Reducing Knee Compression When Sleeping in Those With Knee OA

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04188054
• Other study ID #: IRAS 241876
• Secondary ID: 18/YH/0057
• Status: Completed
• Phase: Phase 2
• Start date: March 19, 2018
• Est. completion date: December 10, 2018

Study information

• Verified date: December 2019
• Source: University of Bradford
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: December 10, 2018
• Est. primary completion date: December 10, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.
• No change in sleeping position
No change to your normal sleeping position

Locations

Country	Name	City	State
United Kingdom	Idle Medical Centre	Bradford	West Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Bradford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)