Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome
NCT06306157
Agnosia, Autonomic Nervous System Diseases
New York, United States
View Trial DetailsNCT Number: NCT07228949
This retrospective observational study aims to describe the use and analyze the effectiveness of various analgesic interventions in patients diagnosed with Complex Regional Pain Syndrome (CRPS) at the Pain Management Center of Hôpital Maisonneuve-Rosemont (HMR) between January 2020 and October 2025.
Background:
Complex Regional Pain Syndrome is a chronic pain condition characterized by severe, persistent pain accompanied by sensory, vasomotor, sudomotor, and motor/trophic changes, often following trauma or surgery. Despite established diagnostic criteria (Budapest criteria), its pathophysiology remains poorly understood, and evidence-based treatments are limited. While multidisciplinary functional rehabilitation remains the cornerstone of management, various analgesic interventions are used to facilitate recovery when medications fail to adequately control pain.
Common interventions include:
* Plexus or peripheral nerve blocks (brachial or sciatic, with or without adjuvants such as dexamethasone or dexmedetomidine) * Intravenous ketamine infusions * Sympathetic blocks (stellate or lumbar) * Intravenous pamidronate infusions
Although all these techniques are used in clinical practice, their relative efficacy and predictive factors for success remain unknown. Clinicians rely on experience rather than data-driven guidance to select an initial intervention. Identifying factors such as CRPS subtype or symptom duration that predict analgesic response could improve treatment efficiency and functional recovery.
Methods:
This is a retrospective chart review including all adult patients with a CRPS diagnosis established using the Budapest criteria who received at least one eligible analgesic intervention during the study period. Data will be extracted from electronic medical records by the research team. Exclusion criteria include incomplete clinical documentation or missing information regarding the first consultation, intervention type, or analgesic outcome.
Collected variables include demographics, medications, CNESST (workers' compensation) status, PTSD diagnosis, trauma type, CRPS characteristics (affected limb, type, subtype, symptom duration), details of the first intervention (technique, dose, use of adjuvants), analgesic response, and adverse effects.
This study is active but is not currently recruiting participants.
All sexes
Observational
Maisonneuve-Rosemont Hospital, Montreal, Quebec, Canada
STUDY MODEL Retrospective observational study in the form of a chart review. STUDIED POPULATION AND PERIOD Patients followed at the Maisonneuve-Rosemont Hospital Pain Management Center (PMC) for complex regional pain syndrome (CRPS) who received at least one analgesic intervention between January 1, 2020 and October 2025.
This period was chosen to obtain a sufficient number of patients and to best reflect current practice.
SAMPLE SIZE A sample size calculation will not be performed for this study. The PMC is a tertiary pain clinic that treats a large number of patients, and it is estimated that the chosen period will yield a sample of approximately 200 patients.
GENERAL PROCEDURE Data will be collected from digitized records in the Clinibase and Oacis clinical applications.
An initial sampling of charts will be performed in Clinibase by the planning, programming, and research department of the CIUSSS de l'Est-de-l'Île-de-Montréal. A search of the Clinibase database using the type of appointment at the Pain Management Center between January 1, 2020, and October 23, 2025, will provide the chart numbers of potentially eligible patients. The appointment types searched will include: block, ketamine infusion, pamidronate, stellate block, and lumbar sympathetic block.
Each chart will then be reviewed in Oacis to locate the first consultation note at the Pain Management Center in order to verify inclusion criteria-specifically, a diagnosis of complex regional pain syndrome as determined by the Budapest criteria. The use of an eligible analgesic intervention (plexus block, pamidronate infusion, ketamine infusion, stellate or lumbar sympathetic block) for the treatment of CRPS pain will be confirmed. The analgesic technique does not necessarily need to have been performed at the first visit to be eligible. Charts meeting the inclusion criteria will be retained for the research project and analyzed in more detail to collect the required data.
DATA COLLECTION
Patient data:
CRPS data:
First intervention performed:
Follow-up visit data:
Data from other follow-up visits:
To better compare the different techniques, a propensity score approach will be used. The probability of receiving each treatment will be calculated based on the following characteristics: age, sex, symptom duration, limb type, CNESST affiliation, medications used, treating physician, and CRPS subgroup. These probabilities will be calculated using multinomial logistic regression and will define the propensity scores. Each patient's characteristics will be weighted using the Inverse Probability of Treatment Weighting (IPTW) method. After weighting, group balance will be verified by ensuring that standardized mean differences (SMD) for each covariate are below 0.1. Finally, the weighted success rate for each technique will be calculated. Weighted Odds Ratios (OR) with 95% confidence intervals will also be computed using weighted logistic regression for each treatment compared to the reference treatment. Sensitivity analyses will be performed using other weighting methods such as Overlap Weighting, 1:1 Matching, and Entropy Balancing.
To identify the best treatment for each subgroup, the probability of success as a function of treatment, subgroup, and a "treatment × subgroup" interaction term will be calculated using logistic regression. If the interaction term is significantly associated with the probability of success, stratified analyses will be conducted by subgroup. For each subgroup, a propensity score will be calculated using the same method described above, excluding the subgroup variable from adjustment. Weighted success probabilities will be calculated for each treatment and each subgroup, as well as ORs with 95% CIs compared to the reference treatment, to identify the optimal treatment for each subgroup.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: within 6 months of first visit at the Pain Clinic
To determine the frequency distribution of first-line analgesic interventions used in patients with complex regional pain syndrome
Ciusss de L'Est de l'Île de Montréal
Other
Real-World Analgesic Management of Complex Regional Pain Syndrome: An Observational Study in a Tertiary Care Setting
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