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 (BLOCALGO)

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 Overview

• Status: Recruiting
• Conditions: CRPS (Complex Regional Pain Syndrome) Type I
• Intervention / Treatment: Procedure: Intensive rehabilitation program with CPNB

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Philippe Gallien, Doctor; Phone Number: 0299295099; Email: philippe.gallien@pole-sthelier.com

Study Locations

• France
  • Bretagne
    • Rennes, Bretagne, France, 35000
      • Recruiting
      • Pole Saint Helier
      • Contact: Philippe Gallien, Doctor; Email: philippe.gallien@pole-sthelier.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: C-BNP with intensive rehabilitation program	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain assessment	EVA (Visual Analogue Scale, VAS) for all the patients at each visit This is a measure of pain intensity on a scale of 0 (no pain) to 10 (very severe pain). We will assess the percentage of pain relief with the EVA scale, before and after the PCNB.	1 year
Anxiety assessment	Hospital Anxiety and Depression (HAD) scale for all the patients at each visit There will be 2 scores One to assess anxiety : from 0 to 21 and one to assess depression : from 0 to 21 Higher scores mean a worse outcome.	1 year
Arthrometry assessment	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)	1 year
hand joint assessment	For an upper limb block : Kapandji Index at each visit (between 0 to 10)	1 year
gripping force assessment	For an upper limb block, gripping force will be evaluated with a Jamar and Pinch dynamometer at each visit after BNPc	1 year
activity assessment	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	1 year
manual dexterity test	For an upper limb block, the dexterity will be evaluated by a Box and Block Test at each visit after BNPc	1 year
Assessment of activity limitation for a block of the upper limb	DASH scale at each visit	1 year
Assessment of activity limitation for a block of the lower limb	WOMAC score at each visit	1 year
Assessment of functional capacity	TDM6 at each visit (number of metres travelled by the patient during 6 minutes)	1 year
Assessment of the restriction of participation in social life	Return to work	1 year
Evaluation of the effective dose	- Recording of effective doses (continuous and bolus)	During the CPNB
Evaluation of the tolerance of CPNB	- Incident reporting	During the CPNB

Collaborators and Investigators

• Sponsor: Pôle Saint Hélier

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2021
• Primary Completion (Anticipated): February 1, 2024
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: February 5, 2021
• First Submitted That Met QC Criteria: February 22, 2021
• First Posted (Actual): February 23, 2021

Study Record Updates

• Last Update Posted (Actual): May 6, 2022
• Last Update Submitted That Met QC Criteria: May 5, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Disease; Neuromuscular Diseases; Peripheral Nervous System Diseases; Autonomic Nervous System Diseases; Syndrome; Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Somatoform Disorders
• Other Study ID Numbers: 2020-A00084-35

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No