Complex Regional Pain Syndrome I of Lower Limb
Conditions
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.
Interventions
DIETARY_SUPPLEMENTliposomal vitamin C
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.
DIETARY_SUPPLEMENTstandard vitamin C
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).
DIETARY_SUPPLEMENTplacebo
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).
Sponsors
Centre Hospitalier de Ham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Operated for Complex Regional Pain Syndrome Who Had Transposition of Anterior Tibial Tuberosity | After one-year of follow-up | 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. |
| Number of Participants Operated for Complex Regional Pain Syndrome Who Had Ligamentoplasty ACL According to Kenneth-Jones | After one-year follow-up | 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. |
| Number of Participants Operated for Complex Regional Pain Syndrome Who Had Internal Unicompartmental Arthroplasty for Centralized Arthritis | After one-year follow-up | 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 |
| Number of Participants Operated for Complex Regional Pain Syndrome Who Had Total Knee Arthroplasty for Eccentric Arthritis | After one-year follow-up | 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. |
Participant flow
Pre-assignment details
All of 66 participants met the inclusion criteria and were randomised to treatment.
Participants by arm
| Arm | Count |
|---|---|
| Allocated to Conventional Vitamin C (n= 22) Participant 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). | 22 |
| Allocated to Liposomal Vitamin C (n= 22) Participant 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. | 22 |
| Allocated to Placebo (n= 22) Participant 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). | 22 |
| Total | 66 |
Baseline characteristics
| Characteristic | Allocated to Conventional Vitamin C (n= 22) | Allocated to Liposomal Vitamin C (n= 22) | Allocated to Placebo (n= 22) | Total |
|---|---|---|---|---|
| Age, Continuous | 44 years STANDARD_DEVIATION 9.46 | 44 years STANDARD_DEVIATION 9.64 | 43.77 years STANDARD_DEVIATION 9.29 | 43.9 years STANDARD_DEVIATION 9.25 |
| BMI (kg/m^2) | 21.75 kg/m^2 STANDARD_DEVIATION 2.1 | 21.57 kg/m^2 STANDARD_DEVIATION 2.07 | 21.75 kg/m^2 STANDARD_DEVIATION 1.98 | 21.69 kg/m^2 STANDARD_DEVIATION 2 |
| Complications (%) Laxity | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Complications (%) None | 10 Participants | 12 Participants | 10 Participants | 32 Participants |
| Complications (%) Pain | 6 Participants | 2 Participants | 6 Participants | 14 Participants |
| Complications (%) Patella Pain | 1 Participants | 2 Participants | 1 Participants | 4 Participants |
| Complications (%) Stiffness | 2 Participants | 2 Participants | 2 Participants | 6 Participants |
| Complications (%) Unimproved | 2 Participants | 3 Participants | 2 Participants | 7 Participants |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Region of Enrollment France | 22 Participants | 22 Participants | 22 Participants | 66 Participants |
| Scintigraphy (%) CRPS = complex regional pain syndrome. | 5 Participants | 0 Participants | 6 Participants | 11 Participants |
| Scintigraphy (%) Negative | 7 Participants | 9 Participants | 6 Participants | 22 Participants |
| Scintigraphy (%) Not made | 10 Participants | 13 Participants | 10 Participants | 33 Participants |
| Sex: Female, Male Female | 22 Participants | 22 Participants | 22 Participants | 66 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Surgery (%) ACL(anterior cruciate ligament) | 5 Participants | 5 Participants | 5 Participants | 15 Participants |
| Surgery (%) ATO = anterior tibial osteotomy | 5 Participants | 5 Participants | 5 Participants | 15 Participants |
| Surgery (%) TKA = total knee arthroplasty | 6 Participants | 6 Participants | 6 Participants | 18 Participants |
| Surgery (%) UKA = unicompartmental knee arthroplasty | 6 Participants | 6 Participants | 6 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 22 | 0 / 22 |
| other Total, other adverse events | 0 / 22 | 0 / 22 | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 | 0 / 22 |
Outcome results
Primary
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
Time frame: After one-year follow-up
Population: Among 18 patients who had Internal unicompartmental arthroplasty for centralized arthritis, results shows the number of cases operated for complex regional pain syndrome (CRPS)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Allocated to Conventional Vitamin C (n= 22) | Number of Participants Operated for Complex Regional Pain Syndrome Who Had Internal Unicompartmental Arthroplasty for Centralized Arthritis | 0 participants |
| Allocated to Liposomal Vitamin C (n= 22) | Number of Participants Operated for Complex Regional Pain Syndrome Who Had Internal Unicompartmental Arthroplasty for Centralized Arthritis | 0 participants |
| Allocated to Placebo (n= 22) | Number of Participants Operated for Complex Regional Pain Syndrome Who Had Internal Unicompartmental Arthroplasty for Centralized Arthritis | 0 participants |
Primary
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.
Time frame: After one-year follow-up
Population: Among 15 patients who had Ligamentoplasty (ACL) according to Kenneth-Jones, results shows the number of cases operated for complex regional pain syndrome (CRPS)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Allocated to Conventional Vitamin C (n= 22) | Number of Participants Operated for Complex Regional Pain Syndrome Who Had Ligamentoplasty ACL According to Kenneth-Jones | 1 participants |
| Allocated to Liposomal Vitamin C (n= 22) | Number of Participants Operated for Complex Regional Pain Syndrome Who Had Ligamentoplasty ACL According to Kenneth-Jones | 0 participants |
| Allocated to Placebo (n= 22) | Number of Participants Operated for Complex Regional Pain Syndrome Who Had Ligamentoplasty ACL According to Kenneth-Jones | 0 participants |
Primary
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.
Time frame: After one-year follow-up
Population: Among 18 patients who had Total knee arthroplasty for eccentric arthritis, results shows the number of cases operated for complex regional pain syndrome (CRPS)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Allocated to Conventional Vitamin C (n= 22) | Number of Participants Operated for Complex Regional Pain Syndrome Who Had Total Knee Arthroplasty for Eccentric Arthritis | 1 participants |
| Allocated to Liposomal Vitamin C (n= 22) | Number of Participants Operated for Complex Regional Pain Syndrome Who Had Total Knee Arthroplasty for Eccentric Arthritis | 0 participants |
| Allocated to Placebo (n= 22) | Number of Participants Operated for Complex Regional Pain Syndrome Who Had Total Knee Arthroplasty for Eccentric Arthritis | 2 participants |
Primary
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.
Time frame: After one-year of follow-up
Population: Among 15 patients who had transposition of anterior tibial tuberosity, results shows the number of cases operated for complex regional pain syndrome (CRPS).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Allocated to Conventional Vitamin C (n= 22) | Number of Participants Operated for Complex Regional Pain Syndrome Who Had Transposition of Anterior Tibial Tuberosity | 1 participants |
| Allocated to Liposomal Vitamin C (n= 22) | Number of Participants Operated for Complex Regional Pain Syndrome Who Had Transposition of Anterior Tibial Tuberosity | 0 participants |
| Allocated to Placebo (n= 22) | Number of Participants Operated for Complex Regional Pain Syndrome Who Had Transposition of Anterior Tibial Tuberosity | 2 participants |