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Neurophysiological Basis of Rehabilitation in Complex Regional Pain Syndrome, Type I and Chronic Low Back Pain (BrainEXPain)

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ClinicalTrials.gov Identifier: NCT02347579
Recruitment Status : Completed
First Posted : January 27, 2015
Last Update Posted : July 23, 2018
Sponsor:
Collaborator:
Maastricht University
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief 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. 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.


Condition or disease
Chronic Pain

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Study Type : Observational
Actual Enrollment : 69 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Neurophysiological Basis of Rehabilitation in Complex Regional Pain Syndrome, Type I and Chronic Low Back Pain
Actual Study Start Date : June 2014
Actual Primary Completion Date : May 2018
Actual Study Completion Date : May 2018


Group/Cohort
Patients with CRPS
Patients with Complex Regional Pain Syndrome, Type I
Patients with CLBP
Patients with chronic low back pain
Healthy controls



Primary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. 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) ]

Secondary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. Change from baseline pain intensity level as assessed on visual analog scale [ Time Frame: daily ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

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
      • 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

Exclusion Criteria:

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
    • CNS lesion

healthy controls:

• (history of) CRPS or other chronic pain syndromes


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02347579


Locations
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Netherlands
Maastricht University
Maastricht, Netherlands, 6200 MD
Sponsors and Collaborators
Maastricht University Medical Center
Maastricht University

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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02347579     History of Changes
Other Study ID Numbers: NL35546.068.11
First Posted: January 27, 2015    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
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Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Back Pain
Low Back Pain
Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases