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Phase 1/2Not yet recruiting

Regenerative Medicine for Joint Hypermobility and Instability

Regenerative Medicine for Joint Hypermobility and Instability: A Prospective, Open-Label, Single-Arm, Step-Care Clinical Study

Sponsor
Manhattan Pain Medicine, PLLC (Academic or other)
Enrolment
100 planned
Conditions
Ehlers-Danlos Syndrome Hypermobility Type (hEDS); Ehlers-Danlos Syndrome (EDS); Joint Hypermobility; Joint Instability; Hypermobility Spectrum Disorder; Chronic Pain Syndrome; Musculoskeletal Pain; Sprain; Subluxation; Dislocation; Craniocervical Disfunction
Interventions
Dextrose 20% Prolotherapy; Autologous Platelet-Rich Plasma; Doxycycline Hyclate Injectable (Investigational); Visco-3 Sodium Hyaluronate Viscosupplementation
Ages
adults, older adults
Registry
NCT07688096

Full record on ClinicalTrials.gov

From the registry

This clinical trial is designed to evaluate whether a stepwise injection-based treatment approach can reduce pain and improve function in adults with joint hypermobility, connective tissue laxity, and joint instability. Joint hypermobility occurs when joints move beyond their normal range, often because of looser connective tissue. For some patients, this can contribute to chronic pain, recurrent instability, reduced function, and disability. This study focuses on adults with hypermobile Ehlers-Danlos syndrome (hEDS), hypermobility spectrum disorder (HSD), or joint instability after injury who have already completed physical therapy without adequate relief. The main question this study aims to answer is whether the first treatment step, dextrose prolotherapy, can reduce pain by 40% or more two weeks after the second injection. Participants will receive treatment in a step-by-step sequence, based on their response: Step 1: Dextrose prolotherapy A dextrose-based injection used to stimulate a healing response in ligament, tendon, or joint-supporting tissue. Step 2: Platelet-rich…

Primary outcomes

  • Global Percentage of Improvement (GPI) Responder Rate After Dextrose Prolotherapy

History

  1. Study completion expected

  2. Primary completion expected

  3. Expected to start

  4. Last registry update

  5. Registered