing
- Grade IV on Kellgren and Lawrence grading system for Osteoarthritis classification
- Medical condition precluding safe exercise such as uncontrolled hypertension or heart condition
- Major joint pain (e.g., back, hip or ankle) to a greater extent than the knee pain that could limit the ability to exercise
- Self-reported psychiatric history such as schizophrenia, epilepsy, and bipolar disorders
- Self-reported diagnosis of current clinical depression
- Neurological condition such as Parkinson's disease, Multiple sclerosis, or stroke
- Inadequate written and spoken Arabic
- Unable to comply with the protocol such as the inability to attend therapy sessions or attend assessment appointments at the health center.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effectiveness of an Internet-Based Cognitive Behavioural Therapy and Exercise in Chronic Knee Patients With Psychological Distress: Clinical Trail Protocol
The goal of this clinical trial is to study the effects of using an internet-based cognitive behavioural therapy (iCBT) program and exercise in chronic knee patients with psychological distress. The main question[s] it aims to answer are:
- 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?
Read more
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.
Read the detailed description
This will be a 2-arm quasi-randomized controlled trial of eight weeks of intervention involving eight sessions of standardized exercise program and either concomitant iCBT and educational sessions or educational sessions only. Measurements will be taken at baseline and eight weeks immediately following the intervention. Primary outcome measures are a numerical pain rating scale, 40-m Fast-Paced Walk Test, Step Test, and 30 seconds Chair Stand Test. Secondary outcome measures are Patient Health Questionnaire, Psychological Distress, Knee Injury and Osteoarthritis Outcome Score Physical Function Short Form, Health-Related Quality of Life-Short Form-12, and Quadriceps Maximum Isometric Muscle Strength.
- Conditions
- Chronic Knee Pain
- Being tested
- Standardized Exercise Program, Internet based Cognitive Behavioral Therapy, Educational Materials
- Keywords
- Internet Based Cognitive Behavioural Therapy, Psychological Distress, Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Exercise ProgramOther
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 TherapyOther
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 MaterialsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Other: Standardized Exercise Program; Other: Internet based Cognitive Behavioral Therapy; Other: Educational Materials |
| Control Group | Active comparator | Participants in this group will be given 8 sessions of a standardized exercise program and a link to access online educational sessions. Receives: Other: Standardized Exercise Program; Other: Educational Materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Single-Item Numerical Rating Scale (NRS)
Participants will be asked to rate their average knee pain in the past week on a scale from 0 to 10, with '0' meaning 'No pain' and '10' meaning 'Pain as bad as you can imagine'. This will be recorded via online form.
Measured: 8 weeks
40-m Fast-Paced Walk Test (40-m FPWT)
A participant will be instructed to walk as quickly but as safely as possible to a mark 10 m away, return, and repeat for a total distance of 40 m. Time of one trial, with turn time excluded, will be recorded and expressed as speed m/s by dividing distance (40 m) by time (s).
Measured: 8 weeks
Step Test (ST)
This test will be performed while the participant maintains balance on the study limb, then the contralateral foot will be stepped on and off a 15-cm step as many times as possible within 15 seconds. The count of the number of times the participant could step the foot up and return it to the floor over a 15-s interval will be recorded. The test will performed with no hand support allowed. For participants with unilateral knee OA, the test will be performed while standing on the affected side. For participants with bilateral knee OA, the most symptomatic limb will be considered the osteoarthritic limb for the purpose of this study.
Measured: 8 weeks
30 seconds Chair Stand Test (30s CTS test)
From the sitting position in the middle of seat with feet shoulder-width apart, flat on the floor, arms crossed at chest, a participant will be asked to stand completely up, then sit completely back down, repeatedly for 30s. The chair will be against a wall. Count the total number of complete chair stands (up and down represents one stand) of one trial. If a full stand is completed at 30s then this is counted in the total. The same chair is used for re-testing.
Measured: 8 weeks
Secondary outcomes (5)
Patient Health Questionnaire (PHQ-2)
This is a 2-item scale for depression screening in primary care. This questionnaire will be administered via online forms. A PHQ-2 score ranges from 0-6, with 0 indicating the lowest level of depression, and 6 indicating the highest level of depression.
Measured: 8 weeks
Psychological Distress (Kessler 6)
This is a 6-item self-report questionnaire that measures psychological distress based on anxiety and depressive symptoms in the patient's most recent 4-week period. The range for summed responses on the K6 Scale is 0 to 24, with 0 suggesting the lowest level of nonspecific psychological distress, and 24 suggesting the highest level of nonspecific psychological distress. This questionnaire will be administered via online forms.
Measured: 8 weeks
Knee Injury and Osteoarthritis Outcome Score Physical Function Short Form (KOOS- PS)
This is a 7-item measure of physical function derived from the items of the Function, daily living and Function, sports, and recreational activity subscales of the KOOS. It will be administered through an online survey. The range for summed responses on the KOOS-PS is 0 to 24, where 24 is the worst possible and 0 is the best possible score. This questionnaire will be administered via online forms.
Measured: 8 weeks
Health-Related Quality of Life-Short Form-12 (SF-12)
This is a questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health-related QoL. Scores range from 0 to 50, with higher scores indicating better health status. It will be administered through an online survey.
Measured: 8 weeks
Maximum Isometric Muscle Strength
Maximal voluntary isometric quadriceps muscle strength will be assessed using a hand-held dynamometer. To do the test, a participant is seated on an examination table with their knees flexed to 60° and their feet off the ground. The hand-held dynamometer is positioned on the anterior aspect of the distal tibia, just superior to the malleoli. The participant grasps the examination table with his/her hands for stabilization, and the participant is instructed to extend his/her knee "as hard as possible" into the hand-held dynamometer. The participant continues to exert force into the hand-held dynamometer for 4 s, and the maximum force across the trial is recorded. Three testing trials will be completed, and the average force (Newtons [N]) across the three trials will be normalized to body mass (N/kg).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Knee PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a 2-arm quasi-randomized controlled trial of eight weeks of intervention involving eight sessions of standardized exercise program and either concomitant iCBT and educational sessions or educational sessions only. Measurements will be taken at baseline and eight weeks immediately following the intervention. Primary outcome measures are a numerical pain rating scale, 40-m Fast-Paced Walk Test, Step Test, and 30 seconds Chair Stand Test. Secondary outcome measures are Patient Health Questionnaire, Psychological Distress, Knee Injury and Osteoarthritis Outcome Score Physical Function Short Form, Health-Related Quality of Life-Short Form-12, and Quadriceps Maximum Isometric Muscle Strength.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bahrain
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amal Alaradi, University of Bahrain
- Investigators
- Amal Alaradi, Principal investigator, Primary Healthcare Centers- Kingdom of Bahrain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06133738
- Sponsor's protocol ID
- iCBTExCKP
- Acronym
- iCBT
- Status last verified
- Nov 2023
- First submitted
- 6 Nov 2023
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of an Internet-Based Cognitive Behavioural Therapy and Exercise in Chronic Knee Patients With Psychological Distress: Clinical Trail Protocol
- ClinicalTrials.gov ID
- NCT06133738
- Acronym / sponsor ID
- iCBT / iCBTExCKP
- Conditions
- Chronic Knee Pain
- Keywords
- Internet Based Cognitive Behavioural Therapy, Psychological Distress, Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of BahrainUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 15 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to study the effects of using an internet-based cognitive behavioural therapy (iCBT) program and exercise in chronic knee patients with psychological distress. The main question[s] it aims to answer are:
- 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.
