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Completed

NCT Number: NCT02680548

Pilot RCT of Efficacy of Perineural Local Anesthetics and Steroids for Chronic Post-traumatic Ankle and Foot Pain

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.

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Key information

Conditions

CHRONIC POST-TRAUMATIC NEUROPATHIC PAIN IN ANKLE AND FOOT Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Toronto Western Hospital

Toronto, Ontario, M5T2S8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pain in foot in neuro-anatomically congruent location following trauma (including surgery) for more than three months
  • Physician-reported DN4 scoring confirming neuropathic pain (score > 3/10)
  • Average intensity of pain more than 3/10 on numerical rating score
  • Failed trial of appropriate doses of first line medications for neuropathic pain (anticonvulsants and/or antidepressants) for six weeks

Exclusion criteria

  • Age < 18 or age ≥ 80 years
  • Perineural or intra-articular steroid injections in the last 6 months
  • Allergy to local anesthetics and/or steroids
  • Ongoing litigation issues related to the patient's pain
  • Pregnancy
  • Coagulopathy or systemic infection
  • Peripheral neuropathy or myopathy, central neuropathic pain (e.g. post-stroke pain)
  • Infection in the ankle or foot
  • An unstable medical or psychiatric condition
  • Significant catastrophizing as indicated by pain catastrophizing scale (PCS) score equal to or more than 30/52

Treatment and study plan

0.9% saline

Drug

Other names: Salt Water

0.25% bupivacaine hydrochloride injectable suspension USP

Drug

Other names: Marcaine

4mg/cc methylprednisolone acetate injectable suspension USP

Drug

Other names: Depo-Medrol

Primary outcomes

  1. Enrollment and retention of participants (SEE DESCRIPTION)

    Time frame: At end of study (1 year)

    Factors considered in assessment: Enrolling at least 75% of eligible patients, enrolling at least 9 patients monthly, retention till study end of at least 90% of participants

Secondary outcomes

  1. Central tendency (mean) and spread (standard deviation) of Numerical Rating Score (NRS) ratings of Foot and Ankle pain

    Time frame: At 1-month and 3-months post-intervention

  2. Change in scores of Pain Catastrophizing Score (PCS)

    Time frame: Baseline and at 1-month post-intervention

  3. Change in scores of Dolores Neuropathique (DN4)

    Time frame: Baseline and at 1-month post-intervention

  4. Change in scores of Neuropathic Pain Symptom Inventory (NPSI)

    Time frame: Baseline and at 1-month post-intervention

  5. Change in scores of anxiety component scores on the Hospital Anxiety and Depression Scale (HADS)

    Time frame: Baseline and at 1-month post-intervention

  6. Change in scores of depression scores on the Patient Health Questionnaire-9 (PHQ-9)

    Time frame: Baseline and at 1-month post-intervention

  7. Change in scores of Brief Pain Inventory interference with activities (BPI-I)

    Time frame: Baseline and at 1-month post-intervention

  8. Change in scores of Short Form-12 (SF-12)

    Time frame: Baseline and at 1-month post-intervention

  9. Change in scores of Lower Extremity Function Score (LEFS)

    Time frame: Baseline and at 1-month post-intervention

  10. 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)

    Time frame: At end of study (1 year)

  11. Change in pre- and post-intervention levels of blood glucose and blood pressure

    Time frame: Baseline and at 1-month post-intervention

  12. Measure incidence of infections at the injection site, skin discoloration or atrophy at the injection site, fractures, and evidence of myopathy

    Time frame: Baseline and at 1-month post-intervention

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study 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

Acronym: PREPLANS

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 11, 2016
Registry last updated
May 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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