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.
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,
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,
Parallel
Observational Learning
BehavioralA 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/SurgeryA standardized high-velocity, low-amplitude lumbar spinal manipulation applied after the observational learning procedure in all study arms.
Pain intensity score on the 11-point Numeric Pain Rating Scale (NPRS-11)
Pain intensity will be assessed using the 11-point Numeric Pain Rating Scale (NPRS-11), where 0 indicates no pain and 10 indicates the worst imaginable pain. This is the primary outcome measure.
Pressure pain threshold at lumbar levels L3-L5 measured by pressure algometry
Pressure pain threshold will be measured using a pressure algometer at lumbar levels L3, L4, and L5. Measurements will be taken over the spinous process and 2 cm laterally on both sides in the lumbar erector spinae region. Participants will indicate when pressure first becomes painful.
Stress score on the 11-point Stress Numeric Rating Scale (SNRS-11)
Stress level will be assessed using the 11-point Stress Numeric Rating Scale (SNRS-11), where 0 indicates no stress and 10 indicates the highest stress level.
Perceived stress score on the 10-item Perceived Stress Scale (PSS-10)
Perceived stress will be assessed using the 10-item Perceived Stress Scale (PSS-10), a licensed self-report questionnaire. Higher scores indicate greater perceived stress.
Empathic concern score on the Interpersonal Reactivity Index
Empathy will be assessed using the Empathic Concern subscale of the Interpersonal Reactivity Index. Higher scores indicate greater empathic concern.
Inflammation-related blood biomarkers
Blood biomarkers related to inflammation will be analyzed, including interleukin-6 (IL-6), high-sensitivity C-reactive protein (hs-CRP), tumor necrosis factor alpha (TNF-α), and interleukin-10 (IL-10).
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