Trial · NCT00822926

Subcutaneous Botulinum Toxin for Cutaneous Allodynia - Enriched Responder Trial

NCT00822926, Not applicable, Terminated, Stanford University; results first posted 2017-08-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Subcutaneous Botulinum Toxin for Cutaneous Allodynia - Enriched Responder Trial. Trials, record NCT00822926. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00822926

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Subcutaneous Botulinum Toxin for Cutaneous Allodynia - Enriched Responder Trial
NCT number: NCT00822926
Status: Terminated
Phases: Not applicable
Enrollment: 5 participants, actual
Lead sponsor: Stanford University
Conditions: Pain
Interventions: Botulinum Toxin Type A, Saline
First posted: 2009-01-15
Last updated: 2017-08-15
Results first posted: 2017-08-15

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Time to Analgesic Failure	Duration of trial (2-20 months, depending on how long pain relief lasts)	Participants completed the Pain Numeric Rating Scale everyday after the injections. Outcome measure represents the number of days before pain returned to baseline levels.
Secondary	Improvement in Psychosocial Function as Assessed by Outcomes as Dictated by the IMMPACT Guidelines	Duration of trial (2-20 months, depending on how long pain relief lasts)	The Beck Depression Inventory was used to assess psychosocial function. Scores were measured at baseline, their final questionnaire following the first injection visit, and their final questionnaire following their second injection visit. Scores range from 0-63, with lower scores representing less severe depression symptoms and higher scores representing more severe depression symptoms.
Secondary	NRS Score Three Weeks After Injection	3 weeks after injection	Pain scores were measured at baseline, 3 weeks after placebo, and 3 weeks after botox. Scores range from 0 (no pain) to 10 (severe, disabling pain).

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Time to Analgesic Failure	Duration of trial (2-20 months, depending on how long pain relief lasts)	A total of 3 participants completed the study (1 received Placebo first then Botox, 2 received Botox first then Placebo). Each of those 3 participants received both Placebo and Botox, as represented in the overall number of participants analyzed for both treatments.	days	MEAN
SECONDARY	Improvement in Psychosocial Function as Assessed by Outcomes as Dictated by the IMMPACT Guidelines	Duration of trial (2-20 months, depending on how long pain relief lasts)	A total of 3 participants completed the study (1 received Placebo first then Botox, 2 received Botox first then Placebo). Each of those 3 participants received both Placebo and Botox, as represented in the overall number of participants analyzed for both treatments.	Units on a scale	MEAN
SECONDARY	NRS Score Three Weeks After Injection	3 weeks after injection	A total of 3 participants completed the study (1 received Placebo first then Botox, 2 received Botox first then Placebo). Each of those 3 participants received both Placebo and Botox, as represented in the overall number of participants analyzed for both treatments.	Units on a scale	MEAN

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Time to Analgesic Failure	Placebo	120.67	Standard Deviation 166.79	days
Time to Analgesic Failure	Botox	20.67	Standard Deviation 22.72	days
Improvement in Psychosocial Function as Assessed by Outcomes as Dictated by the IMMPACT Guidelines	Baseline	12.33	Standard Deviation 3.79	Units on a scale
Improvement in Psychosocial Function as Assessed by Outcomes as Dictated by the IMMPACT Guidelines	Placebo	8	Standard Deviation 7.21	Units on a scale
Improvement in Psychosocial Function as Assessed by Outcomes as Dictated by the IMMPACT Guidelines	Botox	8	Standard Deviation 4.36	Units on a scale
NRS Score Three Weeks After Injection	Baseline	3.39	Standard Deviation 2.46	Units on a scale
NRS Score Three Weeks After Injection	Placebo	0.86	Standard Deviation 0.7	Units on a scale
NRS Score Three Weeks After Injection	Botox	3.2	Standard Deviation 2.18	Units on a scale

Source ClinicalTrials.gov

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
First Injection Visit	STARTED	Placebo Then Botox	2
First Injection Visit	STARTED	Botox Then Placebo	3
First Injection Visit	COMPLETED	Placebo Then Botox	2
First Injection Visit	COMPLETED	Botox Then Placebo	3
First Injection Visit	NOT COMPLETED	Placebo Then Botox	0
First Injection Visit	NOT COMPLETED	Botox Then Placebo	0
Washout (Varies Based on Scheduling)	STARTED	Placebo Then Botox	2
Washout (Varies Based on Scheduling)	STARTED	Botox Then Placebo	3
Washout (Varies Based on Scheduling)	COMPLETED	Placebo Then Botox	2
Washout (Varies Based on Scheduling)	COMPLETED	Botox Then Placebo	3

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events2

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	Stomach flu	General disorders	Placebo Then Botox	0	2	0
other	Stomach flu	General disorders	Botox Then Placebo	1	3	1

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo Then Botox	0	2
Total, all-cause mortality	Botox Then Placebo	0	3
Total, other adverse events	Placebo Then Botox	0	2
Total, other adverse events	Botox Then Placebo	1	3
Total, serious adverse events	Placebo Then Botox	0	2
Total, serious adverse events	Botox Then Placebo	0	3

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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
Placebo Then Botox vs Botox Then Placebo: deaths from any cause	Trial comparisons
Placebo Then Botox vs Botox Then 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00822926

GET https://conductscience.org/api/trials/v1/NCT00822926/registered

API reference For AI assistants