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Contextual Effects on Inflammatory Biomarkers and Pain Relief After Spinal Joint Manipulation

NCT07507604 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2026-04-13

No results posted yet for this study

Summary

The goal of this clinical trial is to learn whether contextual effects created by observational learning can change pain relief and inflammation-related biological responses after spinal joint manipulation in adults with chronic non-specific low back pain. The main questions it aims to answer are:

Does positive, neutral, or negative observational learning change pain after spinal joint manipulation? Does it change disability, lumbar range of motion, stress, fear of movement, empathy, and treatment expectations? Does it change pressure pain threshold, lumbar tissue temperature, and blood markers related to inflammation, including interleukin-6 (IL-6), high-sensitivity C-reactive protein (hs-CRP), tumor necrosis factor alpha (TNF-α), and interleukin-10 (IL-10)?

The researchers will compare 3 groups: a positive expectation group, a neutral group, and a negative expectation group. Before the treatment, each participant will have a short interaction with a trained simulated patient. The simulated patient will present a positive, neutral, or negative experience with spinal manipulation, depending on group assignment. After this, all the participants will receive the same spinal joint manipulation procedure.

The participants will:

* be randomly assigned to 1 of 3 study groups,
* complete baseline questionnaires and clinical tests before treatment,
* take part in a brief observational learning session before manipulation,
* receive 1 spinal joint manipulation treatment,
* complete outcome measurements before treatment, about 60 minutes after treatment, and 24 hours after treatment,
* provide blood samples for analysis of inflammation-related biomarkers.

This study will include adults aged 18 to 65 years with chronic non-specific low back pain. The main outcome is pain intensity. Secondary outcomes include disability, stress, empathy, fear of movement, lumbar range of motion, tissue temperature, pressure pain threshold, and treatment expectations. Exploratory outcomes include blood biomarkers related to inflammation.

Conditions

  • Low Back Pain

Interventions

BEHAVIORAL

Observational Learning

A standardized pre-treatment observational learning procedure delivered through an interaction with a simulated patient presenting positive, neutral, or negative treatment-related expectations and recovery behavior.

PROCEDURE

Spinal Joint Manipulation

A standardized high-velocity, low-amplitude lumbar spinal manipulation applied after the observational learning procedure in all study arms.

Sponsors & Collaborators

  • John Paul II University in Biała Podlaska

    lead OTHER

Principal Investigators

  • Kamil Zaworski, PhD · John Paul II University in Biała Podlaska

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-21
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07507604 on ClinicalTrials.gov