Influence of Verbal Suggestion on the Therapeutic Effect of the Joint Manipulation

NCT06537739 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2025-02-06

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Lumbar manipulation

Participant lies in the supine position, a physiotherapist faces the participant's side that will be manipulated. The participant interlocks their fingers behind their neck. Then the physiotherapist turns the participant on their side and performs a short thrust across the participant's pelvis in a posterior and inferior direction. The manipulation will be carried out on the symptomatic side, based on the participant's indication of the painful side. If the participant is unable to indicate the more symptomatic side, the physiotherapist performing the procedure will select the side. If no audible cavitation occurs during the manipulation, the physiotherapist will attempt to manipulate the opposite side. A maximum of 2 attempts per side will be allowed.

OTHER

Positive communication - placebo

Participants from Group A who will undergo the joint manipulation of the lumbar spine region and receive the following information: "Joint manipulation is a very effective method of treating spinal disorders, which will significantly reduce the low back pain you are experiencing" (positive communication - placebo).

OTHER

Negative communication - nocebo

Participants form Group B who will undergo the joint manipulation of the lumbar spine region and receive the following information: "Joint manipulation is not an effective method of treating spinal disorders, thus it may temporarily increase the low back pain you are experiencing" (negative communication - nocebo).

OTHER

Neutral communication

Participants from Group C who will undergo the joint manipulation of the lumbar spine region and receive the following information: "Joint manipulation has not been verified for its effectiveness in affecting your level of low back pain" (neutral communication).

Sponsors & Collaborators

  • John Paul II University in Biała Podlaska

    lead OTHER

Principal Investigators

  • Kamil Zaworski, Ph.D. · John Paul II University in Biała Podlaska

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-14
Primary Completion
2024-12-16
Completion
2025-01-31

Countries

  • Poland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06537739 on ClinicalTrials.gov