CHRONIC POST-TRAUMATIC NEUROPATHIC PAIN IN ANKLE AND FOOTEarly Phase 1PREPLANSNCT02680548
Pilot RCT of Efficacy of Perineural Local Anesthetics and Steroids for Chronic Post-traumatic Ankle and Foot Pain
A Early Phase 1 study testing 0.9% saline, 0.25% bupivacaine hydrochloride injectable suspension USP and 4mg/cc methylprednisolone acetate injectable suspension USP in people with CHRONIC POST-TRAUMATIC NEUROPATHIC PAIN IN ANKLE AND FOOT, run by University Health Network, Toronto at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- CHRONIC POST-TRAUMATIC NEUROPATHIC PAIN IN ANKLE AND FOOT
- What is being tested?
- 0.9% saline, 0.25% bupivacaine hydrochloride injectable suspension USP and 4mg/cc methylprednisolone acetate injectable suspension USP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2015to Dec 2017
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- 0.9% saline, 0.25% bupivacaine hydrochloride injectable suspension USP, 4mg/cc methylprednisolone acetate injectable suspension USP
- Keywords
- ankle pain, foot pain, methylprednisolone, neuropathic pain
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.9% salineDrug
Also called Salt Water
0.25% bupivacaine hydrochloride injectable suspension USPDrug
Also called Marcaine
4mg/cc methylprednisolone acetate injectable suspension USPDrug
Also called Depo-Medrol
| Study group | Role | What they receive |
|---|---|---|
| 0.9% saline (salt water) | Active comparator | 0.5mL 0.25% bupivacaine subcutaneous injection, 2-6cc 0.9% saline injection per nerve (20cc max) Receives: Drug: 0.9% saline |
| local anesthetic (freezing) | Active comparator | 0.5mL 0.25% bupivacaine subcutaneous injection, 2-6cc 0.25% bupivacaine per nerve (20cc max) Receives: Drug: 0.25% bupivacaine hydrochloride injectable suspension USP |
| local anesthetic (freezing) and steroid | Active comparator | 0.5mL 0.25% bupivacaine subcutaneous injection, 2-6cc 0.25% bupivacaine and 4mg/cc methylprednisolone per nerve (20cc max) Receives: Drug: 0.25% bupivacaine hydrochloride injectable suspension USP; Drug: 4mg/cc methylprednisolone acetate injectable suspension USP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment and retention of participants (SEE DESCRIPTION)
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
Measured: At end of study (1 year)
Secondary outcomes (12)
Central tendency (mean) and spread (standard deviation) of Numerical Rating Score (NRS) ratings of Foot and Ankle pain
Measured: At 1-month and 3-months post-intervention
Change in scores of Pain Catastrophizing Score (PCS)
Measured: Baseline and at 1-month post-intervention
Change in scores of Dolores Neuropathique (DN4)
Measured: Baseline and at 1-month post-intervention
Change in scores of Neuropathic Pain Symptom Inventory (NPSI)
Measured: Baseline and at 1-month post-intervention
Change in scores of anxiety component scores on the Hospital Anxiety and Depression Scale (HADS)
Measured: Baseline and at 1-month post-intervention
Change in scores of depression scores on the Patient Health Questionnaire-9 (PHQ-9)
Measured: Baseline and at 1-month post-intervention
Change in scores of Brief Pain Inventory interference with activities (BPI-I)
Measured: Baseline and at 1-month post-intervention
Change in scores of Short Form-12 (SF-12)
Measured: Baseline and at 1-month post-intervention
Change in scores of Lower Extremity Function Score (LEFS)
Measured: Baseline and at 1-month post-intervention
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)
Measured: At end of study (1 year)
Change in pre- and post-intervention levels of blood glucose and blood pressure
Measured: Baseline and at 1-month post-intervention
Measure incidence of infections at the injection site, skin discoloration or atrophy at the injection site, fractures, and evidence of myopathy
Measured: Baseline and at 1-month post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2016 (estimated)
- Study startNov 2015
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CHRONIC POST-TRAUMATIC NEUROPATHIC PAIN IN ANKLE AND FOOTStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anuj Bhatia, University Health Network, Toronto
- Investigators
- Anuj Bhatia, MD, FRCPC, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02680548
- Sponsor's protocol ID
- 15-9584-A
- Acronym
- PREPLANS
- Status last verified
- Apr 2018
- First submitted
- 11 Dec 2015
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 27334885
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02680548
- Acronym / sponsor ID
- PREPLANS / 15-9584-A
- Keywords
- ankle pain, foot pain, methylprednisolone, neuropathic pain
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 11 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0.9% saline (salt water) | Active comparator | Drug: 0.9% saline0.5mL 0.25% bupivacaine subcutaneous injection, 2-6cc 0.9% saline injection per nerve (20cc max) |
| local anesthetic (freezing) | Active comparator | Drug: 0.25% bupivacaine hydrochloride injectable suspension USP0.5mL 0.25% bupivacaine subcutaneous injection, 2-6cc 0.25% bupivacaine per nerve (20cc max) |
| local anesthetic (freezing) and steroid | Active comparator | Drug: 0.25% bupivacaine hydrochloride injectable suspension USP, Drug: 4mg/cc methylprednisolone acetate injectable suspension USP0.5mL 0.25% bupivacaine subcutaneous injection, 2-6cc 0.25% bupivacaine and 4mg/cc methylprednisolone per nerve (20cc max) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.9% salineAlso: Salt Water | Drug | 0.9% saline (salt water) |
| 0.25% bupivacaine hydrochloride injectable suspension USPAlso: Marcaine | Drug | local anesthetic (freezing), local anesthetic (freezing) and steroid |
| 4mg/cc methylprednisolone acetate injectable suspension USPAlso: Depo-Medrol | Drug | local anesthetic (freezing) and steroid |
Primary outcome
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
12 secondary outcomes
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
Change in scores of Pain Catastrophizing Score (PCS)
Time frame: Baseline and at 1-month post-intervention
Change in scores of Dolores Neuropathique (DN4)
Time frame: Baseline and at 1-month post-intervention
Change in scores of Neuropathic Pain Symptom Inventory (NPSI)
Time frame: Baseline and at 1-month post-intervention
Change in scores of anxiety component scores on the Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline and at 1-month post-intervention
Change in scores of depression scores on the Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline and at 1-month post-intervention
Change in scores of Brief Pain Inventory interference with activities (BPI-I)
Time frame: Baseline and at 1-month post-intervention
Change in scores of Short Form-12 (SF-12)
Time frame: Baseline and at 1-month post-intervention
Change in scores of Lower Extremity Function Score (LEFS)
Time frame: Baseline and at 1-month post-intervention
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)
Change in pre- and post-intervention levels of blood glucose and blood pressure
Time frame: Baseline and at 1-month post-intervention
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
- Derived from this study: PubMed 27334885Bhatia 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anuj Bhatia, MD, FRCPC principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 0.9% saline, 0.25% bupivacaine hydrochloride injectable suspension USP and 4mg/cc methylprednisolone acetate injectable suspension USP in people with CHRONIC POST-TRAUMATIC NEUROPATHIC PAIN IN ANKLE AND FOOT, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment and retention of participants (SEE DESCRIPTION) (time frame: At end of study (1 year)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02680548, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2018.