Ignite Creation Date:
2025-12-18 @ 8:26 AM
Ignite Modification Date:
2025-12-23 @ 10:51 PM
Study NCT ID:
NCT05042115
Status:
None
Last Update Posted:
2024-03-13 00:00:00
First Post:
2021-09-04 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Osteopathic Manipulative Treatment Associated With Pain Education and Clinical Hypnosis
Sponsor:
None
Organization:
Study Overview
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
Status:
None
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: