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Adhesive Capsulitis: Prospective Analysis of Efficacy and Financial Impact for Use of Physical Therapy in Treatment

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv13
  2. Primary completion date: Dec 2024 to Dec 2026 Completion date: Dec 2025 to Dec 2027v12 Show 1 more changeShow less
    • Completion date: Dec 2025 to Dec 2027
  3. Secondary endpoints: details revised at 2 of 2 entriesv11
  4. Primary completion date: Dec 2022 to Dec 2024 Completion date: Dec 2023 to Dec 2025v10 Show 1 more changeShow less
    • Completion date: Dec 2023 to Dec 2025
  5. Re-verified, no change to tracked fieldsv9
Show 7 earlier versionsHide 7 earlier versions
  1. Primary completion date: Dec 2021 to Dec 2022 Completion date: Dec 2022 to Dec 2023 · Site contact updatedv8 Show 2 more changesShow less
    • Completion date: Dec 2022 to Dec 2023
    • Site contact updated
  2. Re-verified, no change to tracked fieldsv7
  3. Primary completion date: Aug 2018 to Dec 2021 Completion date: May 2019 to Dec 2022v6 Show 1 more changeShow less
    • Completion date: May 2019 to Dec 2022
  4. Primary completion date: May 2018 to Aug 2018 Completion date: May 2018 to May 2019 · Study site revisedv5 Show 2 more changesShow less
    • Completion date: May 2018 to May 2019
    • Study site revised

    See this version in full on ClinicalTrials.gov ↗

  5. Lead sponsor: Brigham and Women's Hospital to Massachusetts General Hospital Primary completion date: Nov 2017 to May 2018 · Completion date: May 2018 · Secondary endpoints: details revised at 2 of 2 entries · 1 morev4 Show 4 more changesShow less
    • Primary completion date: Nov 2017 to May 2018
    • Completion date: May 2018
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study site revised

    See this version in full on ClinicalTrials.gov ↗

  6. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Nov 2015 to Nov 2017 · Study sites: 0 to 1v3 Show 2 more changesShow less
    • Primary completion date: Nov 2015 to Nov 2017
    • Study sites: 0 to 1
  7. Secondary endpoints: details revised at 2 of 2 entriesv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to identify individuals 18 or older who have diagnostic presentation of adhesive capsulitis and randomize them into two arms, distinguished by use of physical therapy and steroid injections compared with steroid injections followed by watchful waiting. This prospective study will be used to determine whether there is a significant impact on patient outcome and whether the additional financial burden is justified. There are no experimental interventions for this study. The use of physical therapy, oral and parenteral corticosteroids, and watchful waiting are offered following the standard of care for adhesive capsulitis. Our hypothesis is that patients will not have a significant difference in outcome between the two study arms. One group will undergo regular physical therapy with corticosteroid injections (Arm 1) and the other will have steroid injections during the inflammatory phase only and then be regularly observed (Arm 2). We also hypothesize there will be a significant financial burden associated with the PT arm that is not justified with the possibility of increased symptom reports in that arm.
Trial Details
NCT Number NCT02283996
Lead Sponsor Massachusetts General Hospital
Conditions Adhesive Capsulitis, Frozen Shoulder, Shoulder Frozen
Enrollment 260 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov