Back PainNCT06537739
Influence of Verbal Suggestion on the Therapeutic Effect of the Joint Manipulation
A study testing Lumbar manipulation, Negative communication - nocebo and Neutral communication in people with Back Pain, run by John Paul II University in Biała Podlaska at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 30 years
- Conditions the study is for
- Back Pain
- What is being tested?
- Lumbar manipulation, Negative communication - nocebo and Neutral communication
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 sitePoland
- Study dates
- 14 Oct 2024to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 9Show fewer
- participants with endometriosis,
- participants with endocrine diseases,
- participants with acute inflammation in the lumbar spine region and sciatica symptoms.
Trial locations and contacts
1 site in 1 country.
Poland1 site
John Paul II University in Biała Podlaska
Biała Podlaska, Lublin Voivodeship, 21-500
About this study
Official title: 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
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:
Read more
- 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.
Read the detailed description
Pain is complex in nature and is closely related to the secretion of biochemical markers such as cortisol, serotonin and oxytocin. Higher levels of inflammatory markers, cytokines and chemokines have been found in patients with low back pain, which ultimately affect the clinical manifestations observed in the patients.
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:
- Does the type of verbal suggestion influence the effects of the joint manipulation in relation to the pain level?
- Does the type of verbal suggestion influence the effects of the joint manipulation in relation to the stress level?
- Does the type of verbal suggestion influence the effects of the joint manipulation in relation to the kinesiophobia level?
- Does the type of verbal suggestion influence the effects of the joint manipulation in relation to the lumbar spine range of motion?
- Does the type of verbal suggestion influence the effects of the joint manipulation in relation to the disability level?
- Does the type of verbal suggestion influence the effects of the joint manipulation in relation to sleepiness?
- Does the type of verbal suggestion influence the effects of the joint manipulation in relation to the tissue temperature of the lumbar spine region?
- 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
- Back Pain
- Being tested
- Lumbar manipulation, Positive communication - placebo, Negative communication - nocebo, Neutral communication
- Keywords
- Back Pain, Musculoskeletal Manipulations, Nocebo Effect, Placebo Effect
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar manipulationOther
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 - placeboOther
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 - noceboOther
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 communicationOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Group A (test intervention + placebo communication) | Experimental | Participants who will undergo the joint manipulation of the lumbar spine region and receive positive communication - placebo. Receives: 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. Receives: 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. Receives: Other: Lumbar manipulation; Other: Neutral communication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale (NRS)
The participant gives a score expressed in numbers from 0 to 10
Measured: Before the intervention, immediately after the intervention and 24 hours later
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Immediately after the intervention and 24 hours later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start14 Oct 2024
- Primary completion16 Dec 2024
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It will be a prospective follow-up study, with a type of message used as a differentiating variable (positive - placebo, negative - nocebo, neutral).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- John Paul II University in Biała Podlaska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kamil Zaworski, Ph.D., Study chair, John Paul II University in Biała Podlaska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06537739
- Sponsor's protocol ID
- JohnPaul2U
- Status last verified
- Feb 2025
- First submitted
- 31 Jul 2024
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Analytical data will be available through direct contact with the research team and in the publication process as supplementary materials.
Publications
Zaworski K, Baj-Korpak J, Tokarska-Rodak M, Plazuk E, Nazarewicz A, Rossettini G. Verbal framing, rather than measured cognitive-affective variables, is associated with short-term outcomes after spinal manipulation: a secondary analysis of a randomized controlled trial. Pain Manag. 2026 May;16(5):461-470. doi: 10.1080/17581869.2026.2638403. Epub 2026 Mar 4.
PubMed 41778600Zaworski K, Baj-Korpak J, Tokarska-Rodak M, Plazuk E, Dyrda A, Bialosky J, Rossettini G. Can pre-treatment verbal suggestions influence the short-term effects of spinal manipulation in young adults with chronic non-specific low back pain? A randomized controlled trial. Musculoskelet Sci Pract. 2025 Nov;80:103431. doi: 10.1016/j.msksp.2025.103431. Epub 2025 Oct 10.
PubMed 41106172
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06537739
- Acronym / sponsor ID
- JohnPaul2U
- Conditions
- Back Pain
- Keywords
- Back Pain, Musculoskeletal Manipulations, Nocebo Effect, Placebo Effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- John Paul II University in Biała PodlaskaUniversity, hospital or other
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- 16 Dec 2024 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 5 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Pain is complex in nature and is closely related to the secretion of biochemical markers such as cortisol, serotonin and oxytocin. Higher levels of inflammatory markers, cytokines and chemokines have been found in patients with low back pain, which ultimately affect the clinical manifestations observed in the patients.
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:
- Does the type of verbal suggestion influence the effects of the joint manipulation in relation to the pain level?
- Does the type of verbal suggestion influence the effects of the joint manipulation in relation to the stress level?
