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

NCT ID: NCT00320281

Last Updated: 2020-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2008-08-31

Brief Summary

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.

Conditions

Spinal Cord Injury; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

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.

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.

Group Type: ACTIVE_COMPARATOR

botulinum toxin A

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: OTHER

Other Intervention Names

Botox-A; normal saline dose based on muscles to be injected, multiple injections may occur based on treatment plan. Injection occur at one single clinical visit.

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Craig H. Neilsen Foundation

OTHER

Sponsor Role: collaborator

Allergan

INDUSTRY

Sponsor Role: collaborator

Craig Hospital

OTHER

Sponsor Role: lead

Responsible Party

Cynthia Harrison-Felix, PhD

Department Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gary Maerz, MD

Role: PRINCIPAL_INVESTIGATOR

Craig Hospital

Locations

Craig Hospital

Englewood, Colorado, United States

Countries

United States

Other Identifiers

2691

Identifier Type: -

Identifier Source: org_study_id