Investigating Botulinum Toxin A to Treat Acute Neck/Upper Shoulder Pain Following a New Spinal Cord Injury.

Botulinum Toxin A for the Treatment of Cervical/Shoulder Pain Following Acute Spinal Cord Injury.

As clinicians, it is often a struggle to find effective pain control for a certain subgroup of patients with tetraplegia. These patients often have severe upper back, neck, and shoulder pain, limiting rehabilitation productivity and potential, and always limiting quality of life.

This pain appears to be primarily musculoskeletal. Muscles in the upper back and neck become shortened, rock hard, and extremely tender with even the slightest touch or stretch. Refractory to multiple classes of medications, modalities, and other treatments, patients truly suffer-not only from pain, but from fatigue, sedation, expense, and loss of useful rehabilitation time due to attempted remedies. Unfortunately, this subgroup of patients is not small and the problem is significant, as anyone who specializes in the treatment of spinal cord injury patients will recognize.

In search for another form of treatment, botulinum toxin A (BTXA) may be promising for pain control in that group of patients with tetraplegia whose pain has proven to be refractory to treatment. It did not take long searching the literature to find compelling evidence that BTXA may have another mechanism of action for direct pain control, apart from its well known mechanism for spasticity control. Clinically, it is increasingly being recommended and used for this purpose. In fact, one of the specific indications now recognized by most for BTXA treatment is for myogenic pain due to short, tight, strained muscles-just as we see with our population. Yet, it's application has not been studied in people with tetraplegia. Thus, the genesis of the project and the hope to help our patients evolved.

Study hypotheses:

• In addition to traditional treatments used for pain control, injection of BTXA into cervical and upper back muscles will effectively reduce cervical/shoulder pain severity reported by individuals with cervical spinal cord injuries, regardless of the etiology of pain.
• Pain reduction secondary to the use of BTXA will be associated with a decrease in total analgesic medication use among SCI patients during acute inpatient rehabilitation.
• BTXA to treat cervical/shoulder pain will increase active participation in the rehabilitation program for individuals with tetraplegia during inpatient rehabilitation.

Study Overview

• Status: Completed
• Conditions: Pain; Spinal Cord Injury
• Intervention / Treatment: Other: placebo; Drug: botulinum toxin A

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Englewood, Colorado, United States, 80113
      • Craig Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Inpatient at Craig Hospital for initial rehabilitation following a traumatic spinal cord injury.
• Cervical Injury at C4-C8
• ASIA classification score of A,B,or C
• May still be in halo immobilization device and range of motion scores will therefore not be collected
• Report at least a 6/10 on the VAS for pain in the previous 24 hours prior to randomization
• Orthopedically stable
• Approval of attending physician
• Standard of care management with oral analgesic agents has not resulted in pain symptom resolution
• May not be enrolled in other clinical trial

Exclusion Criteria:

• Pregnant
• Concurrent use of aminoglycoside antibiotics at the time of injection
• Diagnosis of myasthenia gravis or Eaton-Lambert Syndrome
• Known sensitivities to toxins
• Severe bradycardia (HR<50 bpm) or hypotension (systolic blood pressure of <80 mmHg)
• Deep vein thrombosis treatment doses of anticoagulants or coumadin
• History of recent dysphagia
• Ventilator dependent
• Unstable cervical fracture or not surgically stabilized

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo; Normal saline injections were used for placebo injections. Injections were based on treatment plan determined in clinical setting by study PI and physical therapist. 25 cc syringe was used and amount of saline injected was unit based on muscles to be injected according to the treatment plan.	Other: placebo; Injection of normal saline into cervical and upper back muscles was also based on treatment plan prescribed for each participant individually based on muscle soreness and tightness. Injections occured on one single clinic visit. Both the saline and BTXA were dosed in 25 cc syringes and looked the same for the physician performing the injections to ensure both participant and study physician remained blinded.; Other Names: normal saline dose based on muscles to be injected, multiple injections may occur based on treatment plan. Injection occur at one single clinical visit.
Active Comparator: Botulinum toxin A; Botulism toxin A dosage was based on plan developed in clinical setting with study PI and physical therapist. Drug was dosed in 25 cc syringe,diluted with normal saline and injections occured based on treatment plan.	Drug: botulinum toxin A; Injection of BTXA into cervical and upper back muscles based on treatment plan prescribed for each participant individually based on muscle soreness and tightness. Injections occured on one single clinic visit.Both the saline and BTXA were dosed in 25 cc syringes and looked the same for the physician performing the injections to ensure both participant and study physician remained blinded.; Other Names: Botox-A

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical Rating Scale-NRS	The Numerical Rating Scale (NRS) is a numerical scale from 0-10 used to rate pain. Participants were asked to assess the worst pain experienced in the past 5 days and rate it on a numerical scale from 0-10, with 10 being the "worst possible pain" they have experienced and 0 being "no pain."	6 weeks post-injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brief Pain Inventory-Short Form - Interference Score	Interference in daily activities was measured with the Brief Pain Inventory (BPI) Interference Score. Participants rated the extent to which pain interfered with their participation in six general activities during the past week, using a scale of 0 (does not interfere) to 10 (completely interferes). Note that for the purposes of this study, the question regarding walking was removed from the original scale which has seven items). Mean score across the 6 items was calculated (range could be 0 - 10) with higher score indicating more pain interference.	6 months post-injection

Collaborators and Investigators

• Sponsor: Craig Hospital
• Collaborators: Allergan; The Craig H. Neilsen Foundation
• Investigators: Principal Investigator: Gary Maerz, MD, Craig Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2006
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: April 28, 2006
• First Submitted That Met QC Criteria: April 28, 2006
• First Posted (Estimate): May 3, 2006

Study Record Updates

• Last Update Posted (Actual): October 14, 2020
• Last Update Submitted That Met QC Criteria: September 22, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Botox
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Trauma, Nervous System; Spinal Cord Diseases; Arthralgia; Wounds and Injuries; Shoulder Pain; Spinal Cord Injuries; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: 2691