Differences in Mechanistic Measures (Oxytocin and Cortisol) of Therapeutic Alliance Between A Talk-Based Therapy and Soft-Tissue Mobilization in Individuals With Chronic Spinal Pain

Study acronym: COTHA
StatusNot Yet Recruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 7 months later Nov 30, 2026 → Jun 30, 2027
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Record History

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  1. Notable Primary completion pushed from Nov 30, 2026 to Jun 30, 2027 Show 6 more changesShow less
    • Start date: Jun 1, 2026 to Dec 1, 2026
    • Study completion pushed from Nov 30, 2026 to Oct 30, 2027
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 5 of 5 entries
    • Study description revised
    • Site contact updated
  2. Notable Start date: Dec 1, 2025 to Jun 1, 2026
    • Primary and study completion dates: Jun 30, 2026 to Nov 30, 2026
    v4
  3. Notable Start date: Sep 1, 2025 to Dec 1, 2025v3
  4. Notable Start date: Jul 1, 2025 to Sep 1, 2025v2
  5. Minor Study First Submitted
  • 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.
457 trials monitored
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The goal of this randomized cross-over mechanistic trial is to compare pre- and post-level cortisol and oxytocin changes in patients with chronic spine pain who receive either a hand's on (massage) or a hand's off (talk-based) approach. The study plans to address two primary aims. Specific Aim One: Directly compare pre- and post-session oxytocin and cortisol levels across two sessions of massage and talk-based therapy. Hypothesis 1: It is expected that in both treatments, oxytocin will increase and cortisol will decrease, demonstrating no significant between-group differences in hormone levels. Specific Aim Two: The study plans to compare pre- and post-session oxytocin and cortisol change scores a therapeutic alliance (TA) scale change scores and PROMIS patient-reported outcomes associated with pain, depression, and disability. Hypothesis 2a: It is projected that there will be moderate +/- relationships (R\>.4) between the therapeutic alliance change score and oxytocin and cortisol levels, suggesting that the hormones moderately reflect the construct associated with TA. Hypothesis 2b: It is expected that there will be weak (R\>.1) +/-relationships between hormone measures and PROMIS pain/disability/depression measures, which reflects similar findings to preliminary work. Participants will participant in a massage based treatment and a talk-based treatment approach. Participants will also complete patient report outcomes and will receive a total of four salivary swabs.
Trial Details
NCT Number NCT06987786
Lead Sponsor Duke University
Conditions
(from sponsor)
Spine, Low Back Pain, Neck Pain
Related terms Low Back Pain, Neck Pain
Enrollment 25 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov