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

NCT07507604 | Not Yet Recruiting

• 2 other identifiers: JohnPaul2U_KZSN.TJO-61.501.17.2025
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

low back pain; spinal joint manipulation; observational learning; contextual effects; placebo; nocebo

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (pre-intervention), 60 minutes after spinal joint manipulation, and 24 hours after spinal joint manipulation.

Secondary Outcomes (13)

• Pressure pain threshold at lumbar levels L3-L5 measured by pressure algometry

  Baseline (pre-intervention), 60 minutes after spinal joint manipulation, and 24 hours after spinal joint manipulation.

• Stress score on the 11-point Stress Numeric Rating Scale (SNRS-11)

  Baseline (pre-intervention), 60 minutes after spinal joint manipulation, and 24 hours after spinal joint manipulation.

• Perceived stress score on the 10-item Perceived Stress Scale (PSS-10)

  Baseline (pre-intervention), 60 minutes after spinal joint manipulation, and 24 hours after spinal joint manipulation.

• Empathic concern score on the Interpersonal Reactivity Index

  Baseline (pre-intervention)

• Disability score related to low back pain on the Roland-Morris Disability Questionnaire

  Baseline (pre-intervention), 24 hours after spinal joint manipulation.

Other Outcomes (1)

• Inflammation-related blood biomarkers

  Baseline (pre-intervention), 60 minutes after spinal joint manipulation, and 24 hours after spinal joint manipulation.

Study Arms (3)

Positive Observational Learning + Spinal Joint Manipulation

EXPERIMENTAL

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.

Behavioral: Observational Learning; Procedure: Spinal Joint Manipulation

Neutral Observational Learning + Spinal Joint Manipulation

EXPERIMENTAL

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.

Behavioral: Observational Learning; Procedure: Spinal Joint Manipulation

Negative Observational Learning + Spinal Joint Manipulation

EXPERIMENTAL

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.

Behavioral: Observational Learning; Procedure: Spinal Joint Manipulation

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.

Negative Observational Learning + Spinal Joint Manipulation; Neutral Observational Learning + Spinal Joint Manipulation; Positive Observational Learning + Spinal Joint Manipulation

Spinal Joint Manipulation PROCEDURE

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

Negative Observational Learning + Spinal Joint Manipulation; Neutral Observational Learning + Spinal Joint Manipulation; Positive Observational Learning + Spinal Joint Manipulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• John Paul II University in Biała Podlaska: lead

Study Sites (2)

John Paul II University in Biała Podlaska

Biała Podlaska, Lublin Voivodeship, 21-500, Poland

Location

Laboratory of the John Paul II University in Biała Podlaska

Biała Podlaska, Lublin Voivodeship, 21-500, Poland

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kamil Zaworski, PhD

  John Paul II University in Biała Podlaska

  STUDY CHAIR

Central Study Contacts

Kamil Zaworski, PhD

CONTACT

+48506764250; k.zaworski@dyd.akademiabialska.pl

Joanna Baj-Korpak, PhD

CONTACT

+48833456208; j.baj-korpak@dyd.akademiabialska.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The participants, care providers, and outcome assessors will be blinded to group assignment. In addition, the statisticians will remain blinded to group allocation and study hypotheses during the trial. Allocation concealment will be ensured using sequentially numbered, opaque sealed envelopes prepared by an independent researcher. The participants will be informed about the true study aims after completion of their participation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a parallel-group, 3-arm randomized trial. The participants are assigned in a 1:1:1 ratio to positive, neutral, or negative observational learning before receiving the same spinal joint manipulation intervention. The groups differ only in the pre-treatment contextual procedure, and outcomes are measured at baseline, post-treatment, and 24-hour follow-up.

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 2, 2026
• Study Start: April 21, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will become available beginning 6 months after publication of the primary results and will remain available for 5 years thereafter.
• Access Criteria: De-identified individual participant data and supporting documents will be made available to qualified researchers upon reasonable request to the principal investigator. Access will be granted for methodologically sound research purposes, subject to participant consent, ethics committee requirements, institutional policies, and, where applicable, a data access agreement.

Locations

PL (2)