- Does the type of verbal suggestion influence the effects of the joint manipulation in relation to the kinesiophobia level?
- Does the type of verbal suggestion influence the effects of the joint manipulation in relation to the lumbar spine range of motion?
- Does the type of verbal suggestion influence the effects of the joint manipulation in relation to the disability level?
- Does the type of verbal suggestion influence the effects of the joint manipulation in relation to sleepiness?
- Does the type of verbal suggestion influence the effects of the joint manipulation in relation to the tissue temperature of the lumbar spine region?
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- It will be a prospective follow-up study, with a type of message used as a differentiating variable (positive - placebo, negative - nocebo, neutral).
| Arm | Type | Receives |
|---|---|---|
| Group A (test intervention + placebo communication) | Experimental | Other: Lumbar manipulation, Other: Positive communication - placeboParticipants who will undergo the joint manipulation of the lumbar spine region and receive positive communication - placebo. |
| Group B (test intervention + nocebo communication) | Experimental | Other: Lumbar manipulation, Other: Negative communication - noceboParticipants who will undergo the joint manipulation of the lumbar spine region and receive negative communication - nocebo. |
| Group C (test intervention + neutral communication) | Other | Other: Lumbar manipulation, Other: Neutral communicationParticipants who will undergo the joint manipulation of the lumbar spine region and receive neutral communication. |
Who may qualify
- Ages
- 19 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumbar manipulationParticipant 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 | Group A (test intervention + placebo communication), Group B (test intervention + nocebo communication), Group C (test intervention + neutral communication) |
| Positive communication - placeboParticipants 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 | Group A (test intervention + placebo communication) |
| Negative communication - noceboParticipants 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 | Group B (test intervention + nocebo communication) |
| Neutral communicationParticipants 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). | Other | Group C (test intervention + neutral communication) |
Primary outcome
Numerical Rating Scale (NRS)
Time frame: Before the intervention, immediately after the intervention and 24 hours later
The participant gives a score expressed in numbers from 0 to 10
14 secondary outcomes
Tampa Scale of Kinesiophobia (TSK)
Time frame: Before the intervention, immediately after the intervention and 24 hours later
Back Pain Function Scale (BPFS)
Time frame: Before the intervention, immediately after the intervention and 24 hours later
Perceived Stress Scale (PSS-10)
Time frame: Before the intervention, immediately after the intervention and 24 hours later
Stress Numerical Rating Scale-11
Time frame: Before the intervention, immediately after the intervention and 24 hours later
Roland-Morris Disability Questionnaire (RMDQ)
Time frame: Before the intervention, immediately after the intervention and 24 hours later
Epworth Sleepiness Scale (ESS)
Time frame: Before the intervention and 24 hours later
Serological test - cortisol
Time frame: Before the intervention, immediately after the intervention and 24 hours later
Serological test - serotonin
Time frame: Before the intervention, immediately after the intervention and 24 hours later
Serological test - oxytocin
Time frame: Before the intervention, immediately after the intervention and 24 hours later
Tests with a thermal imaging camera (FLIR E54, USA)
Time frame: Before the intervention, immediately after the intervention and 24 hours later
Tests with the Medi-Mouse (Switzerland)
Time frame: Before the intervention, immediately after the intervention and 24 hours later
The assessment of the pain levels with the Baseline dolorimeter
Time frame: 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
Time frame: Before the intervention
Scale for the subjective assessment of the treatment outcomes based on the GRoC methodology
Time frame: Immediately after the intervention and 24 hours later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Derived from this study: PubMed 41778600Zaworski K, Baj-Korpak J, Tokarska-Rodak M, Plazuk E, Nazarewicz A, Rossettini G. Verbal framing, rather than measured cognitive-affective variables, is associated with short-term outcomes after spinal manipulation: a secondary analysis of a randomized controlled trial. Pain Manag. 2026 May;16(5):461-470. doi: 10.1080/17581869.2026.2638403. Epub 2026 Mar 4.
- Derived from this study: PubMed 41106172Zaworski K, Baj-Korpak J, Tokarska-Rodak M, Plazuk E, Dyrda A, Bialosky J, Rossettini G. Can pre-treatment verbal suggestions influence the short-term effects of spinal manipulation in young adults with chronic non-specific low back pain? A randomized controlled trial. Musculoskelet Sci Pract. 2025 Nov;80:103431. doi: 10.1016/j.msksp.2025.103431. Epub 2025 Oct 10.
- Individual participant dataSharing planned: Yes. Analytical data will be available through direct contact with the research team and in the publication process as supplementary materials.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kamil Zaworski, Ph.D. study chair
John Paul II University in Biała Podlaska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbar manipulation, Negative communication - nocebo and Neutral communication in people with Back Pain, run by John Paul II University in Biała Podlaska at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Rating Scale (NRS) (time frame: Before the intervention, immediately after the intervention and 24 hours later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06537739, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.