Reducing Knee Compression When Sleeping in Those With Knee OA
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Change in sleeping position
No change in sleeping position
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee
Eligibility Criteria
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.
Sites / Locations
- Idle Medical Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention
Control
Arm Description
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.
Will be asked to make no change in the way they normally lie on their mattress when sleeping
Outcomes
Primary Outcome Measures
change in KOOS Knee Pain
Knee injury and Osteoarthritis Outcome Scores (KOOS) - sub-scale Pain, from 0 (worst) to 100 (best)
Secondary Outcome Measures
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)
Full Information
NCT ID
NCT04188054
First Posted
November 27, 2019
Last Updated
December 4, 2019
Sponsor
University of Bradford
1. Study Identification
Unique Protocol Identification Number
NCT04188054
Brief Title
Reducing Knee Compression When Sleeping in Those With Knee OA
Official Title
Reducing Knee Compression Loading When Sleeping Supine (on the Back): Benefits in Patients With Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
March 19, 2018 (Actual)
Primary Completion Date
December 10, 2018 (Actual)
Study Completion Date
December 10, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bradford
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Will be asked to make no change in the way they normally lie on their mattress when sleeping
Intervention Type
Behavioral
Intervention Name(s)
Change in sleeping position
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
No change in sleeping position
Intervention Description
No change to your normal sleeping position
Primary Outcome Measure Information:
Title
change in KOOS Knee Pain
Description
Knee injury and Osteoarthritis Outcome Scores (KOOS) - sub-scale Pain, from 0 (worst) to 100 (best)
Time Frame
baseline and 3 months (post intervention)
Secondary Outcome Measure Information:
Title
change in KOOS Knee (other sub-scales)
Description
Knee injury and Osteoarthritis Outcome Scores (KOOS) subscales: Symptoms; Activities-of-Daily-Living; Quality-of-Life, from 0 (worst) to 100 (best)
Time Frame
baseline and 3 months (post intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Idle Medical Centre
City
Bradford
State/Province
West Yorkshire
ZIP/Postal Code
BD10 8RU
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
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Reducing Knee Compression When Sleeping in Those With Knee OA
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