AuthorisedTherapeutic confirmatory (Phase III)Interventional

Role of Vitamin C at 6 Months on Incidence of Complex Regional Pain Syndrome Type I in Upper Limb Surgery (CRPS-VITC)

This research wants to find out if taking vitamin C for six months after an operation on your arm or hand can stop you from developing a condition called Complex Regional Pain Syndrome, or CRPS for short. CRPS is a type of long-term pain that can happen after an injury or surgery. The study will check how often people get CRPS six months after their surgery if they take vitamin C, compared to those who don't. It will also look at how well people tolerate vitamin C and if they follow the study instructions. The aim is to see if vitamin C could be a simple way to prevent this painful condition.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Centre Hospitalier Universitaire Amiens Picardie

Enrolment target

1,000

Start

10 Oct 2024

Algoneurodystrophy CRPS type 1

What is this study about?

This study is investigating a condition called Complex Regional Pain Syndrome (CRPS), sometimes known as algoneurodystrophy. CRPS is a type of long-lasting pain that can sometimes develop after an injury or surgery, particularly in the arms and legs. It's known for causing severe pain, swelling, changes in skin temperature, and stiffness, which can significantly affect a person's life.

The main purpose of this research is to see if taking vitamin C could help prevent CRPS from developing after surgery on an arm or hand. Researchers want to find out if giving people vitamin C for six months after their operation reduces the chance of them getting CRPS compared to people who don't take it. The study will specifically look at how many people get CRPS six months after their surgery.

They will also monitor how common CRPS is at 12 months after surgery, gather more information about people who get CRPS, and check how well participants tolerate the vitamin C and how closely they follow the study plan. This type of research is a 'Phase III' study, which means it’s designed to confirm whether the treatment (vitamin C) is effective and safe in a larger group of people.

Key takeaways

This study explores if Vitamin C can prevent severe pain (CRPS) after arm/hand surgery.
Participants take Vitamin C or a dummy pill for six months after their operation.
The research aims to understand CRPS and its prevention better.
It's a 'Phase III' study, meaning it's confirming if Vitamin C works safely.
Both men and women aged 18 and over can potentially take part.

Who may be eligible?

To be able to take part in this study, you need to be at least 18 years old. There is no upper age limit, meaning older adults can also participate.

This study is open to both men and women. The most important requirement is that you are having surgery on your upper limb, which includes your arm, elbow, wrist, or hand.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you having surgery on your arm, elbow, wrist, or hand?
Are you able to take tablets daily for six months?
Are you willing to attend follow-up appointments for up to a year?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be given either vitamin C tablets or a placebo (a tablet that looks the same but contains no active medicine). You wouldn't know which one you are taking. You would need to take these tablets for six months after your upper limb surgery. The study team will check up on you to see if you develop CRPS at various points, particularly at 6 and 12 months after your surgery. They will also ask about any side effects you might experience and how well you are managing to take the tablets as instructed. The total duration of active participation and follow-up would be at least 12 months.

Potential risks and benefits

Taking part could potentially offer a benefit by helping to prevent CRPS, a very painful condition, although this is what the study aims to find out. As with any medication, there's always a small chance of side effects, even with vitamin C, though serious side effects are rare at typical doses. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
France

Common questions

What is CRPS?

CRPS, or Complex Regional Pain Syndrome, is a type of severe, long-lasting pain that can happen after an injury or surgery, often in an arm or leg.

What does 'upper limb surgery' mean?

Upper limb surgery refers to operations on your arm, elbow, wrist, or hand.

Will I know if I'm taking vitamin C or a dummy pill?

No, this is a 'blinded' study, meaning neither you nor the study team will know if you're taking vitamin C or a placebo to ensure fair results.

How long does the study last?

You would take the study tablets for six months, and the total follow-up period would be at least 12 months after your surgery.

Is vitamin C safe?

Vitamin C is generally considered safe, but as with any medicine, side effects are possible. The study will monitor your tolerance.