Clinical trial NCT04188054: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis, Knee
Lead sponsor: University of Bradford
Sponsor class: OTHER
First posted: 2019-12-05
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: change in KOOS Knee Pain
timeFrame: baseline and 3 months (post intervention)
Secondary outcomes:
measure: change in KOOS Knee (other sub-scales)
timeFrame: baseline and 3 months (post intervention)
Other outcomes:
Locations:
city: Bradford
country: United Kingdom
facility: Idle Medical Centre
state: West Yorkshire
Study officials:
References: