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Completed

NCT Number: NCT04188054

Reducing Knee Compression When Sleeping in Those With Knee OA

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).

Completed

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Idle Medical Centre

Bradford, West Yorkshire, BD10 8RU, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

No change in sleeping position

Behavioral

No change to your normal sleeping position

Primary outcomes

  1. change in KOOS Knee Pain

    Time frame: baseline and 3 months (post intervention)

    Knee injury and Osteoarthritis Outcome Scores (KOOS) - sub-scale Pain, from 0 (worst) to 100 (best)

Secondary outcomes

  1. change in KOOS Knee (other sub-scales)

    Time frame: baseline and 3 months (post intervention)

    Knee injury and Osteoarthritis Outcome Scores (KOOS) subscales: Symptoms; Activities-of-Daily-Living; Quality-of-Life, from 0 (worst) to 100 (best)

Sponsors and collaborators

Lead sponsor

University of Bradford

Other

Registry information

Official study title

Reducing Knee Compression Loading When Sleeping Supine (on the Back): Benefits in Patients With Knee Osteoarthritis

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 5, 2019
Registry last updated
Dec 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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