Interfacial Injection in Low Back Pain

NCT ID: NCT05396508

Last Updated: 2022-06-02

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2022-02-15

Brief Summary

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Its effect on thoracolumbar fascia and low back pain has been investigated in different studies.These studies suggest that the anatomical and histological features of the fascia may have an effect on low back pain. This study aimed to investigate the effectiveness of interfacial injection in patients with chronic back pain.

Detailed Description

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Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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physical therapy

physical therapy

Group Type ACTIVE_COMPARATOR

physical therapy

Intervention Type PROCEDURE

protocol including hot pack for 20 min/session, therapeutic continuous Ultrasound (frequency, 1 MHz; intensity 1.5 W/cm2) for 6 min/session, therapeutic exercises for low back muscles. Therapeutic exercises included stretching ,posterior pelvic tilt ,hyperextension ,bridge and cat-camel exercises

physical therapy + interfacial injection

physical therapy + interfascial injection

Group Type ACTIVE_COMPARATOR

interfacial injection

Intervention Type PROCEDURE

10 ml of bupivacaine and steroid injection was applied between the leaves of the thoracolumbar fascia under the guidance of ultrasonography.

physical therapy

Intervention Type PROCEDURE

protocol including hot pack for 20 min/session, therapeutic continuous Ultrasound (frequency, 1 MHz; intensity 1.5 W/cm2) for 6 min/session, therapeutic exercises for low back muscles. Therapeutic exercises included stretching ,posterior pelvic tilt ,hyperextension ,bridge and cat-camel exercises

Interventions

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interfacial injection

10 ml of bupivacaine and steroid injection was applied between the leaves of the thoracolumbar fascia under the guidance of ultrasonography.

Intervention Type PROCEDURE

physical therapy

protocol including hot pack for 20 min/session, therapeutic continuous Ultrasound (frequency, 1 MHz; intensity 1.5 W/cm2) for 6 min/session, therapeutic exercises for low back muscles. Therapeutic exercises included stretching ,posterior pelvic tilt ,hyperextension ,bridge and cat-camel exercises

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Low back pain for more than 6 months;
* Presence of MR findings radiologically diagnosing LDH;
* Numeric rating scale (NRS) \> 5

Exclusion Criteria

* Spinal stenosis;
* Spondylolisthesis;
* Previous lumbar
* Spinal surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bursa Yuksek Ihtisas Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dr. Burcu Metin Ökmen

Assoc.Phd.M.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Korgün Ökmen, Assoc. PhD.

Role: STUDY_CHAIR

Bursa Yuksek Ihtisas Training and Research Hospital

Locations

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Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi

Bursa, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2019/10-24

Identifier Type: -

Identifier Source: org_study_id

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