Chronic Pain Clinical Trial
— LDN-CRPSOfficial title:
Low Dose Naltrexone (LDN) Therapy for Complex Regional Pain Syndrome (CRPS): A Feasibility Study
NCT number | NCT06306157 |
Other study ID # | 2023-0667 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | June 2024 |
Est. completion date | November 2026 |
Complex Regional Pain Syndrome (CRPS) is a rare and often debilitating chronic pain condition whereby individuals may experience extreme sensitivity, discoloration, and swelling of the affected area -- along with numerous other painful symptoms. There are currently a limited number of treatment options available to those suffering with the condition, with various treatments including nerve blocks, neuropathic medications, and desensitization physical therapy modules. There is budding interesting in the role naltrexone, an opiate antagonist, may play in the pain management of CRPS when prescribed in very low doses. This study aims to collect preliminary data on pain scores, symptom severity, and side-effects in patients with Complex Regional Pain Syndrome randomized to receive low dose naltrexone or placebo capsules. Enrollment of 40 patients total will occur over two years from study start to study end. Each patient will be randomized to receive placebo capsules or active low dose naltrexone capsules, with both the patient and treating clinician blind to the randomization. Each patient will be actively enrolled in the study for six months and will take the medication daily at the instructed dose for the respective duration of time. Following the initial visit and study enrollment, the investigators are asking each patient to return for three (3) in-person follow-up office visits. These office visits will occur 1 month after the patient starts the medication, 3 months afterwards, and 6 months afterwards. The final 6-month office visit will mark the conclusion of the patient's active participation in the study.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | November 2026 |
Est. primary completion date | August 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Between 18 and 65 years old - Meeting CRPS diagnostic criteria using the Budapest Clinical Diagnostic Criteria - CRPS patients with severe pain (NRS>3) that affects their daily life. - CRPS patients with pain and other symptoms for more than 3 months. Exclusion Criteria: - Patients with suspected disc herniation, spinal stenosis, myelopathy, and suspected radiculopathy in detailed examinations and examinations (MRI, CT). - Systemic or local infection - Malignancy - Current or planned pregnancy within the study period. - Uncontrolled medical and psychiatric condition - Patients with known liver issues, including but not limited to end-stage liver disease, severe cirrhosis or an acute hepatic state. - Patients who are currently using opioid drugs - Patients who are currently using alcohol or considering using alcohol during the study period. - Allergy to naltrexone or naloxone |
Country | Name | City | State |
---|---|---|---|
United States | Hospital for Special Surgery | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Hospital for Special Surgery, New York |
United States,
Chopra P, Cooper MS. Treatment of Complex Regional Pain Syndrome (CRPS) using low dose naltrexone (LDN). J Neuroimmune Pharmacol. 2013 Jun;8(3):470-6. doi: 10.1007/s11481-013-9451-y. Epub 2013 Apr 2. — View Citation
Toljan K, Vrooman B. Low-Dose Naltrexone (LDN)-Review of Therapeutic Utilization. Med Sci (Basel). 2018 Sep 21;6(4):82. doi: 10.3390/medsci6040082. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Enrollment rate | Monitored over the course of the study and measured by number of eligible patients who enroll/total number of eligible patients. | At study completion (approximately 2 years after study initiation) | |
Other | Study medication compliance | Patient-reported and patient-prompted qualitative measure of the extent to which a patient complied with the study medication regimen, including taking the daily medication at the appropriate dose. Recorded at office visits and via daily patient diary. At the below time points, medication compliance during the previous time period is being recorded. (i.e During the 3-month office visit, the patient will be asked "Have you missed taking your daily medication on any day since the 1-month visit"). | 1, 3, and 6 months | |
Other | Reasons for study medication non-compliance | Reasons for missing a dose, including side effect(s), forgetting, unsuccessful medication dispensation, or being away from medication (i.e. vacation). Recorded at office visits and via patient diary. At the below time points, reasons for medication non-compliance during the previous time period is being recorded. (i.e During the 3-month office visit if the patient reports missing the medication at least once, they will be asked for the corresponding reason). | 1, 3, and 6 months | |
