The Effect of Physical Therapy Program and Erector Spina Plane Block in Patients With Degenerative Lumbar Scoliosis

Not Applicable

Recruiting

• Conditions: Low Back Pain
• Interventions: Other: physical therapy + espb; Other: physical therapy

• Registration Number: NCT06018402
• Lead Sponsor: Fatih Sultan Mehmet Training and Research Hospital

Brief Summary

Degenerative (de novo) scoliosis is the result of a long and multifactorial process that occurs through degenerative change in the aging population without a pre-existing spinal deformity. Pain is the most important symptom and the major difference from adolescent idiopathic scoliosis. Treatment is often complex and patient-specific. The first aim of our study is to evaluate the effectiveness of physical therapy on pain, disability and quality of life in patients with degenerative lumbar scoliosis and the second aim is to investigate whether erector spina plan block (ESPB) combined with physical therapy has an effect on the results.

Detailed Description

Patients over 60 years of age, with low back or low back-leg pain for at least 3 months, who had received pharmacologic treatment but did not respond, and diagnosed with degenerative lumbar scoliosis are included in the study. Patients are randomized into to groups according to the interventions as: physical therapy group (G-1) and physical therapy and ESPB injection group (G-2). The physical therapy program is planned as a total of 15 sessions in the lumbar region, each session consisting of TENS (50-100 Hz stimulation frequency, 200 µs pulse duration, intensity is increased as much as the patient could tolerate, 20 minutes in total), hotpack (to be placed on the painful area, 20 minutes), US (1 mHz frequency, 10 minutes, 1.5 watt/cm2 intensity). Ultrasound-guided lumbar ESPB is performed using an in-line cephalic approach, and after contacting the corner of the L3 transverse process, a small dose of saline is injected into the fascial space between the L3 transverse process and the erector spinae muscles to "lift off" the fascia. After verification, a mixture of 20 mL of 1% lidocaine and 3 mg betamethasone are administered for unilateral injection. The procedure is performed bilaterallyThe primary endpoint of the study is pain intensity assasment by using a numerical rating scale (NRS), and secondary endpoints are functional status, quality of life and disability status assasment by using SRS-22 and Oswestry disability index. Patients are evaluated before and 1 week, 1 month and 3 months after treatment. In the 2nd group, pain intensity at 1 hour after injection is additionally evaluated with a NRS. As a result of the power analysis, the minimum sample size was planned as a total of 16 patients with 8 patients in each group with a 15% dropout rate. Shapiro Wilk test is applied to examine the normality of the data distribution. The difference between groups is evaluated by Mann Whitney U according to normal distribution and by ANOVA for time-dependent within-group change.

Study Timeline

• Study First Submitted: 2023-08-25
• Study First Submitted QC: 2023-08-25
• Study First Posted: 2023-08-30
• Study Start: 2023-09-15
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-21
• Last Update Posted: 2024-02-22
• Primary Completion: 2024-03-15
• Study Completion: 2024-09-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
physical therapy + espb	physical therapy + espb	same physical therapy program, in addition Ultrasound-guided lumbar ESPB is performed using an in-line cephalic approach, and after contacting the corner of the L3 transverse process, a small dose of saline is injected into the fascial space between the L3 transverse process and the erector spinae muscles to "lift off" the fascia. After verification, a mixture of 20 mL of 1% lidocaine and 3 mg betamethasone is administered for unilateral injection. The procedure is performed bilaterally.
physical therapy	physical therapy	The physical therapy program is planned as a total of 15 sessions in the lumbar region, each session consisting of TENS (50-100 Hz stimulation frequency, 200 µs pulse duration, intensity is increased as much as the patient could tolerate, 20 minutes in total), hotpack (to be placed on the painful area, 20 minutes), US (1 mHz frequency, 10 minutes, 1.5 watt/cm2 intensity)

Primary Outcome Measures

Name	Time	Method
NRS (Numeric Rating Scale)	3 month after physical treatment	Pain Intensity Assessment ( 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"

Secondary Outcome Measures

Name	Time	Method
SRS-22	3 month after physical treatment	22 questions make up the SRS-22, which covers five domains: function/activity, pain, self-perceived image, mental health, and satisfaction with therapy. Scores range from 1 (worst) to 5 (best) for each item.
Oswestry Disability Index	3 month after physical treatment	Each item has six statements and is scored between 0 and 5. The overall score is then calculated as a percentage, with 0% denoting no disability and 100% denoting the highest level of disability, with 0 denoting the least disability and 5 denoting the worst.

Trial Locations

Locations (2)

Farih Sultan Mehmet Training and Research Hospital; 🇹🇷 Istanbul, Turkey

Fatih Sultan Mehmet Training and Research Hospital; 🇹🇷 Istanbul, Turkey