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

NCT02753335 | Unknown

• 1 other identifier: 2014/1671(REK)
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Complex Regional Pain Syndrome

Keywords

CRPS, graded motor imagery, desensitization, fMRI, DMN

Outcome Measures

Primary Outcomes (2)

• Group difference in pain intensity

  Continuous numeric variable using a visual analog scale from minimum 0 to maximum 100

  6 weeks after baseline

• Change from baseline in intra-network connectivity in the Default Mode Network

  Continuous variable

  6 months after baseline

Secondary Outcomes (15)

• Change from baseline in pain intensity

  6 weeks after baseline

• Change from baseline in pain intensity

  6 months after baseline

• Change from baseline in pain intensity

  12 months after baseline

• Group difference in CRPS Severity Score

  6 weeks after baseline

• Change from baseline in CRPS Severity Score

  6 weeks after baseline

Study Arms (2)

GMI and Desensitization

EXPERIMENTAL

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

Desensitization

EXPERIMENTAL

Tactile stimulation of the affected limb with different materials.

Behavioral: Desensitization

Interventions

GMI and Desensitization BEHAVIORAL

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.

GMI and Desensitization

Desensitization BEHAVIORAL

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

Desensitization

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Tromso: lead
• University Hospital of North Norway: collaborator

Study Sites (1)

University Hospital of North Norway

Tromsø, 9038, Norway

RECRUITING

Related Publications (1)

• Smart KM, Ferraro MC, Wand BM, O'Connell NE. Physiotherapy for pain and disability in adults with complex regional pain syndrome (CRPS) types I and II. Cochrane Database Syst Rev. 2022 May 17;5(5):CD010853. doi: 10.1002/14651858.CD010853.pub3.

  PMID: 35579382 DERIVED

MeSH Terms

Conditions

Complex Regional Pain Syndromes

Interventions

Desensitization, Psychologic

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Gunnvald Kvarstein, PhD

  University of Tromso

  STUDY CHAIR

Central Study Contacts

Gunnvald Kvarstein, PhD

CONTACT

gunnvald.kvarstein@uit.no

Danielsson Lena, MD

CONTACT

lena.danielsson@unn.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2016
• First Posted: April 27, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: May 11, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)