Liposomal Encapsulated Vitamin C in Complex Regional Pain Syndrome

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prevention of Complex Regional Pain Syndrome Using Liposomal Encapsulated Vitamin C in Programmed Knee Surgery; A Prospective Randomized Trial

Conditions
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Complex Regional Pain Syndrome I of Lower Limb

Intervention / Treatment
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* Dietary Supplement: liposomal vitamin C
* Dietary Supplement: standard vitamin C
* Dietary Supplement: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Allocated to conventional vitamin C (n= 22)<br>Received allocated conventional vitamin C (n= 22) Did not receive allocated conventional vitamin C (n= 0) | Dietary Supplement: standard vitamin C<br>* The intake of traditional vitamin C with a daily intake of 500 mg in the morning and evening for 28 days (starting 7 days before the operative procedure, on the day of the surgery and ending twenty-one days after surgery).<br>|
| Active Comparator: Allocated to liposomal vitamin C (n= 22)<br>Received allocated liposomal vitamin C (n= 22) Did not receive allocated liposomal vitamin C (n= 0) | Dietary Supplement: liposomal vitamin C<br>* The intake of liposomal vitamin C at 500 mg, in the morning and evening, one week before surgery, one during the day of surgery and lastly, during the first 21 post operation days.<br>|
| Placebo Comparator: Allocated to placebo (n= 22)<br>Received allocated intervention (n= 22) Did not receive allocated intervention (n= 0) | Dietary Supplement: placebo<br>* The intake placebo was taken daily in the morning and the evening for 28 days (7 days before surgery, on the day of surgery and twenty-one days after the surgical procedure).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Operated for Complex Regional Pain Syndrome Who Had Transposition of Anterior Tibial Tuberosity | We take an x-ray of the knee then we calculate of the Index of Caton and Deschamps AT / AP which must be close to 1 cm (from the upper edge to the lower edge of the patella which must be equal to the distance between the tip of the patella and anterior tibial tuberosity) to be interpreted as a transposed tuberosity. | After one-year of follow-up | 
| Number of Participants Operated for Complex Regional Pain Syndrome Who Had Ligamentoplasty ACL According to Kenneth-Jones | Radiographs of the knee in monopodial support at 30° flexion (schuss) were taken. Measurement analysis of the translation of the tibia relative to the femur which must be close to 0 cm for the patient to be positive for the outcome. | After one-year follow-up | 
| Number of Participants Operated for Complex Regional Pain Syndrome Who Had Internal Unicompartmental Arthroplasty for Centralized Arthritis | Radiographs of the knee in Schuss with an external decoaptation which must be close to 0 cm and a pan gono gram standing from the front | After one-year follow-up | 
| Number of Participants Operated for Complex Regional Pain Syndrome Who Had Total Knee Arthroplasty for Eccentric Arthritis | X-rays of the knee and Schuss profile with an internal and external decoaptation which must be close to 0 cm with pan gonogram standing from the front (x-rays of the long axes of the pelvis of the ankles with measurement of the HKA axes on the prosthesis side and on the non-side operated which must be close to 180°) to have eccentric arthritis. | After one-year follow-up |