Trial · NCT00108550

Chronic Low Back Pain Research Project

NCT00108550, Phase 2, Completed, US Department of Veterans Affairs; results first posted 2014-02-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Chronic Low Back Pain Research Project. Trials, record NCT00108550. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00108550

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Trial

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

Title: Chronic Low Back Pain Research Project
NCT number: NCT00108550
Status: Completed
Phases: Phase 2
Enrollment: 108 participants, actual
Lead sponsor: US Department of Veterans Affairs
Conditions: Chronic Low Back Pain
Interventions: gabapentin, Inert placebo
First posted: 2005-04-18
Last updated: 2014-02-10
Results first posted: 2014-02-10
Limitations and caveats: Limitations include small sample size, high rate of early termination, and moderate baseline levels of pain intensity and disability in everyday function which may have limited ability to detect an effect.

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Transformed Descriptor Differential Scale-Pain Intensity Scores Adjusted for Time	Baseline to Week 12 with Interim Measurement at Weeks 1, 2, 3, 4, 5, 7 and 9	Self-report measure of "current" pain intensity of chronic back pain. Participants rate pain on a 20 point scale as being greater or less intense relative to 12 adjectival descriptor word anchors (eg, greater or less than "faint," "moderate," "strong"). Scores range from 0 to 20 with higher scores indicating higher pain intensity. Prior to analysis an order-preserving mean-matching variance-stabilizing transformation was applied to this measure placing it on a continuous 0-1.5 scale. The single values reported below represent adjusted means of transformed pain intensity over all time points.
Secondary	Roland and Morris Disability Index Scores Adjusted for Time	Baseline to Week 12 with Interim Measurement at Weeks 1, 2, 3, 4, 5, 7 and 9	This questionnaire measures disability in everyday function due to back pain. It is a 24-item checklist asking patients to endorse whether or not back pain limits activities they normally do (eg, "I stay at home most of the time because of my back"). Scores range from 0 to 24, with higher scores indicating greater disability in everyday function due to back pain. The single values reported below represent adjusted means of scores over all time points.

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Transformed Descriptor Differential Scale-Pain Intensity Scores Adjusted for Time	Baseline to Week 12 with Interim Measurement at Weeks 1, 2, 3, 4, 5, 7 and 9	Analysis of all randomized participants receiving study drug	units on a scale	MEAN
SECONDARY	Roland and Morris Disability Index Scores Adjusted for Time	Baseline to Week 12 with Interim Measurement at Weeks 1, 2, 3, 4, 5, 7 and 9	Randomized participants who received one dose of study drug	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group4

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

Outcome	Group	Value	Spread	Units
Transformed Descriptor Differential Scale-Pain Intensity Scores Adjusted for Time	Placebo	0.6683	95% Confidence Interval 0.6145 to 0.7220	units on a scale
Transformed Descriptor Differential Scale-Pain Intensity Scores Adjusted for Time	Gabapentin	0.6988	95% Confidence Interval 0.6463 to 0.7512	units on a scale
Roland and Morris Disability Index Scores Adjusted for Time	Placebo	7.50	95% Confidence Interval 4.30	units on a scale
Roland and Morris Disability Index Scores Adjusted for Time	Gabapentin	6.96	95% Confidence Interval 3.53	units on a scale

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Gabapentin	55
Overall Study	STARTED	Placebo	53
Overall Study	COMPLETED	Gabapentin	39
Overall Study	COMPLETED	Placebo	37
Overall Study	NOT COMPLETED	Gabapentin	16
Overall Study	NOT COMPLETED	Placebo	16

Source ClinicalTrials.gov

Adverse events44

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	sleepiness	Nervous system disorders	Placebo	14	53	14
other	sleepiness	Nervous system disorders	Gabapentin	29	55	29
other	asthenia/fatigue	Nervous system disorders	Placebo	15	53	15
other	asthenia/fatigue	Nervous system disorders	Gabapentin	27	55	27
other	orthostatic dizziness	Cardiac disorders	Placebo	14	53	14
other	orthostatic dizziness	Cardiac disorders	Gabapentin	24	55	24
other	decreased salivation	Gastrointestinal disorders	Placebo	10	53	10
other	decreased salivation	Gastrointestinal disorders	Gabapentin	22	55	22
other	increased sleep	Nervous system disorders	Placebo	11	53	11
other	increased sleep	Nervous system disorders	Gabapentin	21	55	21

1 to 10 of 44Source ClinicalTrials.gov

See all 44 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Gabapentin
Total, other adverse events	Placebo	21	53
Total, other adverse events	Gabapentin	42	55
Total, serious adverse events	Placebo	0	53
Total, serious adverse events	Gabapentin	0	55

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
26963844	DERIVED

Source PubMed

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 comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Gabapentin vs Placebo: serious adverse events

Source 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/NCT00108550

GET https://conductscience.org/api/trials/v1/NCT00108550/events?page=2

API reference For AI assistants