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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prolotherapy | Experimental | 5mL of 50% Dextrose + 5mL of 1% Lidocaine (Prolotherapy). |
|
| Control | Active Comparator | 10mL of 1% Lidocaine (Control) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dextrose 50% Intravenous Solution | Drug | 5mL of 50% Dextrose + 5mL of 1% Lidocaine (Prolotherapy). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Orsula Staka, MBA | Contact | 628-800-4354 | ostaka@tulane.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jacques Courseault, MD | Tulane University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tulane Hospital and Clinics | New Orleans | Louisiana | 70118 | United States |
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| ID | Term |
|---|---|
| D004535 | Ehlers-Danlos Syndrome |
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006474 | Hemorrhagic Disorders |
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| ID | Term |
|---|---|
| D005947 | Glucose |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
| D000083 |
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10mL of 1% Lidocaine (Control) or 5mL of 50% Dextrose + 5mL of 1% Lidocaine (Prolotherapy).
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Double blinded randomized
| Lidocaine 1% Injectable Solution | Drug | 10mL of 1% Lidocaine (Control) |
|
| 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. |
| 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. | 12 Months |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D012868 | Skin Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |