Status:
NOT_YET_RECRUITING
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
Lead Sponsor:
Duke University
Conditions:
Spine
Low Back Pain
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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. Participan...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06987786
Start Date
December 1 2025
End Date
June 30 2026
Last Update
October 17 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
CORE 2200 West Main Street
Durham, North Carolina, United States, 27705