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

NCT06018402 | Completed

• 1 other identifier: ozgeilleez1
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

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.

Conditions

Low Back Pain

Keywords

Degenerative lumbar scoliosis; Physical treatment; Erector spinae plane block; Low back pain

Outcome Measures

Primary Outcomes (5)

• NRS (Numeric Rating Scale)

  Pain Intensity Assessment ( 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"

  Day 0

• NRS (Numeric Rating Scale)

  Pain Intensity Assessment ( 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"

  1 hour after injection

• NRS (Numeric Rating Scale)

  Pain Intensity Assessment ( 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"

  1 week after physical treatment

• NRS (Numeric Rating Scale)

  Pain Intensity Assessment ( 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"

  1 month after physical treatment

• NRS (Numeric Rating Scale)

  Pain Intensity Assessment ( 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"

  3 month after physical treatment

Secondary Outcomes (8)

• SRS-22

  Day 0

• SRS-22

  1 week after physical treatment

• SRS-22

  1 month after physical treatment

• SRS-22

  3 month after physical treatment

• Oswestry Disability Index

  Day 0

Study Arms (2)

physical therapy

ACTIVE COMPARATOR

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)

Other: physical therapy

physical therapy + espb

ACTIVE COMPARATOR

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.

Other: physical therapy + espb

Interventions

physical therapy 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

physical therapy + espb 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.

physical therapy + espb

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fatih Sultan Mehmet Training and Research Hospital: lead

Study Sites (2)

Farih Sultan Mehmet Training and Research Hospital

Istanbul, 34752, Turkey (Türkiye)

Location

Fatih Sultan Mehmet Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (6)

• Graham RB, Sugrue PA, Koski TR. Adult Degenerative Scoliosis. Clin Spine Surg. 2016 Apr;29(3):95-107. doi: 10.1097/BSD.0000000000000367.

  PMID: 26945131 BACKGROUND

• Ploumis A, Transfledt EE, Denis F. Degenerative lumbar scoliosis associated with spinal stenosis. Spine J. 2007 Jul-Aug;7(4):428-36. doi: 10.1016/j.spinee.2006.07.015. Epub 2007 Feb 28.

  PMID: 17630141 BACKGROUND

• Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

  PMID: 27501016 BACKGROUND

• Ahiskalioglu A, Alici HA, Ciftci B, Celik M, Karaca O. Continuous ultrasound guided erector spinae plane block for the management of chronic pain. Anaesth Crit Care Pain Med. 2019 Aug;38(4):395-396. doi: 10.1016/j.accpm.2017.11.014. Epub 2017 Dec 15. No abstract available.

  PMID: 29253539 BACKGROUND

• Akyuz ME, Firidin MN. Bilateral ultrasound-guided erector spinae plane block for postoperative persistent low back pain in lumbar disc surgery. Eur Spine J. 2022 Jul;31(7):1873-1878. doi: 10.1007/s00586-022-07212-z. Epub 2022 Apr 14.

  PMID: 35420380 BACKGROUND

• Durmus IE, Surucu S, Muz A, Takmaz SA. The effectiveness of erector spinae plane block in patients with chronic low back pain. Eur Rev Med Pharmacol Sci. 2023 Jan;27(1):138-143. doi: 10.26355/eurrev_202301_30864.

  PMID: 36647861 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Ozge Gulsum Illeez

  Fatih Sultan Mehmet Taining and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective, Randomised, Clinical Study

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: August 30, 2023
• Study Start: September 15, 2023
• Primary Completion: May 15, 2025
• Study Completion: June 3, 2025
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)