Interfacial Injection in Low Back Pain

Study Overview
=================
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.

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

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Procedure: interfacial injection
* Procedure: physical therapy


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: physical therapy<br>physical therapy | Procedure: physical therapy<br>* 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<br>|
| Active Comparator: physical therapy + interfacial injection<br>physical therapy + interfascial injection | Procedure: interfacial injection<br>* 10 ml of bupivacaine and steroid injection was applied between the leaves of the thoracolumbar fascia under the guidance of ultrasonography.<br>Procedure: physical therapy<br>* 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<br>|

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 |