---
title: A Comparative Study of Erector Spinae Fascia (ESF) Injection and Dry Needling Combined With Functional Rehabilitation (FR) in Patients With Chronic Low Back Pain Who Have Undergone Spinal Surgery (SPIN-NEED)
nct_id: NCT07555496
overall_status: NOT_YET_RECRUITING
phase: NA
sponsor: "Clinique de la Côte d'Emeraude"
study_type: INTERVENTIONAL
primary_condition: Back Pain Lower Back Chronic
countries: France
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07555496.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07555496"
ct_last_update_post_date: 2026-04-29
last_seen_at: "2026-05-12T06:59:39.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Comparative Study of Erector Spinae Fascia (ESF) Injection and Dry Needling Combined With Functional Rehabilitation (FR) in Patients With Chronic Low Back Pain Who Have Undergone Spinal Surgery (SPIN-NEED)

**NCT ID:** [NCT07555496](https://clinicaltrials.gov/study/NCT07555496)

## Key Facts

- **Status:** NOT_YET_RECRUITING
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 120
- **Lead Sponsor:** Clinique de la Côte d'Emeraude
- **Conditions:** Back Pain Lower Back Chronic
- **Start Date:** 2026-05
- **Completion Date:** 2029-03-31
- **CT.gov Last Update:** 2026-04-29

## Brief Summary

Chronic low back pain represents a major public health issue, with an estimated prevalence of up to 23% in the adult population and a significant impact on quality of life and functional capacity. Among these patients, a significant proportion undergo spinal surgery-including laminectomy, discectomy, or spinal fusion-when conservative treatment has failed to provide adequate relief. Current treatment strategies involve functional spinal rehabilitation (FSR). Due to the multifaceted and complex pathophysiology of this chronic pain condition, we have previously addressed the spinal syndrome in terms of its functional and muscular component: the myofascial expression. In our clinical practice, we have introduced a minimally invasive paravertebral procedure, guided by ultrasound, targeting the fascia of the erector spinae muscles in the lower lumbar region. The goal of this procedure is to provide pain relief to the patient, enabling them to better adhere to the rehabilitative treatment (functional restoration of the spine) and ultimately improve the patient's quality of life within their environment. This evaluation of professional practices highlights a clear clinical indication in favor of infiltration of the erector spinae fascia, with a significant majority of patients reporting improved pain relief and better adherence to rehabilitation.

Thus, within a coordinated, multidisciplinary care approach, this intervention appears to address patient expectations regarding comfort and leads us to consider the myofascial component of the complaint. The proposed paravertebral intervention is also appropriate in accordance with the updated recommendations, which are very restrictive in the context of a surgically treated spine (PSPS-2). This assessment of current practices justifies the implementation of a prospective controlled study. Through this study, we aim to investigate the treatment's effects and evaluate its pharmacological (via the anti-inflammatory action of corticosteroids) and mechanical (via needle-induced muscle stimulation) components.

## Eligibility

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

```
Inclusion Criteria:

* Patient with chronic back pain, with previous surgery

Exclusion Criteria:

* Patients with specific or common low back pain
* Patients receiving posterior subcutaneous spinal cord stimulation
* Patients with a life expectancy of less than 12 months
* Patients with a contraindication to corticosteroid injections (coagulation disorder)
* Pregnant or breastfeeding patients
* Patients with cognitive and/or psychobehavioral disorders
```

## Arms

- **spinal rehabilitation + placebo** (PLACEBO_COMPARATOR)
- **spinal rehabilitation + dry needling** (SHAM_COMPARATOR)
- **spinal rehabilitation + infiltration** (EXPERIMENTAL)

## Interventions

- **infiltration of the erector spinae fascia** (PROCEDURE) — Injection of half a vial of Diprostene 1.5 mL + Lidocaine 1.5 mL-under ultrasound guidance-targeting the erector spinae muscles medial to the posterior superior iliac spine-bilaterally
- **Dry needling** (PROCEDURE) — Dry needle insertion guided by ultrasound, with manipulation targeting the spinal erector muscles medial to the posterior superior iliac spine-on both sides.
- **Placebo** (PROCEDURE) — simulated procedure (non-invasive puncture with a stylet in the lower lumbar region, medial to the posterior superior iliac spine-on both sides).

## Primary Outcomes

- **Change in lumbar functional disability** _(time frame: between day 0 (intervention) and 3 months after intervention)_ — assessed by Oswestry disability index (ODI)

## Secondary Outcomes

- **Pain evaluation** _(time frame: day 0, 1 month, 3 months)_
- **Quality of life evaluation** _(time frame: Day 0, 1 month, 3 months)_
- **lumbar function evaluation** _(time frame: Day 0, 1 month, 3 months)_
- **Measuring the patient's avoidance behaviors** _(time frame: Day 0, 1 month, 3 months)_

## Locations (1)

- Emerald Coast Clinic, St-Malo, 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.emerald coast clinic|st-malo||france` — added _(2026-05-12)_

---

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