Effects of Osteopathic Manipulative Treatment Associated With Pain Education and Clinical Hypnosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-10

Study Completion Date

2023-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Education in Pain Neuroscience through Clinical Hypnosis associated with Osteopathic Manipulative Treatment

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

A simple randomized sequence will be created through the website www.randomization.com by a collaborator external to the researchers directly involved in the research. After the initial assessment, the researcher will access the randomization envelope and the participant will be allocated to 1 of the 2 treatment groups. The allocation will be hidden using opaque envelopes, sealed, and identified by number. 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 Groups

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Education in pain neurosciences and clinical hypnosis

Pain neuroscience education and clinical hypnosis

Group Type EXPERIMENTAL

Education in pain neurosciences and clinical hypnosis

Intervention Type OTHER

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 treatment

Pain neuroscience education and clinical hypnosis, associated with osteopathic manipulative treatment

Group Type ACTIVE_COMPARATOR

Education in pain neurosciences and clinical hypnosis plus osteopathic manipulative treatment

Intervention Type OTHER

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

Interventions

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Education in pain neurosciences and clinical hypnosis

Will be performed education in pain neurosciences and clinical hypnosis, in 4 sessions during 4 weeks

Intervention Type OTHER

Education in pain neurosciences and clinical hypnosis plus osteopathic manipulative treatment

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Nonspecific Low Back Pain for at least 3 months
* Score on the numerical pain scale of at least 3 points

Exclusion Criteria

* 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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No