Trial · NCT02736890
Injecting Botulinum Toxin A Underneath the Skin to Treat Spinal Cord Pain in Patients With Spinal Cord Injury
NCT02736890, Phase 2, Terminated, Icahn School of Medicine at Mount Sinai; results first posted 2019-04-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Injecting Botulinum Toxin A Underneath the Skin to Treat Spinal Cord Pain in Patients With Spinal Cord Injury. Trials, record NCT02736890. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02736890
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Injecting Botulinum Toxin A Underneath the Skin to Treat Spinal Cord Pain in Patients With Spinal Cord Injury
- NCT number
- NCT02736890
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 8 participants, actual
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Conditions
- Neuropathic Back Pain, Spinal Cord Injury
- Interventions
- Botulinum Toxin A, Placebo
- First posted
- 2016-04-13
- Last updated
- 2019-04-09
- Results first posted
- 2019-04-09
- Limitations and caveats
- Target number of participants needed to achieve target power and statistically reliable results not reached. Unsuccessful questionnaires post injection
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Numeric Pain Rating Scale (NPRS) | up to 12 weeks post-injection, for a total of 24 weeks from baseline | Participant rated pain intensity from 0-10, with higher score indicating more pain |
| Secondary | 7-Point Guy/Farrar Patient Global Impression of Change (PGIC) | up to 12 weeks post-injection, for a total of 24 weeks from baseline | 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. |
| Secondary | International Basic Pain Dataset - Pain Affecting Day-to-day Activities | up to 12 weeks post-injection, for a total of 24 weeks from baseline | 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. |
| Secondary | International Basic Pain Dataset - Pain Affecting Mood | up to 12 weeks post-injection, for a total of 24 weeks from baseline | 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. |
| Secondary | International Basic Pain Dataset - Pain Affecting Sleep | up to 12 weeks post-injection, for a total of 24 weeks from baseline | 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. |
| Secondary | Static Mechanical Allodynia Testing | up to 12 weeks post-injection, for a total of 24 weeks from baseline | 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. |
| Secondary | Dynamic Mechanical Allodynia Testing | up to 12 weeks post-injection, for a total of 24 weeks from baseline | 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 |
| Secondary | Patient-generated Index (PGI) | up to 12 weeks post-injection, for a total of 24 weeks from baseline | PGI measures activity affected by pain. Full score is 0 to 10000, with higher score indicating better function |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Numeric Pain Rating Scale (NPRS) | up to 12 weeks post-injection, for a total of 24 weeks from baseline | only those who completed crossover were included | score on a scale | MEAN |
| SECONDARY | 7-Point Guy/Farrar Patient Global Impression of Change (PGIC) | up to 12 weeks post-injection, for a total of 24 weeks from baseline | only those who completed crossover were included | score on a scale | MEAN |
| SECONDARY | International Basic Pain Dataset - Pain Affecting Day-to-day Activities | up to 12 weeks post-injection, for a total of 24 weeks from baseline | only those who completed crossover were included | units on a scale | MEAN |
| SECONDARY | International Basic Pain Dataset - Pain Affecting Mood | up to 12 weeks post-injection, for a total of 24 weeks from baseline | only those who completed crossover were included | units on a scale | MEAN |
| SECONDARY | International Basic Pain Dataset - Pain Affecting Sleep | up to 12 weeks post-injection, for a total of 24 weeks from baseline | only those who completed crossover were included | units on a scale | MEAN |
