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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
5mL of 50% Dextrose + 5mL of 1% Lidocaine (Prolotherapy).
10mL of 1% Lidocaine (Control)
Tulane Hospital and Clinics
New Orleans, Louisiana, United States
Measuring the functionality of the lumbar spine by using Oswestry Low Back Pain Disability Questionnaire in patients with Hypermobile-Type Ehlers-Danlos Syndrome (hEDS)
The functionality of the lumbar spine will be measured by Oswestry Low Back Pain Disability Questionnaire, which is a tool to measure a patient's permanent functional disability. Each patient uses the questioner the first time they are in clinic and then in each of the follow up visits post treatment until the study completion. The questioner determines if the patient has sustained clinical improvement. The higher the score the more severe low back pain is.
Time frame: 12 Months
Measuring the change of low back pain via the number rating scale in patients with Hypermobile-Type Ehlers-Danlos Syndrome (hEDS)
The change in low back pain will be measured by the number rating scale, which is a scale from 1 to 10 measuring low back pain. The higher the score the more severe the pain is in the low back.
Time frame: 12 Months
The measure of soft tissue inflammation via ultrasound in patients with Hypermobile-Type Ehlers-Danlos Syndrome (hEDS)
Inflammation will be measured by Doppler ultrasound to determine the degree of inflammation in the area of interest which is measured as Pixel Ration (PR) to show if there is a change or decrease of inflammation with prolotherapy treatment.
Time frame: 12 Months
The measure of ligament integrity via ultrasound in patients with Hypermobile-Type Ehlers-Danlos Syndrome (hEDS)
Ligament Integrity will be measured by ultrasound, which will be used to evaluate the quality of ligamentous structures before and after prolotherapy treatment to determine if prolotherapy has the ability to promote tissue regeneration.
Time frame: 12 Months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.