Clinical trial NCT05042115: Effects of Osteopathic Manipulative Treatment Associated With Pain Education and Clinical Hypnosis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Low Back Pain
Lead sponsor: Instituto Docusse de Osteopatia e Terapia Manual
Sponsor class: NETWORK
Collaborators: name: Universidade Estadual do Norte do Paraná
First posted: 2021-09-13
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Education in Pain Neuroscience through Clinical Hypnosis associated with Osteopathic Manipulative Treatment
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pain perception
timeFrame: T0= before the protocol; T1= until 24 hours after the end protocol; T2= four weeks after end protocols
measure: Pain pressure threshold
timeFrame: T0= before the protocol; T1= until 24 hours after the end protocol; T2= four weeks after end protocols
measure: Disability
timeFrame: T0= before the protocol; T1= until 24 hours after the end protocol; T2= four weeks after end protocols
Secondary outcomes:
measure: Patient's global impression of improvement
timeFrame: T0= before the protocol; T1= until 24 hours after the end protocol; T2= four weeks after end protocols
measure: Central Sensitization and biopsychosocial factors
timeFrame: T0= before the protocol; T1= until 24 hours after the end protocol; T2= four weeks after end protocols
measure: Heart Rate Variability
timeFrame: T0= before the protocol; T1= until 24 hours after the end protocol; T2= four weeks after end protocols
Other outcomes:
Locations:
city: Presidente Prudente
country: Brazil
facility: Anne Kastelianne
state: São Paulo
Study officials:
References: