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

NCT00320281 | Completed Phase 4 Results DMC

• 1 other identifier: 2691
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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

Keywords

Botox

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Brief Pain Inventory-Short Form - Interference Score

  6 months post-injection

Study Arms (2)

placebo

PLACEBO COMPARATOR

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

Botulinum toxin A

ACTIVE COMPARATOR

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

Interventions

botulinum toxin A 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.

Also known as: Botox-A

Botulinum toxin A

placebo 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.

Also known as: normal saline dose based on muscles to be injected, multiple injections may occur based on treatment plan. Injection occur at one single clinical visit.

placebo

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Craig Hospital: lead
• The Craig H. Neilsen Foundation: collaborator
• Allergan: collaborator

Study Sites (1)

Craig Hospital

Englewood, Colorado, 80113, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Pain

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Limitations and Caveats

Study outcome measures modified to reflect available study results. AE's monitored daily; specific data is not available (study completed \>10yrs ago). Investigator summary indicates no SAE's/AE's related to study intervention (treatment or sham).

Results Point of Contact

• Title: Dr. Gary Maerz
• Organization: Craig Hospital

adannels@craighospital.org

303-789-8220

Study Officials

• Gary Maerz, MD

  Craig Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department Director

Study Record Dates

• First Submitted: April 28, 2006
• First Posted: May 3, 2006
• Study Start: April 1, 2006
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: October 14, 2020
• Results First Posted: July 29, 2013

Record last verified: 2020-09

Locations

US (1)