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NCT Number: NCT07555496

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)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. Change in lumbar functional disability

    Time frame: between day 0 (intervention) and 3 months after intervention

    assessed by Oswestry disability index (ODI)

Secondary outcomes

  1. Pain evaluation

    Time frame: day 0, 1 month, 3 months

    Assessed by visual analogic scale (VAS) for pain, from 0 (no pain) to 10 (worst pain)

  2. Quality of life evaluation

    Time frame: Day 0, 1 month, 3 months

    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)

  3. lumbar function evaluation

    Time frame: Day 0, 1 month, 3 months

    muscle and functional performance measured using metrological score SHIRADO ITO

  4. Measuring the patient's avoidance behaviors

    Time frame: Day 0, 1 month, 3 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marion Mandon, PhD

CONTACT

[email protected]

+33 6 78 27 76 72

Sponsors and collaborators

Lead sponsor

Clinique de la Côte d'Emeraude

Other

Registry information

Acronym: SPIN-NEED

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Apr 29, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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