Reducing Knee Compression When Sleeping in Those With Knee OA
Reducing Knee Compression Loading When Sleeping Supine (on the Back): Benefits in Patients With Knee Osteoarthritis
2 other identifiers
interventional
51
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2018
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 10, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 10, 2018
CompletedFirst Submitted
Initial submission to the registry
November 27, 2019
CompletedFirst Posted
Study publicly available on registry
December 5, 2019
CompletedDecember 5, 2019
December 1, 2019
9 months
November 27, 2019
December 4, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
change in KOOS Knee (other sub-scales)
baseline and 3 months (post intervention)
Study Arms (2)
Intervention
EXPERIMENTALWill 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 COMPARATORWill be asked to make no change in the way they normally lie on their mattress when sleeping
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Idle Medical Centre
Bradford, West Yorkshire, BD10 8RU, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 27, 2019
First Posted
December 5, 2019
Study Start
March 19, 2018
Primary Completion
December 10, 2018
Study Completion
December 10, 2018
Last Updated
December 5, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share