| SECONDARY | Static Mechanical Allodynia Testing | up to 12 weeks post-injection, for a total of 24 weeks from baseline | Data initially collected incorrectly, then data not collected. | ||
| SECONDARY | Dynamic Mechanical Allodynia Testing | up to 12 weeks post-injection, for a total of 24 weeks from baseline | Data initially collected incorrectly, then data not collected. | ||
| SECONDARY | Patient-generated Index (PGI) | up to 12 weeks post-injection, for a total of 24 weeks from baseline | only those who completed crossover were included | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group106
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Numeric Pain Rating Scale (NPRS) | Botulinum Toxin A Then Placebo | baseline | 7.6 | Standard Deviation 1.5 | score on a scale |
| Numeric Pain Rating Scale (NPRS) | Placebo Then Botulinum Toxin A | baseline | 8 | Standard Deviation 0 | score on a scale |
| Numeric Pain Rating Scale (NPRS) | Botulinum Toxin A Then Placebo | 2 week post injection | 6.4 | Standard Deviation 0.9 | score on a scale |
| Numeric Pain Rating Scale (NPRS) | Placebo Then Botulinum Toxin A | 2 week post injection | 8 | Standard Deviation 0 | score on a scale |
| Numeric Pain Rating Scale (NPRS) | Botulinum Toxin A Then Placebo | 4 week post injection | 5.6 | Standard Deviation 1.7 | score on a scale |
| Numeric Pain Rating Scale (NPRS) | Placebo Then Botulinum Toxin A | 4 week post injection | 8 | Standard Deviation 0 | score on a scale |
| Numeric Pain Rating Scale (NPRS) | Botulinum Toxin A Then Placebo | 8 week post injection | 5.6 | Standard Deviation 2.6 | score on a scale |
| Numeric Pain Rating Scale (NPRS) | Placebo Then Botulinum Toxin A | 8 week post injection | 8 | Standard Deviation 0 | score on a scale |
| Numeric Pain Rating Scale (NPRS) | Botulinum Toxin A Then Placebo | 12 week post injection | 5.6 | Standard Deviation 3.3 | score on a scale |
| Numeric Pain Rating Scale (NPRS) | Placebo Then Botulinum Toxin A | 12 week post injection | 8 | Standard Deviation 0 | score on a scale |
1 to 10 of 106Source ClinicalTrials.gov
See all 106 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First 12 Weeks | STARTED | Botulinum Toxin A Then Placebo | 5 | |
| First 12 Weeks | STARTED | Placebo Then Botulinum Toxin A | 3 | |
| First 12 Weeks | COMPLETED | Botulinum Toxin A Then Placebo | 5 | |
| First 12 Weeks | COMPLETED | Placebo Then Botulinum Toxin A | 3 | |
| First 12 Weeks | NOT COMPLETED | Botulinum Toxin A Then Placebo | 0 | |
| First 12 Weeks | NOT COMPLETED | Placebo Then Botulinum Toxin A | 0 | |
| Crossover Next 12 Weeks | STARTED | Botulinum Toxin A Then Placebo | 5 | |
| Crossover Next 12 Weeks | STARTED | Placebo Then Botulinum Toxin A | 3 | |
| Crossover Next 12 Weeks | COMPLETED | Botulinum Toxin A Then Placebo | 3 | |
| Crossover Next 12 Weeks | COMPLETED | Placebo Then Botulinum Toxin A | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | fever | Infections and infestations | Botulinum Toxin A | 1 | 8 | |
| other | fever | Infections and infestations | Placebo | 0 | 8 | |
| serious | thrombosed IVCF | Vascular disorders | Botulinum Toxin A | 1 | 8 | |
| serious | thrombosed IVCF | Vascular disorders | Placebo | 0 | 8 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Botulinum Toxin A | 0 | 8 |
| Total, all-cause mortality | Placebo | 0 | 8 |
| Total, other adverse events | Botulinum Toxin A | 1 | 8 |
| Total, other adverse events | Placebo | 0 | 8 |
| Total, serious adverse events | Botulinum Toxin A | 1 | 8 |
| Total, serious adverse events | Placebo | 0 | 8 |
Source ClinicalTrials.gov
Papers81
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Botulinum Toxin A vs Placebo: deaths from any cause | Trial comparisons |
| Botulinum Toxin A vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02736890
GET https://conductscience.org/api/trials/v1/NCT02736890/results?page=2