Detailed description
This will be a 2-arm quasi-randomized controlled trial of eight weeks of intervention involving eight sessions of standardized exercise program and either concomitant iCBT and educational sessions or educational sessions only. Measurements will be taken at baseline and eight weeks immediately following the intervention. Primary outcome measures are a numerical pain rating scale, 40-m Fast-Paced Walk Test, Step Test, and 30 seconds Chair Stand Test. Secondary outcome measures are Patient Health Questionnaire, Psychological Distress, Knee Injury and Osteoarthritis Outcome Score Physical Function Short Form, Health-Related Quality of Life-Short Form-12, and Quadriceps Maximum Isometric Muscle Strength.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This will be a 2-arm quasi-randomized controlled trial of eight weeks of intervention involving eight sessions of standardized exercise program and either concomitant iCBT and educational sessions or educational sessions only. Measurements will be taken at baseline and eight weeks immediately following the intervention. Primary outcome measures are a numerical pain rating scale, 40-m Fast-Paced Walk Test, Step Test, and 30 seconds Chair Stand Test. Secondary outcome measures are Patient Health Questionnaire, Psychological Distress, Knee Injury and Osteoarthritis Outcome Score Physical Function Short Form, Health-Related Quality of Life-Short Form-12, and Quadriceps Maximum Isometric Muscle Strength.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Standardized Exercise Program, Other: Internet based Cognitive Behavioral Therapy, Other: Educational MaterialsParticipants 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. |
| Control Group | Active comparator | Other: Standardized Exercise Program, Other: Educational MaterialsParticipants in this group will be given 8 sessions of a standardized exercise program and a link to access online educational sessions. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 45 years
- 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
- Knee pain for more than 3 months and for most days of the previous month
- A minimum average knee pain intensity of 4 on an 11-point numeric rating scale in the previous week
- Mild to moderate difficulty with physical activities on KOOS-PS questionnaire, at least 6 out of 24
Key exclusion criteria (17 listed)
- Knee surgery including arthroscopy within the past 6 months
- Awaiting or planning any back or lower limb surgery within the next 12 months
- Current or past (within 3 months) oral or intra-articular corticosteroid use
- Current long-term use of analgesics or drugs that cause analgesic effects such as the drugs used for epilepsy and bipolar disorders
- Systemic arthritic conditions such as rheumatoid arthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized Exercise ProgramParticipants 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. | Other | Control Group, Intervention Group |
| Internet based Cognitive Behavioral TherapyThis 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. | Other | Intervention Group |
| Educational MaterialsAll 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. | Other | Control Group, Intervention Group |
Primary outcome
The Single-Item Numerical Rating Scale (NRS)
Time frame: 8 weeks
Participants will be asked to rate their average knee pain in the past week on a scale from 0 to 10, with '0' meaning 'No pain' and '10' meaning 'Pain as bad as you can imagine'. This will be recorded via online form.
40-m Fast-Paced Walk Test (40-m FPWT)
Time frame: 8 weeks
A participant will be instructed to walk as quickly but as safely as possible to a mark 10 m away, return, and repeat for a total distance of 40 m. Time of one trial, with turn time excluded, will be recorded and expressed as speed m/s by dividing distance (40 m) by time (s).
Step Test (ST)
Time frame: 8 weeks
This test will be performed while the participant maintains balance on the study limb, then the contralateral foot will be stepped on and off a 15-cm step as many times as possible within 15 seconds. The count of the number of times the participant could step the foot up and return it to the floor over a 15-s interval will be recorded. The test will performed with no hand support allowed. For participants with unilateral knee OA, the test will be performed while standing on the affected side. For participants with bilateral knee OA, the most symptomatic limb will be considered the osteoarthritic limb for the purpose of this study.
30 seconds Chair Stand Test (30s CTS test)
Time frame: 8 weeks
From the sitting position in the middle of seat with feet shoulder-width apart, flat on the floor, arms crossed at chest, a participant will be asked to stand completely up, then sit completely back down, repeatedly for 30s. The chair will be against a wall. Count the total number of complete chair stands (up and down represents one stand) of one trial. If a full stand is completed at 30s then this is counted in the total. The same chair is used for re-testing.
5 secondary outcomes
Patient Health Questionnaire (PHQ-2)
Time frame: 8 weeks
Psychological Distress (Kessler 6)
Time frame: 8 weeks
Knee Injury and Osteoarthritis Outcome Score Physical Function Short Form (KOOS- PS)
Time frame: 8 weeks
Health-Related Quality of Life-Short Form-12 (SF-12)
Time frame: 8 weeks
Maximum Isometric Muscle Strength
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amal Alaradi principal investigator
Primary Healthcare Centers- Kingdom of Bahrain
Questions about this trial
What is this clinical trial studying?
A study testing Standardized Exercise Program, Internet based Cognitive Behavioral Therapy and Educational Materials in people with Chronic Knee Pain, run by University of Bahrain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amal Alaradi, MSc (+97336366300, to.alaradi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Single-Item Numerical Rating Scale (NRS) (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.