Chronic PainBrainEXPainNCT02347579
Neurophysiological Basis of Rehabilitation in Complex Regional Pain Syndrome, Type I and Chronic Low Back Pain
An observational study of Chronic Pain, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Complex Regional Pain syndrome Type I (CRPS-I) is a chronic progressive disease. Patients experience dramatic decline of overall well-being, despite the absence of any apparent physical cause. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain
- How many people
- 69 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2014to May 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People diagnosed with CRPS, type I, and people with chronic low back pain (CLBP) are target population for this study. A group of healthy controls matched for age, gender and handedness will also take part in the study.
Who may be able to join
- CRPS-I patients:
- A clinical diagnosis of CRPS-I according to 'the Budapest criteria' for research purposes (Harden et al., 2007):
- Continuing pain, which is disproportionate to any inciting event
- Must report at least one symptom in all of the four following categories:
- Sensory: Reports of hyperesthesia and/or allodynia
- Vasomotor: Reports of temperature asymmetry and/or skin color changes and/or skin color asymmetry
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- Sudomotor / Edema: Reports of edema and/or sweating changes and/or sweating asymmetry
- Motor / Trophic: Reports of decreased range of motion and/or motor dysfunction (weakness, tremor, dystonia) and/or trophic changes (hair, nail, skin)
- Must display at least one sign at time of evaluation in two or more of the following categories:
- Sensory: Evidence of hyperalgesia (to pinprick) and/or allodynia (to light touch and/or temperature sensation and/or deep somatic pressure and/or joint movement)
- Vasomotor: Evidence of temperature asymmetry and/or skin color changes and/or asymmetry
- Sudomotor / Edema: Evidence of edema and/or sweating changes and/or sweating asymmetry
- Motor / Trophic: Evidence of decreased range of motion and/or motor dysfunction (weakness, tremor, dystonia) and/or trophic changes (hair, nail, skin)
- There is no other diagnosis that better explains the signs and symptoms
- Unilateral localization on upper or lower extremity
- CLBP patients:
- Experience of non-specific lower back pain for at least three months
- No other diagnosis better explaining the signs and symptoms. both patient groups:
- Report of substantial fear of movement/(re)-injury
- Age between 18 and 65 years
- Stable medication
- healthy controls:
- Age between 18 and 65 years
- Matched for age, gender and handedness
Who cannot join
- patients and healthy controls:
- Neuropathy of the upper or lower extremities
- MRI incompatible health condition (e. g. pacemaker, metal prosthetic devices)
- Psychiatric condition and ongoing medication that would alter emotional/sensory processing
- Previous tactile impairment in the upper or lower extremity caused by:
- damage to the sensory apparatus
Show all 9Show fewer
- CNS lesion
- healthy controls:
- (history of) CRPS or other chronic pain syndromes
Trial locations and contacts
1 site in 1 country.
About this study
Complex Regional Pain syndrome Type I (CRPS-I) is a chronic progressive disease. Patients experience dramatic decline of overall well-being, despite the absence of any apparent physical cause. The main symptoms are hypersensitivity to pain (hyperalgesia) and experiencing normal tactile stimulation as painful (allodynia) in the absence of peripheral nerve damage. The debate on the aetiology of CRPS-I is still open.
The therapy offered to CRPS-I patients is diverse and can involve invasive and non-invasive interventions. Current (inter)national guidelines recommend physiotherapy as the best non-invasive treatment for rehabilitation. Recently, cognitive and behavioural Graded Exposure in Vivo (GEXP) therapy aimed at reducing pain-related fear was found to be effective (De Jong et al. 2005), and more effective than standard physical therapy (ReMOVE study, articles in preparation). By reducing pain-related fear EXP might reconcile motor output and sensory feedback.
Read more
Another type of pain is lower back pain (LBP), which affects 70% to 85% of general population, but usually heals within 12 weeks in 90% of patients. The rest of the patients suffer from intractable, chronic LBP despite no evident organic abnormality. Research shows that also in these patients cognitive and behavioural aspects of pain are important and related to physical performance and self-reported disability (Vlaeyen et al., 2000). Several studies have demonstrated the success of GEXP in this patient group: GEXP resulted in improvements in pain-related fear, catastrophizing, performance of daily relevant activities, and in pain intensity (Leeuw et al., 2008).
