Evaluating physical therapy and nerve block for low back pain in older adults with scoliosis
The Effect of Physical Therapy Program in Combination With Erector Spina Plane Block on Pain, Disability and Quality of Life in Patients With Degenerative Lumbar Scoliosis: Prospective, Randomized, Clinical Study
This study is testing if adding a nerve block to physical therapy helps older adults with scoliosis and low back pain feel better than just physical therapy alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Fatih Sultan Mehmet Training and Research Hospital Academic / other |
| Locations | 2 sites (Istanbul and 1 other locations) |
| Trial ID | NCT06018402 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a physical therapy program combined with an erector spinae plane block (ESPB) in patients over 60 years old suffering from low back pain due to degenerative lumbar scoliosis. Participants will be randomized into two groups: one receiving only physical therapy and the other receiving both physical therapy and the ESPB injection. The physical therapy consists of 15 sessions that include TENS, hot packs, and ultrasound treatment. The primary outcome will be assessed using a numerical rating scale for pain intensity, while secondary outcomes will evaluate functional status, quality of life, and disability.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 60 and older with a diagnosis of degenerative lumbar scoliosis and persistent low back pain for at least 3 months.
Not a fit: Patients with severe comorbidities, recent lumbar surgery, or specific contraindications to the interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce pain and improve quality of life for older patients with degenerative lumbar scoliosis.
How similar studies have performed: While similar approaches have been explored, this specific combination of physical therapy and ESPB in this patient population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Being 60 years or older * Having a scoliosis of 10 degrees or more in the lumbar region according to the measurement made with the cobb method * Having pain in the axial waist or radiating from the waist to the leg * Pain that persists for at least 3 months * NRS \> 4 Exclusion Criteria: * Systemic or local infection at the injection site * Past or current history of malignant disease * Presence of neurological or orthopedic disease * Presence of uncontrolled hypertension, diabetes mellitus * Presence of severe heart failure * Presence of bleeding diathesis * Anticoagulant use * Lidocaine allergy * Psychiatric disorder or mental problem * inflammatory spine pain * Severe osteoporosis / previous vertebral fracture * Body mass index \>35 * Having had previous surgery on the lumbar region * Injection was applied to the waist region within 6 months or physical have been treated
Where this trial is running
Istanbul and 1 other locations
- Farih Sultan Mehmet Training and Research Hospital — Istanbul, Turkey (Recruiting)
- Fatih Sultan Mehmet Training and Research Hospital — Istanbul, Turkey (Recruiting)
Study contacts
- Study coordinator: Ozge Gulsum Illeez
- Email: ozgeilleez@hotmail.com
- Phone: +905326255684
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.