Clinical trial NCT02680548: Pilot RCT of Efficacy of Perineural Local Anesthetics and Steroids for Chronic Post-traumatic Ankle and Foot Pain
Official title: A Pilot Randomized Controlled Trial of Efficacy of Perineural Local Anesthetics and Steroids for Chronic Post-traumatic Neuropathic Pain in the Ankle and the Foot: The PREPLAN Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: CHRONIC POST-TRAUMATIC NEUROPATHIC PAIN IN ANKLE AND FOOT
Keywords: ankle pain
foot pain
methylprednisolone
neuropathic pain
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2016-02-11
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Injections of local anesthetics (freezing) and steroids are often performed around injured nerves in individuals with nerve injury-related pain. The current standard of medical care is to inject a combination of local anesthetics and steroids around injured nerves, but there is no proof that this is better than injecting only local anesthetic, or even just sterile salt water. There is evidence to believe 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. The aim of this study is to compare pain relief and possible adverse effects from these three different treatments for foot and ankle nerve pain relief.

All 30 participants will be recruited over 9 months from the Altum Health clinic at Toronto Western Hospital. 10 participants will be randomly assigned to each treatment. Each patient will receive 3 injections over 3 weeks or so. Participants will have an in-clinic follow-up at 1 month after the last injection, and a phone follow-up 3 months after the last injection.

This is a small-scale study, and information obtained from this study will help in planning and conduct of a larger study with more participants. The larger study will help determine the best possible option for injection in patients with nerve-related injury pain.


Eligibility criteria: 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 and/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

Primary outcomes:
measure: Enrollment and retention of participants (SEE DESCRIPTION)
timeFrame: At end of study (1 year)
Secondary outcomes:
measure: Central tendency (mean) and spread (standard deviation) of Numerical Rating Score (NRS) ratings of Foot and Ankle pain
timeFrame: At 1-month and 3-months post-intervention
measure: Change in scores of Pain Catastrophizing Score (PCS)
timeFrame: Baseline and at 1-month post-intervention
measure: Change in scores of Dolores Neuropathique (DN4)
timeFrame: Baseline and at 1-month post-intervention
measure: Change in scores of Neuropathic Pain Symptom Inventory (NPSI)
timeFrame: Baseline and at 1-month post-intervention
measure: Change in scores of anxiety component scores on the Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline and at 1-month post-intervention
measure: Change in scores of depression scores on the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline and at 1-month post-intervention
measure: Change in scores of Brief Pain Inventory interference with activities (BPI-I)
timeFrame: Baseline and at 1-month post-intervention
measure: Change in scores of Short Form-12 (SF-12)
timeFrame: Baseline and at 1-month post-intervention
measure: Change in scores of Lower Extremity Function Score (LEFS)
timeFrame: Baseline and at 1-month post-intervention
measure: Evaluate the impact of study interventions on requirement for opioids (measured as average daily oral morphine equivalents in mg) and neuropathic medications (average daily doses of gabapentin and/or amitriptyline in mg)
timeFrame: At end of study (1 year)
measure: Change in pre- and post-intervention levels of blood glucose and blood pressure
timeFrame: Baseline and at 1-month post-intervention
measure: Measure incidence of infections at the injection site, skin discoloration or atrophy at the injection site, fractures, and evidence of myopathy
timeFrame: Baseline and at 1-month post-intervention
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Anuj Bhatia, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bhatia A, Bril V, Brull RT, Perruccio A, Wijeysundera D, Alvi S, Lau J, Gandhi R, Mahomed N, Davis AM. Study protocol for a pilot, randomised, double-blinded, placebo controlled trial of perineural local anaesthetics and steroids for chronic post-traumatic neuropathic pain in the ankle and foot: the PREPLANS study. BMJ Open. 2016 Jun 22;6(6):e012293. doi: 10.1136/bmjopen-2016-012293.