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

Sponsor
John Paul II University in Biała Podlaska
Study ID
NCT07507604
Status
Recruiting
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Conditions

  • Low Back Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Observational Learning — BEHAVIORAL
    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.
  • Spinal Joint Manipulation — PROCEDURE
    A standardized high-velocity, low-amplitude lumbar spinal manipulation applied after the observational learning procedure in all study arms.

Study Details

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.

Key Dates

First listed
Apr 2, 2026
Start date
Apr 21, 2026
Status verified
Mar 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
73 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Positive Observational Learning + Spinal Joint Manipulation
    The participants are exposed to a standardized positive observational learning procedure before treatment. A simulated patient describes clear improvement in low back pain and lumbar mobility after spinal manipulation and demonstrates comfortable lumbar movement. After this interaction, the participants receive the same spinal joint manipulation procedure as in the other study arms.
  • Experimental: Neutral Observational Learning + Spinal Joint Manipulation
    The participants are exposed to a standardized neutral observational learning procedure before treatment. A simulated patient has a brief neutral interaction and does not describe treatment effects or demonstrate functional improvement. After this interaction, the participants receive the same spinal joint manipulation procedure as in the other study arms.
  • Experimental: Negative Observational Learning + Spinal Joint Manipulation
    The participants are exposed to a standardized negative observational learning procedure before treatment. A simulated patient reports little or no improvement in low back pain after spinal manipulation and demonstrates limited lumbar movement with visible discomfort. After this interaction, the participants receive the same spinal joint manipulation procedure as in the other study arms.

Primary Outcome Measure

Pain intensity score on the 11-point Numeric Pain Rating Scale (NPRS-11) [ Time Frame: Baseline (pre-intervention), 60 minutes after spinal joint manipulation, and 24 hours after spinal joint manipulation. ]

Central Contacts

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