Effects of Osteopathic Visceral Manipulation on the Autonomic Nervous System, Balance and Gastrointestinal Disturbances in Individuals With Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Effects of Osteopathic Visceral Manipulation on the Autonomic Nervous System, Balance and Gastrointestinal Disturbances in Individuals With Parkinson's Disease: a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05047796
• Other study ID #: 18945219.4.0000.5402
• Status: Completed
• Phase: N/A
• Start date: September 15, 2021
• Est. completion date: October 30, 2021

Study information

• Verified date: March 2024
• Source: Instituto Docusse de Osteopatia e Terapia Manual
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Introduction: Parkinson's disease (PD) is responsible for several changes in the body, such as balance, gastrointestinal and autonomic disorders and are associated with impairments in the clinical prognosis of these individuals. In this sense, therapies capable of minimizing this impact are extremely important. Osteopathy has become an alternative treatment for individuals with neurological disorders and has been shown to be effective in treating various conditions, including PD. Objective: a) to evaluate the acute effect of visceral manipulation directed to the intestines and visceral plexuses in the autonomic nervous system of PD patients; b) identify the effect of this approach, after four visits, on balance, plantar pressure, gastrointestinal disorders and autonomic nervous system in this population. Materials and Methods: For this randomized clinical trial, 28 adults diagnosed with PD will be recruited. Subjects will be randomized to protocols in two groups: intervention protocol and placebo protocol, where both will consist of 4 visits twice a week. The intervention protocol will consist of osteopathic manipulative techniques and the sham protocol will consist of simulation of therapy, where the therapist will place his hands in the same regions of the intervention protocol, with superficial contact and without therapeutic intention in each region. The outcome measures of the study will consist of Berg balance assessment and plantar pressure, Rome survey on gastrointestinal disorders, and assessment of autonomic modulation by means of heart rate variability analysis. Volunteers and evaluators will be blind to the protocol and not informed of their order. Only the person responsible for the intervention will not be blind to the protocol. Data will be analyzed according to normality (Shapiro-Wilk test), and comparisons of outcomes between the moments (pre and post) will be performed using the T-student test for paired data or Wilcoxon, as normal and for comparisons between protocols. placebo and intervention, Student's T-test for unpaired data or Mann-Whitney test according to normality will be applied. The adopted statistical significance will be fixed at 5%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: October 30, 2021
• Est. primary completion date: October 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of Parkinson's;
• Not having cardiorespiratory diseases;
• Not being a smoker;
• Do not use alcoholic beverages;
• No cognitive deficit;
• No osteoarticular deformities, plantar ulcers, total or partial amputation of the feet;
• They do not need auxiliary devices for walking

Exclusion Criteria:

• Data from individuals with a series of heart rate intervals with less than 95% of sinus beats will be excluded from the study.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• Intervention Protocol
The intervention protocol will consist of visceral osteopathic techniques and will be performed by a professional who has 17 years of clinical experience in the field of Osteopathy.
• Sham Protocol
The sham protocol will be performed by a professional who has 17 years of clinical experience in the field of Osteopathy. The sham protocol will consist of simulation of therapy, where the therapist will place his hands in the same regions of the intervention protocol, without therapeutic intent

Locations

Country	Name	City	State
Brazil	Anne Kastelianne	Presidente Prudente	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Docusse de Osteopatia e Terapia Manual

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in heart rate variability	For the analysis, frequency domain indices (LF, HF, LF/HF), time domain (SDNN, RMSSD) and geometric indices will be used	T0= before the protocol (15 minutes); T1= until 48 hours after the end protocol (15 minutes)
Secondary	Change in balance	For balance analysis we will use the Berg balance scale, validated for the Brazilian population. The overall score is 56 points. A score from 0 to 20 represents impairment of balance, 21 to 40 is acceptable balance, and 41-56 is good balance.	T0= before the protocol; T1= until 48 hours after the end protocol
Secondary	Change in plantar pressure	The static plantar pressure profile will be obtained through pressure sensors present in the platform	T0= before the protocol; T1= until 48 hours after the end protocol