Evaluation of Initiation Time on the Efficacy of Gabapentin in Treating Neuropathic Pain in SCI

Evaluation of Initiation Time on the Efficacy of Gabapentin in Treating Neuropathic Pain in Spinal Cord Injury (SCI)

Neuropathic pain is a common complaint in those with spinal cord injury (SCI) that has a significant negative effect on quality of life. Efficacy of various treatments, however, remains controversial. There is evidence to support that gabapentin and pregabalin have some benefit in reducing neuropathic pain. Gabapentin is effective in the management of symptoms and concerns related to SCI including motor recovery, spasticity, and mood among others. This makes gabapentin an important pharmacologic intervention, which compels providers to define treatment guidelines related to its use. One aspect of which should relate to the timing of initiation of therapy. The goal of this study is to determine whether timing of initiation of treatment with gabapentin will decrease prevalence and intensity of neuropathic pain.

Study Overview

• Status: Completed
• Conditions: Neuropathic Pain; Spinal Cord Injuries
• Intervention / Treatment: Drug: Gabapentin; Other: No gabapentin

Detailed Description

Neuropathic pain is a common complaint in those with spinal cord injury (SCI) that has a significant negative effect on quality of life. This makes the treatment of neuropathic pain a priority in the SCI population. Efficacy of various treatments, however, remains controversial. There is evidence to support that gabapentin and pregabalin have some benefit in reducing neuropathic pain. Other positive effects of gabapentin on those with SCI have also been demonstrated. However, there has not been a study on the influence of timing of initiation of gabapentin on the efficacy of using it to treat neuropathic pain in the SCI population. Such a finding could change the standard of care in treatment of acute SCI.

The pooled prevalence of neuropathic pain post spinal cord injury is 53%. Not only common, neuropathic pain is pervasive, affecting aspects of patients' lives including sleep, physical function, and mood that in turn impact their activities- work and recreational alike. Thus, neuropathic pain management contributes to quality of life for a majority of people with SCI.

Although a high priority, the treatment of neuropathic pain in SCI remains notoriously difficult. Treatments options may be divided into pharmacologic and non-pharmacologic. Pharmacologic agents studied include amitriptyline, gabapentin, pregabalin, opiates, lidocaine, ketamine, valproate, lamotrigine, levetiracetam and carbamazepine; the most studied of which are amitriptyline, gabapentin, and pregabalin.

Gabapentin's potential is not limited to neuropathic pain management, making it a particularly compelling treatment option in the population with acute SCI. Gabapentin leads to improvement in total motor scores, reduced spasticity, reduced autonomic dysreflexia, and improved mood. Animal models suggest it may be neuroprotective in the acute phase of injury. In those who undergo spine surgery, regardless of presence of SCI, gabapentin given perioperatively leads to reduced opiate use and decreased pain in post-operative period. Additionally, when compared to narcotic alternatives, gabapentin has minimal side effects.

Neuropathic pain in SCI is common, impactful, and difficult to treat. Gabapentin is effective in the management of symptoms and concerns related to SCI including motor recovery, spasticity, and mood among others. This makes gabapentin an important pharmacologic intervention, which compels providers to define treatment guidelines related to its use. One aspect of which should relate to the timing of initiation of therapy. The goal of this study is to determine whether early initiation of treatment with gabapentin will decrease average pain scores and opiate use when comparted to late initiation of treatment with gabapentin in the population with acute SCI. Gabapentin, although used commonly, is not started in all patients with acute SCI but is often started at the onset of neuropathic pain. If gabapentin is found to be more effective when initiated early, it would be reasonable to start gabapentin immediately following acute SCI in all patients in whom it is not otherwise contraindicated.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44109
      • MetroHealth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Clinical diagnosis of acute spinal cord injury
2. Admission to acute inpatient rehabilitation

Exclusion Criteria:

1. Unable to communicate verbally or by writing, unable to follow basic instructions, or unable to answer questions regarding their symptoms

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Gabapentin early; Gabapentin prior to admission	Drug: Gabapentin; Timing of gabapentin initiation
Other: Gabapentin late; Gabapentin during admission	Drug: Gabapentin; Timing of gabapentin initiation
Other: No gabapentin	Other: No gabapentin; No gabapentin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuropathic Pain	To determine if the time from injury influences the prevalence of neuropathic pain in acute SCI. Average of the pain during the previous 7 days on self-identified nerve or neuropathic pain levels (0-10) on 5 different measurements at the time of discharge on the Neuropathic Pain Scale. 0 being best (no pain)- 10 being worst pain. Total score range from 0 to 50.	Through completion of the study, up to 4 weeks after injury.

Collaborators and Investigators

• Sponsor: MetroHealth Medical Center
• Investigators: Principal Investigator: C Kim, Metro Health, Michigan

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): March 30, 2020
• Study Completion (Actual): April 1, 2020

Study Registration Dates

• First Submitted: February 1, 2020
• First Submitted That Met QC Criteria: February 4, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): November 15, 2021
• Last Update Submitted That Met QC Criteria: November 11, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: neuropathic pain; spinal cord injury
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Wounds and Injuries; Neuromuscular Diseases; Peripheral Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Neuralgia; Spinal Cord Injuries; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Gabapentin
• Other Study ID Numbers: IRB19-00117

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No