Feasibility of a Combination of Graded Pain Exposure and Graded Motor Imagery in People With Complex Regional Pain Syndrome Type 1
NCT ID: NCT05998889
Last Updated: 2024-01-17
Study Results
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Basic Information
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RECRUITING
NA
26 participants
INTERVENTIONAL
2024-01-25
2025-05-31
Brief Summary
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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),
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intervention group: GPE+GMI
Pain Education program based on Neuroscience of pain and the Fear-Avoidance model + Graded Pain Exposure Exercises + Graded Motor Imagery
Experimental group
Education, Graded Pain Exposure Exercises and Graded Motor Imagery. One supervision a week/9 weeks + exercises at home + encourage returning relevant activities despite pain
Control group: GMI
Graded Motor Imagery
Control group
Graded Motor Imagery following the GRaMI protocol, One supervision a week/9 weeks + exercises at home, activities encourage but pain contingency.
Interventions
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Experimental group
Education, Graded Pain Exposure Exercises and Graded Motor Imagery. One supervision a week/9 weeks + exercises at home + encourage returning relevant activities despite pain
Control group
Graded Motor Imagery following the GRaMI protocol, One supervision a week/9 weeks + exercises at home, activities encourage but pain contingency.
Eligibility Criteria
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Inclusion Criteria
* Diagnosed according to Budapest criteria.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Institut Català de la Salut
OTHER
University of Vic - Central University of Catalonia
OTHER
Responsible Party
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Jordi Alcaide Altet
Principal investigator, physiotherapist
Principal Investigators
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Jordi Alcaide Altet, PT
Role: PRINCIPAL_INVESTIGATOR
University of Vic - UCC
Locations
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CAP El Maresme
Mataró, Barcelona, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
Other Identifiers
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ABILITIES-1
Identifier Type: -
Identifier Source: org_study_id
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