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
Not yet recruitingNot applicableNCT06987786
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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)
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.
Study details
- Official title
- 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
- Conditions
- Interventions
- Other: Massage
- Other: Talk-based therapy
- Sponsor
- Duke University
- Start date
- 2026-12-01
- Primary completion
- 2027-06-30
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria include: * Individuals with chronic spine pain (3 months or greater) (and); * who are 18 years of age and older (and) * who experience persistent pain of ≥3 on a 10-point scale for the majority of days during the previous 3-months (The study operationally defines chronic pain using the International Association of the Study of Pain (IASP) pragmatic criteria of pain lasting for 3 months or more that cannot be attributed to another diagnosis or condition). \- Exclusion Criteria include: * Participants with medical conditions that may influence hormone levels during the study (e.g., Cushing's Syndrome, Addison's Disease, etc.) (or), * Use of medications (e.g., steroids, antidepressants, or hormonal treatments) that could influence the results (or) * Previously diagnosed conditions or factors known to affect cortisol or oxytocin levels, such as chronic stress disorders, hormonal imbalances, or pregnancy. (After obtaining consent and prior to treatment), the study will screen for potential massage contraindications or other clinical safety considerations and will exclude if: * participants have infection, skin lesions, (or) * Fractures in the region of the massage
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06987786