Reducing Knee Compression When Sleeping in Those With Knee OA

University of Bradford

Status and phase: Completed; Phase 2

Conditions: Osteoarthritis, Knee

Treatments: Behavioral: No change in sleeping position; Behavioral: Change in sleeping position

Study type: Interventional

Funder types: Other

Identifiers

NCT04188054

18/YH/0057 (Other Identifier)

IRAS 241876

Details and patient eligibility

About

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).

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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51 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

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.

Treatment:

Behavioral: Change in sleeping position

Control

Placebo Comparator group

Description:

Will be asked to make no change in the way they normally lie on their mattress when sleeping

Treatment:

Behavioral: No change in sleeping position