Clinical trial NCT05998889: Feasibility of a Combination of Graded Pain Exposure and Graded Motor Imagery in People With Complex Regional Pain Syndrome Type 1
Official title: A Feasibility Study of a Combination of Graded Pain Exposure and Graded Motor Imagery in People With Complex Regional Pain Syndrome Type 1
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Complex Regional Pain Syndrome I (CRPS I)
Keywords: Complex Regional Pain Syndrome
Physiotherapy (specialty)
Pain Management
Exposure Therapy
Efficacy
Safety
Lead sponsor: University of Vic - Central University of Catalonia
Sponsor class: OTHER
Collaborators: name: Institut Català de la Salut
First posted: 2023-08-21
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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),


Eligibility criteria: 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.

Primary outcomes:
measure: Severity of the disease
timeFrame: Pre-treatment, post-treatment (9 weeks) and at 1 and 3 months follow-up after treatment.
measure: Safety Outcome 1: oedema
timeFrame: Weekly during during the intervention (9 weeks)
measure: Safety Outcome 2: pain
timeFrame: Weekly during during the intervention (9 weeks)
measure: Safety Outcome 3: temperature
timeFrame: Weekly during during the intervention (9 weeks)
measure: Safety outcome 4: range of motion
timeFrame: Weekly during during the intervention (9 weeks)
Secondary outcomes:
measure: Quality, Intensity and location of pain
timeFrame: Pre-treatment, post-treatment (9 weeks) and at 1 and 3 months follow-up after treatment.
measure: Pain pressure level
timeFrame: Pre-treatment, post-treatment (9 weeks) and at 1 and 3 months follow-up after treatment.
measure: Conditioned Pain Modulation
timeFrame: Pre-treatment, post-treatment (9 weeks) and at 1 and 3 months follow-up after treatment.
measure: Upper limb function
timeFrame: Pre-treatment, post-treatment (9 weeks) and at 1 and 3 months follow-up after treatment.
measure: Lower limb function
timeFrame: Pre-treatment, post-treatment (9 weeks) and at 1 and 3 months follow-up after treatment.
measure: Quality of life (EQ-5D-5L)
timeFrame: Pre-treatment, post-treatment (9 weeks) and at 1 and 3 months follow-up after treatment.
measure: Catastrophism
timeFrame: Pre-treatment, post-treatment (9 weeks) and at 1 and 3 months follow-up after treatment.
measure: Self-efficacy
timeFrame: Pre-treatment, post-treatment (9 weeks) and at 1 and 3 months follow-up after treatment.
measure: Strength
timeFrame: Pre-treatment, post-treatment (9 weeks) and at 1 and 3 months follow-up after treatment.
Other outcomes:
Locations:
city: Mataró
country: Spain
facility: CAP El Maresme
state: Barcelona
Study officials:
affiliation: University of Vic - UCC
name: Jordi Alcaide Altet, PT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.