Osteoarthritis, KneePhase 2NCT04188054
Reducing Knee Compression When Sleeping in Those With Knee OA
A Phase 2 study testing Change in sleeping position and No change in sleeping position in people with Osteoarthritis, Knee, run by University of Bradford at 1 site in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Change in sleeping position and No change in sleeping position
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Mar 2018to 10 Dec 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site
Idle Medical Centre
Bradford, West Yorkshire, BD10 8RU
About this study
Official title: 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).
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Change in sleeping position, No change in sleeping position
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Change in sleeping positionBehavioural
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 positionBehavioural
No change to your normal sleeping position
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: Change in sleeping position |
| Control | Placebo comparator | Will be asked to make no change in the way they normally lie on their mattress when sleeping Receives: Behavioral: No change in sleeping position |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in KOOS Knee Pain
Knee injury and Osteoarthritis Outcome Scores (KOOS) - sub-scale Pain, from 0 (worst) to 100 (best)
Measured: baseline and 3 months (post intervention)
Secondary outcomes (1)
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)
Measured: baseline and 3 months (post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start19 Mar 2018
- Primary completion10 Dec 2018
- Study completion10 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bradford
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John G Buckley, University of Bradford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04188054
- Sponsor's protocol ID
- IRAS 241876
- Other IDs
- 18/YH/0057
- Status last verified
- Dec 2019
- First submitted
- 27 Nov 2019
- Last updated
- 5 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Knee Compression Loading When Sleeping Supine (on the Back): Benefits in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04188054
- Acronym / sponsor ID
- IRAS 241876
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of BradfordUniversity, hospital or other
- Study start
- 19 Mar 2018 (actual)
- Primary completion
- 10 Dec 2018 (actual)
- Study completion
- 10 Dec 2018 (actual)
- First posted
- 5 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Change in sleeping positionWill 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. |
| Control | Placebo comparator | Behavioral: No change in sleeping positionWill be asked to make no change in the way they normally lie on their mattress when sleeping |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Change in sleeping positionThe 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. | Behavioural | Intervention |
| No change in sleeping positionNo change to your normal sleeping position | Behavioural | Control |
Primary outcome
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)
1 secondary outcome
change in KOOS Knee (other sub-scales)
Time frame: baseline and 3 months (post intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Change in sleeping position and No change in sleeping position in people with Osteoarthritis, Knee, run by University of Bradford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in KOOS Knee Pain (time frame: baseline and 3 months (post intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2019.