Reducing Knee Compression When Sleeping in Those With Knee OA

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-19

Study Completion Date

2018-12-10

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention

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.

Group Type EXPERIMENTAL

Change in sleeping position

Intervention Type 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.

Control

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

Group Type PLACEBO_COMPARATOR

No change in sleeping position

Intervention Type BEHAVIORAL

No change to your normal sleeping position

Interventions

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Change in sleeping position

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

No change in sleeping position

No change to your normal sleeping position

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes