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

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Education in pain neurosciences and clinical hypnosis; Other: Education in pain neurosciences and clinical hypnosis plus osteopathic manipulative treatment

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Presidente Prudente, São Paulo, Brazil
      • Anne Kastelianne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Education in pain neurosciences and clinical hypnosis; Pain neuroscience education and clinical hypnosis	Other: Education in pain neurosciences and clinical hypnosis; Will be performed education in pain neurosciences and clinical hypnosis, in 4 sessions during 4 weeks
Active Comparator: Education in pain neurosciences and clinical hypnosis plus Osteopathic manipulative treatment; Pain neuroscience education and clinical hypnosis, associated with osteopathic manipulative treatment	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain perception	The Pain suffered in the last week will be assessed by the Numerical pain scale, with a range of 0 - 10	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.	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	T0= before the protocol; T1= until 24 hours after the end protocol; T2= four weeks after end protocols

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	T0= before the protocol; T1= until 24 hours after the end protocol; T2= four weeks after end protocols

Collaborators and Investigators

• Sponsor: Instituto Docusse de Osteopatia e Terapia Manual
• Collaborators: Universidade Estadual do Norte do Parana

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2022
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: September 4, 2021
• First Submitted That Met QC Criteria: September 4, 2021
• First Posted (Actual): September 13, 2021

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Low Back Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 43063621.3.0000.8123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The IPD will be shared by request
• IPD Sharing Time Frame: After one year from publication
• IPD Sharing Access Criteria: The request must be sent to the email address provided in the registration
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No