NCT01753726

Brief Summary

Physical therapists have traditionally included various forms of manual therapy among the therapeutic approaches to spinal pathologies. The aim of this study was to evaluate the effect of diaphragmatic stretching on spine and thoracic movement in healthy adults.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 20, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

November 1, 2016

Status Verified

October 1, 2016

Enrollment Period

2.6 years

First QC Date

December 17, 2012

Last Update Submit

October 30, 2016

Conditions

Keywords

stretching, diaphragm, spinal movement, thoracic movement

Outcome Measures

Primary Outcomes (1)

  • Assessment of lumbar mobility

    Schober test is a flexion trunk test to evaluate lumbar spine mobility. During this test, while the patient is in the standing position, marks are made in the midpoint between the posterior superior iliac spines (PSISs) and 10 cm superiorly to this point.

    up to 2 months

Secondary Outcomes (3)

  • Assessment of trunk mobility

    baseline, 2 months

  • Cervical mobility

    baseline, 2 months.

  • Abdominal and Thoracic Dimensions and Kinematics

    baseline, 2 months.

Study Arms (2)

Experimental group

EXPERIMENTAL

43 people are recruited in order to the inclusion criteria for the study. They are healthy people. A diaphragm stretching technique was employed in this experimental group.

Other: Diaphragm stretching.

Placebo group

PLACEBO COMPARATOR

37 healthy people were recruited in order to the inclusion criteria.

Other: Placebo.

Interventions

A manual technique of diaphragm stretching during 7 minutes. The participants were situated in a seated position.

Also known as: Manual technique
Experimental group

Disconnected ultrasound was used for the 7 min as sham treatment

Also known as: Placebo
Placebo group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy subjects
  • Age: between 18 and 65 years old.

You may not qualify if:

  • Pathological subjects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Health Sciences. University of Granada.

Granada, Granada, 18071, Spain

Location

Related Publications (1)

  • Gonzalez-Alvarez FJ, Valenza MC, Torres-Sanchez I, Cabrera-Martos I, Rodriguez-Torres J, Castellote-Caballero Y. Effects of diaphragm stretching on posterior chain muscle kinematics and rib cage and abdominal excursion: a randomized controlled trial. Braz J Phys Ther. 2016 Jun 16;20(5):405-411. doi: 10.1590/bjpt-rbf.2014.0169.

Related Links

Study Officials

  • M. Carmen Valenza, PH MD

    Department of Physical Therapy. University of Granada.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

December 17, 2012

First Posted

December 20, 2012

Study Start

June 1, 2012

Primary Completion

January 1, 2015

Study Completion

May 1, 2015

Last Updated

November 1, 2016

Record last verified: 2016-10

Locations