---
title: Are Paraspinous Intramuscular Injections of Botulinum Toxin A (BoNT-A) Efficient in the Treatment of Chronic Low-back Pain (LBP)?
nct_id: NCT03181802
overall_status: COMPLETED
phase: PHASE3
sponsor: University Hospital, Bordeaux
study_type: INTERVENTIONAL
primary_condition: Chronic Low-back Pain
countries: France
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03181802.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03181802"
ct_last_update_post_date: 2017-06-09
last_seen_at: "2026-05-12T06:24:53.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Are Paraspinous Intramuscular Injections of Botulinum Toxin A (BoNT-A) Efficient in the Treatment of Chronic Low-back Pain (LBP)?

**Official Title:** Are Paraspinous Intramuscular Injections of Botulinum Toxin A (BoNT-A) Efficient in the Treatment of Chronic Low-back Pain?

**NCT ID:** [NCT03181802](https://clinicaltrials.gov/study/NCT03181802)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 19
- **Lead Sponsor:** University Hospital, Bordeaux
- **Conditions:** Chronic Low-back Pain
- **Start Date:** 2003-11-18
- **Completion Date:** 2005-05-08
- **CT.gov Last Update:** 2017-06-09

## Brief Summary

Studying the therapeutic effect of paravertebral injections of BoNT-A (botulinum toxin A) requires further studies to confirm the reported short-term therapeutic effect and to determine potential predictive factors of efficacy.

## Detailed Description

This study was a randomized, double-blinded, placebo-controlled phase 3 trial comparing BoNT-A Type A injections to a placebo in patients with chronic Low-back Pain (LBP). This superiority trial obtained support from the French Hospital Clinical Research Project (PHRC) and the approval of a French ethics committee (2003/02) ("Comité Sud-Ouest et Outre-Mer III", consent obtained in February 2003).

The number of participants included in the study was chosen to be similar as those included in previous studies, that showed a strong positive effect of BoNT-A injections on LBP. Furthermore, the design of our study (i.e. a crossover) increased the power of the statistical analysis. A scientific committee has been solicited at this step, after including 19 patients, to assess the results.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* LBP defined as a pain located between the thoracic lumbar hinge and the gluteal sulcus, where pain had evolved over a period of 6 months despite well conducted medical treatment, self-assessed lumbar pain intensity over 50 millimeters long on a visual analogue scale of 100 millimeters (0=no pain; 100=maximal pain),
* having been on sick leave for 60 or more days in the year preceding the inclusion (in order to include patients with high consequences of chronic low-back pain on their work),
* same long-term chronic pain treatment for at least 6 weeks

Exclusion Criteria:

* age under 18 or over 55 years (to avoid secondary causes of low back pain, like spinal tumor),
* ongoing pregnancy or breast-feeding,
* a neuromuscular pathology (myasthenia gravis, amyotrophic lateral sclerosis, myopathy, polymyositis), aminoglycoside treatment at the time of inclusion,
* skin infection at injection points,
* diabetes and alcoholism (in order to avoid other etiologies of chronic pain),
* a history of injecting BoNT-A A,
* anticoagulation treatment, sciatica,
* suspected spinal inflammatory disorder (spondylitis, inflammatory rheumatism, tumoral pathology),
* a failed back surgery syndrome (when surgery failed to relieve low-back pain), - incapacity to stand, cardiorespiratory deficiency which does not allow the isokinetic exploration of the spinal muscles,
* cognitive disorders limiting patient participation,
* conflicts of interest owing to existing pain (unconsolidated work accident, ongoing damage compensation).
* Spine infection, tumour or trauma had been specifically excluded by an MRI done by all patients before the inclusion in the present study.
* No patient was allowed to take opiates during the time of the study,
* facet joint injections were also not permitted during the study period.
```

## Arms

- **botulinum toxin A** (EXPERIMENTAL)
- **Placebo** (PLACEBO_COMPARATOR)

## Interventions

- **Botox** (DRUG) — single injection of 200 International Unit of BoNT-A in 10 bilateral paravertebral intramuscular points for treating chronic LBP
- **Placebos** (DRUG) — 4 ml of physiological serum injected intramuscularly into the lumbar paravertebral muscles.

## Primary Outcomes

- **effect of paravertebral injections of BoNT-A, 30 days after its administration in chronic LBP sufferers.** _(time frame: Day 30)_ — Pain intensity was measured on a horizontal visual analogue scale (VAS) 100 mm long, with " no pain " written on one end and " maximum pain " on the other. The question asked was: "How was the intensity of your LBP over the last 8 days?"

## Secondary Outcomes

- **Evaluate the analgesic effect of paravertebral injections of BoNT-A, 90 days after its administration in chronic LBP sufferers.** _(time frame: Day 90)_
- **Measure the impact of paravertebral injections of 200 IU of BoNT-A in a single administration on lumbar stiffness and on spinal extensor muscle strength in patients with chronic LBP.** _(time frame: Day 30)_
- **Measure the impact of paravertebral injections of 200 IU of BoNT-A in a single administration on lumbar stiffness and on spinal extensor muscle strength in patients with chronic LBP.** _(time frame: Day 120)_

## Locations (1)

- Bordeaux University Hospital, Bordeaux, France

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.bordeaux university hospital|bordeaux||france` — added _(2026-05-12)_

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