Knee OsteoarthritisNCT01545258
Exercise and Pain Sensitivity in Knee Osteoarthritis
A study testing Exercise in people with Knee Osteoarthritis, run by Frederiksberg University Hospital at 1 site in Denmark.
Trial summary
A commonly administered conservative non-pharmacological treatment for OA is exercise, with beneficial effects in terms of reduced pain and disability. While the link between exercise and reduced disability is mediated by e.g. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2012to Mar 2013
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age above 40 years
- Clinical diagnosis of tibiofemoral osteoarthritis
- Radiographic verification of diagnosis (Kellgren\&Lawrence 2 or 3)
- Ability to participate in examinations
- Ability to participate in exercise sessions
- 20≤ Body Mass Index (BMI) ≤35 kg/m2
- Ability to comply with rules about concomitant medication and therapy
- Speak, read and write Danish
Who cannot join
- Participation in exercise training for the knee osteoarthritis within 3 months of enrollment
- Counterindications for exercise
- Pregnant or breastfeeding
- Current or previous autoimmune disease
- History of surgical joint replacement in the lower limbs
- Planned surgery
Show all 15Show fewer
- Current or previous diagnosis or signs of cardiovascular disease
- Neurological disorders
- Alcohol or drug abuse
- Diabetes
- Psychiatric disorders
- Regional pain syndromes
- Regional pain caused by lumbar or cervical nerve root compression
- Counterindications to MR scan
- Counterindications to MR contrast
Trial locations and contacts
1 site in 1 country.
Denmark1 site
The Parker Institute, Dept of rheumatology, Frederiksberg hospital
Copenhagen, 2000 F
About this study
Official title: Exercise and Changes in Pain Sensitivity in Patients With Knee Osteoarthritis
A commonly administered conservative non-pharmacological treatment for OA is exercise, with beneficial effects in terms of reduced pain and disability.
While the link between exercise and reduced disability is mediated by e.g. increased muscle strength and endurance, the analgesic mechanisms related to exercise are unexplored. knee OA patients have both peripheral and central sensitization of pain mechanisms resulting in hyperalgesia. Thus, targeted pain treatment in these patients may focus on both peripheral and central mechanisms but it unknown if exercise affects either of these mechanisms.
It is hypothesized that in knee OA patients exercise reduces the pain sensitivity
- Conditions
- Knee Osteoarthritis
- Being tested
- Exercise
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Also called Exercise training
Physiotherapy supervised exercise training. 60 minutes 3 times per week
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Exercise training supervised by trained physiotherapists lasting 60 minutes performed 3 times/week. Receives: Other: Exercise |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in mechanical pain sensitivity
Pain thresholds and temporal summation of pain
Measured: Baseline and at 12 weeks
Secondary outcomes (4)
Change from baseline in proinflammatory cytokines and biomarkers of cartilage breakdown in blood and urine
Measured: Baseline and at 12 weeks
Change from baseline in patient reported pain and function
KOOS questionnaire
Measured: Baseline and at 12 weeks
Change from baseline in functional pain test
Pain is assessed during continuous tradmill walking at self-selected pace for 20 minutes.
Measured: Baseline and at 12 weeks
Change from baseline in imaged based quantification of inflammation in the knee
Contrast enhanced MRI imaging used to quantify inflammation (DYNAMICA software)
Measured: Baseline and at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frederiksberg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marius Henriksen, Frederiksberg University Hospital
- Investigators
- Marius Henriksen, PhD, Principal investigator, The Parker Institute, Frederiksberg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01545258
- Sponsor's protocol ID
- PI101.03
- Status last verified
- Dec 2016
- First submitted
- 1 Mar 2012
- Last updated
- 2 Dec 2016
- Results posted
- No
Publications
Bandak E, Boesen M, Bliddal H, Daugaard C, Hangaard S, Bartholdy C, Damm Nybing J, Kubassova O, Henriksen M. The effect of exercise therapy on inflammatory activity assessed by MRI in knee osteoarthritis: Secondary outcomes from a randomized controlled trial. Knee. 2021 Jan;28:256-265. doi: 10.1016/j.knee.2020.12.022. Epub 2021 Jan 13.
PubMed 33453514Bandak E, Boesen M, Bliddal H, Riis RGC, Nielsen SM, Klokker L, Bartholdy C, Nybing JD, Henriksen M. Exercise-induced pain changes associate with changes in muscle perfusion in knee osteoarthritis: exploratory outcome analyses of a randomised controlled trial. BMC Musculoskelet Disord. 2019 Oct 27;20(1):491. doi: 10.1186/s12891-019-2858-8.
PubMed 31656173Henriksen M, Klokker L, Bartholdy C, Schjoedt-Jorgensen T, Bandak E, Bliddal H. No effects of functional exercise therapy on walking biomechanics in patients with knee osteoarthritis: exploratory outcome analyses from a randomised trial. BMJ Open Sport Exerc Med. 2017 Mar 27;2(1):e000230. doi: 10.1136/bmjsem-2017-000230. eCollection 2016.
PubMed 28879038Bartholdy C, Klokker L, Bandak E, Bliddal H, Henriksen M. A Standardized "Rescue" Exercise Program for Symptomatic Flare-up of Knee Osteoarthritis: Description and Safety Considerations. J Orthop Sports Phys Ther. 2016 Nov;46(11):942-946. doi: 10.2519/jospt.2016.6908. Epub 2016 Sep 28.
