Influence of Verbal Suggestion on the Therapeutic Effect of the Joint Manipulation
NCT ID: NCT06537739
Last Updated: 2025-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
64 participants
INTERVENTIONAL
2024-10-14
2025-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Impact of Positive, Neutral and Negative Expectation Speech on Manipulative Therapy Effects
NCT05996991
Effects of Manipulative Therapy and Pain Education in Individuals With CLBP
NCT02982382
Investigating the Hypoalgesic Effects of Manipulative Therapy Using Pain Conditioning and Expectations in Low Back Pain
NCT05202704
The Effectiveness of Manual Therapy and PNF Compared With Kinesiotherapy in the Treatment of Non-specific Low Back Pain
NCT03733964
Spinal Manipulative Therapy Treatment Effect Modifiers in Individuals With Low Back Pain
NCT02476383
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
One of the methods of physiotherapeutic treatment of spinal disorders involving manual diagnostic and therapeutic techniques is manual therapy. In the therapy, among others, joint manipulation techniques are used. However, the mechanisms underlying the effects of the joint manipulation on the body have not been fully explained. Undoubtedly, one of the main mechanisms of action of manual therapy is pain modulation.
In recent years, research has been increasingly focusing on manipulation in a psychological context, including mechanisms of fear-avoidance, pain catastrophizing and kinesiophobia. Furthermore, manipulation can affect immune and endocrine system responses.
One of the significant non-specific effects accompanying any medical procedure is a placebo effect. The way health care professionals discuss, describe and inform patients about characteristic symptoms of a given disease its prevention, diagnosis and treatment, influences the patients' feelings and expectations, which in turn affect their psycho-biological reactions, subjective perception and treatment outcomes.
The appropriate choice of words by clinicians influences patients' responses to medical treatments and procedures, whether active or sham. The way in which information about the outcome of a treatment is communicated to patients can induce the reinforcing effects of a given treatment (placebo) or reverse the clinically proven effects of an active treatment, or even increase its adverse outcomes in the form of a nocebo effect.
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.
Research questions:
1. Does the type of verbal suggestion influence the effects of the joint manipulation in relation to the pain level?
2. Does the type of verbal suggestion influence the effects of the joint manipulation in relation to the stress level?
3. Does the type of verbal suggestion influence the effects of the joint manipulation in relation to the kinesiophobia level?
4. Does the type of verbal suggestion influence the effects of the joint manipulation in relation to the lumbar spine range of motion?
5. Does the type of verbal suggestion influence the effects of the joint manipulation in relation to the disability level?
6. Does the type of verbal suggestion influence the effects of the joint manipulation in relation to sleepiness?
7. Does the type of verbal suggestion influence the effects of the joint manipulation in relation to the tissue temperature of the lumbar spine region?
8. Does the type of verbal suggestion influence the effects of the joint manipulation in relation to the selected blood biochemical markers (cortisol, serotonin and oxytocin)?
The participants will be selected for the study from the group of students from John Paul II University in Biała Podlaska, Poland. The participation in the study will be voluntary.
The study will mainly consist of the three stages, i.e. before the intervention, immediately after the intervention and 24 hours later. Once, before the intervention, a scale will be used for the subjective assessment of the expectations for the treatment outcomes based on the GRoC methodology. The other research tools will be used in two stages: an information questionnaire (before the intervention and 24 hours after the intervention) and a scale for the subjective assessment of the treatment outcomes based on the GRoC methodology (immediately after the intervention and 24 hours later).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group A (test intervention + placebo communication)
Participants who will undergo the joint manipulation of the lumbar spine region and receive positive communication - placebo.
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.
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).
Group B (test intervention + nocebo communication)
Participants who will undergo the joint manipulation of the lumbar spine region and receive negative communication - nocebo.
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.
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).
Group C (test intervention + neutral communication)
Participants who will undergo the joint manipulation of the lumbar spine region and receive neutral communication.
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.
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).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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).
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).
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).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
19 Years
30 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
John Paul II University in Biała Podlaska
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kamil Zaworski, Ph.D.
Role: STUDY_CHAIR
John Paul II University in Biała Podlaska
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
John Paul II University in Biała Podlaska
Biała Podlaska, Lublin Voivodeship, Poland
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
JohnPaul2U
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.