Influence of Verbal Suggestion on the Therapeutic Effect of the Joint Manipulation
NCT Number: NCT06537739
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Back Pain
Interventions: OTHER: Lumbar manipulation|OTHER: Positive communication - placebo|OTHER: Negative communication - nocebo|OTHER: Neutral communication
Sponsor: John Paul II University in Biała Podlaska
Sex: ALL
Age: ADULT
Enrollment: 66
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10-14
Completion Date: 2025-05-30

Summary:
The aim of the study is to evaluate the influence of verbal suggestion on the therapeutic effect of the joint manipulation of the lumbar spine in patients with chronic non-specific low back pain in relation to the pain level, stress, disability, function, sleepiness, tissue temperature and selected blood biochemical markers.

The study participants will be randomly assigned (sealed allocation envelopes) to the following groups:

* Group A (test intervention + placebo communication)
* Group B (test intervention + nocebo communication)
* Group C (test intervention + neutral communication)

The study will mainly consist of the three stages, i.e. before the intervention, immediately after the intervention and 24 hours later.

Primary Outcome Measures: Numerical Rating Scale (NRS), The participant gives a score expressed in numbers from 0 to 10, Before the intervention, immediately after the intervention and 24 hours later
Secondary Outcome Measures: Tampa Scale of Kinesiophobia (TSK), The 17 item TSK total scores range from 17 to 68, where the lowest 17 means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia., Before the intervention, immediately after the intervention and 24 hours later|Back Pain Function Scale (BPFS), In the Back Pain Function Scale (BFPS), the participant assesses twelve actions related to everyday life activity in a scale of 0 to 5. The results fall within a range of 0 to 60 points, whereby the higher the final result, the lower the level of pain., Before the intervention, immediately after the intervention and 24 hours later|Perceived Stress Scale (PSS-10), The scale consists of 10 questions, with answers scored from 0 to 4., Before the intervention, immediately after the intervention and 24 hours later|Stress Numerical Rating Scale-11, The participant gives a score expressed in numbers from 0 to 10., Before the intervention, immediately after the intervention and 24 hours later|Roland-Morris Disability Questionnaire (RMDQ), The participant is asked to tick a statement when it applies to him/her that specific day; this makes it possible to follow changes in time. The end score is the sum of the ticked boxes. The score ranges from 0 (no disability) to 24 (max. disability) depending on the questionnaire used. Roland and Morris omitted describing the various levels of disability (for example, 40%-60% of disability is severe)., Before the intervention, immediately after the intervention and 24 hours later|Epworth Sleepiness Scale (ESS), The ESS is a self-administered questionnaire with 8 questions. The participants are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities., Before the intervention and 24 hours later|Serological test - cortisol, During the blood collection, the participants will be placed in a sitting position. Before the blood collection, the following information should be reported: susceptibility to bleeding (bleeding diathesis), susceptibility to fainting during blood collection. In order to determine cortisol levels, the laboratory tests (with the use of immunoenzymatic methods (ELISA tests)) will be performed at the Medical Laboratory of the Innovation Research Center of John Paul II University in Biała Podlaska. The result will be expressed in nmol/L., Before the intervention, immediately after the intervention and 24 hours later|Serological test - serotonin, During the blood collection, the participants will be placed in a sitting position. Before the blood collection, the following information should be reported: susceptibility to bleeding (bleeding diathesis), susceptibility to fainting during blood collection. In order to determine serotonin levels, the laboratory tests (with the use of immunoenzymatic methods (ELISA tests)) will be performed at the Medical Laboratory of the Innovation Research Center of John Paul II University in Biała Podlaska. The result will be expressed in ng/ml., Before the intervention, immediately after the intervention and 24 hours later|Serological test - oxytocin, During the blood collection, the participants will be placed in a sitting position. Before the blood collection, the following information should be reported: susceptibility to bleeding (bleeding diathesis), susceptibility to fainting during blood collection. In order to determine oxytocin levels, the laboratory tests (with the use of immunoenzymatic methods (ELISA tests)) will be performed at the Medical Laboratory of the Innovation Research Center of John Paul II University in Biała Podlaska. The result will be expressed in mU/l., Before the intervention, immediately after the intervention and 24 hours later|Tests with a thermal imaging camera (FLIR E54, USA), The measurement will be taken in the forward lying position at the level of the three segments: L3, L4 and L5, at three points: the spinous process and on its both sides (2 cm from the spinous process laterally) in the area of the extensor muscles of the lumbar spine.The result will be marked in degrees Celsius., Before the intervention, immediately after the intervention and 24 hours later|Tests with the Medi-Mouse (Switzerland), The assessment of the range of motion of the lumbar spine flexion and extension.The result will be expressed in degrees., Before the intervention, immediately after the intervention and 24 hours later|The assessment of the pain levels with the Baseline dolorimeter, The measurement will be taken in the forward lying position at the level of the three segments: L3, L4 and L5, at three points: the spinous process and on its both sides (2 cm from the spinous process laterally) in the area of the extensor muscles of the lumbar spine. A participant will be asked to report when they feel pain at an intensity of 1/10, and a researcher will read the pressure on the dolorimeter., Before the intervention, immediately after the intervention and 24 hours later|Scale for the subjective assessment of the expectations for the treatment outcomes based on the GRoC methodology, 15-point Likert scale - from -7 (lowest expectations) to +7 (highest expectations)., Before the intervention|Scale for the subjective assessment of the treatment outcomes based on the GRoC methodology, 15-point Likert scale - from -7 (significant worsening of symptoms) to +7 (significant improvement)., Immediately after the intervention and 24 hours later