Feasibility of a Combination of Graded Pain Exposure and Graded Motor Imagery in People With Complex Regional Pain Syndrome Type 1 (ABILITIES-1)

University of Vic - Central University of Catalonia

Status: Enrolling

Conditions: Complex Regional Pain Syndrome I (CRPS I)

Treatments: Behavioral: Experimental group; Behavioral: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT05998889

ABILITIES-1

Details and patient eligibility

About

Background:

There is low quality evidence supporting the use of rehabilitation in Complex Regional Pain Syndrome (CRPS), despite it is the first line approach in the Guidelines . Graded Motor Imagery (GMI) may be useful to improve pain and function at mid term (6 months). Graded Pain Exposure Approaches (GPE) seem to improve pain but not function at mid term. In other type of chronic pain conditions GPE offers better outcomes than "pain contingent" (exercises avoiding pain) approaches at short term (3 months) and similar at mid term. Following the recommendations of Authors, we will evaluate the efficacy and safety of a combined therapy of GMI and GPE in people with CRPS type 1.

Objective:

To evaluate the feasibility of a combined therapy of GPE and GMI in front of only GMI in people with CRPS-1 and the clinical impact on the primary outcome (Severity of the disease) of the intervention.

Design:

Feasibility Randomized controlled Trial, single blind of evaluator, 2 parallel arms. Measurement pre-intervention, post-intervention , 1 and 3 months follow-up.

Population:

People 18 years old or above with CRPS type 1 diagnosed by Budapest criteria and (1) without any psychological or psychiatric disease, (2) nor any neurosensorial issue that could compromise the realization of the therapy proposed (3) neither any major surgery intervention related to CRPS (e.g neurostimulation or sympathectomy) (4) nor minor intervention on the last 3 months (e.g. nerve blocks).

Outcomes:

Primary outcomes: Complex Regional Pain Syndrome Severity Scale (severity of the disease) and Safety Outcomes ( oedema, pain, temperature, Range of Motion). Secondary outcomes: 5Q-5D-5L (quality of life), SF-MPQ (Quality, Intensity and location of pain), PPT (pain pressure threshold), CPM ( pain inhibition pathways), FAAM or Quick Dash (function), PCS (catastrophism), Self efficacy in chronic pain questionnaire (self-efficacy), Dynamometry (Hand Grip strength),

Enrollment: 26 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• No difficulties understanding Spanish or Catalan.
• Diagnosed according to Budapest criteria.

Exclusion criteria

• Diagnosis of psychological or psychiatric illness
• Having received any major invasive treatment (e.g: Spinal cord Implants or sympathectomy of the affected extremity).
• Having received any minor invasive treatment (e.g: Nerves block) in the last three months.
• Having any neurosensorial difficulty that could compromise the execution of the therapy proposed.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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26 participants in 2 patient groups

Intervention group: GPE+GMI

Experimental group

Description:

Pain Education program based on Neuroscience of pain and the Fear-Avoidance model + Graded Pain Exposure Exercises + Graded Motor Imagery

Treatment:

Behavioral: Experimental group

Control group: GMI

Active Comparator group

Description:

Graded Motor Imagery

Treatment:

Behavioral: Control group