Complex Regional Pain Syndrome (CRPS) TYPE IPhase 3SDRCNCT02390505
Role of Vitamin C at 6 Months on Incidence of Complex Regional Pain Syndrome Type I in Upper Limb Surgery
A Phase 3 study testing Vitamin C in people with Complex Regional Pain Syndrome (CRPS) TYPE I, run by Centre Hospitalier Universitaire, Amiens at 3 sites in France.
Trial summary
Vitamin C with its antioxidant role has many indications. The objective of this study is to demonstrate that taking vitamin C as a preventive significantly reduces the occurrence of complex regional pain syndrome (CRPS) type 1 in the aftermath of a scheduled surgery of the upper limb. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complex Regional Pain Syndrome (CRPS) TYPE I
- What is being tested?
- Vitamin C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 995 participants
- Where
- 3 sitesFrance
- Study dates
- 18 Jul 2016to 8 Dec 2025
- Phase
- Phase 3
- 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
- patients over 18 yo
- patients undergoing major surgery of the upper limb
- patients able to give their consent to follow the protocol of treatment and monitoring.
Who cannot join
- children,
- patients under guardianship,
- pregnant or lactating women,
- patients with hemochromatosis,
- allergy or known hypersensitivity to one of the molecules of treatment,
- patients suffering or having already suffered from complex regional pain syndrome type 1 or type 2,
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- patients unable due to personal or professional mobility, to conduct post-operative follow up,
- patients undergoing surgery with nerve suture with nerve graft, emergency surgery,
- patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency,
- patients with chronic kidney disease
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU Amiens
Amiens, 80054
CHU Rouen
Rouen, 76031
CH Saint-Quentin
Saint-Quentin, 02321
About this study
Vitamin C with its antioxidant role has many indications. The objective of this study is to demonstrate that taking vitamin C as a preventive significantly reduces the occurrence of complex regional pain syndrome (CRPS) type 1 in the aftermath of a scheduled surgery of the upper limb.
Read the detailed description
The preventive role of vitamin C on the development of CRPS type 1 was already demonstrated in traumatology and foot surgery.
The management of CRPS type 1 is long and expensive. A preventive care seems beneficial. Some studies already performed suggest a similar role in scheduled surgery of the upper limb, major provider of CRPS type 1.The aim of the study is to demonstrate a significant reduction of CRPS 1 when taking vitamin C during the perioperative period in upper limb surgery. It is a prospective, randomized, double-blind, with placebo use, in two parallel group, multicenter and national. Patients are followed by their surgeon, under the terms of monitoring their disease. Two visits are required: one at 6 months and at 12 months. The patients will be reviewed at least in the two consultations looking for CRPS type 1 according to the criteria of the International Association for the Study of Pain (IASP)
- Being tested
- Vitamin C, Placebo
- Keywords
- vitamin C, CRPS, Upper limb surgery
- 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.
Vitamin CDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Vitamin C | Experimental | Patients receive vitamin C at a daily dose of 500 mg orally: 7 days before and during 6 weeks after surgery Receives: Drug: Vitamin C |
| Placebo | Placebo comparator | Patients receive placebo at a daily dose of 500 mg orally: 7 days before and during 6 weeks after surgery Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appearance of a complex regional pain syndrome (CRPS) 6 months after surgery
Comparison of the occurrence of participants with CRPS type 1, between the two arms
Measured: 6 months after surgery
Secondary outcomes (3)
Appearance of a complex regional pain syndrome 12 months after surgery
Comparison of the occurrence of participants with CRPS type 1, between the two arms
Measured: 12 months after surgery
Tolerance
Evaluation of tolerance of vitamin C in pre- and post-operative period by adverse events registration
Measured: 6 months after surgery
Observance to treatment
The observance to the treatment is estimated based on an adherence form completed by the patient
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study start18 Jul 2016
- Primary completion7 Jul 2025
- Study completion8 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Regional Pain Syndrome (CRPS) TYPE IStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 995 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel DAVID, MD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02390505
- Sponsor's protocol ID
- PI2015_843_0001
- Other IDs
- 2015-000145-24, 2015
- Acronym
- SDRC
- Status last verified
- Jun 2026
- First submitted
- 16 Feb 2015
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Vitamin C at 6 Months on Incidence of Complex Regional Pain Syndrome Type I in Upper Limb Surgery
- ClinicalTrials.gov ID
- NCT02390505
- Acronym / sponsor ID
- SDRC / PI2015_843_0001
- Keywords
- vitamin C, CRPS, Upper limb surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 995 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 18 Jul 2016 (actual)
- Primary completion
- 7 Jul 2025 (actual)
- Study completion
- 8 Dec 2025 (actual)
- First posted
- 17 Mar 2015 (estimated)
- 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.
Vitamin C with its antioxidant role has many indications. The objective of this study is to demonstrate that taking vitamin C as a preventive significantly reduces the occurrence of complex regional pain syndrome (CRPS) type 1 in the aftermath of a scheduled surgery of the upper limb.
Detailed description
The preventive role of vitamin C on the development of CRPS type 1 was already demonstrated in traumatology and foot surgery.
The management of CRPS type 1 is long and expensive. A preventive care seems beneficial. Some studies already performed suggest a similar role in scheduled surgery of the upper limb, major provider of CRPS type 1.The aim of the study is to demonstrate a significant reduction of CRPS 1 when taking vitamin C during the perioperative period in upper limb surgery. It is a prospective, randomized, double-blind, with placebo use, in two parallel group, multicenter and national. Patients are followed by their surgeon, under the terms of monitoring their disease. Two visits are required: one at 6 months and at 12 months. The patients will be reviewed at least in the two consultations looking for CRPS type 1 according to the criteria of the International Association for the Study of Pain (IASP)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin C | Experimental | Drug: Vitamin CPatients receive vitamin C at a daily dose of 500 mg orally: 7 days before and during 6 weeks after surgery |
| Placebo | Placebo comparator | Drug: PlaceboPatients receive placebo at a daily dose of 500 mg orally: 7 days before and during 6 weeks after surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients over 18 yo
- patients undergoing major surgery of the upper limb
- patients able to give their consent to follow the protocol of treatment and monitoring.
Key exclusion criteria (10 listed)
- children,
- patients under guardianship,
- pregnant or lactating women,
- patients with hemochromatosis,
- allergy or known hypersensitivity to one of the molecules of treatment,
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 |
|---|---|---|
| Vitamin C | Drug | Vitamin C |
| Placebo | Drug | Placebo |
Primary outcome
Appearance of a complex regional pain syndrome (CRPS) 6 months after surgery
Time frame: 6 months after surgery
Comparison of the occurrence of participants with CRPS type 1, between the two arms
3 secondary outcomes
Appearance of a complex regional pain syndrome 12 months after surgery
Time frame: 12 months after surgery
Tolerance
Time frame: 6 months after surgery
Observance to treatment
Time frame: 6 months after surgery
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 11 Jun 2026.
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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.
Emmanuel DAVID, MD principal investigator
CHU Amiens
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin C in people with Complex Regional Pain Syndrome (CRPS) TYPE I, run by Centre Hospitalier Universitaire, Amiens at 3 sites 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 3 inclusion and 10 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 11 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 3 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Appearance of a complex regional pain syndrome (CRPS) 6 months after surgery (time frame: 6 months after surgery). 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 11 Jun 2026.