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

NCT06537739 | Completed

• 1 other identifier: JohnPaul2U
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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

Back Pain

Keywords

Back Pain; Musculoskeletal Manipulations; Nocebo Effect; Placebo Effect

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Tampa Scale of Kinesiophobia (TSK)

  Before the intervention, immediately after the intervention and 24 hours later

• Back Pain Function Scale (BPFS)

  Before the intervention, immediately after the intervention and 24 hours later

• Perceived Stress Scale (PSS-10)

  Before the intervention, immediately after the intervention and 24 hours later

• Stress Numerical Rating Scale-11

  Before the intervention, immediately after the intervention and 24 hours later

• Roland-Morris Disability Questionnaire (RMDQ)

  Before the intervention, immediately after the intervention and 24 hours later

Study Arms (3)

Group A (test intervention + placebo communication)

EXPERIMENTAL

Participants who will undergo the joint manipulation of the lumbar spine region and receive positive communication - placebo.

Other: Lumbar manipulation; Other: Positive communication - placebo

Group B (test intervention + nocebo communication)

EXPERIMENTAL

Participants who will undergo the joint manipulation of the lumbar spine region and receive negative communication - nocebo.

Other: Lumbar manipulation; Other: Negative communication - nocebo

Group C (test intervention + neutral communication)

OTHER

Participants who will undergo the joint manipulation of the lumbar spine region and receive neutral communication.

Other: Lumbar manipulation; Other: Neutral communication

Interventions

Lumbar manipulation OTHER

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.

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

Positive communication - placebo OTHER

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).

Group A (test intervention + placebo communication)

Negative communication - nocebo OTHER

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).

Group B (test intervention + nocebo communication)

Neutral communication OTHER

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).

Group C (test intervention + neutral communication)

Eligibility Criteria

• Age: 19 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• participants with low back pain lasting more than 3 months,
• participants who have not been taking any non-steroidal anti-inflammatory drugs (NSAIDs) for at least one week prior to the start of the study,
• participants who are not taking any steroid drugs,
• participants who have never had the joint manipulation before,
• participants within the age range of 19-30 years,
• written consent to participate in the study.

You may not qualify if:

• participants who are students of physiotherapy,
• participants with a BMI \>33,
• participants after a lumbar spine surgery,
• participants who, in the 6 months prior to the start of the study, suffered from a lumbar spine injury,
• participants with diabetes,
• participants with rheumatic diseases,
• participants with endometriosis,
• participants with endocrine diseases,
• participants with acute inflammation in the lumbar spine region and sciatica symptoms.

Sponsors & Collaborators

• John Paul II University in Biała Podlaska: lead

Study Sites (1)

John Paul II University in Biała Podlaska

Biała Podlaska, Lublin Voivodeship, 21-500, Poland

Location

MeSH Terms

Conditions

Back Pain

Interventions

Manipulation, Spinal

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Kamil Zaworski, Ph.D.

  John Paul II University in Biała Podlaska

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants will be randomly assigned to groups. One of the researchers will then give the person a verbal message (dependent on the study group). The physiotherapist performing the joint manipulation will not know which study group a given patient belongs to. The researcher collecting results and performing statistical analysis will also be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: It will be a prospective follow-up study, with a type of message used as a differentiating variable (positive - placebo, negative - nocebo, neutral).

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 5, 2024
• Study Start: October 14, 2024
• Primary Completion: December 16, 2024
• Study Completion: January 31, 2025
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: From the completion of the research for the next five years.
• Access Criteria: Direct contact with the research team.

Locations

PL (1)