Interfacial Injection in Low Back Pain

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

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Procedure: physical therapy; Procedure: interfacial injection

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Bursa, Turkey, 16320
    • Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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: 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; Procedure: interfacial injection; 10 ml of bupivacaine and steroid injection was applied between the leaves of the thoracolumbar fascia under the guidance of ultrasonography.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 month
NSAİD	The monthly consumption of NSAIDs was queried (pcs/month)	6 month

Collaborators and Investigators

• Sponsor: Bursa Yüksek İhtisas Education and Research Hospital
• Investigators: Study Chair: Korgün Ökmen, Assoc. PhD., Bursa Yuksek Ihtisas Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): February 15, 2022

Study Registration Dates

• First Submitted: May 25, 2022
• First Submitted That Met QC Criteria: May 25, 2022
• First Posted (Actual): May 31, 2022

Study Record Updates

• Last Update Posted (Actual): June 2, 2022
• Last Update Submitted That Met QC Criteria: May 27, 2022
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 2019/10-24

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No