Interfacial Injection in Low Back Pain

Sponsor

Bursa Yüksek İhtisas Education and Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05396508

Collaborator

(none)

Enrollment

Location

Arms

34.5

Actual Duration (Months)

1.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain	Procedure: interfacial injection Procedure: physical therapy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

61 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 2019

Actual Primary Completion Date :

Jan 1, 2022

Actual Study Completion Date :

Feb 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: physical therapy physical therapy	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
Active Comparator: physical therapy + interfacial injection physical therapy + interfascial injection	Procedure: interfacial injection 10 ml of bupivacaine and steroid injection was applied between the leaves of the thoracolumbar fascia under the guidance of ultrasonography. 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

Arm

Intervention/Treatment

Active Comparator: physical therapy

physical therapy

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

Active Comparator: physical therapy + interfacial injection

physical therapy + interfascial injection

Procedure: interfacial injection

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

Procedure: physical therapy

Outcome Measures

Primary Outcome Measures

NRS [6 month]
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 [6 month]
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 [6 month]
The monthly consumption of NSAIDs was queried (pcs/month)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi	Bursa		Turkey	16320

Sponsors and Collaborators

Bursa Yüksek İhtisas Education and Research Hospital

Investigators

Study Chair: Korgün Ökmen, Assoc. PhD., Bursa Yuksek Ihtisas Training and Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Burcu Metin Ökmen, Assoc.Phd.M.D, Bursa Yüksek İhtisas Education and Research Hospital

ClinicalTrials.gov Identifier:

NCT05396508

Other Study ID Numbers:

2019/10-24

First Posted:

May 31, 2022

Last Update Posted:

Jun 2, 2022

Last Verified:

Mar 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Back Pain

Low Back Pain

Study Results

No Results Posted as of Jun 2, 2022