Regenerative Medicine for Joint Hypermobility and Instability

Sponsor
Manhattan Pain Medicine, PLLC
Study ID
NCT07688096
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Chronic Pain Syndrome
  • Craniocervical Disfunction
  • Dislocation
  • Ehlers-Danlos Syndrome (EDS)
  • Ehlers-Danlos Syndrome Hypermobility Type (hEDS)
  • Hypermobility Spectrum Disorder
  • Joint Hypermobility
  • Joint Instability
  • Musculoskeletal Pain
  • Sprain
  • Subluxation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dextrose 20% Prolotherapy — DRUG
    Hypertonic dextrose solution injected at periarticular ligament-bone junctions at 20% final concentration, combined with local anesthetic. Two injections approximately 2 weeks apart per phase. Up to 4 injections total.
  • Autologous Platelet-Rich Plasma — BIOLOGICAL
    Leukocyte-poor platelet-rich plasma prepared from a 30-60 mL autologous whole blood draw using an FDA-cleared PRP preparation system. Two injections approximately 2 weeks apart per phase. Up to 4 injections total.
  • Doxycycline Hyclate Injectable (Investigational) — DRUG
    Doxycycline hyclate 10 mg/mL reconstituted from commercially available lyophilized powder at point of care, combined with 20% dextrose and local anesthetic. Dose: 5-25 mg per joint site; maximum 100 mg per session. Two injections approximately 2 weeks apart per phase. Up to 4 injections total. Use as prolotherapy agent is investigational.
  • Visco-3 Sodium Hyaluronate Viscosupplementation — DEVICE
    Visco-3 (sodium hyaluronate 25 mg/2.5 mL), FDA-approved for knee osteoarthritis. Used as an alternative pathway for participants who do not respond to or cannot tolerate regenerative phases. Up to 3 syringes per joint per course. Off-label use in non-knee joints is disclosed in the informed consent form.

Study Details

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.

Key Dates

First listed
Jul 7, 2026
Start date
Jul 15, 2026
Status verified
Jun 2026
Primary completion
Sep 30, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Step-Care Regenerative Injection Treatment
    All participants receive a step-care sequence beginning with dextrose prolotherapy. Those who do not improve by 40% or more are offered rotation to platelet-rich plasma (PRP) prolotherapy, then to investigational doxycycline prolotherapy. A hyaluronic acid viscosupplementation pathway is available as an alternative for participants who do not respond to or cannot tolerate the regenerative steps.

Primary Outcome Measure

Global Percentage of Improvement (GPI) Responder Rate After Dextrose Prolotherapy [ Time Frame: 2 weeks after the second dextrose prolotherapy injection (approximately 4 weeks after enrollment) ]

Central Contacts

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