Knee Pain ChronicNCT05822401
Prevention, Management and Rehabilitation of Knee Osteoarthritis at the Workplace
A study testing Blood flow restriction (BFR) in people with Knee Pain Chronic and Knee Osteoarthritis, run by National Research Centre for the Working Environment, Denmark.
Trial summary
The goal of this intervention study is to assess the effect of blood flow restricted (BFR) exercise integrated into the daily work tasks among hospital workers with or at increased risk of chronic knee pain. Read more about this study
- Who is it for?
- Ages 18 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Pain Chronic, Knee Osteoarthritis, Knee Discomfort
- What is being tested?
- Blood flow restriction (BFR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 11 Apr 2023to 31 Dec 2023
- Phase
- Interventional
- 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 to 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hospital workers working at least 20 hours per week with or without chronic knee pain (>3 months)
Who cannot join
- Life-threatening disease
- Conditions where BFR training may be contraindicated, e.g. pregnancy, cancer, diabetes, major cardiovascular disease, current, previous or family history of clotting disorders, recent immobilization, major surgery or injections into the joint (i.e. corticosteroid injection)
- Systolic/diastolic blood pressure above 160/100 mmHg
Trial locations and contacts
No sites are listed yet.
About this study
The goal of this intervention study is to assess the effect of blood flow restricted (BFR) exercise integrated into the daily work tasks among hospital workers with or at increased risk of chronic knee pain.
The main questions are:
Can BFR exercise integrated into the daily work tasks reduce knee pain (primary outcome) and improve function and work ability among hospital workers with or at increased risk of chronic knee pain? Participants in the intervention group will for shorts bouts during their workdays integrate BFR into their daily work tasks involving walking, whereas the control group will continue as usual.
- Conditions
- Knee Pain Chronic, Knee Osteoarthritis, Knee Discomfort
- Being tested
- Blood flow restriction (BFR), Usual care (control)
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood flow restriction (BFR)Behavioural
Blood flow restricted training integrated into the daily work tasks for 8 weeks.
Usual care (control)Behavioural
Will continue their work as usual
| Study group | Role | What they receive |
|---|---|---|
| Blood flow restriction (BFR) | Experimental | Blood flow restricted training (BFR) integrated into the daily work tasks for 8 weeks. Receives: Behavioral: Blood flow restriction (BFR); Behavioral: Usual care (control) |
| Usual care (control) | Active comparator | Will continue their work as usual Receives: Behavioral: Usual care (control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Change in worst knee pain intensity during the last week rated on a 11-point numeric rating scale (NRS)
Measured: Change pre-post 8 weeks of intervention
Secondary outcomes (2)
Functional performance
30-s chair-stand test, 40 m fast-paced walk test, a stair-climb test, maximal isometric knee extensor muscle strength
Measured: Change pre-post 8 weeks of intervention
Work ability
Single-item on physical work ability derived from the Work Ability Index (WAI)
Measured: Change pre-post 8 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start11 Apr 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Pain ChronicStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Research Centre for the Working Environment, Denmark
- Sponsor type
- Other government
- Collaborators
- University of Southern Denmark, University Hospital Bispebjerg and Frederiksberg
- Responsible party
- Principal investigator, Lars L. Andersen, National Research Centre for the Working Environment, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05822401
- Sponsor's protocol ID
- 10429
- Other IDs
- H-22016339
- Status last verified
- Apr 2023
- First submitted
- 10 Apr 2023
- Last updated
- 20 Apr 2023
- Results posted
- 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 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention, Management and Rehabilitation of Knee Osteoarthritis at the Workplace
- ClinicalTrials.gov ID
- NCT05822401
- Acronym / sponsor ID
- 10429
- Conditions
- Knee Pain Chronic, Knee Osteoarthritis, Knee Discomfort
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Research Centre for the Working Environment, DenmarkOther government
- Collaborators
- University of Southern Denmark, University Hospital Bispebjerg and Frederiksberg
- Study start
- 11 Apr 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 20 Apr 2023 (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.
The goal of this intervention study is to assess the effect of blood flow restricted (BFR) exercise integrated into the daily work tasks among hospital workers with or at increased risk of chronic knee pain.
The main questions are:
Can BFR exercise integrated into the daily work tasks reduce knee pain (primary outcome) and improve function and work ability among hospital workers with or at increased risk of chronic knee pain? Participants in the intervention group will for shorts bouts during their workdays integrate BFR into their daily work tasks involving walking, whereas the control group will continue as usual.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blood flow restriction (BFR) | Experimental | Behavioral: Blood flow restriction (BFR), Behavioral: Usual care (control)Blood flow restricted training (BFR) integrated into the daily work tasks for 8 weeks. |
| Usual care (control) | Active comparator | Behavioral: Usual care (control)Will continue their work as usual |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hospital workers working at least 20 hours per week with or without chronic knee pain (>3 months)
Key exclusion criteria (3 listed)
- Life-threatening disease
- Conditions where BFR training may be contraindicated, e.g. pregnancy, cancer, diabetes, major cardiovascular disease, current, previous or family history of clotting disorders, recent immobilization, major surgery or injections into the joint (i.e. corticosteroid injection)
- Systolic/diastolic blood pressure above 160/100 mmHg
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 |
|---|---|---|
| Blood flow restriction (BFR)Blood flow restricted training integrated into the daily work tasks for 8 weeks. | Behavioural | Blood flow restriction (BFR) |
| Usual care (control)Will continue their work as usual | Behavioural | Blood flow restriction (BFR), Usual care (control) |
Primary outcome
Pain intensity
Time frame: Change pre-post 8 weeks of intervention
Change in worst knee pain intensity during the last week rated on a 11-point numeric rating scale (NRS)
2 secondary outcomes
Functional performance
Time frame: Change pre-post 8 weeks of intervention
Work ability
Time frame: Change pre-post 8 weeks of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Blood flow restriction (BFR) in people with Knee Pain Chronic and Knee Osteoarthritis, run by National Research Centre for the Working Environment, Denmark.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 20 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sebastian Skovlund (40385166, svs@nfa.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Change pre-post 8 weeks of 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 20 Apr 2023.