Reducing Knee Compression When Sleeping in Those With Knee OA

Study Overview
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Brief Summary
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To determine whether a change in sleeping position so as to prevent the knee being 'pushed' into full extension when lying supine provides pain relief and/or symptom improvement in individuals with knee osteoarthritis (OA).

Detailed Description
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Only those who normally sleep lying on their back will be recruited. Participants will be recruited into two groups: Group 1, 'intervention'; Group 2, 'control'. Participants in group 1 will be asked to change the position they lie on their bed when sleeping; that is, to re-position themselves when lying on their back so that their feet (and ankles) hang over the end of the mattress. Participants in group 2 will be asked to make no change in the way they normally lie on their mattress when sleeping. Participants will be asked to complete a questionnaire, asking them about the pain and/or discomfort they are currently experiencing, and their current level of physical functioning. The questionnaire used will be the Knee Injury and Osteoarthritis Outcome Score (KOOS) which has been widely used to assess intervention outcomes in individuals with knee OA. They will be asked to complete this questionnaire three times over a 4-month period; for Group 1 this will be before (x2) and after (x1) changing to the new sleeping position (i.e. day of consent, 1 month later on day of change, and 3 months after change); for Group 2 this will be matching the intervals in the intervention group. The primary outcome measure will be the KOOS Pain score, which will be compared pre and post- changing to the new sleeping position.

Official Title
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Reducing Knee Compression Loading When Sleeping Supine (on the Back): Benefits in Patients With Knee Osteoarthritis

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Behavioral: Change in sleeping position
* Behavioral: No change in sleeping position


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: presence of mild, moderate or severe tibiofemoral-OA (radiologically determined in either or both knees) regularly (routinely) spend periods lying on their back when sleeping. Exclusion Criteria: those with: rheumatoid arthritis chronic cardiopulmonary problems lower-limb joint(or joint surface) replacement and/or previous knee surgery within previous 12 months unable to lie supine in bed (medical or practical reason) diagnosed with inflammatory arthropathy peripheral neuropathy or other sensory problems steroid injection in the knee within previous 3 months under 18 years of age unable to give consent due to lack of mental capacity currently involved in any research study related to knee OA.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Will be asked to change the position they lie on their bed when sleeping; that is, to re-position themselves when lying on their back so that their feet (and ankles) hang over the end of the mattress. | Behavioral: Change in sleeping position<br>* The new sleeping position requires you to re-position yourself in your bed when lying on your back so that your feet (and ankles) hang over the end of the mattress, i.e. off the end of the bed.<br>|
| Placebo Comparator: Control<br>Will be asked to make no change in the way they normally lie on their mattress when sleeping | Behavioral: No change in sleeping position<br>* No change to your normal sleeping position<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in KOOS Knee Pain | Knee injury and Osteoarthritis Outcome Scores (KOOS) - sub-scale Pain, from 0 (worst) to 100 (best) | baseline and 3 months (post intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in KOOS Knee (other sub-scales) | Knee injury and Osteoarthritis Outcome Scores (KOOS) subscales: Symptoms; Activities-of-Daily-Living; Quality-of-Life, from 0 (worst) to 100 (best) | baseline and 3 months (post intervention) |