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

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).

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Behavioral: Change in sleeping position; Behavioral: No change in sleeping position

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.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • West Yorkshire
    • Bradford, West Yorkshire, United Kingdom, BD10 8RU
      • Idle Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
Placebo Comparator: Control; Will be asked to make no change in the way they normally lie on their mattress when sleeping	Behavioral: No change in sleeping position; No change to your normal sleeping position

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in KOOS Knee (other sub-scales)	Knee injury and Osteoarthritis Outcome Scores (KOOS) subscales: Symptoms; Activities-of-Daily-Living; Quality-of-Life, from 0 (worst) to 100 (best)	baseline and 3 months (post intervention)

Collaborators and Investigators

• Sponsor: University of Bradford

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2018
• Primary Completion (Actual): December 10, 2018
• Study Completion (Actual): December 10, 2018

Study Registration Dates

• First Submitted: November 27, 2019
• First Submitted That Met QC Criteria: December 4, 2019
• First Posted (Actual): December 5, 2019

Study Record Updates

• Last Update Posted (Actual): December 5, 2019
• Last Update Submitted That Met QC Criteria: December 4, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: IRAS 241876; 18/YH/0057 (Other Identifier: Research Ethics Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No