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Interfacial Injection in Low Back Pain

Primary Purpose

Low Back Pain

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

interfacial injection

physical therapy

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

physical therapy

physical therapy + interfacial injection

Arm Description

physical therapy

physical therapy + interfascial injection

Outcomes

Primary Outcome Measures

NRS

Numeric rating scale(NRS) A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable

Secondary Outcome Measures

ODI

Oswestry Disability Index Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability.The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible

NSAİD

The monthly consumption of NSAIDs was queried (pcs/month)

Full Information

NCT ID

NCT05396508

First Posted

May 25, 2022

Last Updated

May 27, 2022

Sponsor

Bursa Yüksek İhtisas Education and Research Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05396508

Brief Title

Interfacial Injection in Low Back Pain

Official Title

The Effectiveness of Interfacial Injection Applied in Addition to Physical Therapy Applications in Chronic Low Back Pain

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

April 1, 2019 (Actual)

Primary Completion Date

January 1, 2022 (Actual)

Study Completion Date

February 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Bursa Yüksek İhtisas Education and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Back Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

61 (Actual)

8. Arms, Groups, and Interventions

Arm Title

physical therapy

Arm Type

Active Comparator

Arm Description

physical therapy

Arm Title

physical therapy + interfacial injection

Arm Type

Active Comparator

Arm Description

physical therapy + interfascial injection

Intervention Type

Procedure

Intervention Name(s)

interfacial injection

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

physical therapy

Intervention Description

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

Primary Outcome Measure Information:

Title

NRS

Description

Numeric rating scale(NRS) A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable

Time Frame

6 month

Secondary Outcome Measure Information:

Title

ODI

Description

Time Frame

6 month

Title

NSAİD

Description

The monthly consumption of NSAIDs was queried (pcs/month)

Time Frame

6 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Korgün Ökmen, Assoc. PhD.

Organizational Affiliation

Bursa Yuksek Ihtisas Training and Research Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi

City

Bursa

ZIP/Postal Code

16320

Country

Turkey

12. IPD Sharing Statement

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Interfacial Injection in Low Back Pain

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