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A Comparison of Two Treatments for CRPS and Changes in Resting-State Connectivity of Cerebral Networks.

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ClinicalTrials.gov Identifier: NCT02753335
Recruitment Status : Recruiting
First Posted : April 27, 2016
Last Update Posted : May 14, 2018
Sponsor:
Collaborator:
University Hospital of North Norway
Information provided by (Responsible Party):
University of Tromso

Brief Summary:
The intention of this trial is to investigate whether combined Graded Motor Imagery (GMI) and Desensitization (D) among patients with CRPS is clinically more effective than only D and to study changes in connectivity in the Default Mode Network before and after treatment.

Condition or disease Intervention/treatment Phase
Complex Regional Pain Syndrome Behavioral: GMI and Desensitization Behavioral: Desensitization Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial of Patients With Complex Regional Pain Syndrome Comparing Graded Motor Imagery and Desensitization Versus Simple Desensitization and Changes in Resting-State Connectivity of Cerebral Networks Before and After Treatment.
Study Start Date : September 2016
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: GMI and Desensitization
Left/right judgement, imagine movements of the affected area, mirror treatment and tactile stimulation of the affected limb with different materials.
Behavioral: GMI and Desensitization

Graded Motor Imagery (GMI) is used to treat chronic pain conditions and movement problems related to alterations in the nervous system such as CRPS, postamputation limb pain and back pain. The patient is trained in monitored steps. The three treatment components include left/right discrimination training, motor imagery exercises and mirror observations of the unaffected limb, appearing as the affected limb. They are performed sequentially, but require a flexible approach to suit the individual patient. The imagined movements have been demonstrated to activate motor cortical areas similar to those activated in the actual execution of that movement.

Desensitization (D) is used to decrease hyperalgesia by repeated tactile stimulation of the affected area with various materials.


Experimental: Desensitization
Tactile stimulation of the affected limb with different materials.
Behavioral: Desensitization
Desensitization (D) is used to decrease hyperalgesia and allodynia by repeated tactile stimulation of the affected area with various materials.




Primary Outcome Measures :
  1. Group difference in pain intensity [ Time Frame: 6 weeks after baseline ]
    Continuous numeric variable using a visual analog scale from minimum 0 to maximum 100

  2. Change from baseline in intra-network connectivity in the Default Mode Network [ Time Frame: 6 months after baseline ]
    Continuous variable


Secondary Outcome Measures :
  1. Change from baseline in pain intensity [ Time Frame: 6 weeks after baseline ]
    Continuous numeric variable using a visual analog scale from minimum 0 to maximum 100

  2. Change from baseline in pain intensity [ Time Frame: 6 months after baseline ]
    Continuous numeric variable using a visual analog scale from minimum 0 to maximum 100

  3. Change from baseline in pain intensity [ Time Frame: 12 months after baseline ]
    Continuous numeric variable using a visual analog scale from minimum 0 to maximum 100

  4. Group difference in CRPS Severity Score [ Time Frame: 6 weeks after baseline ]
    Continuous variable using a numeric scale from minimum 0 to maximum 17

  5. Change from baseline in CRPS Severity Score [ Time Frame: 6 weeks after baseline ]
    Continuous variable using a numeric scale from minimum 0 to maximum 17

  6. Change from baseline in CRPS Severity Score [ Time Frame: 6 months after baseline ]
    Continuous variable using a numeric scale from minimum 0 to maximum 17

  7. Change from baseline in CRPS Severity Score [ Time Frame: 12 months after baseline ]
    Continuous variable using a numeric scale from minimum 0 to maximum 17

  8. Group difference in Quick DASH score/percent lower extremity functional scale score [ Time Frame: 6 weeks after baseline ]
    Continous variable using a numeric scale from minimum 0 to maximum 100

  9. Relative change from baseline in Quick DASH/Lower extremity functional scale score [ Time Frame: 6 weeks after baseline ]
    Continous variable using scales from minimum 0 to maximum 100

  10. Relative change from baseline in Quick DASH/Lower extremity functional scale score [ Time Frame: 6 months after baseline ]
    Continous variable using scales from minimum 0 to maximum 100

  11. Relative change from baseline in Quick DASH/Lower extremity functional scale score [ Time Frame: 12 months after baseline ]
    Continous variable using scales from minimum 0 to maximum 100

  12. Group difference in responder rate [ Time Frame: 6 weeks after baseline ]
    Categorical variable indicating the proportion of patients who reaches a clinically meaningful change (33 % pain reduction) on a numeric rating scale (0-10).

  13. Change from baseline in responder rate [ Time Frame: 6 weeks after baseline ]
    Categorical variable indicating the proportion of patients who reaches a clinically meaningful change (33 % pain reduction) on a numeric rating scale (0-10).

  14. Change from baseline in responder rate [ Time Frame: 6 months after baseline ]
    Categorical variable indicating the proportion of patients who reaches a clinically meaningful change (33 % pain reduction) on a numeric rating scale (0-10).

  15. Change from baseline in responder rate [ Time Frame: 12 months after baseline ]
    Categorical variable indicating the proportion of patients who reaches a clinically meaningful change (33 % pain reduction) on a numeric rating scale (0-10).



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Patients 18 - 70 years old. For patients who only participate in the clinical RCT (without fMRI) no upper age limit.
  • CRPS affecting one single upper or lower limb diagnosed by the IASP (2012) Budapest research criteria (Harden et al., 2010).
  • Triggering trauma or the onset of pain >3 months ago.
  • If possible drugs that can influence the fMRI scans should be avoided. Documentation if used.

Exclusion criteria

  • Drug abuse.
  • Malignant/progressive, systemic or neurodegenerative disease.
  • Other severe pain conditions.
  • Severe clinical anxiety or depression, symptoms of fatigue or ME of a disabling level.

For patients who participate in the MRI related analyses:

  • Metallic implants incompatible with the MR technology or medical condition not recommended for fMRI.
  • Pregnancy.
  • Phobia for MRI examination.
  • Diseases that can cause structural changes and interfere with the interpretation of the MRI-scans (like severe diabetes mellitus, heart disease, ischemic stroke and vascular conditions).

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): NCT02753335


Contacts
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Contact: Gunnvald Kvarstein, PhD gunnvald.kvarstein@uit.no
Contact: Danielsson Lena, MD lena.danielsson@unn.no

Locations
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Norway
University Hospital of North Norway Recruiting
Tromsø, Norway, 9038
Contact: Lena Danielsson    +4777669307    lena.danielsson@unn.no   
Contact: Gunnvald Kvarstein       gunnvald.kvarstein@unn.no   
Sponsors and Collaborators
University of Tromso
University Hospital of North Norway
Investigators
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Study Chair: Gunnvald Kvarstein, PhD University of Tromso

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Responsible Party: University of Tromso
ClinicalTrials.gov Identifier: NCT02753335     History of Changes
Other Study ID Numbers: 2014/1671(REK)
First Posted: April 27, 2016    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Tromso:
CRPS, graded motor imagery, desensitization, fMRI, DMN

Additional relevant MeSH terms:
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Syndrome
Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Disease
Pathologic Processes
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases