Chronic Low Back PainNCT05202704
Investigating the Hypoalgesic Effects of Manipulative Therapy Using Pain Conditioning and Expectations in Low Back Pain
A study testing Procedure/Surgery: Experimental: Hidden conditioning + Positive Expectation, Procedure/Surgery: Active Comparator: Positive Expectation and Procedure/Surgery: Active Comparator: Neutral Expectation in people with Chronic Low Back Pain, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
Trial summary
The objective of this study will be to identify whether a conditioning procedure by the surreptitious downgrade of a noxious stimulus intensity associated with induced positive expectations about treatment will result in greater hypoalgesic effects when compared to positive verbal suggestions (positive expectation… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Procedure/Surgery: Experimental: Hidden conditioning + Positive Expectation, Procedure/Surgery: Active Comparator: Positive Expectation and Procedure/Surgery: Active Comparator: Neutral Expectation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Feb 2022to 10 Mar 2024
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The inclusion criteria for patients were as follows:
- Patients who report non-specific CLBP (in which the specific nociceptive source cannot be identified, confirmed by a medical assessment) for at least three months duration;
- Age ranged from 18 years to 60 years
- Baseline pain intensity score ≥3 on a Numeric Pain Rating Scale (NPRS) (because of the measurement error > 2 reported for the NPRS);
- Score greater than 14% on the Oswestry Disability Index (ODI) (to surpass the smallest detectable change of the ODI total score
- Patients able to speak and understand Portuguese well to fill out the questionnaires.
Show all 13Show fewer
- Patients will be excluded if they met any of the following criteria:
- Previous poor experiences with SMT through the application of a brief screening questionnaire
- Pregnancy
- Specific low back pain disorders like radiculopathy or lumbar stenosis or chronic degenerative disorders, i.e., uncontrolled cardiovascular, metabolic, or systemic diseases, neurological or psychiatric diseases, and stroke sequelae
- Undergoing other therapeutic interventions for chronic pain and low back pain (including surgeries) in the last 3 months
- Presence of contraindications to SMT
- Patients who reach the upper limit of 50ºC, which is the maximum temperature provided by the Q-sense equipment described in the Medoc, Israel website
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Unidade Saúde Escola - USE
São Carlos, São Paulo, 13.565-905
Helen Nogueira Carrer, PhD, 05516981638793, helennogueira@ufscar.br
About this study
Official title: Investigating the Hypoalgesic Effects of Spinal Manipulative Therapy Using Hidden Pain Conditioning and Positive Expectation in Chronic Low Back Pain Patients: Protocol for a Randomized Controlled Trial
The objective of this study will be to identify whether a conditioning procedure by the surreptitious downgrade of a noxious stimulus intensity associated with induced positive expectations about treatment will result in greater hypoalgesic effects when compared to positive verbal suggestions (positive expectation induction) alone regarding the effects of spinal manipulative therapy intervention in patients with CLBP. This study will enroll 264 individuals with CLBP aged between 18 and 60 years. Spinal Manipulative Therapy in the lumbar spine will be administered to all participants during 5 sessions.
First assessment session - participants will be submitted to a quantitative sensory testing (QST) to determine the heat pain threshold (calibration test) to run the conditioning procedure. Afterward, participants will be allocated by a blinded researcher into the following subgroups: hidden conditioning + positive expectation (G1); positive expectation alone (G2) and a group submitted to neutral expectations (G3) about the treatment.
Read more
First treatment session - Firstly, participants will receive instructions with the aim to induce positive (or neutral) expectations by means of a workshop. Secondly, all the participants will be submitted again to the pre-conditioning test, using the more intense pain stimulus obtained in the calibration test, then patients will be assessed regarding pain intensity and finally submitted to the manipulative therapy. At the end of the first treatment session, the conditioning test will be repeated, but the heat pain threshold of the hidden conditioning group (G1) will be surreptitiously downgraded (from intense pain stimulus to moderate pain stimulus) as a means of conditioning patients to believe that manipulative therapy promoted pain relief. Pain intensity will be assessed again to confirm a decrease in pain intensity.
Outcomes will be assessed three times: immediately after the five therapy sessions, one month later, and three months later. The primary outcomes assessed will be pain intensity and global perceived effect of improvement. The secondary outcome will be low back pain disability.
Read the detailed description
Background: The term "contextual effect" has been used to reinforce the view that the placebo effect should be understood as an effect related to the therapeutic context, and not restricted to the use of inert treatments. Thus, the placebo effect is inherent to any therapeutic context and also can be used to enhance the effects of treatment with active components. There is evidence of the effectiveness of manipulative therapy in the treatment of chronic low back pain (CLBP), however, for most physical therapy interventions, its effect is small. Thus, strategies to enhance the effects of this therapy, such as through the use of context factors, may contribute to better therapeutic outcomes. The literature describes conditioning or positive induced expectation models to favor the placebo effect. Although some previous studies have shown that expectation alone or associated with conditioning procedures may intensify the hypoalgesic effects of therapies, no previous work has verified the isolated or associated hypoalgesic effect of conditioning and induction of expectancy on treatment in patients with CLBP undergoing manipulative therapy. Thus, the objective of this study will be to identify whether a conditioning procedure through surreptitious downgrade of nociceptive stimulus intensity associated with positive induced expectation about treatment will result in greater hypoalgesic effects when compared to positive verbal suggestions (expectations) induced or expectation alone regarding the effects of the Spinal Manipulative Therapy intervention in patients with CLBP. Methods: it will be a randomized controlled trial with a blinded assessor. It will be investigated the effect of the use of a hidden conditioning procedure and the induction of positive expectations on pain intensity after the administration of a manipulative therapy approach. We will enroll 264 patients with nonspecific CLBP aged 18 to 60 years will participate in this study. The sample size calculation was based on a minimal difference between groups of 2 units on pain intensity and overall perception of improvement (primary outcomes). All patients will undergo 5 sessions of Manipulative Therapy in the lumbar spine, except the no-treatment group (G3). In the first session, patients will be subjected to the inclusion and exclusion criteria and the calibration test (quantitative sensory testing) to determine the intense, moderate and weak thermal pain threshold, using the Q-sense equipment, for the conditioning procedure.
In the second session (beginning of the treatment), firstly the patients will be randomized to one of the three groups by a blinded assessor: hidden conditioning + positive expectations (G1) group; positive expectations group (G2) and neutral expectation group (G3). Following, participants will receive specific instructions to induce expectation in G1 and G2, and for G3, neutral instructions.
In the first treatment session - patients will receive the pre-conditioning test (heat pain), then they will be submitted to the manipulative therapy and again undergo the heat-conditioning post-testing. However, G1 will receive hidden conditioning (surreptitiously downgrade of noxious stimulus intensity from intense to moderate pain) to reinforce the association between manipulative therapy and pain intensity reduction. Pain intensity will be assessed just after the conditioning procedures as a manipulation check of the downgrading of the noxious stimulus.
The main hypothesis of this study is that the group undergoing hidden conditioning associated with positive induced expectation will have a higher hypoalgesic effect than the other groups immediately post-treatment.
Outcomes will be assessed three times: immediately after the five therapy sessions, one month later, and three months later. The primary outcomes assessed will be pain intensity and global perceived effect of improvement. The secondary outcome will be low back pain disability.
- Conditions
- Chronic Low Back Pain
- Being tested
- Procedure/Surgery: Experimental: Hidden conditioning + Positive Expectation, Procedure/Surgery: Active Comparator: Positive Expectation, Procedure/Surgery: Active Comparator: Neutral Expectation, Spinal Manipulative Therapy
- Keywords
- Placebo Effect, Contextual Effect, Spinal Manipulative Therapy, Expectations, Chronic Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedure/Surgery: Experimental: Hidden conditioning + Positive ExpectationProcedure or surgery
Patients will be submitted to quantitative sensory testing to determine different thresholds of noxious heat pain stimulus (intense, moderate or weak). Afterward, participants will receive instructions with the aim to induce positive expectations about the treatment by means of a workshop. Immediately after the first session of manipulative therapy, participants will be submitted again to the QST but now the heat pain threshold of the hidden conditioning group will be surreptitiously downgraded (the intense noxious stimulus will be downgraded to the moderate stimulus - individually obtained during the QST) as a mean to conditioning patients to believe that spinal manipulative therapy promoted pain relief. Patients will be invited to report the pain intensity perceived just after the QST (second test - conditioning procedure). The objective of questioning the pain intensity after the conditioning test is a procedure check to ensure that the conditioning procedure worked.
