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

Primary Purpose

Low Back Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
physical therapy
physical therapy + espb
Sponsored by
Fatih Sultan Mehmet Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Degenerative lumbar scoliosis, Physical treatment, Erector spinae plane block, Low back pain

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    physical therapy

    physical therapy + espb

    Arm Description

    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)

    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.

    Outcomes

    Primary Outcome Measures

    NRS (Numeric Rating Scale)
    Pain Intensity Assessment ( 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
    NRS (Numeric Rating Scale)
    Pain Intensity Assessment ( 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
    NRS (Numeric Rating Scale)
    Pain Intensity Assessment ( 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
    NRS (Numeric Rating Scale)
    Pain Intensity Assessment ( 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
    NRS (Numeric Rating Scale)
    Pain Intensity Assessment ( 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"

    Secondary Outcome Measures

    SRS-22
    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.
    SRS-22
    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.
    SRS-22
    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.
    SRS-22
    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
    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.
    Oswestry Disability Index
    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.
    Oswestry Disability Index
    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.
    Oswestry Disability Index
    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.

    Full Information

    First Posted
    August 25, 2023
    Last Updated
    August 30, 2023
    Sponsor
    Fatih Sultan Mehmet Training and Research Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06018402
    Brief Title
    The Effect of Physical Therapy Program and Erector Spina Plane Block in Patients With Degenerative Lumbar Scoliosis
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 15, 2023 (Anticipated)
    Primary Completion Date
    March 15, 2024 (Anticipated)
    Study Completion Date
    September 15, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Fatih Sultan Mehmet Training and Research Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Low Back Pain
    Keywords
    Degenerative lumbar scoliosis, Physical treatment, Erector spinae plane block, Low back pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomised, Single Blinded Study
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    physical therapy
    Arm Type
    Active Comparator
    Arm Description
    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)
    Arm Title
    physical therapy + espb
    Arm Type
    Active Comparator
    Arm Description
    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
    Intervention Name(s)
    physical therapy
    Intervention Description
    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
    Intervention Name(s)
    physical therapy + espb
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    NRS (Numeric Rating Scale)
    Description
    Pain Intensity Assessment ( 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
    Time Frame
    Day 0
    Title
    NRS (Numeric Rating Scale)
    Description
    Pain Intensity Assessment ( 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
    Time Frame
    1 hour after injection
    Title
    NRS (Numeric Rating Scale)
    Description
    Pain Intensity Assessment ( 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
    Time Frame
    1 week after physical treatment
    Title
    NRS (Numeric Rating Scale)
    Description
    Pain Intensity Assessment ( 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
    Time Frame
    1 month after physical treatment
    Title
    NRS (Numeric Rating Scale)
    Description
    Pain Intensity Assessment ( 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
    Time Frame
    3 month after physical treatment
    Secondary Outcome Measure Information:
    Title
    SRS-22
    Description
    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.
    Time Frame
    Day 0
    Title
    SRS-22
    Description
    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.
    Time Frame
    1 week after physical treatment
    Title
    SRS-22
    Description
    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.
    Time Frame
    1 month after physical treatment
    Title
    SRS-22
    Description
    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.
    Time Frame
    3 month after physical treatment
    Title
    Oswestry Disability Index
    Description
    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.
    Time Frame
    Day 0
    Title
    Oswestry Disability Index
    Description
    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.
    Time Frame
    1 week after physical treatment
    Title
    Oswestry Disability Index
    Description
    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.
    Time Frame
    1 month after physical treatment
    Title
    Oswestry Disability Index
    Description
    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.
    Time Frame
    3 month after physical treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ozge Gulsum Illeez
    Phone
    +905326255684
    Email
    ozgeilleez@hotmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yunus Emre Doğan
    Phone
    +905060512500
    Email
    ynsemredogan91@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ozge Gulsum Illeez
    Organizational Affiliation
    Fatih Sultan Mehmet Taining and Research Hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    26945131
    Citation
    Graham RB, Sugrue PA, Koski TR. Adult Degenerative Scoliosis. Clin Spine Surg. 2016 Apr;29(3):95-107. doi: 10.1097/BSD.0000000000000367.
    Results Reference
    background
    PubMed Identifier
    17630141
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    27501016
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    29253539
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    35420380
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    36647861
    Citation
    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.
    Results Reference
    background

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

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