Low Back PainNCT05042115
Effects of Osteopathic Manipulative Treatment Associated With Pain Education and Clinical Hypnosis
A study testing Education in pain neurosciences and clinical hypnosis and Education in pain neurosciences and clinical hypnosis plus osteopathic manipulative treatment in people with Low Back Pain, run by Instituto Docusse de Osteopatia e Terapia Manual at 1 site in Brazil.
Trial summary
INTRODUCTION: Chronic low back pain (CLBD) is one of the major public health problems in the world. Given the complexity of the situation, complementary and alternative practices such as pain neuroscience education (PNE), clinical hypnosis (HC) and osteopathic manipulative treatment (OMT) are options for we manage… Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Education in pain neurosciences and clinical hypnosis and Education in pain neurosciences and clinical hypnosis plus osteopathic manipulative treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Sep 2022to 28 Feb 2023
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Nonspecific Low Back Pain for at least 3 months
- Score on the numerical pain scale of at least 3 points
Who cannot join
- Data from participants with less than 95% of sinus beats
- Participants that present increased symptoms in any stages of the study
- Patients who are undergoing concomitant physical therapy treatment, patients with contraindications to exercise, smokers/alcoholics, severe vertebral or neural pathologies, previous spine surgeries, cardiorespiratory disease, LBP as a secondary complaint, pregnancy, hearing problems, or illiteracy patients, not will are able to participate the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Osteopathic Manipulative Treatment Associated With Education About Pain and Clinical Hypnosis and Their Repercussions on Pain and Disability in Chronic Low Back Pain - Randomized Clinical Trial
INTRODUCTION: Chronic low back pain (CLBD) is one of the major public health problems in the world. Given the complexity of the situation, complementary and alternative practices such as pain neuroscience education (PNE), clinical hypnosis (HC) and osteopathic manipulative treatment (OMT) are options for we manage these patients. OBJECTIVE: The aim of this study will be to evaluate the effects of OMT associated with PNE through HC on pain and disability in patients with CLBP compared to PNE and HC. MATERIALS AND METHODS: The study design will be a randomized clinical trial and 40 adults diagnosed with chronic low back pain will be recruited. Subjects will be randomized in two groups: the first group (G1) will be submitted to the PNE based on information from the book "Explain Pain" with hypnotic suggestions. Group 2 (G2) will receive PNE following the book "Explain Pain" with hypnotic suggestions associated with OMT. Volunteers will be evaluated by a blind researcher the interventions performed in the allocation of groups. The evaluation moments will be pre-intervention and immediately after the end of the last intervention for G1 and G2. Volunteers continued to be evaluated 4 weeks after completion of the protocols. Pain will be evaluated as the main outcome, being evaluated by the numerical pain scale. Pain will also be assessed by the pressure threshold using a pressure algometer device (Fnd-50, PIAB 50-n, Italy) in the lumbar region. Still as the main outcome, disability will be assessed using the Oswestry Disability Questionnaire. As secondary outcomes, the patient's global impression of improvement, central sensitization, biopsychosocial factors will be evaluated. The patient's global impression of improvement will be assessed using the Percentage of Improvement Scale with a score of -5 to +5; the Central Sensitization will be assessed using the Central Sensitization Questionnaire and the biopsychosocial factors using the Start Beck Toll questionnaire. In addition, the behavior of the autonomic nervous system will be evaluated through the Heart Rate Variability (HRV), which will be analyzed through linear methods, in the domains of time and frequency, and by geometric indices. The researcher/evaluator will be blinded to the allocation of intervention groups. Given the nature of the study, it is impossible to blind the researcher/therapist and volunteers.
- Conditions
- Low Back Pain
- Being tested
- Education in pain neurosciences and clinical hypnosis, Education in pain neurosciences and clinical hypnosis plus osteopathic manipulative treatment
- Keywords
- Low Back Pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education in pain neurosciences and clinical hypnosisOther
Will be performed education in pain neurosciences and clinical hypnosis, in 4 sessions during 4 weeks
Education in pain neurosciences and clinical hypnosis plus osteopathic manipulative treatmentOther
Will be performed education in pain neurosciences and clinical hypnosis, and only for this group will be delivered osteopathic manipulative treatment, in 4 sessions during 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Education in pain neurosciences and clinical hypnosis | Experimental | Pain neuroscience education and clinical hypnosis Receives: Other: Education in pain neurosciences and clinical hypnosis |
| Education in pain neurosciences and clinical hypnosis plus Osteopathic manipulative treatment | Active comparator | Pain neuroscience education and clinical hypnosis, associated with osteopathic manipulative treatment Receives: Other: Education in pain neurosciences and clinical hypnosis plus osteopathic manipulative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain perception
The Pain suffered in the last week will be assessed by the Numerical pain scale, with a range of 0 - 10
Measured: T0= before the protocol; T1= until 24 hours after the end protocol; T2= four weeks after end protocols
Pain pressure threshold
Pain will be assessed by the pressure threshold using a pressure algometer device in the lumbar region. The assessment will be conducted specifically in the paravertebral muscles bilaterally at levels L1 to L5.
