Spinal Cord InjuryPhase 4NCT00320281
Investigating Botulinum Toxin A to Treat Acute Neck/Upper Shoulder Pain Following a New Spinal Cord Injury.
A Phase 4 study testing botulinum toxin A in people with Spinal Cord Injury and Pain, run by Craig Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Spinal Cord Injury, Pain
- What is being tested?
- botulinum toxin A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Aug 2008
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- History of recent dysphagia
- Ventilator dependent
- Unstable cervical fracture or not surgically stabilized
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- botulinum toxin A, placebo
- Keywords
- Botox
- Medical subject headings
- Spinal Cord Injuries, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
botulinum toxin ADrug
Also called Botox-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.
placeboOther
Also called normal saline dose based on muscles to be injected, multiple injections may occur based on treatment plan. Injection occur at one single clinical visit.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: botulinum toxin A |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 6 weeks post-injection
Secondary outcomes (1)
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.
Measured: 6 months post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2006 (estimated)
- Study startApr 2006
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Craig Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation, Allergan
- Responsible party
- Principal investigator, Cynthia Harrison-Felix, PhD, Craig Hospital
- Investigators
- Gary Maerz, MD, Principal investigator, Craig Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00320281
- Sponsor's protocol ID
- 2691
- Status last verified
- Sep 2020
- First submitted
- 28 Apr 2006
- Last updated
- 14 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes