Chronic Low-back PainNCT05996991
The Impact of Positive, Neutral and Negative Expectation Speech on Manipulative Therapy Effects
A study testing Positive expectation speech regarding spinal manipulative therapy, Neutral expectation speech regarding spinal manipulative therapy and Negative expectation speech regarding spinal manipulative therapy 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 the short-term impact of positive, neutral, or negative speech on pain intensity (primary outcome). The secondary outcomes assessed will be the global perceived effect of improvement, patient's expectations regarding spinal manipulative therapy (SMT) intervention, and… 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?
- Positive expectation speech regarding spinal manipulative therapy, Neutral expectation speech regarding spinal manipulative therapy and Negative expectation speech regarding spinal manipulative therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2023to 15 Dec 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
- 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);
- Patients able to speak and understand Portuguese well to fill out the questionnaires.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of São Carlos - Department of Physical Therapy
São Carlos, São Paulo, 13.565-905
Thais C Chaves, PhD, 05516996092206, thaischaves@ufscar.br
Thamiris C Lima, PhD, 05516991533628, thamiriscl@estudante.ufscar.br
About this study
Official title: Understanding the Impact of Positive, Neutral and Negative Expectation Speech Regarding Manual Therapy Intervention in Patients With Chronic Low Back Pain: a Pilot Study
The objective of this study will be to identify the short-term impact of positive, neutral, or negative speech on pain intensity (primary outcome). The secondary outcomes assessed will be the global perceived effect of improvement, patient's expectations regarding spinal manipulative therapy (SMT) intervention, and perception of empathy in the therapeutic encounter in patients with chronic low back pain (CLBP). This study will enroll 60 participants with CLBP aged between 18 and 60 years.
This is an exploratory randomized clinical trial. The three groups will receive a manual therapy session after watching the video proposed for their group.
Read more
First participants will be assessed for pain intensity, low back pain disability, psychosocial aspects, and expectations related to treatment. Secondly, a researcher not involved in the recruitment of patients will randomly allocate the participants into three different groups (G1- group submitted to positive expectation, G2- group submitted to neutral expectation, and G3- group submitted to negative expectation). After the allocation, the participants will watch a short video (no more than 3 minutes) delivering positive, negative, or neutral messages regarding SMT. And finally, a physiotherapist will administer one session of SMT and participants will be re-assessed to investigate the immediate effect of the videos on the pain intensity, global perceived effect of improvement, and expectations.
Ultimately, patients will be submitted to a semi-structured interview in which their perceptions about the videos will be investigated.
Outcomes will be assessed just immediately after one SMT session.
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 that positively induced expectations can trigger a placebo effect. There are previous studies that investigated the effect of different speech on SMT in patients with chronic neck pain, but there is no study in CLBP. In addition, no previous study investigated further the perceptions of patients regarding the content and perceptions of the videos.
The objective of this study will be to identify the short-term impact of positive, neutral, or negative speech on pain intensity (primary outcome). The secondary outcomes assessed will be the global perceived effect of improvement, patient's expectations regarding spinal manipulative therapy (SMT) intervention, and perception of empathy in the therapeutic encounter in patients with chronic low back pain (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.
This is an exploratory randomized clinical trial. The three groups will receive one session of SMT after watching the video proposed for their group.
First participants will be assessed for pain intensity, low back pain disability, psychosocial aspects, and expectations related to treatment. Secondly, a researcher not involved in the recruitment of patients will randomly allocate the participants into three different groups (G1- group submitted to positive expectation, G2- group submitted to neutral expectation, and G3- group submitted to negative expectation). After the allocation, the participants will watch a short video (no more than 3 minutes) delivering positive, negative, or neutral messages regarding SMT. And finally, a physiotherapist will administer one session of SMT and participants will be re-assessed to investigate the immediate effect of the videos on the pain intensity, global perceived effect of improvement, and expectations. Ultimately, patients will be submitted to a semi-structured interview in which their perceptions about the videos will be investigated. It will help to understand if the content of the videos actually causes an impact on the expectations of the patients.
The main hypothesis of this study is that the group submitted to the positive expectation speech will have a higher hypoalgesic effect, greater perception of improvement, and higher expectations regarding SMT than the other groups immediately post-treatment.
Outcomes will be assessed just immediately after one SMT session.
- Conditions
- Chronic Low-back Pain
- Being tested
- Positive expectation speech regarding spinal manipulative therapy, Neutral expectation speech regarding spinal manipulative therapy, Negative expectation speech regarding spinal manipulative therapy, Spinal Manipulative Therapy
- Keywords
- Placebo Effect, Chronic low-back Pain, Spinal Manipulative Therapy, Expectations, contextual effect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive expectation speech regarding spinal manipulative therapyOther
Patients will watch a short video with positive expectations regarding spinal manipulative therapy.
Neutral expectation speech regarding spinal manipulative therapyOther
Patients will watch a short video with neutral expectations regarding spinal manipulative therapy.
Negative expectation speech regarding spinal manipulative therapyOther
Also called Manual Therapy
Patients will watch a short video with negative expectations regarding spinal manipulative therapy.
Spinal Manipulative TherapyProcedure or surgery
Also called Manual Therapy
One session of Spinal Manipulative Therapy. The researcher will administer a posterior and inferior push on the opposite anterior superior iliac spine (ASIS) while passively rotating the subject on the side to be manipulated. The spinal manipulations will be repeated four times during a 5-minute period, with impulses oscillating between the right and left ASIS. In addition, we will administrate mobilizations (anterior-posterior central mobilization), applied for 1 minute in each lumbar vertebra (from L5 to L1), using grade I joint mobilization (patients positioned in the ventral decubitus position).
| Study group | Role | What they receive |
|---|---|---|
| G1 - Positive Expectation Group + Spinal Manipulative Therapy | Experimental | The participants of G1 will watch a short video (no more than 3 minutes) delivering a positive message regarding SMT. Secondly, a physiotherapist will administer one session of SMT and participants will be re-assessed to investigate the immediate effect of the videos on the pain intensity, global perceived effect of improvement, and expectations. Ultimately, patients will be submitted to a semi-structured interview in which their perceptions about the videos will be investigated. Receives: Other: Positive expectation speech regarding spinal manipulative therapy; Procedure: Spinal Manipulative Therapy |
| G2 - Neutral Expectation Group + Spinal Manipulative Therapy | Active comparator | The participants of G1 will watch a short video (no more than 3 minutes) delivering a neutral message regarding SMT. Secondly, a physiotherapist will administer one session of SMT and participants will be re-assessed to investigate the immediate effect of the videos on the pain intensity, global perceived effect of improvement, and expectations. Ultimately, patients will be submitted to a semi-structured interview in which their perceptions about the videos will be investigated. Receives: Other: Neutral expectation speech regarding spinal manipulative therapy; Procedure: Spinal Manipulative Therapy |
| G2 - Negative Expectation Group + Spinal Manipulative Therapy | Active comparator | The participants of G1 will watch a short video (no more than 3 minutes) delivering a negative message regarding SMT. Secondly, a physiotherapist will administer one session of SMT and participants will be re-assessed to investigate the immediate effect of the videos on the pain intensity, global perceived effect of improvement, and expectations. Ultimately, patients will be submitted to a semi-structured interview in which their perceptions about the videos will be investigated. Receives: Other: Negative expectation speech regarding spinal manipulative therapy; Procedure: Spinal Manipulative Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
The Numeric Pain Rating Scale (NPRS) will be used to assess pain intensity in this trial and consists in a sequence of numbers from zero to ten, in which zero represents "no pain" and 10 represents "worst pain imaginable"
Measured: one-hour after the baseline assessment
Secondary outcomes (4)
Global Perceived Effect (GPE) of Improvement
The GPE of improvement used for this trial is an 11-point scale that ranges from "-5" ("vastly worse") through zero ("no change") to "+5" ("completely recovered") and patients 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: one-hour after the baseline assessment
Low-back Pain (LBP) Expectation Scale
The LBP Expectation Scale assesses the patient's previous expectation that the LBP will improve. The participant is asked to respond using an 11-point scale, ranging from zero to ten, where zero represents "no chance" and ten represents "very likely".
Measured: one-hour after the baseline assessment
Treatment Expectations in Chronic Pain Scale (TEC)
The TEC scale is a self-report questionnaire measuring patients' ideal and predicted expectations. The scale has 9 items which were designed to measure two aspects of expectations, namely process and outcome expectations. Instructions are as follows: 'The following questions are about your expectations of the treatment you will receive for your chronic pain. For each question, please check the box that best corresponds to (1) what you ideally hope will happen (in an ideal world, what would you want to happen) during your health care appointment(s) and (2) what you realistically expect will happen (in real life, what do you expect will actually happen) during your health care appointment(s). For each item, patients are asked to select the extent to which they agree with the statement on a 5-point scale (1 = strongly disagree to 5 = strongly agree) in terms of their ideal and predicted expectations. Each item is thus scored twice by participants.
Measured: one-hour after the baseline assessment
Empathy - Care Scale
The Consultation and Relational Empathy (CARE) Measure is a person-centred process measure that was developed and researched at the Departments of General Practice in Glasgow University and Edinburgh University. The CARE Measure is a quick (only 10 questions), clear and easy to complete patient-completed questionnaire. It measures empathy in the context of the therapeutic relationship during a one-on-one consultation between a clinician and a patient. The score of the CARE ranges from 10 to 50. Higher the score, higher the perceived quality of the encounter with healthcare professionals.
Measured: one-hour after the baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start1 Oct 2023 (estimated)
- Primary completion1 Mar 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Randomized Clinical Trial with three parallel arms
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sao Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thais Chaves, Universidade Federal de Sao Carlos
- Investigators
- Thais C Chaves, PHD, Study chair, Federal University of São Carlos - UFSCar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05996991
- Sponsor's protocol ID
- 62827822.2.0000.5504
- Status last verified
- Aug 2023
- First submitted
- 4 Aug 2023
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Impact of Positive, Neutral and Negative Expectation Speech Regarding Manual Therapy Intervention in Patients With Chronic Low Back Pain: a Pilot Study
- ClinicalTrials.gov ID
- NCT05996991
- Acronym / sponsor ID
- 62827822.2.0000.5504
- Conditions
- Chronic Low-back Pain
- Keywords
- Placebo Effect, Chronic low-back Pain, Spinal Manipulative Therapy, Expectations, contextual effect
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidade Federal de Sao CarlosUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 18 Aug 2023 (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 the short-term impact of positive, neutral, or negative speech on pain intensity (primary outcome). The secondary outcomes assessed will be the global perceived effect of improvement, patient's expectations regarding spinal manipulative therapy (SMT) intervention, and perception of empathy in the therapeutic encounter in patients with chronic low back pain (CLBP). This study will enroll 60 participants with CLBP aged between 18 and 60 years.
This is an exploratory randomized clinical trial. The three groups will receive a manual therapy session after watching the video proposed for their group.
First participants will be assessed for pain intensity, low back pain disability, psychosocial aspects, and expectations related to treatment. Secondly, a researcher not involved in the recruitment of patients will randomly allocate the participants into three different groups (G1- group submitted to positive expectation, G2- group submitted to neutral expectation, and G3- group submitted to negative expectation). After the allocation, the participants will watch a short video (no more than 3 minutes) delivering positive, negative, or neutral messages regarding SMT. And finally, a physiotherapist will administer one session of SMT and participants will be re-assessed to investigate the immediate effect of the videos on the pain intensity, global perceived effect of improvement, and expectations.
Ultimately, patients will be submitted to a semi-structured interview in which their perceptions about the videos will be investigated.
Outcomes will be assessed just immediately after one SMT session.
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 that positively induced expectations can trigger a placebo effect. There are previous studies that investigated the effect of different speech on SMT in patients with chronic neck pain, but there is no study in CLBP. In addition, no previous study investigated further the perceptions of patients regarding the content and perceptions of the videos.
The objective of this study will be to identify the short-term impact of positive, neutral, or negative speech on pain intensity (primary outcome). The secondary outcomes assessed will be the global perceived effect of improvement, patient's expectations regarding spinal manipulative therapy (SMT) intervention, and perception of empathy in the therapeutic encounter in patients with chronic low back pain (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.
This is an exploratory randomized clinical trial. The three groups will receive one session of SMT after watching the video proposed for their group.
First participants will be assessed for pain intensity, low back pain disability, psychosocial aspects, and expectations related to treatment. Secondly, a researcher not involved in the recruitment of patients will randomly allocate the participants into three different groups (G1- group submitted to positive expectation, G2- group submitted to neutral expectation, and G3- group submitted to negative expectation). After the allocation, the participants will watch a short video (no more than 3 minutes) delivering positive, negative, or neutral messages regarding SMT. And finally, a physiotherapist will administer one session of SMT and participants will be re-assessed to investigate the immediate effect of the videos on the pain intensity, global perceived effect of improvement, and expectations. Ultimately, patients will be submitted to a semi-structured interview in which their perceptions about the videos will be investigated. It will help to understand if the content of the videos actually causes an impact on the expectations of the patients.
The main hypothesis of this study is that the group submitted to the positive expectation speech will have a higher hypoalgesic effect, greater perception of improvement, and higher expectations regarding SMT than the other groups immediately post-treatment.
