Regenerative Medicine for Joint Hypermobility and Instability

Not yet recruitingPhase 1, Phase 2NCT07688096

View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (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 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.

Study details

Official title: Regenerative Medicine for Joint Hypermobility and Instability: A Prospective, Open-Label, Single-Arm, Step-Care Clinical Study
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: Drug: Dextrose 20% Prolotherapy
Biological: Autologous Platelet-Rich Plasma
Drug: Doxycycline Hyclate Injectable (Investigational)
Device: Visco-3 Sodium Hyaluronate Viscosupplementation
Sponsor: Manhattan Pain Medicine, PLLC
Start date: 2027-01-15
Primary completion: 2027-12-31
Sex: All
Age range: from 18 Years
Results posted: No results posted in this snapshot
Total sites listed: 0

Eligibility criteria

Show eligibility criteria (verbatim from the registry)

Inclusion Criteria: * Adults age 18 years or older, any gender. * Symptomatic joint hypermobility or instability attributable to one of the following: 1. hEDS diagnosed using the 2017 International Classification of the Ehlers-Danlos Syndromes diagnostic criteria; 2. HSD classified using the 2017 framework (generalized, peripheral, localized, or historical HSD) with Beighton scoring; or 3. post-traumatic joint instability with ligamentous injury documented by examination and/or imaging. * Objective evidence of instability or clinically relevant hypermobility at one or more target joints, defined as at least one of: 1. a positive joint-specific instability provocation test on standardized physical examination; 2. generalized hypermobility (Beighton score ≥ 5/9 for adults) or documented joint-specific hypermobility at the target joint; or 3. imaging evidence of ligamentous laxity or injury at the target joint (dynamic ultrasound, stress radiograph, or MRI). * Pain attributable to the target joint for at least 3 months. * Baseline pain score of 4 or greater on a 0-10 numeric rating scale. * Failure of conservative treatment, including at least 6 weeks of physical therapy directed at the affected joint(s). * Not currently using NSAIDs and willing to avoid NSAIDs during the active treatment period, when clinically appropriate. * Able to provide informed consent and to comply with study procedures and follow-up. Additional eligibility for the Hyaluronic Acid (HA) alternative pathway - a participant may enter the HA pathway if ALL of the following apply, in addition to the inclusion criteria above: * Has completed at least one regenerative medicine phase (dextrose, PRP, or doxycycline) and either 1. was classified as an inadequate responder at the phase decision point (GPI \< 40%) and declined further regenerative rotation, 2. completed all available regenerative phases without adequate response, or 3. experienced an adverse reaction during a regenerative phase that, in the investigator's judgment, contraindicates further regenerative treatment. * A minimum waiting period of 4 weeks has elapsed since the last regenerative medicine treatment attempted, to allow resolution of post-injection effects before HA administration. * The target joint(s) have clinical or imaging features amenable to HA viscosupplementation (e.g., articular/osteoarthritic pain component identifiable on examination or imaging). * No contraindication to HA (see Exclusion Criteria). Exclusion C…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07688096