Measured: T0= before the protocol; T1= until 24 hours after the end protocol; T2= four weeks after end protocols
Disability
Disability will be assessed using the Oswestry Disability Questionnaire
Measured: T0= before the protocol; T1= until 24 hours after the end protocol; T2= four weeks after end protocols
Secondary outcomes (3)
Patient's global impression of improvement
The patient's global impression of improvement will be assessed using the Percentage of Improvement Scale with a score of -5 to +5
Measured: T0= before the protocol; T1= until 24 hours after the end protocol; T2= four weeks after end protocols
Central Sensitization and biopsychosocial factors
The Central Sensitization Questionnaire and the biopsychosocial factors will be assessed using the Start Beck Toll questionnaire
Measured: T0= before the protocol; T1= until 24 hours after the end protocol; T2= four weeks after end protocols
Heart Rate Variability
Heart Rate Variability, which will be analyzed through linear methods, in the domains of time and frequency, and by geometric indices
Measured: T0= before the protocol; T1= until 24 hours after the end protocol; T2= four weeks after end protocols
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start10 Sep 2022
- Primary completion30 Nov 2022
- Study completion28 Feb 2023
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 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
- Education in Pain Neuroscience through Clinical Hypnosis associated with Osteopathic Manipulative Treatment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Docusse de Osteopatia e Terapia Manual
- Sponsor type
- Research network
- Collaborators
- Universidade Estadual do Norte do Paraná
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05042115
- Sponsor's protocol ID
- 43063621.3.0000.8123
- Status last verified
- Mar 2024
- First submitted
- 4 Sep 2021
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD will be shared by request
Publications
Luchesi GLS, da Silva AKF, Chaves TC, Jassi FJ. Osteopathic manipulative treatment, pain neuroscience education and clinical hypnosis as pain management interventions in chronic low back pain: a randomized sham-controlled feasibility pilot trial. J Bodyw Mov Ther. 2026 Jun;46:632-640. doi: 10.1016/j.jbmt.2025.12.032. Epub 2025 Dec 24.
PubMed 41927231Luchesi GLS, da Silva AKF, Amaral OHB, de Paula VCG, Jassi FJ. Effects of osteopathic manipulative treatment associated with pain education and clinical hypnosis in individuals with chronic low back pain: study protocol for a randomized sham-controlled clinical trial. Trials. 2022 Dec 30;23(1):1066. doi: 10.1186/s13063-022-07040-y.
PubMed 36581902
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteopathic Manipulative Treatment Associated With Education About Pain and Clinical Hypnosis and Their Repercussions on Pain and Disability in Chronic Low Back Pain - Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05042115
- Acronym / sponsor ID
- 43063621.3.0000.8123
- Conditions
- Low Back Pain
- Keywords
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Instituto Docusse de Osteopatia e Terapia ManualResearch network
- Collaborators
- Universidade Estadual do Norte do Paraná
- Study start
- 10 Sep 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 13 Sep 2021 (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.
INTRODUCTION: Chronic low back pain (CLBD) is one of the major public health problems in the world. Given the complexity of the situation, complementary and alternative practices such as pain neuroscience education (PNE), clinical hypnosis (HC) and osteopathic manipulative treatment (OMT) are options for we manage these patients. OBJECTIVE: The aim of this study will be to evaluate the effects of OMT associated with PNE through HC on pain and disability in patients with CLBP compared to PNE and HC. MATERIALS AND METHODS: The study design will be a randomized clinical trial and 40 adults diagnosed with chronic low back pain will be recruited. Subjects will be randomized in two groups: the first group (G1) will be submitted to the PNE based on information from the book "Explain Pain" with hypnotic suggestions. Group 2 (G2) will receive PNE following the book "Explain Pain" with hypnotic suggestions associated with OMT. Volunteers will be evaluated by a blind researcher the interventions performed in the allocation of groups. The evaluation moments will be pre-intervention and immediately after the end of the last intervention for G1 and G2. Volunteers continued to be evaluated 4 weeks after completion of the protocols. Pain will be evaluated as the main outcome, being evaluated by the numerical pain scale. Pain will also be assessed by the pressure threshold using a pressure algometer device (Fnd-50, PIAB 50-n, Italy) in the lumbar region. Still as the main outcome, disability will be assessed using the Oswestry Disability Questionnaire. As secondary outcomes, the patient's global impression of improvement, central sensitization, biopsychosocial factors will be evaluated. The patient's global impression of improvement will be assessed using the Percentage of Improvement Scale with a score of -5 to +5; the Central Sensitization will be assessed using the Central Sensitization Questionnaire and the biopsychosocial factors using the Start Beck Toll questionnaire. In addition, the behavior of the autonomic nervous system will be evaluated through the Heart Rate Variability (HRV), which will be analyzed through linear methods, in the domains of time and frequency, and by geometric indices. The researcher/evaluator will be blinded to the allocation of intervention groups. Given the nature of the study, it is impossible to blind the researcher/therapist and volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Education in Pain Neuroscience through Clinical Hypnosis associated with Osteopathic Manipulative Treatment
| Arm | Type | Receives |
|---|---|---|
| Education in pain neurosciences and clinical hypnosis | Experimental | Other: Education in pain neurosciences and clinical hypnosisPain neuroscience education and clinical hypnosis |
| Education in pain neurosciences and clinical hypnosis plus Osteopathic manipulative treatment | Active comparator | Other: Education in pain neurosciences and clinical hypnosis plus osteopathic manipulative treatmentPain neuroscience education and clinical hypnosis, associated with osteopathic manipulative treatment |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Nonspecific Low Back Pain for at least 3 months
- Score on the numerical pain scale of at least 3 points
Key exclusion criteria (3 listed)
- Data from participants with less than 95% of sinus beats
- Participants that present increased symptoms in any stages of the study
- Patients who are undergoing concomitant physical therapy treatment, patients with contraindications to exercise, smokers/alcoholics, severe vertebral or neural pathologies, previous spine surgeries, cardiorespiratory disease, LBP as a secondary complaint, pregnancy, hearing problems, or illiteracy patients, not will are able to participate the protocol.
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 |
|---|---|---|
| Education in pain neurosciences and clinical hypnosisWill be performed education in pain neurosciences and clinical hypnosis, in 4 sessions during 4 weeks | Other | Education in pain neurosciences and clinical hypnosis |
| Education in pain neurosciences and clinical hypnosis plus osteopathic manipulative treatmentWill be performed education in pain neurosciences and clinical hypnosis, and only for this group will be delivered osteopathic manipulative treatment, in 4 sessions during 4 weeks | Other | Education in pain neurosciences and clinical hypnosis plus Osteopathic manipulative treatment |
Primary outcome
Pain perception
Time frame: T0= before the protocol; T1= until 24 hours after the end protocol; T2= four weeks after end protocols
The Pain suffered in the last week will be assessed by the Numerical pain scale, with a range of 0 - 10
Pain pressure threshold
Time frame: T0= before the protocol; T1= until 24 hours after the end protocol; T2= four weeks after end protocols
Pain will be assessed by the pressure threshold using a pressure algometer device in the lumbar region. The assessment will be conducted specifically in the paravertebral muscles bilaterally at levels L1 to L5.
Disability
Time frame: T0= before the protocol; T1= until 24 hours after the end protocol; T2= four weeks after end protocols
Disability will be assessed using the Oswestry Disability Questionnaire
3 secondary outcomes
Patient's global impression of improvement
Time frame: T0= before the protocol; T1= until 24 hours after the end protocol; T2= four weeks after end protocols
Central Sensitization and biopsychosocial factors
Time frame: T0= before the protocol; T1= until 24 hours after the end protocol; T2= four weeks after end protocols
Heart Rate Variability
Time frame: T0= before the protocol; T1= until 24 hours after the end protocol; T2= four weeks after end protocols
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 13 Mar 2024.
- Derived from this study: PubMed 41927231Luchesi GLS, da Silva AKF, Chaves TC, Jassi FJ. Osteopathic manipulative treatment, pain neuroscience education and clinical hypnosis as pain management interventions in chronic low back pain: a randomized sham-controlled feasibility pilot trial. J Bodyw Mov Ther. 2026 Jun;46:632-640. doi: 10.1016/j.jbmt.2025.12.032. Epub 2025 Dec 24.
- Derived from this study: PubMed 36581902Luchesi GLS, da Silva AKF, Amaral OHB, de Paula VCG, Jassi FJ. Effects of osteopathic manipulative treatment associated with pain education and clinical hypnosis in individuals with chronic low back pain: study protocol for a randomized sham-controlled clinical trial. Trials. 2022 Dec 30;23(1):1066. doi: 10.1186/s13063-022-07040-y.
- Individual participant dataSharing planned: Yes. The IPD will be shared by request
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in pain neurosciences and clinical hypnosis and Education in pain neurosciences and clinical hypnosis plus osteopathic manipulative treatment in people with Low Back Pain, run by Instituto Docusse de Osteopatia e Terapia Manual 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 2 inclusion and 3 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 13 Mar 2024. 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?
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?
Pain perception (time frame: T0= before the protocol; T1= until 24 hours after the end protocol; T2= four weeks after end protocols). The study lists 3 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 NCT05042115, 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 13 Mar 2024.