Procedure/Surgery: Active Comparator: Positive ExpectationProcedure or surgery
Patients in this group will be submitted to a quantitative sensory testing to determine different thresholds of noxious heat pain stimulus (intense, moderate or weak). Afterward, participants will receive instructions with the aim to induce positive expectation about the treatment by means of a workshop. Immediately after the first session of spinal manipulative therapy, participants will be submitted again to the QST (without downgrading of the intense noxious heat stimulus). Patients will be invited to report the pain intensity perceived during the QST after the intervention. The objective of questioning the pain intensity in this group is a procedure check - to investigate whether the positive instructions will show any effect.
Procedure/Surgery: Active Comparator: Neutral ExpectationProcedure or surgery
Patients in this group will be submitted to a quantitative sensory testing to determine different thresholds of noxious heat pain stimulus (intense, moderate or weak). Afterward, participants will receive instructions with the aim to induce neutral expectation about the treatment by means of a workshop. Immediately after the first session of spinal manipulative therapy, participants will be submitted again to the QST (without downgrading of the intense noxious heat stimulus). Patients will be invited to report the pain intensity perceived during the QST after the intervention. The objective of questioning the pain intensity in this group is a procedure check - to investigate/confirm the effect of neutral instructions.
Spinal Manipulative TherapyProcedure or surgery
All the groups recruited in the study will receive five sessions of Spinal Manipulative Therapy. The intervention will be performed with the patient in the supine position. The clinician-researcher will passively lean over the patient to the side to be manipulated and ask the patient to place their hands behind their head. The researcher will then passively rotate the patient on the side to be manipulated and perform a posterior and inferior thrust on the opposite anterosuperior spine. The patients will receive 4 maneuvers (twice towards right side and twice towards left side).
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Hidden conditioning procedure + Positive Expectation | Experimental | Patients with chronic low back pain will receive verbal delivered positive instructions regarding manipulative therapy. Then, after the spinal manipulative therapy they will be submitted to a hidden conditioning procedure in which the pain threshold will be surreptitiously downgrade to conditioning pain decrease to manipulative therapy (G1). Receives: Procedure: Procedure/Surgery: Experimental: Hidden conditioning + Positive Expectation; Procedure: Spinal Manipulative Therapy |
| Active Comparator: Positive expectations | Active comparator | Patients with chronic low back pain will receive verbal delivered positive instructions regarding spinal manipulative therapy (G2) before the administration of a spinal manipulative therapy approach. Receives: Procedure: Procedure/Surgery: Active Comparator: Positive Expectation; Procedure: Spinal Manipulative Therapy |
| Active Comparator: Neutral Expectations | Active comparator | Patients with chronic low back pain will receive verbal delivered neutral instructions regarding spinal manipulative therapy (G3) before the administration of a spinal manipulative therapy approach. Receives: Procedure: Procedure/Surgery: Active Comparator: Neutral Expectation; Procedure: Spinal Manipulative Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric pain rating scale (NPRS)
The NPRS used in this trial will consist of numbers from 0 to 10, in which 0 represents "no pain" and 10 represents "worst pain imaginable". High scores mean worse pain intensity.
Measured: 6 weeks after randomization
Global Perceived Effect (GPE)
The GPE of improvement used for this trial is an 11-point scale that ranges from - 5 ("vastly worse") through 0 ("no change") to + 5 ("completely recovered") and participants are asked: "Compared to when this episode first started, how would you describe your orofacial pain these days?". A higher score indicates higher perception of recovery from the condition.
Measured: 6 weeks after randomization
Secondary outcomes (1)
Oswestry Disability Index (ODI)
The ODI consists of 10 items, each of which has six response options. The total score will be calculated by summing up all the points, ranging from 10 to 50. This sum will be transformed into a percentage (0 to 100). High scores mean worse disability.
Measured: 6 weeks and 3 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start20 Feb 2022
- Primary completion10 Dec 2023 (estimated)
- Study completion10 Mar 2024 (estimated)
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 Chronic Low 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sao Carlos
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Thais Chaves, Universidade Federal de Sao Carlos
- Investigators
- Thais Chaves, PhD, Study chair, Federal University of São Carlos - UFSCar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05202704
- Sponsor's protocol ID
- 52925921.5.0000.5504
- Status last verified
- Mar 2023
- First submitted
- 3 Dec 2021
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nogueira Carrer HC, de Lima TC, Campanha BES, George SZ, Reis FJJ, Dias DLC, Chaves TC. Effects of Hidden Conditioning and Positive Expectations on Pain Intensity Following Spinal Manipulative Therapy: A Three-Arm Randomized Controlled Trial. Eur J Pain. 2026 Oct;30(9):e70414. doi: 10.1002/ejp.70414.
