CRPS (Complex Regional Pain Syndrome) Type IBLOCALGONCT04767646
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
A study testing Intensive rehabilitation program with CPNB in people with CRPS (Complex Regional Pain Syndrome) Type I, run by Pôle Saint Hélier at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CRPS (Complex Regional Pain Syndrome) Type I
- What is being tested?
- Intensive rehabilitation program with CPNB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 23 Feb 2021to 10 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- CRPS Type 2
- Contra-indication to the analgesics used (bupivacaine, ropivacaine, levobupivacaine)
- Severe psychiatric decompensation
- Under legal protection measures
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Intensive rehabilitation program with CPNB
- Medical subject headings
- Complex Regional Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive rehabilitation program with CPNBProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| C-BNP with intensive rehabilitation program | Experimental | Not described Receives: Procedure: Intensive rehabilitation program with CPNB |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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)
Measured: 1 year
hand joint assessment
For an upper limb block :
Kapandji Index at each visit (between 0 to 10)
Measured: 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
Measured: 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
Measured: 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
Measured: 1 year
Assessment of activity limitation for a block of the upper limb
DASH scale at each visit
Measured: 1 year
Assessment of activity limitation for a block of the lower limb
WOMAC score at each visit
Measured: 1 year
Assessment of functional capacity
TDM6 at each visit (number of metres travelled by the patient during 6 minutes)
Measured: 1 year
Assessment of the restriction of participation in social life
Return to work
Measured: 1 year
Evaluation of the effective dose
- Recording of effective doses (continuous and bolus)
Measured: During the CPNB
Evaluation of the tolerance of CPNB
- Incident reporting
Measured: During the CPNB
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start23 Feb 2021
- Primary completion10 Mar 2026
- Study completion10 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CRPS (Complex Regional Pain Syndrome) Type IStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pôle Saint Hélier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Gallien, Doctor, Principal investigator, Pôle Saint Hélier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04767646
- Sponsor's protocol ID
- 2020-A00084-35
- Acronym
- BLOCALGO
- Status last verified
- Jun 2026
- First submitted
- 5 Feb 2021
- Last updated
- 3 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04767646
- Acronym / sponsor ID
- BLOCALGO / 2020-A00084-35
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Pôle Saint HélierUniversity, hospital or other
- Study start
- 23 Feb 2021 (actual)
- Primary completion
- 10 Mar 2026 (actual)
- Study completion
- 10 Mar 2026 (actual)
- First posted
- 23 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| C-BNP with intensive rehabilitation program | Experimental | Procedure: Intensive rehabilitation program with CPNB |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- CRPS Type 2
- Contra-indication to the analgesics used (bupivacaine, ropivacaine, levobupivacaine)
- Severe psychiatric decompensation
- Under legal protection measures
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive rehabilitation program with CPNBThe 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 | Procedure or surgery | C-BNP with intensive rehabilitation program |
Primary outcome
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.
13 secondary outcomes
Pain assessment
Time frame: 1 year
Anxiety assessment
Time frame: 1 year
Arthrometry assessment
Time frame: 1 year
hand joint assessment
Time frame: 1 year
gripping force assessment
Time frame: 1 year
activity assessment
Time frame: 1 year
manual dexterity test
Time frame: 1 year
Assessment of activity limitation for a block of the upper limb
Time frame: 1 year
Assessment of activity limitation for a block of the lower limb
Time frame: 1 year
Assessment of functional capacity
Time frame: 1 year
Assessment of the restriction of participation in social life
Time frame: 1 year
Evaluation of the effective dose
Time frame: During the CPNB
Evaluation of the tolerance of CPNB
Time frame: During the CPNB
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
Related trials for CRPS (Complex Regional Pain Syndrome) Type I
Enrolling by invitationPhase 4
Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome
Complex Regional Pain Syndrome, Chronic Pain
RecruitingPhase 3
Evaluation of IV AMBTX-01 (Neridronate) for Treatment of CRPS Type 1 (CRPS-RISE)
Complex Regional Pain Syndrome Type I
RecruitingPhase 3
Phase 3, Open-Label Extension Study of AMBTX-01 (Neridronate) for Complex Regional Pain Syndrome Type 1
Complex Regional Pain Syndrome Type I
RecruitingObservational study
CRPS-RISE Outcomes Registry
Complex Regional Pain Syndrome I (CRPS I)
Recruiting
ESWT for CRPS-I After Distal Radius Fracture
Complex Regional Pain Syndrome Type I (CRPS-I), Distal Radius Fracture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Gallien, Doctor principal investigator
Pôle Saint Hélier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive rehabilitation program with CPNB in people with CRPS (Complex Regional Pain Syndrome) Type I, run by Pôle Saint Hélier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The composite score (the summation of the 3 Goal Attainment Scaling (GAS) scores) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.