Outcomes will be assessed just immediately after one SMT session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized Clinical Trial with three parallel arms
| Arm | Type | Receives |
|---|---|---|
| G1 - Positive Expectation Group + Spinal Manipulative Therapy | Experimental | Other: Positive expectation speech regarding spinal manipulative therapy, Procedure: Spinal Manipulative TherapyThe participants of G1 will watch a short video (no more than 3 minutes) delivering a positive message regarding SMT. Secondly, a physiotherapist will administer one session of SMT and participants will be re-assessed to investigate the immediate effect of the videos on the pain intensity, global perceived effect of improvement, and expectations. Ultimately, patients will be submitted to a semi-structured interview in which their perceptions about the videos will be investigated. |
| G2 - Neutral Expectation Group + Spinal Manipulative Therapy | Active comparator | Other: Neutral expectation speech regarding spinal manipulative therapy, Procedure: Spinal Manipulative TherapyThe participants of G1 will watch a short video (no more than 3 minutes) delivering a neutral message regarding SMT. Secondly, a physiotherapist will administer one session of SMT and participants will be re-assessed to investigate the immediate effect of the videos on the pain intensity, global perceived effect of improvement, and expectations. Ultimately, patients will be submitted to a semi-structured interview in which their perceptions about the videos will be investigated. |
| G2 - Negative Expectation Group + Spinal Manipulative Therapy | Active comparator | Other: Negative expectation speech regarding spinal manipulative therapy, Procedure: Spinal Manipulative TherapyThe participants of G1 will watch a short video (no more than 3 minutes) delivering a negative message regarding SMT. Secondly, a physiotherapist will administer one session of SMT and participants will be re-assessed to investigate the immediate effect of the videos on the pain intensity, global perceived effect of improvement, and expectations. Ultimately, patients will be submitted to a semi-structured interview in which their perceptions about the videos will be investigated. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 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);
- Patients able to speak and understand Portuguese well to fill out the questionnaires.
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Positive expectation speech regarding spinal manipulative therapyPatients will watch a short video with positive expectations regarding spinal manipulative therapy. | Other | G1 - Positive Expectation Group + Spinal Manipulative Therapy |
| Neutral expectation speech regarding spinal manipulative therapyPatients will watch a short video with neutral expectations regarding spinal manipulative therapy. | Other | G2 - Neutral Expectation Group + Spinal Manipulative Therapy |
| Negative expectation speech regarding spinal manipulative therapyAlso: Manual TherapyPatients will watch a short video with negative expectations regarding spinal manipulative therapy. | Other | G2 - Negative Expectation Group + Spinal Manipulative Therapy |
| Spinal Manipulative TherapyAlso: Manual TherapyOne session of Spinal Manipulative Therapy. The researcher will administer a posterior and inferior push on the opposite anterior superior iliac spine (ASIS) while passively rotating the subject on the side to be manipulated. The spinal manipulations will be repeated four times during a 5-minute period, with impulses oscillating between the right and left ASIS. In addition, we will administrate mobilizations (anterior-posterior central mobilization), applied for 1 minute in each lumbar vertebra (from L5 to L1), using grade I joint mobilization (patients positioned in the ventral decubitus position). | Procedure or surgery | G1 - Positive Expectation Group + Spinal Manipulative Therapy, G2 - Negative Expectation Group + Spinal Manipulative Therapy, G2 - Neutral Expectation Group + Spinal Manipulative Therapy |
Primary outcome
Pain intensity
Time frame: one-hour after the baseline assessment
The Numeric Pain Rating Scale (NPRS) will be used to assess pain intensity in this trial and consists in a sequence of numbers from zero to ten, in which zero represents "no pain" and 10 represents "worst pain imaginable"
4 secondary outcomes
Global Perceived Effect (GPE) of Improvement
Time frame: one-hour after the baseline assessment
Low-back Pain (LBP) Expectation Scale
Time frame: one-hour after the baseline assessment
Treatment Expectations in Chronic Pain Scale (TEC)
Time frame: one-hour after the baseline assessment
Empathy - Care Scale
Time frame: one-hour after the baseline assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
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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 C 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 Positive expectation speech regarding spinal manipulative therapy, Neutral expectation speech regarding spinal manipulative therapy and Negative expectation speech regarding spinal manipulative therapy 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 4 inclusion and 5 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 18 Aug 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 Thais C Chaves, PhD (05516 996092206, thaischaves@ufscar.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: one-hour after the baseline assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Aug 2023.