PubMed 42862041Nogueira Carrer HC, Lima TC, George SZ, Reis FJJD, Dias DLC, Campanha BES, Chaves TC. Investigating the hypoalgesic effects of spinal manipulative therapy using hidden pain conditioning and positive expectation in patients with chronic low back pain: protocol for a randomised controlled trial. BMJ Open. 2023 Apr 12;13(4):e066199. doi: 10.1136/bmjopen-2022-066199.
PubMed 37045570
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Hypoalgesic Effects of Spinal Manipulative Therapy Using Hidden Pain Conditioning and Positive Expectation in Chronic Low Back Pain Patients: Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05202704
- Acronym / sponsor ID
- 52925921.5.0000.5504
- Conditions
- Chronic Low Back Pain
- Keywords
- Placebo Effect, Contextual Effect, Spinal Manipulative Therapy, Expectations, Chronic Low Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Universidade Federal de Sao CarlosUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 20 Feb 2022 (actual)
- Primary completion
- 10 Dec 2023 (estimated)
- Study completion
- 10 Mar 2024 (estimated)
- First posted
- 21 Jan 2022 (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 objective of this study will be to identify whether a conditioning procedure by the surreptitious downgrade of a noxious stimulus intensity associated with induced positive expectations about treatment will result in greater hypoalgesic effects when compared to positive verbal suggestions (positive expectation induction) alone regarding the effects of spinal manipulative therapy intervention in patients with CLBP. This study will enroll 264 individuals with CLBP aged between 18 and 60 years. Spinal Manipulative Therapy in the lumbar spine will be administered to all participants during 5 sessions.
First assessment session - participants will be submitted to a quantitative sensory testing (QST) to determine the heat pain threshold (calibration test) to run the conditioning procedure. Afterward, participants will be allocated by a blinded researcher into the following subgroups: hidden conditioning + positive expectation (G1); positive expectation alone (G2) and a group submitted to neutral expectations (G3) about the treatment.
First treatment session - Firstly, participants will receive instructions with the aim to induce positive (or neutral) expectations by means of a workshop. Secondly, all the participants will be submitted again to the pre-conditioning test, using the more intense pain stimulus obtained in the calibration test, then patients will be assessed regarding pain intensity and finally submitted to the manipulative therapy. At the end of the first treatment session, the conditioning test will be repeated, but the heat pain threshold of the hidden conditioning group (G1) will be surreptitiously downgraded (from intense pain stimulus to moderate pain stimulus) as a means of conditioning patients to believe that manipulative therapy promoted pain relief. Pain intensity will be assessed again to confirm a decrease in pain intensity.
Outcomes will be assessed three times: immediately after the five therapy sessions, one month later, and three months later. The primary outcomes assessed will be pain intensity and global perceived effect of improvement. The secondary outcome will be low back pain disability.
Detailed description
Background: The term "contextual effect" has been used to reinforce the view that the placebo effect should be understood as an effect related to the therapeutic context, and not restricted to the use of inert treatments. Thus, the placebo effect is inherent to any therapeutic context and also can be used to enhance the effects of treatment with active components. There is evidence of the effectiveness of manipulative therapy in the treatment of chronic low back pain (CLBP), however, for most physical therapy interventions, its effect is small. Thus, strategies to enhance the effects of this therapy, such as through the use of context factors, may contribute to better therapeutic outcomes. The literature describes conditioning or positive induced expectation models to favor the placebo effect. Although some previous studies have shown that expectation alone or associated with conditioning procedures may intensify the hypoalgesic effects of therapies, no previous work has verified the isolated or associated hypoalgesic effect of conditioning and induction of expectancy on treatment in patients with CLBP undergoing manipulative therapy. Thus, the objective of this study will be to identify whether a conditioning procedure through surreptitious downgrade of nociceptive stimulus intensity associated with positive induced expectation about treatment will result in greater hypoalgesic effects when compared to positive verbal suggestions (expectations) induced or expectation alone regarding the effects of the Spinal Manipulative Therapy intervention in patients with CLBP. Methods: it will be a randomized controlled trial with a blinded assessor. It will be investigated the effect of the use of a hidden conditioning procedure and the induction of positive expectations on pain intensity after the administration of a manipulative therapy approach. We will enroll 264 patients with nonspecific CLBP aged 18 to 60 years will participate in this study. The sample size calculation was based on a minimal difference between groups of 2 units on pain intensity and overall perception of improvement (primary outcomes). All patients will undergo 5 sessions of Manipulative Therapy in the lumbar spine, except the no-treatment group (G3). In the first session, patients will be subjected to the inclusion and exclusion criteria and the calibration test (quantitative sensory testing) to determine the intense, moderate and weak thermal pain threshold, using the Q-sense equipment, for the conditioning procedure.
In the second session (beginning of the treatment), firstly the patients will be randomized to one of the three groups by a blinded assessor: hidden conditioning + positive expectations (G1) group; positive expectations group (G2) and neutral expectation group (G3). Following, participants will receive specific instructions to induce expectation in G1 and G2, and for G3, neutral instructions.
In the first treatment session - patients will receive the pre-conditioning test (heat pain), then they will be submitted to the manipulative therapy and again undergo the heat-conditioning post-testing. However, G1 will receive hidden conditioning (surreptitiously downgrade of noxious stimulus intensity from intense to moderate pain) to reinforce the association between manipulative therapy and pain intensity reduction. Pain intensity will be assessed just after the conditioning procedures as a manipulation check of the downgrading of the noxious stimulus.
The main hypothesis of this study is that the group undergoing hidden conditioning associated with positive induced expectation will have a higher hypoalgesic effect than the other groups immediately post-treatment.
Outcomes will be assessed three times: immediately after the five therapy sessions, one month later, and three months later. The primary outcomes assessed will be pain intensity and global perceived effect of improvement. The secondary outcome will be low back pain disability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental: Hidden conditioning procedure + Positive Expectation | Experimental | Procedure: Procedure/Surgery: Experimental: Hidden conditioning + Positive Expectation, Procedure: Spinal Manipulative TherapyPatients with chronic low back pain will receive verbal delivered positive instructions regarding manipulative therapy. Then, after the spinal manipulative therapy they will be submitted to a hidden conditioning procedure in which the pain threshold will be surreptitiously downgrade to conditioning pain decrease to manipulative therapy (G1). |
| Active Comparator: Positive expectations | Active comparator | Procedure: Procedure/Surgery: Active Comparator: Positive Expectation, Procedure: Spinal Manipulative TherapyPatients with chronic low back pain will receive verbal delivered positive instructions regarding spinal manipulative therapy (G2) before the administration of a spinal manipulative therapy approach. |
| Active Comparator: Neutral Expectations | Active comparator | Procedure: Procedure/Surgery: Active Comparator: Neutral Expectation, Procedure: Spinal Manipulative TherapyPatients with chronic low back pain will receive verbal delivered neutral instructions regarding spinal manipulative therapy (G3) before the administration of a spinal manipulative therapy approach. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Patients who report non-specific CLBP (in which the specific nociceptive source cannot be identified, confirmed by a medical assessment) for at least three months duration;
- Age ranged from 18 years to 60 years
- Baseline pain intensity score ≥3 on a Numeric Pain Rating Scale (NPRS) (because of the measurement error > 2 reported for the NPRS);
- Score greater than 14% on the Oswestry Disability Index (ODI) (to surpass the smallest detectable change of the ODI total score
- Patients able to speak and understand Portuguese well to fill out the questionnaires.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Procedure/Surgery: Experimental: Hidden conditioning + Positive ExpectationPatients will be submitted to quantitative sensory testing to determine different thresholds of noxious heat pain stimulus (intense, moderate or weak). Afterward, participants will receive instructions with the aim to induce positive expectations about the treatment by means of a workshop. Immediately after the first session of manipulative therapy, participants will be submitted again to the QST but now the heat pain threshold of the hidden conditioning group will be surreptitiously downgraded (the intense noxious stimulus will be downgraded to the moderate stimulus - individually obtained during the QST) as a mean to conditioning patients to believe that spinal manipulative therapy promoted pain relief. Patients will be invited to report the pain intensity perceived just after the QST (second test - conditioning procedure). The objective of questioning the pain intensity after the conditioning test is a procedure check to ensure that the conditioning procedure worked. | Procedure or surgery | Experimental: Hidden conditioning procedure + Positive Expectation |
| Procedure/Surgery: Active Comparator: Positive ExpectationPatients in this group will be submitted to a quantitative sensory testing to determine different thresholds of noxious heat pain stimulus (intense, moderate or weak). Afterward, participants will receive instructions with the aim to induce positive expectation about the treatment by means of a workshop. Immediately after the first session of spinal manipulative therapy, participants will be submitted again to the QST (without downgrading of the intense noxious heat stimulus). Patients will be invited to report the pain intensity perceived during the QST after the intervention. The objective of questioning the pain intensity in this group is a procedure check - to investigate whether the positive instructions will show any effect. | Procedure or surgery | Active Comparator: Positive expectations |
| Procedure/Surgery: Active Comparator: Neutral ExpectationPatients in this group will be submitted to a quantitative sensory testing to determine different thresholds of noxious heat pain stimulus (intense, moderate or weak). Afterward, participants will receive instructions with the aim to induce neutral expectation about the treatment by means of a workshop. Immediately after the first session of spinal manipulative therapy, participants will be submitted again to the QST (without downgrading of the intense noxious heat stimulus). Patients will be invited to report the pain intensity perceived during the QST after the intervention. The objective of questioning the pain intensity in this group is a procedure check - to investigate/confirm the effect of neutral instructions. | Procedure or surgery | Active Comparator: Neutral Expectations |
| Spinal Manipulative TherapyAll the groups recruited in the study will receive five sessions of Spinal Manipulative Therapy. The intervention will be performed with the patient in the supine position. The clinician-researcher will passively lean over the patient to the side to be manipulated and ask the patient to place their hands behind their head. The researcher will then passively rotate the patient on the side to be manipulated and perform a posterior and inferior thrust on the opposite anterosuperior spine. The patients will receive 4 maneuvers (twice towards right side and twice towards left side). | Procedure or surgery | Active Comparator: Neutral Expectations, Active Comparator: Positive expectations, Experimental: Hidden conditioning procedure + Positive Expectation |
Primary outcome
Numeric pain rating scale (NPRS)
Time frame: 6 weeks after randomization
The NPRS used in this trial will consist of numbers from 0 to 10, in which 0 represents "no pain" and 10 represents "worst pain imaginable". High scores mean worse pain intensity.
Global Perceived Effect (GPE)
Time frame: 6 weeks after randomization
The GPE of improvement used for this trial is an 11-point scale that ranges from - 5 ("vastly worse") through 0 ("no change") to + 5 ("completely recovered") and participants are asked: "Compared to when this episode first started, how would you describe your orofacial pain these days?". A higher score indicates higher perception of recovery from the condition.
1 secondary outcome
Oswestry Disability Index (ODI)
Time frame: 6 weeks and 3 months after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Derived from this study: PubMed 42862041Nogueira Carrer HC, de Lima TC, Campanha BES, George SZ, Reis FJJ, Dias DLC, Chaves TC. Effects of Hidden Conditioning and Positive Expectations on Pain Intensity Following Spinal Manipulative Therapy: A Three-Arm Randomized Controlled Trial. Eur J Pain. 2026 Oct;30(9):e70414. doi: 10.1002/ejp.70414.
- Derived from this study: PubMed 37045570Nogueira Carrer HC, Lima TC, George SZ, Reis FJJD, Dias DLC, Campanha BES, Chaves TC. Investigating the hypoalgesic effects of spinal manipulative therapy using hidden pain conditioning and positive expectation in patients with chronic low back pain: protocol for a randomised controlled trial. BMJ Open. 2023 Apr 12;13(4):e066199. doi: 10.1136/bmjopen-2022-066199.
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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.
Thais Chaves, PhD study chair
Federal University of São Carlos - UFSCar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Procedure/Surgery: Experimental: Hidden conditioning + Positive Expectation, Procedure/Surgery: Active Comparator: Positive Expectation and Procedure/Surgery: Active Comparator: Neutral Expectation in people with Chronic Low Back Pain, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
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 13 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 23 Mar 2023. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thaís C Chaves, PhD (+55 (16) 3602-4694, thaischaves@ufscar.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric pain rating scale (NPRS) (time frame: 6 weeks after randomization). The study lists 2 primary outcomes in all. 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 NCT05202704, 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 23 Mar 2023.