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Regenerative Medicine for Joint Hypermobility and Instability

StatusNot Yet Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Sep 30, 2027 → Dec 31, 2027
See other at-risk trials from Manhattan Pain Medicine, PLLC

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Start date: Jul 15, 2026 to Jan 15, 2027 Show 4 more changesShow less
    • Primary completion pushed from Sep 30, 2027 to Dec 31, 2027
    • Eligibility criteria expanded, about 37 words
    • Secondary endpoints: details revised at 11 of 14 entries
    • Publications: details revised at 25 of 29 entries
  2. Minor Eligibility criteria expanded, about 41 words
    • Secondary endpoints: details revised at 1 of 14 entries
    • Study description revised
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 plasma (PRP) An injection prepared from the participant's own blood, designed to support tissue repair and recovery. Step 3: Doxycycline injections A low-dose injectable treatment used in this study to help protect joint-supporting tissue. It is not being used to treat infection. Alternative option: Hyaluronic acid injections An injection into the joint that may be offered if the earlier treatment steps do not provide enough improvement. Each treatment step begins with two injections, given approximately two weeks apart. If a participant improves by 40% or more, they may continue with that treatment pathway. If they do not improve enough, they may be offered the next step in the study. Participants will be followed for up to 12 months, with study visits used to monitor pain, function, treatment response, and safety.
Trial Details
NCT Number NCT07688096
Lead Sponsor Manhattan Pain Medicine, PLLC
Conditions
(from sponsor)
Ehlers-Danlos Syndrome Hypermobility Type (hEDS), Ehlers-Danlos Syndrome (EDS), Joint Hypermobility, Joint Instability, Hypermobility Spectrum Disorder, Chronic Pain Syndrome, Musculoskeletal Pain, Sprain +3 more
Related terms Ehlers-Danlos Syndrome, Ehlers-Danlos syndrome type 3, Joint Dislocations, Joint Instability, Musculoskeletal Pain, Sprains and Strains
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov