Back Pain Lower Back ChronicSPIN-NEEDNCT07555496
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)
A study testing infiltration of the erector spinae fascia and Dry needling in people with Back Pain Lower Back Chronic, run by Clinique de la Côte d'Emeraude at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Back Pain Lower Back Chronic
- What is being tested?
- infiltration of the erector spinae fascia and Dry needling
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 7 Sep 2026to 31 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with chronic back pain, with previous surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Emerald Coast Clinic
St-Malo, 35400
Marion Mandon, PhD, +33 6 78 27 76 72, mmandon@vivalto-sante.com
About this study
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
- Being tested
- infiltration of the erector spinae fascia, Dry needling, Placebo
- Keywords
- chronic back pain, infiltration, epineurium of the erector spinae muscles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infiltration of the erector spinae fasciaProcedure or surgery
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 needlingProcedure or surgery
Dry needle insertion guided by ultrasound, with manipulation targeting the spinal erector muscles medial to the posterior superior iliac spine-on both sides.
PlaceboProcedure or surgery
simulated procedure (non-invasive puncture with a stylet in the lower lumbar region, medial to the posterior superior iliac spine-on both sides).
| Study group | Role | What they receive |
|---|---|---|
| spinal rehabilitation + placebo | Placebo comparator | Not described Receives: Procedure: Placebo |
| spinal rehabilitation + dry needling | Sham comparator | Not described Receives: Procedure: Dry needling |
| spinal rehabilitation + infiltration | Experimental | Not described Receives: Procedure: infiltration of the erector spinae fascia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lumbar functional disability
assessed by Oswestry disability index (ODI)
Measured: between day 0 (intervention) and 3 months after intervention
Secondary outcomes (4)
Pain evaluation
Assessed by visual analogic scale (VAS) for pain, from 0 (no pain) to 10 (worst pain)
Measured: 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)
Measured: Day 0, 1 month, 3 months
lumbar function evaluation
muscle and functional performance measured using metrological score SHIRADO ITO
Measured: 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.
Measured: Day 0, 1 month, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start7 Sep 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back Pain Lower Back ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique de la Côte d'Emeraude
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien Baglione-Streliski, MD, Principal investigator, Emerald Coast Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07555496
- Sponsor's protocol ID
- 2025-14-CDE
- Acronym
- SPIN-NEED
- Status last verified
- Sep 2026
- First submitted
- 21 Apr 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT07555496
- Acronym / sponsor ID
- SPIN-NEED / 2025-14-CDE
- Conditions
- Back Pain Lower Back Chronic
- Keywords
- chronic back pain, infiltration, epineurium of the erector spinae muscles
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Clinique de la Côte d'EmeraudeUniversity, hospital or other
- Study start
- 7 Sep 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient with chronic back pain, with previous surgery
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| infiltration of the erector spinae fasciaInjection 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 | Procedure or surgery | spinal rehabilitation + infiltration |
| Dry needlingDry needle insertion guided by ultrasound, with manipulation targeting the spinal erector muscles medial to the posterior superior iliac spine-on both sides. | Procedure or surgery | spinal rehabilitation + dry needling |
| Placebosimulated procedure (non-invasive puncture with a stylet in the lower lumbar region, medial to the posterior superior iliac spine-on both sides). | Procedure or surgery | spinal rehabilitation + placebo |
Primary outcome
Change in lumbar functional disability
Time frame: between day 0 (intervention) and 3 months after intervention
assessed by Oswestry disability index (ODI)
4 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Back Pain Lower Back Chronic
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julien Baglione-Streliski, MD principal investigator
Emerald Coast Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing infiltration of the erector spinae fascia and Dry needling in people with Back Pain Lower Back Chronic, run by Clinique de la Côte d'Emeraude at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marion Mandon, PhD (+33 6 78 27 76 72, mmandon@vivcalto-sante.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lumbar functional disability (time frame: between day 0 (intervention) and 3 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.