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)

NCT07555496 | Not Yet Recruiting

• 1 other identifier: 2025-14-CDE
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Back Pain Lower Back Chronic

Keywords

chronic back pain; infiltration; epineurium of the erector spinae muscles

Outcome Measures

Primary Outcomes (1)

• Change in lumbar functional disability

  assessed by Oswestry disability index (ODI)

  between day 0 (intervention) and 3 months after intervention

Secondary Outcomes (4)

• Pain evaluation

  day 0, 1 month, 3 months

• Quality of life evaluation

  Day 0, 1 month, 3 months

• lumbar function evaluation

  Day 0, 1 month, 3 months

• Measuring the patient's avoidance behaviors

  Day 0, 1 month, 3 months

Study Arms (3)

spinal rehabilitation + placebo

PLACEBO COMPARATOR

Procedure: Placebo

spinal rehabilitation + dry needling

SHAM COMPARATOR

Procedure: Dry needling

spinal rehabilitation + infiltration

EXPERIMENTAL

Procedure: infiltration of the erector spinae fascia

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

spinal rehabilitation + infiltration

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.

spinal rehabilitation + dry needling

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).

spinal rehabilitation + placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with chronic back pain, with previous surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinique de la Côte d'Emeraude: lead

Study Sites (1)

Emerald Coast Clinic

St-Malo, 35400, France

Location

MeSH Terms

Interventions

Dry Needling

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Officials

• Julien Baglione-Streliski, MD

  Emerald Coast Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marion Mandon, PhD

CONTACT

+33 6 78 27 76 72; mmandon@vivcalto-sante.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: April 29, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): March 31, 2029
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)