This study aims to investigate the effect of GEXP on brain regions involved in the processing of harmless tactile stimuli in CRPS-I and CLBP patients, as well as its effect on tactile discrimination thresholds. We hypothesize that GEXP will induce 1) an improvement of tactile discrimination thresholds, 2) a functional reorganization of primary and secondary somatosensory cortex (in regions related to the affected limb in CRPS-I; and to the back in LBP), 3) changes in activation of emotional brain circuits during non-noxious stimulation, 4) changes in resting state connectivity between emotional and sensory brain areas, 5) changes in measures reflecting white matter integrity. No systematic changes are expected in the healthy controls.
Patients diagnosed with CRPS-I and CLBP will participate in a Magnetic Resonance Imaging (MRI) experiment. In this observational study, we examine the effects of GEXP treatment that all patients receive as part of usual care. Anatomical as well as diffusion-weighted and T2*-weighted (Blood oxygenation level dependent) MR images will be acquired. The study has a 3x4 split plot design with group (CRPS-I patients and CLBP receiving GEXP treatment / healthy controls) as between-subjects variable and time (pre-, during, post-treatment and follow-up) as within-subject variable.
- Conditions
- Chronic Pain
- Medical subject headings
- Chronic Pain
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 |
|---|---|---|
| Patients with CRPS | Patients with Complex Regional Pain Syndrome, Type I | |
| Patients with CLBP | Patients with chronic low back pain | |
| Healthy controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline blood oxygenation level dependent (BOLD) signal (fMRI) during tactile stimulation and during rest
Measured: participants will be assessed repeatedly during the treatment; at baseline, at 5/6 weeks after start of treatment, at end of treatment (approximately 10 weeks after start) and at follow-up (6 months after end of treatment)
Change from baseline diffusion MRI measures (fractional anisotropy, neurite density, orientation dispersion)
Measured: participants will be assessed repeatedly during the treatment; at baseline, at 5/6 weeks after start of treatment, at end of treatment (approximately 10 weeks after start) and at follow-up (6 months after end of treatment)
Change from baseline tactile discrimination threshold in mm
Measured: participants will be assessed repeatedly during the treatment; at baseline, at 5/6 weeks after start of treatment, at end of treatment (approximately 10 weeks after start) and at follow-up (6 months after end of treatment)
Secondary outcomes (3)
Change from baseline pain-related fear (TSK, PHODA)
Measured: participants will be assessed repeatedly during the treatment; at baseline, at 5/6 weeks after start of treatment, at end of treatment (approximately 10 weeks after start) and at follow-up (6 months after end of treatment)
Change from baseline pain catastrophizing (PCS)
Measured: participants will be assessed repeatedly during the treatment; at baseline, at 5/6 weeks after start of treatment, at end of treatment (approximately 10 weeks after start) and at follow-up (6 months after end of treatment)
Change from baseline pain intensity level as assessed on visual analog scale
Measured: daily
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2015 (estimated)
- Study startJun 2014
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02347579
- Sponsor's protocol ID
- NL35546.068.11
- Acronym
- BrainEXPain
- Status last verified
- Jul 2018
- First submitted
- 8 Jan 2015
- Last updated
- 23 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiological Basis of Rehabilitation in Complex Regional Pain Syndrome, Type I and Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT02347579
- Acronym / sponsor ID
- BrainEXPain / NL35546.068.11
- Conditions
- Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Maastricht University
- Study start
- Jun 2014 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 27 Jan 2015 (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.
Complex Regional Pain syndrome Type I (CRPS-I) is a chronic progressive disease. Patients experience dramatic decline of overall well-being, despite the absence of any apparent physical cause. The main symptoms are hypersensitivity to pain (hyperalgesia) and experiencing normal tactile stimulation as painful (allodynia) in the absence of peripheral nerve damage. The debate on the aetiology of CRPS-I is still open.
The therapy offered to CRPS-I patients is diverse and can involve invasive and non-invasive interventions. Current (inter)national guidelines recommend physiotherapy as the best non-invasive treatment for rehabilitation. Recently, cognitive and behavioural Graded Exposure in Vivo (GEXP) therapy aimed at reducing pain-related fear was found to be effective (De Jong et al. 2005), and more effective than standard physical therapy (ReMOVE study, articles in preparation). By reducing pain-related fear EXP might reconcile motor output and sensory feedback.
Another type of pain is lower back pain (LBP), which affects 70% to 85% of general population, but usually heals within 12 weeks in 90% of patients. The rest of the patients suffer from intractable, chronic LBP despite no evident organic abnormality. Research shows that also in these patients cognitive and behavioural aspects of pain are important and related to physical performance and self-reported disability (Vlaeyen et al., 2000). Several studies have demonstrated the success of GEXP in this patient group: GEXP resulted in improvements in pain-related fear, catastrophizing, performance of daily relevant activities, and in pain intensity (Leeuw et al., 2008).
