OsteoarthritisNCT01700634
fMRI Evaluation of Pain Central Sensitization Phenomena in Subjects With Knee Osteoarthritis
An observational study of Osteoarthritis, run by Parc de Salut Mar at 1 site in Spain.
Trial summary
The aim of this project is to investigate fMRI ability to identify pain central sensitization in chronic knee OA. Patients with high and low central sensitization and healthy control subjects will be included. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2012to Oct 2016
- 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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with HIGH / LOW central sensitation, and control subjects.
Who may be able to join
- Patients:
- A diagnosis of knee OA and suitable for the study as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
- Have a radiological and clinical diagnosis of knee OA based upon American College of Rheumatology (ACR) criteria (1986) affecting at least one knee of a minimum of 3 months in symptom duration prior to screening.
- Subject is either male or female and at least 45 years of age.
- A minimum of 4 out of 10 on the numerical rating scale (Brief Pain Inventory- BPI item 5) at screening and/ or a requirement for the use of an analgesic for the pain in the OA knee. In addition, baseline pain must be stable for at least 72 hours prior to fMRI assessment or fMRI assessment may be delayed.
- A maximum of 8 out of 10 on the NRS at screening. Enrolment may be delayed if, in the opinion of the investigator, the severity of pain represents an isolated incident.
Show all 19Show fewer
- A female subject is eligible to participate if she is of non-childbearing potential.
- Body weight <120kg.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Subject demonstrates an understanding of the study and a willingness to participate as evidenced by voluntary written informed consent.
- Controls:
- Subject is either male or female and at least 45 years of age.
- Absence of clinically relevant neurologic and psychiatric disease and history of head trauma with loss of consciousness.
- Absence of non-compensated medical diseases and pain disorders that may relevantly affect brain function and pain perception.
- No clinical evidence of knee OA.
- A female subject is eligible to participate if she is of non-childbearing potential.
- Body weight <120kg.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Subject demonstrates an understanding of the study and a willingness to participate as evidenced by voluntary written informed consent.
Who cannot join
- - Subjects will not be permitted to heavily exercise for 12 hours prior to fMRI assessment
- - Subjects will be required to refrain from the following treatments: I.- Analgesic and anti-inflammatory drugs for 3 days prior to fMRI assessment except for rescue medication. Rescue medication will be based on paracetamol (dosed 1g/8h), which in any case must be withdrawn for a minimum of 24 h prior to fMRI assessment or the fMRI assessment may be delayed.
- II.- Steroid injections into the joint or muscle for three months prior to fMRI assessment III.- Hyaluronan injections into index knee within the previous 6 months prior fMRI assessment IV.- Non-pharmacological treatments, such as heat wraps or massage for 24 hours prior to fMRI assessment.
- V.- Antidepressants not allowed: MAOIs, Tricyclic antidepressants, mixed 5HT \& NE reuptake inhibitors (eg. Duloxetine). SISR are not allowed as a recent prescription, moreover they are allowed in case of chronic use (more than 6 weeks). If those drugs are used for less than 6 weeks, patients could participate in the study after a washout period.
- VI.- Anticonvulsant indicated as a pain killer are not allowed, but patients could participate in the study after a washout period.
- VII.- Patients can take low doses of hypnotic drugs (eg. Lorazepam 1mg/OD or Diazepam 5mg/OD) if they are used as a chronic prescription (more than 6 weeks). If they are used for less than 6 weeks, patients could participate in the study after a washout period.
- Subjects will be allowed to take their chronic (non-analgesic and non-anti-inflammatory) medications if the treatments have been used continuously for at least six weeks prior to assessment.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this project is to investigate fMRI ability to identify pain central sensitization in chronic knee OA. Patients with high and low central sensitization and healthy control subjects will be included. Central sensitization will be clinically defined based on the evidence of regional spread of pain (spreading sensitization) and increased pain response to repeated stimulation (temporal summation). Operatively, a patient will be assigned to high sensitization group when showing (i) clinical evidence of pain or altered sensations spread beyond the knee joint by manual palpation, (ii) a minimum of 3 anatomical sites around the knee showing a pressure pain threshold below 4 kg/cm2 (tender points), (iii) pain score of 4 points or more in a 11-point scale during 4 kg/cm2 pressure stimulation on the anterior/medial surface of the tibial bone (the site selected for the fMRI experiment) and (iv) increase of at least 1 point in a 11-point scale after 10 repeated pressure stimulation on the tenderest point around the knee.
A three-step strategy is proposed to characterize the phenomenon by assessing (i) brain response to direct pressure stimulation on the painful knee, which will reflect the combination of peripheral and central sensitization; (ii) brain response to pressure stimulation on a non-arthritic hyperalgesic area (i.e., the anterior surface of the tibia), which will mostly reflect central sensitization mediated at the spinal cord level, and (iii) brain response to moderately painful heat stimulation on a healthy skin area (i.e., volar forearm), which will reflect central sensitization occurring in the brain and involving the highest-level pain modulatory mechanisms. An additional evaluation is proposed using resting-state fMRI to assess potential alterations in baseline brain functional organization.
- Conditions
- Osteoarthritis
- Keywords
- fMRI, BOLD, pressure stimuli
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| OA patients with HIGH central sensitization | Central sensitization will be defined by the presence of both spreading sensitization and temporal summation to repeated pressure pain stimulation (Arendt-Nielsen et al. 2010, Graven-Nielsen et al. 2010, Woolf 2010, Imamura et al. 2008, Nijs et al. 2010). | |
| OA patients with LOW central sensitization | Not described | |
| Control subjects | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood oxygenation level dependent (BOLD) in response to pressure stimuli applied to the knee using fMRI
BOLD in response to pressure stimuli applied to the knee assessed using fMRI, that measures endogenous haemodynamic signal reflecting blood oxygenation changes linked to neuronal activity.
