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NCT07507604

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

Sponsor: John Paul II University in Biała Podlaska

View on ClinicalTrials.gov

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.

Official title: The Influence of Contextual Effects on Biochemical Parameters Associated With Inflammation and the Analgesic Efficacy of Spinal Joint Manipulation Therapy

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-04-21

Completion Date

2026-09-30

Last Updated

2026-04-02

Healthy Volunteers

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.

Inclusion Criteria: * people with low back pain lasting longer than 3 months, aged 18 to 65 years, * highest reported pain intensity during the last 24 hours of at least 4 out of 10 on the 11-point Numeric Pain Rating Scale (NPRS-11), where 0 = no pain and 10 = worst imaginable pain, * clinical diagnosis of chronic non-specific low back pain (NSCLBP) based on symptoms located in the lumbar spine region and not on imaging findings, * no use of nonsteroidal anti-inflammatory drugs (NSAIDs) for at least 7 days before the study, * no use of pain medication for at least 24 hours before the study, * no use of corticosteroids, * no previous spinal manipulation therapy, * no alcohol, nicotine, or coffee consumption for at least 12 hours before the study, * written informed consent to participate in the study. Exclusion Criteria: * physiotherapy students, * presence of red flags, such as a history of cancer, constant or non-mechanical pain, progressive or radiating pain, sensory deficits in the trunk or - lower limbs, lower limb muscle weakness, or bladder/bowel dysfunction, * body mass index (BMI) greater than 30, * previous lumbar spine surgery, * lumbar spine injury within 6 months before the study, * diagnosed diabetes, * diagnosed rheumatic diseases, * affective disorders such as post-traumatic stress disorder (PTSD) or schizophrenia, * spondylolisthesis or spondylolysis confirmed by imaging, * diagnosed endometriosis, * use of hormonal medications, * sleep disorders, * shift work, * musculoskeletal injury within the last 14 days, * active infection, * pregnancy, * endocrine disorders such as hyperthyroidism or hypothyroidism, * use of opioid medications, including over-the-counter combination products such as codeine with paracetamol, * current or recent use of antidepressants affecting serotonin or dopamine (including SSRIs, SNRIs, tricyclic antidepressants, MAO inhibitors, or ketamine), * current diagnosis of major depressive disorder or bipolar disorder, as well as PTSD or schizophrenia, * ongoing psychotherapy during the study period, * cognitive impairment or significant hearing impairment that may interfere with understanding or processing the observational learning procedure.

Locations (2)

John Paul II University in Biała Podlaska

Biała Podlaska, Lublin Voivodeship, Poland

Laboratory of the John Paul II University in Biała Podlaska