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Neuropathic Back PainPhase 2NCT02736890

Injecting Botulinum Toxin A Underneath the Skin to Treat Spinal Cord Pain in Patients With Spinal Cord Injury

A Phase 2 study testing Botulinum Toxin A in people with Neuropathic Back Pain and Spinal Cord Injury, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Back pain is a common secondary condition of both acute and chronic spinal cord injury (SCI). Current existing treatment including both pharmacologic and non-pharmacologic are limited by marginal efficacy or intolerable side effects. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Neuropathic Back Pain, Spinal Cord Injury
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
8 participants
Where
1 siteUnited States
Study dates
Mar 2016to 17 Jul 2018
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Between the ages of 18 and 80 years old
  • Diagnosed with traumatic spinal cord injury
  • Target pain is considered by the physician as at-level SCI in nature to a high degree of certainty (4 or 5 using a Likert confidence scale ranging from 0-5 where 0 is "purely a guess" and 5 is "absolutely certain")
  • Able to give written informed consent
  • Target pain that has been continuously present for at least one month
  • Target pain is of at least moderate average intensity over the past week, e.g., greater than or equal to 4/10 on a numeric rating scale, the cutoff point for moderate pain in an SCI population.
  • Target pain is localized within the dermatome which identifies the NLI or within 3 levels below the NLI
  • Subject has been on a stable dose of analgesic mediation (or not on analgesic medication) for at least 3 weeks and is agreeable to remaining on current regimen for the duration of the study (previous prescribed breakthrough analgesics will be allowed)

Who cannot join

  • Pregnancy
  • History of intolerance, hypersensitivity or known allergy to botulinum toxin or its preservatives
  • History of intolerance, hypersensitivity or known allergy to EMLA cream (lignocaine/prilocaine eutectic mixture) which is used as an analgesic during BoNT injection
  • Recent history of administration of botulinum toxin (within previous 6 months)
  • Contraindications to botulinum toxin (myasthenia gravis or other disease of the neuromuscular junction)
  • Coagulation disorder
  • Current infection
  • Insufficient command of English to complete self-report instruments.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mount Sinai Hospital

    New York, New York, 10029

Other trials in United States

About this study

Official title: Subcutaneous Injection of Botulinum Toxin A for At--Level Back Pain in Patients With Spinal Cord Injury

Back pain is a common secondary condition of both acute and chronic spinal cord injury (SCI). Current existing treatment including both pharmacologic and non-pharmacologic are limited by marginal efficacy or intolerable side effects. The purpose of this study is to evaluate the potential of subcutaneous injections of botulinum toxin A to provide pain relief in spinal cord injury patients with back pain near the level of injury in the spine. Botulinum toxin A has been shown in both pre-clinical and clinical studies to help with nerve pain. The researchers propose a double blinded placebo controlled crossover study to study the effects of subcutaneous botulinum injections to at--level SCI back pain in patients with spinal cord injury.

Read the detailed description

In this study, there will be 2 procedure performed. The first procedure will be named P1 and consists of subcutaneous injection of either placebo or Botulinum Toxin A. The second procedure will be the cross-over procedure named P2. For the cross-over procedure, the subjects who had initially received Botulinum Toxin A will receive placebo and the subjects who had initially received placebo will receive Botulinum Toxin A. This is a Randomized Double-Blinded Placebo Controlled Trial. Recruited subjects will be consented, enrolled and evaluated immediately prior to P1 (or during a visit prior to the visit for P1). After the initial pre-treatment evaluation, subjects will randomly receive either placebo or Botulinum Toxin A subcutaneously (P1). A telephone follow-up (or e-mail follow up) will be performed at 2 weeks and 8 weeks post- P1. An onsite follow up will be performed 4 weeks post P1 and 12 weeks post P1.

Cross-over Study: After the 3rd month on-site evaluation (12 weeks post P1), during the same visit, the subject will proceed to the cross-over study. At this time, the patient will have the option to receive a repeat subcutaneous injection of the cross-over agent. If they desire one, a subcutaneous injection of the cross-over agent will be performed at that same visit. If they wish to defer the repeat injection, they will be contacted and asked every 4 weeks - between 12 weeks and 24 weeks post P1 (no subject will receive P2 after week 24) if they would like to have the subcutaneous injection of the cross-over agent. If they desire one, a repeat injection will be scheduled for the following week.

The rationale for a variable length of time after the initial Botulinum Toxin A/Placebo injection (P1) is to document the variability of individuals' pain response after Botulinum Toxin A. It has been reported in literature, of the subjects that respond to subcutaneous Botulinum Toxin A injections for pain, most will return to their base-line pain score in 12--24 weeks.

Being tested
Botulinum Toxin A, Placebo
Keywords
Botulinum Toxin A, Neuropathic pain, Spinal cord injury, Pain management, Rehabilitation
Medical subject headings
Spinal Cord Injuries, Neuralgia, Agnosia

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

    Subjects will receive subcutaneous Botulinum Toxin A injections into the marked painful region. The syringes will be prepared by a third party prior to the injection and the administrator of the procedure will be blinded to syringe content. This physician will be performing the injections under sterile conditions. Local anesthesia, EMLA (lignocaine/prilocaine eutectic mixture) cream, up to 4 grams, will be applied topically for local anesthesia. After 50 minutes, the cream will be cleaned off. Overlying skin will be sterilized with either betadine or alcohol solution.

  • PlaceboDrug

    Subjects will receive subcutaneous placebo injections into the marked painful region. The syringes will be prepared by a third party prior to the injection and the administrator of the procedure will be blinded to syringe content. This physician will be performing the injections under sterile conditions. Local anesthesia, EMLA (lignocaine/prilocaine eutectic mixture) cream, up to 4 grams, will be applied topically for local anesthesia. After 50 minutes, the cream will be cleaned off. Overlying skin will be sterilized with either betadine or alcohol solution.

Study groups in NCT02736890
Study groupRoleWhat they receive
Botulinum Toxin AActive comparatorEach vial of botulin toxin (100U, BOTOX, Allergan) will be reconstituted with 4ml non-preserved saline solution (0.9%) as recommended by the manufacturer (concentration of 5 units Botulinum Toxin A/0.2ml). Each injection will be 0.2mL (BOTOX, 5 units), administered through a 25 gauge needle. The marked area will have subcutaneous injections, each separated by a radius of 1 cm, from the other injections into the marked area,(maximum of 80 injections, 400 Units).
Receives: Drug: Botulinum Toxin A
PlaceboPlacebo comparatorPlacebo consists of 0.9% normal saline. Each injection will be 0.2mL, administered with a 25 gauge needle subcutaneously into the affected area. The marked area will have subcutaneous injections (maximum of 80) each separated from the surrounding ones by a radius of 1 cm.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Numeric Pain Rating Scale (NPRS)

    Participant rated pain intensity from 0-10, with higher score indicating more pain

    Measured: up to 12 weeks post-injection, for a total of 24 weeks from baseline

Secondary outcomes (7)

  1. 7-Point Guy/Farrar Patient Global Impression of Change (PGIC)

    Mean change from baseline. Participants are asked "Taking into account your pain level and how it affects your life, are you feeling better, the same or worse than when you started treatment?" and then to quantify the magnitude of the change. with the 7-Point guy Farrar which measures the global treatment effect from with scale from 0 to 6, higher score indicates worse outcomes.

    Measured: up to 12 weeks post-injection, for a total of 24 weeks from baseline

  2. International Basic Pain Dataset - Pain Affecting Day-to-day Activities

    The International Basic Pain Dataset is an assessment tool which includes several components including: location of pain, temporal qualities of the pain, type of pain, pain interference measures of activity, sleep, and mood. It has been shown to be valid in an interview/self -report format. The pain affecting day-to-day activities subset of the dataset is scored is from 0 to 10, with higher score indicating less favorable outcomes.

    Measured: up to 12 weeks post-injection, for a total of 24 weeks from baseline

  3. International Basic Pain Dataset - Pain Affecting Mood

    The International Basic Pain Dataset is an assessment tool which includes several components including: location of pain, temporal qualities of the pain, type of pain, pain interference measures of activity, sleep, and mood. It has been shown to be valid in an interview/self -report format. The pain affecting mood subset of the dataset is scored is from 0 to 10, with higher score indicating less favorable outcomes.

    Measured: up to 12 weeks post-injection, for a total of 24 weeks from baseline

  4. International Basic Pain Dataset - Pain Affecting Sleep

    The International Basic Pain Dataset is an assessment tool which includes several components including: location of pain, temporal qualities of the pain, type of pain, pain interference measures of activity, sleep, and mood. It has been shown to be valid in an interview/self -report format. The pain affecting sleep subset of the dataset is scored is from 0 to 10, with higher score indicating less favorable outcomes.

    Measured: up to 12 weeks post-injection, for a total of 24 weeks from baseline

  5. Static Mechanical Allodynia Testing

    Mechanical allodynia is a characteristic of evoked pain in subjects with neuropathic pain. Static allodynia to mechanical stimuli will be defined as a sensation of pain evoked by the pressure of the end of a wooden stick. The end of a wooden stick will touch the affected region with enough pressure to indent the skin, for 10 seconds. Afterwards, the subject will be asked to rate the perceived pain on an 11-point NRS.

    Measured: up to 12 weeks post-injection, for a total of 24 weeks from baseline

  6. Dynamic Mechanical Allodynia Testing

    Dynamic allodynia will be tested by stroking the affected region gently with a cotton swab, 4 times at a rate of 3-5cm per second over an area of 5cm. If there is an evoked clear sensation of pain, the subject is asked to rate the intensity of dynamic allodynia using the 11-point NRS. The region of static and dynamic allodynia, if present, will be marked and recorded

    Measured: up to 12 weeks post-injection, for a total of 24 weeks from baseline

  7. Patient-generated Index (PGI)

    PGI measures activity affected by pain. Full score is 0 to 10000, with higher score indicating better function

    Measured: up to 12 weeks post-injection, for a total of 24 weeks from baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2016 (estimated)
  2. Study startMar 2016
  3. Primary completion17 Jul 2018
  4. Study completion17 Jul 2018

Why it stopped: funding not available to continue

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02736890
Sponsor's protocol ID
GCO 14-2212
Status last verified
Apr 2019
First submitted
8 Apr 2016
Last updated
9 Apr 2019
Data monitoring committee
No
Individual data sharing
Yes: The following will be shared: demographic information, pain response to interventions, adverse events and functional outcomes. The above information will be obtain in the forms of questionnaires and surveys. The data will be available when the study concludes.

