Low Back Pain Clinical Trial
Official title:
The Use of Ultrasound-Guided Dextrose Prolotherapy in Low Back Pain in Patients With Hypermobile-Type, Ehlers-Danlos Syndrome
1. Specific Aim: To show the safety and efficacy of prolotherapy injection for chronic sacroiliac and myofascial lumbar pain while standardizing an ultrasound guided injection technique 2. Specific Aim: To demonstrate that dextrose prolotherapy subjectively decreases lumbar back pain (LBP) associated with chronic sacroiliac (SI) and myofascial lumbar back pain/injury in patients with Hypermobile-Type Ehlers-Danlos Syndrome (hEDS). 3. Specific Aim: To use ultrasound (US) guidance to identify SI and myofascial lumbar back pain/injury for targeted dextrose prolotherapy treatment and to provide objective measures of decreasing inflammation via Power Doppler and ligament repair. 4. Specific Aim: To determine if US-guided dextrose prolotherapy decreases the direct costs of care for chronic LBP in contrast to conventional therapies by reducing return visits, specialty referrals, physical therapy, medications, and unnecessary procedures.
The goal of this research project is to prove that ultrasound-guided prolotherapy is a cost effective and curative treatment option for chronic low back pain in Hypermobile-Type Ehlers-Danlos Syndrome (hEDS). Ultrasound (US) will be used to assist in proper evaluation of the thoracolumbar fascial complex (TLFC), long posterior sacroiliac ligament (LPSL), multifidi and gluteus maximus along with precise administration of medication into identified regions of interest. By comparing targeted lidocaine and concentrated dextrose (prolotherapy) injections, placebo effect or therapeutic local trauma created by the needle, like dry needling can be ruled out. The combination of subjective data collection with Owestry Disability Index (ODI) and the Number Rating Scale (NRS) assessments and objective findings on ultrasound imaging such as Pixel Ratio and ligament integrity will provide sufficient information to determine if prolotherapy is effective at reducing inflammation, providing prolonged pain relief, and return to function in patients with hEDS. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03916705 -
Thoraco-Lumbar Fascia Mobility
|
N/A | |
| Completed |
NCT04007302 -
Modification of the Activity of the Prefrontal Cortex by Virtual Distraction in the Lumbago
|
N/A | |
| Completed |
NCT03273114 -
Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain
|
N/A | |
| Recruiting |
NCT03600207 -
The Effect of Diaphragm Muscle Training on Chronic Low Back Pain
|
N/A | |
| Completed |
NCT04284982 -
Periodized Resistance Training for Persistent Non-specific Low Back Pain
|
N/A | |
| Recruiting |
NCT05600543 -
Evaluation of the Effect of Lumbar Belt on Spinal Mobility in Subjects With and Without Low Back Pain
|
N/A | |
| Withdrawn |
NCT05410366 -
Safe Harbors in Emergency Medicine, Specific Aim 3
|
||
| Completed |
NCT03673436 -
Effect of Lumbar Spinal Fusion Predicted by Physiotherapists
|
||
| Completed |
NCT02546466 -
Effects of Functional Taping on Static Postural Control in Patients With Non-specific Chronic Low Back Pain
|
N/A | |
| Completed |
NCT00983385 -
Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics
|
Phase 3 | |
| Recruiting |
NCT05156242 -
Corticospinal and Motor Behavior Responses After Physical Therapy Intervention in Patients With Chronic Low Back Pain.
|
N/A | |
| Recruiting |
NCT04673773 -
MY RELIEF- Evidence Based Information to Support People Aged 55+ Years Living and Working With Persistent Low-back Pain.
|
N/A | |
| Completed |
NCT06049251 -
ELDOA Technique Versus Lumbar SNAGS With Motor Control Exercises
|
N/A | |
| Completed |
NCT06049277 -
Mulligan Technique Versus McKenzie Extension Exercise Chronic Unilateral Radicular Low Back Pain
|
N/A | |
| Completed |
NCT04980469 -
A Study to Explore the Effect of Vitex Negundo and Zingiber Officinale on Non-specific Chronic Low Back Pain Due to Sedentary Lifestyle
|
N/A | |
| Completed |
NCT04055545 -
High Intensity Interval Training VS Moderate Intensity Continuous Training in Chronic Low Back Pain Subjects
|
N/A | |
| Recruiting |
NCT05552248 -
Assessment of the Safety and Performance of a Lumbar Belt
|
||
| Recruiting |
NCT05944354 -
Wearable Spine Health System for Military Readiness
|
||
| Completed |
NCT05801588 -
Participating in T'ai Chi to Reduce Back Pain and Improve Quality of Life
|
N/A | |
| Recruiting |
NCT05811143 -
Examining the Effects of Dorsal Column Stimulation on Pain From Lumbar Spinal Stenosis Related to Epidural Lipomatosis.
|