Manhattan Pain Medicine is conducting a prospective, open-label, single-arm, step-care clinical study evaluating regenerative medicine for adults with symptomatic joint hypermobility and instability.
This study is designed for patients with hypermobile Ehlers-Danlos syndrome, hypermobility spectrum disorder, or joints that feel unstable, loose, or prone to giving out. The study uses a structured treatment sequence beginning with dextrose prolotherapy, followed by platelet-rich plasma, doxycycline prolotherapy, or hyaluronic acid when clinically appropriate.
Rather than moving directly to more invasive options, the study is designed to identify the least invasive treatment that provides meaningful improvement in pain, stability, and function for each participant. This study is currently enrolling, and outcomes are pending.
Key Research Details
| Detail | Value |
|---|---|
| Principal Investigator | Jason W. Siefferman, MD |
| Institution | Manhattan Pain Medicine, PLLC, New York, NY |
| Study Type | Prospective, open-label, single-arm, step-care interventional study |
| Study Size | Up to 100 adult participants |
| Follow-Up Period | 12 months of follow-up per participant |
| Enrollment Status | Currently enrolling |
| Referral Partners | Rheumatology, orthopedic surgery, sports medicine, physical therapy, and primary care |
| Conditions Studied | Symptomatic joint hypermobility and instability, hypermobile Ehlers-Danlos syndrome, hypermobility spectrum disorder, and post-traumatic joint instability |
| Treatments Studied | Dextrose prolotherapy, platelet-rich plasma, doxycycline prolotherapy, and hyaluronic acid viscosupplementation |
What This Study Involves
This study evaluates a step-care regenerative medicine approach for patients with loose, unstable, or painful joints. Participants begin with dextrose prolotherapy, a hypertonic sugar solution injected to stimulate the body’s natural tissue repair response.
If the first treatment provides meaningful improvement, the participant may continue with that treatment pathway. If improvement is not sufficient, the care team discusses whether to rotate to the next option in the sequence.
Treatments Studied in Sequence
- Step 1: Dextrose Prolotherapy
A hypertonic sugar solution injected to stimulate a controlled healing response in loose or painful joints. - Step 2: Platelet-Rich Plasma
A regenerative treatment using concentrated platelets and growth factors from the patient’s own blood. - Step 3: Doxycycline Prolotherapy
An injection approach studied for its potential role in reducing collagen breakdown in loose joints. - Step 4: Hyaluronic Acid Viscosupplementation
A treatment designed to lubricate and cushion joints for patients who may need an alternative pathway.
How Patients Progress Through the Study
Each patient starts with dextrose prolotherapy. If they achieve at least 40% improvement, they may continue with that treatment. If not, the care team discusses rotating to the next treatment option.
This individualized structure reflects real-world clinical care while allowing the research team to collect organized data on pain, function, joint stability, and treatment response over time.
Why This Research Matters
Patients with hypermobility and joint instability often experience pain, poor joint control, repeated injuries, and a sense that joints may give out during daily activity. For patients with hypermobile Ehlers-Danlos syndrome or hypermobility spectrum disorder, surgical approaches can carry added complexity, and treatment may need to be more gradual, targeted, and tissue-aware.
This study is designed to better understand how a structured regenerative medicine sequence may help selected patients improve pain and function while avoiding unnecessary escalation when a less invasive option is effective.