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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDuke University

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

participants have infection, skin lesions, (or)

Trial design

Treatments tested in this trial

  • Massage
  • Talk-based therapy

Treatment groups

25 Participants
are divided into 2 treatment groups

Sponsors and collaborators