Interfacial Injection in Low Back Pain
The Effectiveness of Interfacial Injection Applied in Addition to Physical Therapy Applications in Chronic Low Back Pain
1 other identifier
interventional
61
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable low-back-pain
Started Apr 2019
Longer than P75 for not_applicable low-back-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2022
CompletedFirst Submitted
Initial submission to the registry
May 25, 2022
CompletedFirst Posted
Study publicly available on registry
May 31, 2022
CompletedJune 2, 2022
March 1, 2019
2.8 years
May 25, 2022
May 27, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
ODI
6 month
NSAİD
6 month
Study Arms (2)
physical therapy
ACTIVE COMPARATORphysical therapy
physical therapy + interfacial injection
ACTIVE COMPARATORphysical therapy + interfascial injection
Interventions
10 ml of bupivacaine and steroid injection was applied between the leaves of the thoracolumbar fascia under the guidance of ultrasonography.
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
Eligibility Criteria
You may qualify if:
- Low back pain for more than 6 months;
- Presence of MR findings radiologically diagnosing LDH;
- Numeric rating scale (NRS) \> 5
You may not qualify if:
- Spinal stenosis;
- Spondylolisthesis;
- Previous lumbar
- Spinal surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi
Bursa, 16320, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Korgün Ökmen, Assoc. PhD.
Bursa Yuksek Ihtisas Training and Research Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assoc.Phd.M.D
Study Record Dates
First Submitted
May 25, 2022
First Posted
May 31, 2022
Study Start
April 1, 2019
Primary Completion
January 1, 2022
Study Completion
February 15, 2022
Last Updated
June 2, 2022
Record last verified: 2019-03