Evaluation of the Relationship Between the Duration of the Evolution of the Complex Regional Pain Syndrome Type 1 (CRPS 1) and Effectiveness of the Continuous Peripheral Nerve Block (CPNB) Associated With an Intensive Rehabilitation Program

Overview

The study evaluates the relationship between the duration of evolution of SDRC1 and the efficacy of continuous peripheral nerve block (c-PNB) associated with an intensive rehabilitation program to improve the therapeutic strategy of SDRC1. The main hypothesis of this study is that if c-PNB is proposed earlier, the recovery, measured with a scale achievement of objectives, will be better.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2024

Interventions

  • Procedure: Intensive rehabilitation program with CPNB
    • The patient will have an intensive rehabilitation program (two 30-minute kinesitherapy sessions every day and 30-minute occupational therapy sessions 5 days a week) with the CPNB. The patient will have follow-up consultation at 1 month, 3 month, 6 month and 1 year after the beggining of the intensive rehabilitation program

Arms, Groups and Cohorts

  • Experimental: C-BNP with intensive rehabilitation program

Clinical Trial Outcome Measures

Primary Measures

  • The composite score (the summation of the 3 Goal Attainment Scaling (GAS) scores)
    • Time Frame: 1 year
    • The improvement of the composite score following BNPc combined with intensive rehabilitation.

Secondary Measures

  • Pain assessment
    • Time Frame: 1 year
    • EVA for all the patients at each visit
  • Anxiety assessment
    • Time Frame: 1 year
    • Hospital Anxiety and Depression scale for all the patients at each visit
  • functional evaluation
    • Time Frame: 1 year
    • For an upper limb block : Passive and active arthrometry (angular measurements for shoulder, elbow and wrist) For a block of the lower limb : Passive and active arthrometry (angular measurements for hip, knee and ankle)
  • hand joint assessment
    • Time Frame: 1 year
    • For an upper limb block : Kapandji Index at each visit (between 0 to 10)
  • gripping force assessment
    • Time Frame: 1 year
    • For an upper limb block, gripping force will be evaluated with a Jamar and Pinch dynamometer at each visit after BNPc
  • activity assessment
    • Time Frame: 1 year
    • For an upper limb block, the activity limitation will be evaluated by leroux’s scapular index (LSI) with a global score out of 100 at each visit after BNPc
  • manual dexterity test
    • Time Frame: 1 year
    • For an upper limb block, the dexterity will be evaluated by a Box and Block Test at each visit after BNPc
  • Assessment of activity limitation for a block of the upper limb
    • Time Frame: 1 year
    • DASH scale at each visit
  • Assessment of activity limitation for a block of the lower limb
    • Time Frame: 1 year
    • WOMAC score at each visit
  • Assessment of activity limitation for a block of the lower limb
    • Time Frame: 1 year
    • TDM6 at each visit (number of metres travelled by the patient during 6 minutes)
  • Assessment of the restriction of participation in social life
    • Time Frame: 1 year
    • Return to work
  • Evaluation of the effective dose
    • Time Frame: During the CPNB
    • – Recording of effective doses (continuous and bolus)
  • Evaluation of the tolerance of CPNB
    • Time Frame: During the CPNB
    • – Incident reporting

Participating in This Clinical Trial

Inclusion Criteria

  • informed consent signed – Diagnosis of CRPS type 1 according to BUDAPEST criteria to the upper or lower limb – Affiliated to a social security scheme (beneficiary or entitled person) – Patients justifying the installation of a Continuous Peripheral Nerve Block (CPNB) including pain rebellious to physical and medicinal treatments, the presence of fixed dystonia, or kinesiphobia or who are no longer progressing in the rehabilitation algorithm and requiring the need for a specialised technical platform. Exclusion Criteria:

  • CRPS Type 2 – Contra-indication to the analgesics used (bupivacaine, ropivacaine, levobupivacaine) – Severe psychiatric decompensation – Under legal protection measures – Pregnant women

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pôle Saint Hélier
  • Provider of Information About this Clinical Study
    • Sponsor

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