Other | Drop-out rate | Whether a patient prematurely withdrew due to any reason from the study before reaching the final 6-month office visit, measured as "Yes, patient dropped out of the study," or "No, patient did not drop out". The investigators will consider the study as having a low-drop rate at its conclusion if 80% of patients are retained through the 6-month follow-up. If the patient contacts the study team to drop out in between the time points listed below, the data will be recorded on the form corresponding to the next office visit. (i.e. if the patient contacts the study team on day 70 and requests to drop out, the team will record the subsequent information in the 3-month office visit form, recording the exact day the patient dropped out. Otherwise, the data will be collected at the time points listed below). | 1, 3, and 6 months | |
Other | Reasons for drop-out | Reasons for a patient dropping out of the study early, including whether it was a self-withdrawal or study team-withdrawal. Reasons include compliance issue, undesirable side effect, lost to follow up, medication dispensation logistic issue, or major contraindication to the study protocol. | 1, 3, and 6 months | |
Primary | Number of study patients enrolled | Enrollment of 40 patients within two years is the target (i.e. enrollment of 1-2 patients a month). If 1-2 patients a month is not being met within first 6 months, an invitation to other chronic pain co-investigators with high volume CRPS will be considered. Because this is a feasibility study, determining whether 40 patients can be enrolled with the current inclusion and exclusion criteria within a specified time frame is an essential step in ensuring such a long-term outpatient study can be conducted. | Within 2 years of study start | |
Primary | Number of study patients randomized | Measured as completed or not. Quadruple blinded randomization of each study patient to one of the two treatment arms after enrollment and before medication dispensation will be deemed successful. Because this is a feasibility study, determining whether 40 patients can be blindly randomized to a group according to the protocol is an essential step in ensuring such a long-term drug study can be conducted. | At initial time of enrollment | |
Primary | Number of study patients who received the study medication | Dispensation of medication to all enrolled study patients at point of enrollment and at 3 months will be considered successful. If deemed necessary, dispensation can occur at time points other than the two previously defined and will still be considered successful if patient receives medication on time. Because this is a feasibility study implementing a long-term interventional drug treatment, it is essential that the investigators are measuring whether medication dispensation is occurring on time and according to the protocol. | At initial time of enrollment and at 3 months. | |
Secondary | Incidence of side effects/adverse events | Side effects or adverse events, including sleep disturbances, mild headaches, mild agitation, and nausea. Study patients are encouraged to contact the study team outside of study visits to report side effects/adverse events as they arise throughout course of the study, but the outcome is formally assessed at the below time points. | 1, 3, and 6 months | |
Secondary | Average NRS pain | Pain measured using numerical rating scale (NRS) from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable. NRS at baseline will be self-reported average at time of visit; NRS at 1, 3, and 6 months will be 7-day average leading up to those timepoints, collected via a patient diary. | Baseline, 1, 3, and 6 months. | |
Secondary | CRPS symptom severity | CRPS symptom severity score (CSS) based on the Budapest Criteria which measures the severity of CRPS over time on a scale from 0-16 via the presence or absence of 8 specific symptoms and 8 specific signs. CSS will be measured at the respective in-person office visit. | Baseline, 1, 3, and 6 months. | |
Secondary | PROMIS-10 score | The PROMIS-10 (Patient-Reported Outcomes Measurement Information System) score has two components, a physical score and a mental score, and is captured via a self-administered questionnaire with the purpose of assessing the patient's health-related quality of life. PROMIS-10 assessments are scored using T-score metrics and are calculated based on patient responses to the 10-item questionnaire. For the physical PROMIS-10 score, the lowest possible is 16.2 and the highest possible is 67.7. For the mental score, the lowest is 21.2 and the highest is 67.6. The higher a patient scores in each category, the greater their respective health is. A physical and mental T-score above 58 and 56, respectively, is rated "Excellent", whereas a physical and mental T-score below 35 and 29 is rated "Poor". | Baseline, 1, 3, and 6 months | |
Secondary | S-LANSS score | S-LANSS (Self-Administered Leeds Assessment of Neuropathic Symptoms and Signs) score which aims to characterize the extent to which pain is neuropathic in origin on a scale from 0-24. The score is captured via a 7-item self-administered questionnaire. | Baseline, 1, 3, and 6 months | |
Secondary | Blinding assessment | Patients are asked which treatment they think they received. The correctness of their guesses is then measured using the bang-blinding index to see if patients were able to accurately guess which treatment they received. It is measured on a scale of -1 to 1. Scores closer to 0 indicate better blinding, or patients not being able to guess their treatment. | 1, 3, and 6 months |
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