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Completed

NCT Number: NCT04767646

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pôle Saint Hélier

Rennes, Brittany Region, 35000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intensive rehabilitation program with CPNB

Procedure

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

Primary outcomes

  1. 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 outcomes

  1. Pain assessment

    Time frame: 1 year

    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.

  2. Anxiety assessment

    Time frame: 1 year

    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.

  3. Arthrometry assessment

    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)

  4. hand joint assessment

    Time frame: 1 year

    For an upper limb block :

    Kapandji Index at each visit (between 0 to 10)

  5. 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

  6. 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

  7. 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

  8. Assessment of activity limitation for a block of the upper limb

    Time frame: 1 year

    DASH scale at each visit

  9. Assessment of activity limitation for a block of the lower limb

    Time frame: 1 year

    WOMAC score at each visit

  10. Assessment of functional capacity

    Time frame: 1 year

    TDM6 at each visit (number of metres travelled by the patient during 6 minutes)

  11. Assessment of the restriction of participation in social life

    Time frame: 1 year

    Return to work

  12. Evaluation of the effective dose

    Time frame: During the CPNB

    • Recording of effective doses (continuous and bolus)
  13. Evaluation of the tolerance of CPNB

    Time frame: During the CPNB

    • Incident reporting

Sponsors and collaborators

Lead sponsor

Pôle Saint Hélier

Other

Registry information

Acronym: BLOCALGO

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Feb 23, 2021
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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