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) (SPIN-NEED)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Back Pain Lower Back Chronic
• Intervention / Treatment: Procedure: Placebo; Procedure: Dry needling; Procedure: infiltration of the erector spinae fascia

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marion Mandon, PhD; Phone Number: +33 6 78 27 76 72; Email: mmandon@vivcalto-sante.com

Study Locations

• France
  • St-Malo, France, 35400
    • Emerald Coast Clinic
    • Contact: Marion Mandon, PhD; Phone Number: +33 6 78 27 76 72; Email: mmandon@vivalto-sante.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: spinal rehabilitation + placebo	Procedure: Placebo; simulated procedure (non-invasive puncture with a stylet in the lower lumbar region, medial to the posterior superior iliac spine-on both sides).
Sham Comparator: spinal rehabilitation + dry needling	Procedure: Dry needling; Dry needle insertion guided by ultrasound, with manipulation targeting the spinal erector muscles medial to the posterior superior iliac spine-on both sides.
Experimental: spinal rehabilitation + infiltration	Procedure: infiltration of the erector spinae fascia; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in lumbar functional disability	assessed by Oswestry disability index (ODI)	between day 0 (intervention) and 3 months after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain evaluation	Assessed by visual analogic scale (VAS) for pain, from 0 (no pain) to 10 (worst pain)	day 0, 1 month, 3 months
Quality of life evaluation	Measured by Study Questionnaire Short Form 36 Health Survey (SF-36) : The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 (Lower scores = more disability, higher scores = less disability)	Day 0, 1 month, 3 months
lumbar function evaluation	muscle and functional performance measured using metrological score SHIRADO ITO	Day 0, 1 month, 3 months
Measuring the patient's avoidance behaviors	Assessed by Fear Avoidance Belief Questionnaire (FABQ) : The complete FABQ is administered as a single 16-item questionnaire. Patients rate each item on a 7-point scale: 0 = completely disagree, 6 = completely agree.	Day 0, 1 month, 3 months

Collaborators and Investigators

• Sponsor: Clinique de la Côte d'Emeraude
• Investigators: Principal Investigator: Julien Baglione-Streliski, MD, Emerald Coast Clinic

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): March 31, 2029

Study Registration Dates

• First Submitted: April 21, 2026
• First Submitted That Met QC Criteria: April 21, 2026
• First Posted (Actual): April 29, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: infiltration; chronic back pain; epineurium of the erector spinae muscles
• Additional Relevant MeSH Terms: Therapeutics; Complementary Therapies; Physical Therapy Modalities; Dry Needling
• Other Study ID Numbers: 2025-14-CDE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No