Step-by-Step injections aim to ease chronic pain in Loose-Joint conditions
NCT ID NCT07688096
First seen Jul 07, 2026 · Last updated Jul 10, 2026 · Updated 2 times
Summary
This study tests a stepwise injection plan for adults with joint hypermobility and instability who haven't improved enough with physical therapy. The first step uses dextrose prolotherapy to stimulate healing in ligaments. If that doesn't reduce pain by at least 40%, participants may move to platelet-rich plasma (PRP) from their own blood, then to doxycycline or hyaluronic acid injections. The goal is to see if these treatments can safely reduce pain and improve function over 12 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Dextrose prolotherapy, platelet-rich plasma (PRP), doxycycline injections, hyaluronic acid injections
- What this could lead to
- If successful, this step-care approach could offer a non-surgical way to reduce chronic pain and improve joint stability in people with hypermobility disorders.
- What could go wrong
- This is an early-phase, single-arm study with no placebo group, so results may not prove the treatments work better than natural recovery. Injection risks include pain, infection, or allergic reaction.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 Criteria: * Impaired decision-making capacity that precludes valid informed consent. * Active local or systemic infection. * Known allergy or contraindication to study injections, local anesthetics, iodinated contrast (if fluoroscopy is planned), or required procedural materials. * Known hypersensitivity or intolerance to tetracycline-class antibiotics, including doxycycline (relevant to the doxycycline treatment phase). * Mast cell activation syndrome (MCAS) or other mast cell disorder that, in the investigator's judgment, elevates the risk of injection-related hypersensitivity or systemic reactions. * Active autoimmune or systemic inflammatory connective-tissue disease that, in the investigator's judgment, may confound the response to regenerative treatment or increase procedural risk. * Known hypersensitivity to sodium hyaluronate or to the specific HA product to be used (Visco-3); active skin disease or infection over the planned injection site; venous or lymphatic stasis in the limb of the planned injection. * Active malignancy or anticancer treatment within the prior 12 months; a prior malignancy in documented remission may be enrolled at the investigator's discretion with documented rationale. * Uncontrolled diabetes mellitus, defined as HbA1c ≥ 8.5% on the most recent value within the prior 3 months; the investigator may also exclude for other objectively documented diabetes-related procedural or healing risk. * Prior joint replacement at the target joint. * Planned surgery during study participation. * Corticosteroid injection to the target joint(s) within the prior 6 weeks. * Concurrent enrollment in another interventional study for the same pain condition. * Active litigation or disability claim related to the target condition (to limit secondary-gain confounding of self-reported outcomes). * Pregnancy, or unwillingness to undergo pregnancy testing when fluoroscopy is planned (persons of childbearing potential). * Inability to comply with study procedures or follow-up.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
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The official record
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Study contacts
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Contact
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Contact
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