Publications

  • Siddall PJ, McClelland JM, Rutkowski SB, Cousins MJ. A longitudinal study of the prevalence and characteristics of pain in the first 5 years following spinal cord injury. Pain. 2003 Jun;103(3):249-257. doi: 10.1016/S0304-3959(02)00452-9.

    PubMed 12791431

  • Cardenas DD, Bryce TN, Shem K, Richards JS, Elhefni H. Gender and minority differences in the pain experience of people with spinal cord injury. Arch Phys Med Rehabil. 2004 Nov;85(11):1774-81. doi: 10.1016/j.apmr.2004.04.027.

    PubMed 15520972

  • Rintala DH, Loubser PG, Castro J, Hart KA, Fuhrer MJ. Chronic pain in a community-based sample of men with spinal cord injury: prevalence, severity, and relationship with impairment, disability, handicap, and subjective well-being. Arch Phys Med Rehabil. 1998 Jun;79(6):604-14. doi: 10.1016/s0003-9993(98)90032-6.

    PubMed 9630137

  • Jensen MP, Hoffman AJ, Cardenas DD. Chronic pain in individuals with spinal cord injury: a survey and longitudinal study. Spinal Cord. 2005 Dec;43(12):704-12. doi: 10.1038/sj.sc.3101777.

    PubMed 15968299

  • Vogel LC, Krajci KA, Anderson CJ. Adults with pediatric-onset spinal cord injury: part 2: musculoskeletal and neurological complications. J Spinal Cord Med. 2002 Summer;25(2):117-23. doi: 10.1080/10790268.2002.11753611.

    PubMed 12137215

  • McColl MA, Charlifue S, Glass C, Lawson N, Savic G. Aging, gender, and spinal cord injury. Arch Phys Med Rehabil. 2004 Mar;85(3):363-7. doi: 10.1016/j.apmr.2003.06.022.

    PubMed 15031818

  • Knutsdottir S. Spinal cord injuries in Iceland 1973-1989. A follow up study. Paraplegia. 1993 Jan;31(1):68-72. doi: 10.1038/sc.1993.10.

    PubMed 8446450

  • Samuelsson KK. Back pain and spinal Deformity-Common among wheelchair users with spinal cord injuries. Scandinavian journal of occupational therapy. 1996 -01;3(1):28-32.

  • Waisbrod H, Hansen D, Gerbershagen HU. Chronic pain in paraplegics. Neurosurgery. 1984 Dec;15(6):933-4.

    PubMed 6514167

  • Hardcastle P, Bedbrook G, Curtis K. Long-term results of conservative and operative management in complete paraplegics with spinal cord injuries between T10 and L2 with respect to function. Clin Orthop Relat Res. 1987 Nov;(224):88-96.

    PubMed 3665258

  • Walter JS, Sacks J, Othman R, Rankin AZ, Nemchausky B, Chintam R, Wheeler JS. A database of self-reported secondary medical problems among VA spinal cord injury patients: its role in clinical care and management. J Rehabil Res Dev. 2002 Jan-Feb;39(1):53-61.

    PubMed 11926327

  • Rintala DH, Hart KA, Priebe MM. Predicting consistency of pain over a 10-year period in persons with spinal cord injury. J Rehabil Res Dev. 2004 Jan-Feb;41(1):75-88. doi: 10.1682/jrrd.2004.01.0075.

    PubMed 15273900

  • Cardenas DD, Jensen MP. Treatments for chronic pain in persons with spinal cord injury: A survey study. J Spinal Cord Med. 2006;29(2):109-17. doi: 10.1080/10790268.2006.11753864.

    PubMed 16739554

  • Cardenas DD, Warms CA, Turner JA, Marshall H, Brooke MM, Loeser JD. Efficacy of amitriptyline for relief of pain in spinal cord injury: results of a randomized controlled trial. Pain. 2002 Apr;96(3):365-373. doi: 10.1016/S0304-3959(01)00483-3.

    PubMed 11973011

  • Levendoglu F, Ogun CO, Ozerbil O, Ogun TC, Ugurlu H. Gabapentin is a first line drug for the treatment of neuropathic pain in spinal cord injury. Spine (Phila Pa 1976). 2004 Apr 1;29(7):743-51. doi: 10.1097/01.brs.0000112068.16108.3a.

    PubMed 15087796

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Botulinum Toxin A in people with Neuropathic Back Pain and Spinal Cord Injury, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Numeric Pain Rating Scale (NPRS) (time frame: up to 12 weeks post-injection, for a total of 24 weeks from baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02736890, which also lists 82 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2019.

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