Measured: Baseline
BOLD in response to painful contact heat stimuli applied to healthy forearm skin assessed using fMRI
BOLD in response to painful contact heat stimuli applied to healthy forearm skin assessed using fMRI, that measures endogenous haemodynamic signal reflecting blood oxygenation changes linked to neuronal activity.
Measured: Baseline
Secondary outcomes (1)
BOLD during resting-state using fMRI
BOLD during resting-state using fMRI, that measures endogenous haemodynamic signal reflecting blood oxygenation changes linked to neuronal activity.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionJul 2014
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jordi Monfort, Parc de Salut Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01700634
- Sponsor's protocol ID
- MON-SC-2012-01
- Status last verified
- Oct 2016
- First submitted
- 2 Oct 2012
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- fMRI Evaluation of Pain Central Sensitization Phenomena in Subjects With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT01700634
- Acronym / sponsor ID
- MON-SC-2012-01
- Conditions
- Osteoarthritis
- Keywords
- fMRI, BOLD, pressure stimuli
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 4 Oct 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.
The aim of this project is to investigate fMRI ability to identify pain central sensitization in chronic knee OA. Patients with high and low central sensitization and healthy control subjects will be included. Central sensitization will be clinically defined based on the evidence of regional spread of pain (spreading sensitization) and increased pain response to repeated stimulation (temporal summation). Operatively, a patient will be assigned to high sensitization group when showing (i) clinical evidence of pain or altered sensations spread beyond the knee joint by manual palpation, (ii) a minimum of 3 anatomical sites around the knee showing a pressure pain threshold below 4 kg/cm2 (tender points), (iii) pain score of 4 points or more in a 11-point scale during 4 kg/cm2 pressure stimulation on the anterior/medial surface of the tibial bone (the site selected for the fMRI experiment) and (iv) increase of at least 1 point in a 11-point scale after 10 repeated pressure stimulation on the tenderest point around the knee.
A three-step strategy is proposed to characterize the phenomenon by assessing (i) brain response to direct pressure stimulation on the painful knee, which will reflect the combination of peripheral and central sensitization; (ii) brain response to pressure stimulation on a non-arthritic hyperalgesic area (i.e., the anterior surface of the tibia), which will mostly reflect central sensitization mediated at the spinal cord level, and (iii) brain response to moderately painful heat stimulation on a healthy skin area (i.e., volar forearm), which will reflect central sensitization occurring in the brain and involving the highest-level pain modulatory mechanisms. An additional evaluation is proposed using resting-state fMRI to assess potential alterations in baseline brain functional organization.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OA patients with HIGH central sensitization | – | –Central sensitization will be defined by the presence of both spreading sensitization and temporal summation to repeated pressure pain stimulation (Arendt-Nielsen et al. 2010, Graven-Nielsen et al. 2010, Woolf 2010, Imamura et al. 2008, Nijs et al. 2010). |
| OA patients with LOW central sensitization | – | – |
| Control subjects | – | – |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with HIGH / LOW central sensitation, and control subjects.
Key inclusion criteria (19 listed)
- Patients:
- Controls:
Key exclusion criteria (7 listed)
- - Subjects will not be permitted to heavily exercise for 12 hours prior to fMRI assessment
- - Subjects will be required to refrain from the following treatments: I.- Analgesic and anti-inflammatory drugs for 3 days prior to fMRI assessment except for rescue medication. Rescue medication will be based on paracetamol (dosed 1g/8h), which in any case must be withdrawn for a minimum of 24 h prior to fMRI assessment or the fMRI assessment may be delayed.
- II.- Steroid injections into the joint or muscle for three months prior to fMRI assessment III.- Hyaluronan injections into index knee within the previous 6 months prior fMRI assessment IV.- Non-pharmacological treatments, such as heat wraps or massage for 24 hours prior to fMRI assessment.
- V.- Antidepressants not allowed: MAOIs, Tricyclic antidepressants, mixed 5HT \& NE reuptake inhibitors (eg. Duloxetine). SISR are not allowed as a recent prescription, moreover they are allowed in case of chronic use (more than 6 weeks). If those drugs are used for less than 6 weeks, patients could participate in the study after a washout period.
- VI.- Anticonvulsant indicated as a pain killer are not allowed, but patients could participate in the study after a washout period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Blood oxygenation level dependent (BOLD) in response to pressure stimuli applied to the knee using fMRI
Time frame: Baseline
BOLD in response to pressure stimuli applied to the knee assessed using fMRI, that measures endogenous haemodynamic signal reflecting blood oxygenation changes linked to neuronal activity.
BOLD in response to painful contact heat stimuli applied to healthy forearm skin assessed using fMRI
Time frame: Baseline
BOLD in response to painful contact heat stimuli applied to healthy forearm skin assessed using fMRI, that measures endogenous haemodynamic signal reflecting blood oxygenation changes linked to neuronal activity.
1 secondary outcome
BOLD during resting-state using fMRI
Time frame: Baseline
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 Oct 2016.
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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?
An observational study of Osteoarthritis, run by Parc de Salut Mar at 1 site in Spain.
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 19 inclusion and 7 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 Oct 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 Spain. 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?
Blood oxygenation level dependent (BOLD) in response to pressure stimuli applied to the knee using fMRI (time frame: Baseline). 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 Oct 2016.