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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-15

Study Completion Date

2025-06-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Optimizing Impact of Manual Therapy on Lumbar Spinal Stenosis

NCT06023498

Lumbar Spinal Stenosis

ACTIVE_NOT_RECRUITING NA

Comparison of the Order of Treatment in Lumbar Spinal Stenosis

NCT02103543

Lumbar Spinal Stenosis

WITHDRAWN NA

Erector Spina Plan Block in Patients With Lumbar Disc Herniation

NCT06469905

Low Back Pain

RECRUITING NA

Fatty Infiltration in Paraspinal Muscles and Lumbar Erector Spina Plane Block

NCT06208865

Low Back Pain

COMPLETED

Study on the Treatment of Degenerative Lumbar Spine Stenosis With a Percutaneous Interspinous Implant

NCT01057641

Lumbar Spinal Stenosis

TERMINATED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Low Back Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, Randomised, Clinical Study

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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)

Group Type ACTIVE_COMPARATOR

physical therapy

Intervention Type OTHER

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).

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.

Group Type ACTIVE_COMPARATOR

physical therapy + espb

Intervention Type OTHER

the 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type OTHER

physical therapy + espb

the 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No