Osteoarthritis, KneeNCT03718663
Predictors for Analgesic Effect to Standardized Exercise Therapy for Osteoarthritic Pain
An observational study of Osteoarthritis, Knee and Healthy Subjects, run by Kristian Kjær Petersen at 1 site in Denmark.
Trial summary
Pain sensitization has been associated with pain severity in people with knee osteoarthritis (KOA) and a neuropathic pain component has been identified in up to 30% of KOA patients. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis, Knee, Healthy Subjects
- What is being tested?
- Physiotherapy-guided Evidence-based Exercise Therapy and Part 2: Military training
- How many people
- 28 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2017to 1 Nov 2018
- Phase
- Observational
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 25 patients with knee osteoarthritis scheduled for PEET. Part 2 40 healthy subjects (age 18-28) signed up as recruits in Defence Command Denmark
Who may be able to join
- The American College of Rheumatology for clinical knee osteoarthritis (excluding radiological OA assessment)
- starting as recruits in Defence Command Denmark
Who cannot join
- Known factors to influence pain and pain sensitization.
- Part 2:
- Known factors to influence pain and pain sensitization.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Kliniske Smertetests Som prædiktorer for Effekten af GLA:D®-træningsforløb Hos Patienter Med Symptomgivende Slidgigt i knæene
Pain sensitization has been associated with pain severity in people with knee osteoarthritis (KOA) and a neuropathic pain component has been identified in up to 30% of KOA patients. In addition, exercise-induced hypoalgesia (EIH), a measure of descending pain control, has previously been found dysfunctional in a subgroup of people with painful KOA and has also been utilized as a predictive factor for pain progression following total knee replacement.
Measures of pain sensitization have been used prognostic to identify responders to treatment but EIH as a prognostic tool for Physiotherapy-guided Evidence-based Exercise Therapy (PEET) has not been investigated. The primary aim of this explorative study is to investigate if EIH assessed pre-PEET was associated with changes in pain, disability and PainDETECT (PDQ) score post-PEET. The secondary aim is to investigate if PEET changes EIH and PDQ score in patients with painful KOA.
Read more
Part 2:
Cross-sectional studies indicate, that daily level of activity influence the effectivity of the EIH mechanims, while pain patients (e.g. KOA patients) can have normal of dysfunctional EIH. It has not been investigated if EIH changes after prolonged exercise in healthy subjects. The aim of this secord part of the study, is to investigate if EIH changes after 6-9 weeks of intensive military training in healthy subjects
- Conditions
- Osteoarthritis, Knee, Healthy Subjects
- Being tested
- Physiotherapy-guided Evidence-based Exercise Therapy, Part 2: Military training
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy-guided Evidence-based Exercise TherapyOther
Standardized supervised exercise therapy for 6-8 weeks (two times per week).
Part 2: Military trainingOther
Part 2: standardized military training for 6-8 weeks in Defence Command Denmark
| Study group | Role | What they receive |
|---|---|---|
| Knee OA patients (part 1) | Painful knee OA patients signed up for standardized exercise therapy Receives: Other: Physiotherapy-guided Evidence-based Exercise Therapy | |
| Healthy subjects (part 2) | Healthy subjects (age 18-28) signed up military service in Defence Command Denmark Receives: Other: Part 2: Military training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Pain measured on a numerical analog scale from 0 (no pain) to 10 (worst pain imaginable)
Measured: 1-2 weeks after last exercise session
Part 2: Exercise-induced hypoalgesia (EIH)
Change in EIH
Measured: 6-8 weeks into standardized pre-planned military training that continues after the tests
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start1 Oct 2017
- Primary completion31 Oct 2018
- Study completion1 Nov 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kristian Kjær Petersen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kristian Kjær Petersen, Aalborg University
- Investigators
- Kristian K Petersen, PhD, Principal investigator, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03718663
- Sponsor's protocol ID
- N-20170070
- Status last verified
- Jul 2019
- First submitted
- 11 Oct 2018
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kliniske Smertetests Som prædiktorer for Effekten af GLA:D®-træningsforløb Hos Patienter Med Symptomgivende Slidgigt i knæene
- ClinicalTrials.gov ID
- NCT03718663
- Acronym / sponsor ID
- N-20170070
- Conditions
- Osteoarthritis, Knee, Healthy Subjects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Kristian Kjær PetersenUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 24 Oct 2018 (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.
Pain sensitization has been associated with pain severity in people with knee osteoarthritis (KOA) and a neuropathic pain component has been identified in up to 30% of KOA patients. In addition, exercise-induced hypoalgesia (EIH), a measure of descending pain control, has previously been found dysfunctional in a subgroup of people with painful KOA and has also been utilized as a predictive factor for pain progression following total knee replacement.
Measures of pain sensitization have been used prognostic to identify responders to treatment but EIH as a prognostic tool for Physiotherapy-guided Evidence-based Exercise Therapy (PEET) has not been investigated. The primary aim of this explorative study is to investigate if EIH assessed pre-PEET was associated with changes in pain, disability and PainDETECT (PDQ) score post-PEET. The secondary aim is to investigate if PEET changes EIH and PDQ score in patients with painful KOA.
Part 2:
Cross-sectional studies indicate, that daily level of activity influence the effectivity of the EIH mechanims, while pain patients (e.g. KOA patients) can have normal of dysfunctional EIH. It has not been investigated if EIH changes after prolonged exercise in healthy subjects. The aim of this secord part of the study, is to investigate if EIH changes after 6-9 weeks of intensive military training in healthy subjects
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Knee OA patients (part 1) | – | Other: Physiotherapy-guided Evidence-based Exercise TherapyPainful knee OA patients signed up for standardized exercise therapy |
| Healthy subjects (part 2) | – | Other: Part 2: Military trainingHealthy subjects (age 18-28) signed up military service in Defence Command Denmark |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 25 patients with knee osteoarthritis scheduled for PEET. Part 2 40 healthy subjects (age 18-28) signed up as recruits in Defence Command Denmark
Key inclusion criteria (2 listed)
- The American College of Rheumatology for clinical knee osteoarthritis (excluding radiological OA assessment)
- starting as recruits in Defence Command Denmark
Key exclusion criteria (3 listed)
- Known factors to influence pain and pain sensitization.
- Known factors to influence pain and pain sensitization.
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 |
|---|---|---|
| Physiotherapy-guided Evidence-based Exercise TherapyStandardized supervised exercise therapy for 6-8 weeks (two times per week). | Other | Knee OA patients (part 1) |
| Part 2: Military trainingPart 2: standardized military training for 6-8 weeks in Defence Command Denmark | Other | Healthy subjects (part 2) |
Primary outcome
Pain Intensity
Time frame: 1-2 weeks after last exercise session
Pain measured on a numerical analog scale from 0 (no pain) to 10 (worst pain imaginable)
Part 2: Exercise-induced hypoalgesia (EIH)
Time frame: 6-8 weeks into standardized pre-planned military training that continues after the tests
Change in EIH
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 Jul 2019.
- Individual participant dataSharing planned: Undecided
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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.
Kristian K Petersen, PhD principal investigator
Aalborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee and Healthy Subjects, run by Kristian Kjær Petersen 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 2 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: finished, as of the sponsor's last update on 5 Jul 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 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?
Pain Intensity (time frame: 1-2 weeks after last exercise session). The study lists 2 primary outcomes in all. 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 Jul 2019.