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

NCT05042115 | Completed DMC

• 1 other identifier: 43063621.3.0000.8123
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

Low Back Pain

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Patient's global impression of improvement

  T0= before the protocol; T1= until 24 hours after the end protocol; T2= four weeks after end protocols

• Central Sensitization and biopsychosocial factors

  T0= before the protocol; T1= until 24 hours after the end protocol; T2= four weeks after end protocols

• Heart Rate Variability

  T0= before the protocol; T1= until 24 hours after the end protocol; T2= four weeks after end protocols

Study Arms (2)

Education in pain neurosciences and clinical hypnosis

EXPERIMENTAL

Pain neuroscience education and clinical hypnosis

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

Other: Education in pain neurosciences and clinical hypnosis plus osteopathic manipulative treatment

Interventions

Education in pain neurosciences and clinical hypnosis OTHER

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

Education in pain neurosciences and clinical hypnosis

Education in pain neurosciences and clinical hypnosis plus osteopathic manipulative treatment 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

Education in pain neurosciences and clinical hypnosis plus Osteopathic manipulative treatment

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Docusse de Osteopatia e Terapia Manual: lead
• Universidade Estadual do Norte do Paraná: collaborator

Study Sites (1)

Anne Kastelianne

Presidente Prudente, São Paulo, Brazil

Location

Related Publications (1)

• Luchesi 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.

  PMID: 36581902 DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Educational Status; Hypnosis; Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities; Musculoskeletal Manipulations; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: September 4, 2021
• First Posted: September 13, 2021
• Study Start: September 10, 2022
• Primary Completion: November 30, 2022
• Study Completion: February 28, 2023
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After one year from publication
• Access Criteria: The request must be sent to the email address provided in the registration

Locations

BR (1)