Clinical trial NCT06987786: 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
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Spine
Low Back Pain
Neck Pain
Keywords: Oxytocin
Cortisol
spinal pain
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2025-05-23
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This proposal involves a randomized, cross-over mechanistic clinical trial that includes a cohort of participants with chronic spine pain. A randomized, cross-over mechanistic trial is useful because it allows each participant to serve as their own control, reducing variability and increasing the statistical power to detect treatment effects.
Primary purpose: TREATMENT

Brief 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.

Detailed description: Recruitment at Duke University: Recruitment will follow a well-versed, successful process at Duke University. MaestroCare will be used to identify, recruit, and conduct this research study. Participants will be invited to participate in this study via a MyChart patient portal invitation sent by a clinical research coordinator (CRC). The CRC will screen participants for eligibility via telephone encounter. Prior to obtaining consent, participants will be screened for medical conditions that may influence hormone levels during the study (e.g., Cushing's Syndrome, Addison's Disease, etc.), use of medications (e.g., steroids, antidepressants, or hormonal treatments) that could influence the results, and exclude participants if necessary, and 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 STM contraindications or other clinical safety considerations (i.e., infection, skin lesions, etc) using a limited systems-screening to rule out pertinent clinical contraindications to STM (e.g., radiculopathy, fracture, etc.).

Participants: Individuals with CSP (3 months or greater), 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 will be eligible for the study. 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.

Variables: In addition to pertinent demographics and patient characteristics, the study will capture baseline PROMIS pain interference, pain intensity, depression, and physical function values. Onsite, to improve the likelihood that hormone related changes are not influenced by external factors, the study will capture a Perceived Stress Scale (PSS), which measures subjective stress levels, State-Trait Anxiety Inventory (STAI), which assesses temporary and long-term anxiety states, blood pressure and pulse prior to each visit. For the PSS, a score of 27 or above is typically considered high. For the STAI, a score above 60 is often considered high, signaling significant anxiety. If individuals score high in either measure, the participants will be rescheduled. Those with Blood pressure: ≥140/90 mmHg and a heart rate \>100bpm will be asked to reschedule.

The study's primary variables of interest in the study involve cortisol and oxytocin levels. The study will capture 525 μL salivary concentrations of oxytocin and cortisol through a SalivaBio Oral Swab (SOS) Method. Testing will be completed with Salimetrics Assay Kits. The study will also capture the self-report WAI short-form and the PROMIS pain interference, pain intensity, and physical function measures at baseline and after completion of both visits.

Interventions: After describing the study design and purpose, participants will be randomized into a single treatment of STM-first or a single treatment of ER-first. All treatments will be provided by Dr. Cook, a licensed physical therapist with 35 years of clinical experience and fellowship-level training in STM (e.g., manual therapies) and a 2.5-year post-professional, certification-level training in chronic pain management/psychologically informed practice. A designated clinical research coordinator (CRC) and Dr. Cook will be responsible for screening of each applicant to ensure the participants are appropriate and safe for study inclusion.

Eligibility criteria: 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).

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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

Primary outcomes:
measure: Cortisol changes
timeFrame: Day 1 and day 15
measure: Oxytocin changes
timeFrame: Day 1 and day 15
Secondary outcomes:
measure: Therapeutic alliance
timeFrame: Day 1 and day 15
measure: PROMIS pain interference
timeFrame: Day 1 and day 15
measure: PROMIS Pain intensity
timeFrame: Day 1 and day 15
measure: PROMIS Depression
timeFrame: Day 1 and day 15
measure: PROMIS physical function
timeFrame: Day 1 and day 15
Other outcomes:
Locations:
city: Durham
country: United States
facility: CORE 2200 West Main Street
state: North Carolina
Study officials:
affiliation: Duke University
name: Chad E Cook
role: PRINCIPAL_INVESTIGATOR
References: