Effects of an Osteopathic Treatment Protocol on Sleep Quality

Ramón Mateos Alpuente

Status: Unknown

Conditions: Sleep Disorder

Treatments: Other: Sham technique; Other: Osteopathic treatment protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT04955392

SQ001

Details and patient eligibility

About

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

Full description

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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

72 participants in 2 patient groups

Intervention group

Experimental group

Description:

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

Treatment:

Other: Osteopathic treatment protocol

Control group

Sham Comparator group

Description:

Group of patients that will receive a sham technique

Treatment:

Other: Sham technique