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

• ClinicalTrials.gov Identifier: NCT05047796
• Recruitment Status: Completed
• First Posted: September 17, 2021
• Last Update Posted: March 13, 2024
• Sponsor: Instituto Docusse de Osteopatia e Terapia Manual
• Information provided by (Responsible Party): Instituto Docusse de Osteopatia e Terapia Manual

Study Description

Brief 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%.

Condition or disease	Intervention/treatment	Phase
Parkinson Disease	Other: Intervention Protocol; Other: Sham Protocol	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: Each participant will be randomly assigned to the intervention group or placebo group by an independent study evaluator. Data will be secretly allocated through sealed, opaque envelopes. After the randomization process, the participant will be evaluated by a researcher who will not have knowledge about the distribution of the groups.
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: September 15, 2021
• Actual Primary Completion Date: October 5, 2021
• Actual Study Completion Date: October 30, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention Protocol; Visceral osteopathic techniques	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 Comparator: Sham Protocol; Simulated visceral osteopathic techniques	Other: 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

Outcome Measures

Primary Outcome Measures :

1. Change in heart rate variability [ Time Frame: T0= before the protocol (15 minutes); T1= until 48 hours after the end protocol (15 minutes) ]
   For the analysis, frequency domain indices (LF, HF, LF/HF), time domain (SDNN, RMSSD) and geometric indices will be used

Secondary Outcome Measures :

1. Change in balance [ Time Frame: T0= before the protocol; T1= until 48 hours after the end protocol ]
   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.
2. Change in plantar pressure [ Time Frame: T0= before the protocol; T1= until 48 hours after the end protocol ]
   The static plantar pressure profile will be obtained through pressure sensors present in the platform

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Brazil

Anne Kastelianne

Presidente Prudente, São Paulo, Brazil

Sponsors and Collaborators

Instituto Docusse de Osteopatia e Terapia Manual

More Information

• Responsible Party: Instituto Docusse de Osteopatia e Terapia Manual
• ClinicalTrials.gov Identifier: NCT05047796
• Other Study ID Numbers: 18945219.4.0000.5402
• First Posted: September 17, 2021
• Last Update Posted: March 13, 2024
• Last Verified: March 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: The data will be shared for any researcher that requests the data by electronic address
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP)
• Time Frame: After one year of publication
• Access Criteria: To receive the data, the researcher must have sent a request to nupi@idot.com.br

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Instituto Docusse de Osteopatia e Terapia Manual:

Parkinson

Additional relevant MeSH terms:

Parkinson Disease; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases