Clinical trial NCT04204200: "Liposomal Encapsulated Vitamin C in Complex Regional Pain Syndrome"
Official title: Prevention of Complex Regional Pain Syndrome Using Liposomal Encapsulated Vitamin C in Programmed Knee Surgery; A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complex Regional Pain Syndrome I of Lower Limb
Lead sponsor: Centre Hospitalier de Ham
Sponsor class: OTHER
First posted: 2019-12-18
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Abstract:

Complex regional pain syndrome (CRPS) is a significant complication in operated osteoarticular pathology and may adversely affect patient's quality of life. Vitamin C is an anti-oxidant and a neuro-modulating agent. Intake of vitamin C appears to be the only preventative factor. The objective of this study seeks to assess the effectiveness of liposomal conditioning of vitamin-C in reducing CRPS and to show evidence that it is more effective than taking vitamin C in its usual form.

Detailed description: Methods:

Three series of patients undergone for identical pathologies the same surgery performed in the same centre by a single surgeon using the same operative techniques and the same implants. The first group took vitamin C in liposomal form. The second one took classical vitamin C tablets while the third one received placebo pills. Comparison was made between both groups which were identical in number and were the same average age. Results were compared and analysed at the end of one-year follow-up.

Eligibility criteria: Inclusion Criteria:

* Female, Age \> 18 years
* The woman of childbearing age - if applicable - must have a negative urine pregnancy test result and must agree to use adequate contraception (hormonal or barrier contraception method, or abstinence) during the study and one month later)
* Consenting patient
* Agrees to maintain the current level of physical activity throughout the study.
* Agrees to avoid vitamins and supplements for 30 days before enrolment and during the study.
* Avoid nutritious yeasts, whey protein, energy drinks, pomegranate, pomegranate juice, grapefruit, grapefruit juice and alcohol 7 days before enrolment and during the study
* Willingness and ability to comply with scheduled visits, cellular phone calls, treatment plans, laboratory tests and completion of other study procedures specified in the protocol.

Exclusion Criteria:

* Pregnant, breastfeeding or considering pregnancy during the trial
* Diabetic women
* No renal lithiasis
* No deficiency Glucose-6-phosphate dehydrogenase
* Unstable medical conditions
* Immunocompromised persons such as subjects who have undergone organ transplantation
* Subjects who planned surgery during the clinical study
* History of blood disorders / bleeding
* Alcohol abuse (\> 2 standard alcoholic beverages per day) or drug addiction in the last 6 months
* Participation in a clinical research trial within 30 days of randomization
* Allergy or sensitivity to the product during the clinical study.
* Persons who have a cognitive impairment and/or are unable to give an informed opinion.
* Any other condition that, in the opinion of the physician, could affect the subject and lead to the successful completion of the study, action or pose a significant risk to the subject.

Primary outcomes:
measure: Number of Participants Operated for Complex Regional Pain Syndrome Who Had Transposition of Anterior Tibial Tuberosity
timeFrame: After one-year of follow-up
measure: Number of Participants Operated for Complex Regional Pain Syndrome Who Had Ligamentoplasty ACL According to Kenneth-Jones
timeFrame: After one-year follow-up
measure: Number of Participants Operated for Complex Regional Pain Syndrome Who Had Internal Unicompartmental Arthroplasty for Centralized Arthritis
timeFrame: After one-year follow-up
measure: Number of Participants Operated for Complex Regional Pain Syndrome Who Had Total Knee Arthroplasty for Eccentric Arthritis
timeFrame: After one-year follow-up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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