PubMed 27681448Henriksen M, Klokker L, Graven-Nielsen T, Bartholdy C, Schjodt Jorgensen T, Bandak E, Danneskiold-Samsoe B, Christensen R, Bliddal H. Association of exercise therapy and reduction of pain sensitivity in patients with knee osteoarthritis: a randomized controlled trial. Arthritis Care Res (Hoboken). 2014 Dec;66(12):1836-43. doi: 10.1002/acr.22375.
PubMed 24905427
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise and Changes in Pain Sensitivity in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT01545258
- Acronym / sponsor ID
- PI101.03
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Frederiksberg University HospitalUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Mar 2013 (actual)
- First posted
- 6 Mar 2012 (estimated)
- 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.
A commonly administered conservative non-pharmacological treatment for OA is exercise, with beneficial effects in terms of reduced pain and disability.
While the link between exercise and reduced disability is mediated by e.g. increased muscle strength and endurance, the analgesic mechanisms related to exercise are unexplored. knee OA patients have both peripheral and central sensitization of pain mechanisms resulting in hyperalgesia. Thus, targeted pain treatment in these patients may focus on both peripheral and central mechanisms but it unknown if exercise affects either of these mechanisms.
It is hypothesized that in knee OA patients exercise reduces the pain sensitivity
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: ExerciseExercise training supervised by trained physiotherapists lasting 60 minutes performed 3 times/week. |
| Control | No intervention | – |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age above 40 years
- Clinical diagnosis of tibiofemoral osteoarthritis
- Radiographic verification of diagnosis (Kellgren\&Lawrence 2 or 3)
- Ability to participate in examinations
- Ability to participate in exercise sessions
Key exclusion criteria (15 listed)
- Participation in exercise training for the knee osteoarthritis within 3 months of enrollment
- Counterindications for exercise
- Pregnant or breastfeeding
- Current or previous autoimmune disease
- History of surgical joint replacement in the lower limbs
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 |
|---|---|---|
| ExerciseAlso: Exercise trainingPhysiotherapy supervised exercise training. 60 minutes 3 times per week | Other | Exercise |
Primary outcome
Change from baseline in mechanical pain sensitivity
Time frame: Baseline and at 12 weeks
Pain thresholds and temporal summation of pain
4 secondary outcomes
Change from baseline in proinflammatory cytokines and biomarkers of cartilage breakdown in blood and urine
Time frame: Baseline and at 12 weeks
Change from baseline in patient reported pain and function
Time frame: Baseline and at 12 weeks
Change from baseline in functional pain test
Time frame: Baseline and at 12 weeks
Change from baseline in imaged based quantification of inflammation in the knee
Time frame: Baseline and at 12 weeks
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 2 Dec 2016.
- Derived from this study: PubMed 33453514Bandak E, Boesen M, Bliddal H, Daugaard C, Hangaard S, Bartholdy C, Damm Nybing J, Kubassova O, Henriksen M. The effect of exercise therapy on inflammatory activity assessed by MRI in knee osteoarthritis: Secondary outcomes from a randomized controlled trial. Knee. 2021 Jan;28:256-265. doi: 10.1016/j.knee.2020.12.022. Epub 2021 Jan 13.
- Derived from this study: PubMed 31656173Bandak E, Boesen M, Bliddal H, Riis RGC, Nielsen SM, Klokker L, Bartholdy C, Nybing JD, Henriksen M. Exercise-induced pain changes associate with changes in muscle perfusion in knee osteoarthritis: exploratory outcome analyses of a randomised controlled trial. BMC Musculoskelet Disord. 2019 Oct 27;20(1):491. doi: 10.1186/s12891-019-2858-8.
- Derived from this study: PubMed 28879038Henriksen M, Klokker L, Bartholdy C, Schjoedt-Jorgensen T, Bandak E, Bliddal H. No effects of functional exercise therapy on walking biomechanics in patients with knee osteoarthritis: exploratory outcome analyses from a randomised trial. BMJ Open Sport Exerc Med. 2017 Mar 27;2(1):e000230. doi: 10.1136/bmjsem-2017-000230. eCollection 2016.
- Derived from this study: PubMed 27681448Bartholdy C, Klokker L, Bandak E, Bliddal H, Henriksen M. A Standardized "Rescue" Exercise Program for Symptomatic Flare-up of Knee Osteoarthritis: Description and Safety Considerations. J Orthop Sports Phys Ther. 2016 Nov;46(11):942-946. doi: 10.2519/jospt.2016.6908. Epub 2016 Sep 28.
- Derived from this study: PubMed 24905427Henriksen M, Klokker L, Graven-Nielsen T, Bartholdy C, Schjodt Jorgensen T, Bandak E, Danneskiold-Samsoe B, Christensen R, Bliddal H. Association of exercise therapy and reduction of pain sensitivity in patients with knee osteoarthritis: a randomized controlled trial. Arthritis Care Res (Hoboken). 2014 Dec;66(12):1836-43. doi: 10.1002/acr.22375.
- Related InfoLink provided by the sponsor.
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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.
Marius Henriksen, PhD principal investigator
The Parker Institute, Frederiksberg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Knee Osteoarthritis, run by Frederiksberg University Hospital at 1 site in 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 8 inclusion and 15 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 2 Dec 2016. 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 Denmark. 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. 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?
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 from baseline in mechanical pain sensitivity (time frame: Baseline and at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01545258, which also lists 5 linked publications.
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 2 Dec 2016.