Not Yet RecruitingPhase 1/2

Regenerative Medicine for Joint Hypermobility and Instability

100 participantsStarted 2026-07-15

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. hEDS diagnosed using the 2017 International Classification of the Ehlers-Danlos Syndromes diagnostic criteria;
. HSD classified using the 2017 framework (generalized, peripheral, localized, or historical HSD) with Beighton scoring; or
. post-traumatic joint instability with ligamentous injury documented by examination and/or imaging.
. a positive joint-specific instability provocation test on standardized physical examination;
. generalized hypermobility (Beighton score ≥ 5/9 for adults) or documented joint-specific hypermobility at the target joint; or
. imaging evidence of ligamentous laxity or injury at the target joint (dynamic ultrasound, stress radiograph, or MRI).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is using dextrose prolotherapy as a regenerative medicine approach for hEDS and hypermobility spectrum disorder — can you help me understand how prolotherapy is thought to work for joint instability, and whether there's any existing evidence you'd want me to know about before I consider something like this?
2Since this is a Phase 1/2 trial, it's still in relatively early stages of testing — what does that mean for how much is already known about the safety and effectiveness of this specific approach for EDS or hypermobility conditions like mine?
3The trial isn't recruiting yet — if I were potentially interested down the road, what would you want me to have already tried or documented beforehand, and are there standard treatments for my joint instability we should pursue in the meantime?
4The trial covers a wide range of conditions from chronic pain and subluxations to craniocervical dysfunction — given my specific symptoms and diagnosis, do you think I'd even be a plausible candidate for something like this, or are there aspects of my case that might not fit well?
5The main thing they're measuring is a 'Global Percentage of Improvement' — can you help me understand what that kind of outcome measure really tells us, and whether it would reflect the specific improvements that matter most to my daily functioning and quality of life?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 2 weeks after the second dextrose prolotherapy injection (approximately 4 weeks after enrollment)

Trial details

NCT IDNCT07688096

SponsorManhattan Pain Medicine, PLLC

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09-30

Contact for this trial

Mariia Safroshkina, MD, Medical Doctor

2139329721 research@manhattanpainmedicine.com

View on ClinicalTrials.gov More Ehlers-Danlos Syndrome Hypermobility Type (hEDS) trials