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

NCT05998889 | Unknown

• 1 other identifier: ABILITIES-1
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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),

Conditions

Complex Regional Pain Syndrome I (CRPS I)

Keywords

Complex Regional Pain Syndrome; Physiotherapy (specialty); Pain Management; Exposure Therapy; Efficacy; Safety

Outcome Measures

Primary Outcomes (5)

• Severity of the disease

  Complex Regional Pain Syndrome Severity Score: This questionnaire contains self-reported items of persistent disproportionate pain, allodynia /hyperalgesia, asymmetry of temperature, color, sweating, oedema, trophic changes and motor changes . It also includes items observed by the examiner: allodynia , hyperalgesia , bilateral asymmetry of temperature by palpation, skin color changes, sweating, edema, trophic changes , and motor changes , as well as a decrease in active joint range of motion. The items are evaluated dichotomously; 0 indicates absence, and 1 indicates presence, resulting in a possible score range of 0 to 16, where higher scores indicate greater severity. The internal consistency obtained for the 16 items was adequate (Cronbach's α = 0.71).

  Pre-treatment, post-treatment (9 weeks) and at 1 and 3 months follow-up after treatment.

• Safety Outcome 1: oedema

  Perimetry ( measured with a measuring tape in centimeters ) of the metacarpofalangical joint line of the affected hand or the metatarsofalangical joint line of the affected foot. Control before and after the exercise intervention. Registered in a dichotomous way, absence if no changes observed, presence if the perimeter has raised 2 centimeters or more.

  Weekly during during the intervention (9 weeks)

• Safety Outcome 2: pain

  Changes in Verbal Pain Numerical Rating Scale after the exercises (recorded verbally). Control before and after the intervention. Registered in a dichotomous way, absence if no changes observed, presence if the Pain has raised 2 points or more.

  Weekly during during the intervention (9 weeks)

• Safety Outcome 3: temperature

  Changes in temperature (in Celsius Degrees, taken with a Hand Infrared thermometer). Control before and after the exercise intervention at 1 cm in the center of the back of the affected hand / foot and compared to the other side. Registered in a dichotomous way, absence if no changes observed, presence if the temperature raises 2ºC or more.

  Weekly during during the intervention (9 weeks)

• Safety outcome 4: range of motion

  Changes in active Range of Motion (measured with a finger goniometer in degrees). Control before and after the exercise intervention. Registered in a dichotomous way, absence if no changes observed, presence if active range of motion decreases 10º or more.

  Weekly during during the intervention (9 weeks)

Secondary Outcomes (9)

• Quality, Intensity and location of pain

  Pre-treatment, post-treatment (9 weeks) and at 1 and 3 months follow-up after treatment.

• Pain pressure level

  Pre-treatment, post-treatment (9 weeks) and at 1 and 3 months follow-up after treatment.

• Conditioned Pain Modulation

  Pre-treatment, post-treatment (9 weeks) and at 1 and 3 months follow-up after treatment.

• Upper limb function

  Pre-treatment, post-treatment (9 weeks) and at 1 and 3 months follow-up after treatment.

• Lower limb function

  Pre-treatment, post-treatment (9 weeks) and at 1 and 3 months follow-up after treatment.

Study Arms (2)

Intervention group: GPE+GMI

EXPERIMENTAL

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

Behavioral: Experimental group

Control group: GMI

ACTIVE COMPARATOR

Graded Motor Imagery

Behavioral: Control group

Interventions

Experimental group BEHAVIORAL

Education, Graded Pain Exposure Exercises and Graded Motor Imagery. One supervision a week/9 weeks + exercises at home + encourage returning relevant activities despite pain

Intervention group: GPE+GMI

Control group BEHAVIORAL

Graded Motor Imagery following the GRaMI protocol, One supervision a week/9 weeks + exercises at home, activities encourage but pain contingency.

Control group: GMI

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Vic - Central University of Catalonia: lead
• Institut Català de la Salut: collaborator

Study Sites (1)

CAP El Maresme

Mataró, Barcelona, 08304, Spain

RECRUITING

Related Publications (5)

• Shafiee E, MacDermid J, Packham T, Walton D, Grewal R, Farzad M. The Effectiveness of Rehabilitation Interventions on Pain and Disability for Complex Regional Pain Syndrome: A Systematic Review and Meta-analysis. Clin J Pain. 2023 Feb 1;39(2):91-105. doi: 10.1097/AJP.0000000000001089.

  PMID: 36650605 BACKGROUND

• Harden RN, McCabe CS, Goebel A, Massey M, Suvar T, Grieve S, Bruehl S. Complex Regional Pain Syndrome: Practical Diagnostic and Treatment Guidelines, 5th Edition. Pain Med. 2022 Jun 10;23(Suppl 1):S1-S53. doi: 10.1093/pm/pnac046.

  PMID: 35687369 BACKGROUND

• 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 BACKGROUND

• Smith BE, Hendrick P, Smith TO, Bateman M, Moffatt F, Rathleff MS, Selfe J, Logan P. Should exercises be painful in the management of chronic musculoskeletal pain? A systematic review and meta-analysis. Br J Sports Med. 2017 Dec;51(23):1679-1687. doi: 10.1136/bjsports-2016-097383. Epub 2017 Jun 8.

  PMID: 28596288 BACKGROUND

• van de Meent H, Oerlemans M, Bruggeman A, Klomp F, van Dongen R, Oostendorp R, Frolke JP. Safety of "pain exposure" physical therapy in patients with complex regional pain syndrome type 1. Pain. 2011 Jun;152(6):1431-1438. doi: 10.1016/j.pain.2011.02.032. Epub 2011 Apr 6.

  PMID: 21474244 BACKGROUND

MeSH Terms

Conditions

Complex Regional Pain Syndromes; Agnosia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Jordi Alcaide Altet, PT

  University of Vic - UCC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jordi Alcaide Altet, PT

CONTACT

+34 666703823; jordi.alcaide@uvic.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, physiotherapist

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 21, 2023
• Study Start: January 25, 2024
• Primary Completion: December 1, 2024
• Study Completion: May 1, 2025
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)