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| ID | Type | Description | Link |
|---|---|---|---|
| 18/YH/0057 | Other Identifier | Research Ethics Committee |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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. |
|
| Control | Placebo Comparator | Will be asked to make no change in the way they normally lie on their mattress when sleeping |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Change in sleeping position | Behavioral | 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. |
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Idle Medical Centre | Bradford | West Yorkshire | BD10 8RU | United Kingdom |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| No change in sleeping position | Behavioral | No change to your normal sleeping position |
|
| D012216 |
| Rheumatic Diseases |