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NCT06987786 · ClinicalTrials.gov registry record · NA
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
A NA study, sponsored by Duke University.
- Not yet
- Registry status
- NA
- Development phase
- 25
- Enrollment target
NCT06987786 is a NA study that has not yet begun recruiting, run by Duke University. The registered enrollment target is 25 participants.
The verdict
NCT06987786, a NA study, has not yet begun recruiting, sponsored by Duke University.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 25 participants
- Enrollment target
Study Summary
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.
Interventions
- OTHER Massage
- OTHER Talk-based therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2026-06-01 |
| Est. Completion | 2026-11-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06987786
The ClinicalTrials.gov registry entry for NCT06987786 describes a study currently listed as not yet recruiting, categorized as NA. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Massage is the first listed.
NCT06987786 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06987786 about?
NCT06987786 is a clinical study titled "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". 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:...
What is the current status of trial NCT06987786?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 25 participants. The study started on 2026-06-01. Estimated completion is 2026-11-30.
What interventions are being tested in trial NCT06987786?
The interventions under investigation include: Massage (OTHER), Talk-based therapy (OTHER).
Who is sponsoring clinical trial NCT06987786?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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