Neuralgia Clinical Trial
— RESPERISTOfficial title:
A Multi-center Randomized Controlled Trial of Efficacy and Safety of Perineural Local Anesthetics and Steroids for Chronic Peripheral Post-traumatic Neuropathic Pain: The Resperist Study
NCT number | NCT03009500 |
Other study ID # | 16-5927 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | January 2017 |
Est. completion date | June 2019 |
Verified date | March 2020 |
Source | University Health Network, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate three different injectable solutions used to block
ankle nerves to manage ankle pain. The current standard of medical care is to inject a
combination of local anesthetics and steroids around injured nerves. There is evidence that
injection of local anesthetic (without the steroid) can calm the injured nerve and provide
pain relief from a few days up to a few months. Injection of sterile salt water also has the
potential to provide pain relief by breaking scar tissue around the nerve thereby relieving
compression. Injections of local anesthetic and steroids around injured nerves have been used
for many years to provide relief of pain but the specific reason is not well known for this
benefit.
There are three possibilities: 1) Steroids can reduce inflammation and calm the nerves, 2)
local anesthetics can have similar actions but with shorter duration (few days), and 3)
injection of any solution can break scarring around an injured/compressed nerve.
The study will compare pain relief and possible adverse effects from these three different
solutions. This study will help provide definitive answers regarding pain relief and possible
adverse effects of the three solutions. This, in turn, will determine the best possible
option for injection in patients with nerve-related injury pain.
Status | Completed |
Enrollment | 3 |
Est. completion date | June 2019 |
Est. primary completion date | March 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. Pain in foot in neuro-anatomically congruent location following trauma (including surgery) for more than three months 2. Physician-reported DN4 scoring confirming neuropathic pain (score >3/10) 3. Average intensity of pain more than 3/10 on numerical rating score 4. Failed trial of appropriate doses of first line medications for neuropathic pain (anticonvulsants and/or antidepressants) for six weeks Exclusion Criteria: 1. Age < 18 or Age > 80 years 2. Perineural or intra-articular steroid injections in the last 6 months 3. Allergy to local anesthetics or steroids 4. Ongoing litigation issues related to the patient's pain 5. Pregnancy 6. Coagulopathy or systemic infection 7. Peripheral neuropathy or myopathy, central neuropathic pain (e.g. post-stroke pain) 8. Infection in the ankle or foot 9. An unstable medical or psychiatric condition 10. Significant catastrophizing as indicated by pain catastrophizing scale (PCS) score equal to or more than 30/52. |
Country | Name | City | State |
---|---|---|---|
Canada | Toronto Western Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determination of Numerical Rating Scores (NRS) (range 0-10) for foot and ankle pain | One month after intervention | ||
Secondary | Measuring NRS (range 0-10) for foot and ankle pain | Three months after intervention compared to pre-intervention | ||
Secondary | Measuring changes in the PCS (Pain Catastrophizing Scale) Questionnaire | One month and three months after intervention compared to pre-intervention | ||
Secondary | Measuring changes in the Douleur Neuropathique (DN4) Questionnaire | One month and three months after intervention compared to pre-intervention | ||
Secondary | Measuring change in the NPSI (Neuropathic Pain Symptom Inventory) Questionnaire | One month and three months after intervention compared to pre-intervention | ||
Secondary | Measuring change in the Anxiety and Depression component scores on the Hospital Anxiety and Depression Scale (HADS) | One month and three months after intervention compared to pre-intervention | ||
Secondary | Measuring change in Depression scores on the Patient Health Questionnaire (PHQ-9) | One month and three months after intervention compared to pre-intervention | ||
Secondary | Measuring change in Brief Pain Inventory interference with activities (BPI-I) score | One month and three months after intervention compared to pre-intervention | ||
Secondary | Measuring change in Short Form-12 (SF-12) score | One month and three months after intervention compared to pre-intervention | ||
Secondary | Measuring change in Lower Extremity Function Score (LEFS) | One month and three months after intervention compared to pre-intervention | ||
Secondary | Measuring change in pain (cold pain and heat pain) thresholds as determined by quantitative sensory testing (QST) | One month and three months after intervention compared to pre-intervention | ||
Secondary | Measuring change in sensory (cold and hot detection) thresholds as determined by quantitative sensory testing (QST) | One month and three months after intervention compared to pre-intervention | ||
Secondary | Measurement of the cross-sectional area of tibial nerve for neural edema between interventions | One month and three months after intervention compared to pre-intervention | ||
Secondary | Measuring incidence of adverse effects | Hyperglycemia (change in blood glucose levels) and hypertension (change in blood pressure levels) Infections at the injection site, skin discolouration or atrophy at the injection site, fractures, and evidence of myopathy |
One month and three months after intervention compared to pre-intervention |
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