This study aims to investigate the effect of GEXP on brain regions involved in the processing of harmless tactile stimuli in CRPS-I and CLBP patients, as well as its effect on tactile discrimination thresholds. We hypothesize that GEXP will induce 1) an improvement of tactile discrimination thresholds, 2) a functional reorganization of primary and secondary somatosensory cortex (in regions related to the affected limb in CRPS-I; and to the back in LBP), 3) changes in activation of emotional brain circuits during non-noxious stimulation, 4) changes in resting state connectivity between emotional and sensory brain areas, 5) changes in measures reflecting white matter integrity. No systematic changes are expected in the healthy controls.
Patients diagnosed with CRPS-I and CLBP will participate in a Magnetic Resonance Imaging (MRI) experiment. In this observational study, we examine the effects of GEXP treatment that all patients receive as part of usual care. Anatomical as well as diffusion-weighted and T2*-weighted (Blood oxygenation level dependent) MR images will be acquired. The study has a 3x4 split plot design with group (CRPS-I patients and CLBP receiving GEXP treatment / healthy controls) as between-subjects variable and time (pre-, during, post-treatment and follow-up) as within-subject variable.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with CRPS | – | –Patients with Complex Regional Pain Syndrome, Type I |
| Patients with CLBP | – | –Patients with chronic low back pain |
| Healthy controls | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People diagnosed with CRPS, type I, and people with chronic low back pain (CLBP) are target population for this study. A group of healthy controls matched for age, gender and handedness will also take part in the study.
Key inclusion criteria (24 listed)
- A clinical diagnosis of CRPS-I according to 'the Budapest criteria' for research purposes (Harden et al., 2007):
- Unilateral localization on upper or lower extremity
- Experience of non-specific lower back pain for at least three months
- No other diagnosis better explaining the signs and symptoms. both patient groups:
- Report of substantial fear of movement/(re)-injury
Key exclusion criteria (9 listed)
- Neuropathy of the upper or lower extremities
- MRI incompatible health condition (e. g. pacemaker, metal prosthetic devices)
- Psychiatric condition and ongoing medication that would alter emotional/sensory processing
- Previous tactile impairment in the upper or lower extremity caused by:
- (history of) CRPS or other chronic pain syndromes
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
Change from baseline blood oxygenation level dependent (BOLD) signal (fMRI) during tactile stimulation and during rest
Time frame: participants will be assessed repeatedly during the treatment; at baseline, at 5/6 weeks after start of treatment, at end of treatment (approximately 10 weeks after start) and at follow-up (6 months after end of treatment)
Change from baseline diffusion MRI measures (fractional anisotropy, neurite density, orientation dispersion)
Time frame: participants will be assessed repeatedly during the treatment; at baseline, at 5/6 weeks after start of treatment, at end of treatment (approximately 10 weeks after start) and at follow-up (6 months after end of treatment)
Change from baseline tactile discrimination threshold in mm
Time frame: participants will be assessed repeatedly during the treatment; at baseline, at 5/6 weeks after start of treatment, at end of treatment (approximately 10 weeks after start) and at follow-up (6 months after end of treatment)
3 secondary outcomes
Change from baseline pain-related fear (TSK, PHODA)
Time frame: participants will be assessed repeatedly during the treatment; at baseline, at 5/6 weeks after start of treatment, at end of treatment (approximately 10 weeks after start) and at follow-up (6 months after end of treatment)
Change from baseline pain catastrophizing (PCS)
Time frame: participants will be assessed repeatedly during the treatment; at baseline, at 5/6 weeks after start of treatment, at end of treatment (approximately 10 weeks after start) and at follow-up (6 months after end of treatment)
Change from baseline pain intensity level as assessed on visual analog scale
Time frame: daily
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 23 Jul 2018.
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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 Chronic Pain, run by Maastricht University Medical Center at 1 site in Netherlands.
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 24 inclusion and 9 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 23 Jul 2018. 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 Netherlands. 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 blood oxygenation level dependent (BOLD) signal (fMRI) during tactile stimulation and during rest (time frame: participants will be assessed repeatedly during the treatment; at baseline, at 5/6 weeks after start of treatment, at end of treatment (approximately 10 weeks after start) and at follow-up (6 months after end of treatment)). The study lists 3 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 23 Jul 2018.