Effects of an Osteopathic Treatment Protocol on Sleep Quality

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2021-11-30

Brief Summary

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SIngle-centre interventional single-blinded randomized controlled trial, with random assignment of the subjects in two groups (intervention and control, 1: 1 ratio) and to be carried out with volunteers that present alterations in the quality of sleep. Eligible and accepting subjects participating in the study will be assigned to receive an osteopathic treatment protocol or a placebo technique

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Detailed Description

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Intervention protocol in the intervention group:

The intervention protocol consists of 4 techniques that will be performed according to the following order:

1. Inhibition of the suboccipital muscles.
2. Parietal Lift.
3. Sutherland Technique of Sphenobasilar Synchondrosis.
4. Compression technique of the fourth ventricle (CV4).

Intervention protocol in the control group:

Placebo technique that consists of placing the hands on top of the skull without any therapeutic intention for five minutes.

Conditions

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Sleep Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

SIngle-centre interventional single-blinded randomized contsubjectsrolled trial, with random assignment of the subjects in two groups (intervention and control, 1: 1 ratio)

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Eligible and recruited patients will be Randomized using OxMaR software (Oxford Minimization and Randomization).

Study Groups

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Intervention group

Group of patients that will receive the 4 techniques proposed to evaluate the changes on sleep quality

Group Type EXPERIMENTAL

Osteopathic treatment protocol

Intervention Type OTHER

The intervention protocol consists of 4 techniques that will be performed according to the following order:

1. Inhibition of the suboccipital muscles.
2. Parietal Lift.
3. Sutherland Technique of Sphenobasilar Synchondrosis.
4. Compression technique of the fourth ventricle (CV4).

Control group

Group of patients that will receive a sham technique

Group Type SHAM_COMPARATOR

Sham technique

Intervention Type OTHER

Sham technique that consists of placing the hands on top of the skull without any therapeutic intention for five minutes.

Interventions

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Osteopathic treatment protocol

The intervention protocol consists of 4 techniques that will be performed according to the following order:

1. Inhibition of the suboccipital muscles.
2. Parietal Lift.
3. Sutherland Technique of Sphenobasilar Synchondrosis.
4. Compression technique of the fourth ventricle (CV4).

Intervention Type OTHER

Sham technique

Sham technique that consists of placing the hands on top of the skull without any therapeutic intention for five minutes.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adults ranging from 18 to 80 years old and with a score greater than 5 on the Pittsburgh Sleep Quality Index

Exclusion Criteria

1. Recent head injuries or fractures.
2. Having suffered a stroke or intracranial hemorrhage.
3. Tumors.
4. Epilepsy.
5. Bradycardia.
6. Hypotension.
7. Heart disease
8. Neurological problems
9. Psychiatric problems

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes