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OpenTrials
Completed

NCT Number: NCT00320281

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

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Key information

Conditions

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

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Craig Hospital

Englewood, Colorado, 80113, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Botox-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.

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.

Primary outcomes

  1. Numerical Rating Scale-NRS

    Time frame: 6 weeks post-injection

    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."

Secondary outcomes

  1. Brief Pain Inventory-Short Form - Interference Score

    Time frame: 6 months post-injection

    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.

Sponsors and collaborators

Lead sponsor

Craig Hospital

Other

Collaborators

  • Allergan
  • The Craig H. Neilsen Foundation

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
May 3, 2006
Registry last updated
Oct 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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