NCT04411095

Brief Summary

Testing the effect of a specific stretch technique versus sham treatment, to objectify the influence of that specific technique on thoracic rotation mobility.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 28, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 2, 2020

Completed
Last Updated

June 2, 2020

Status Verified

May 1, 2020

Enrollment Period

1 month

First QC Date

April 22, 2020

Last Update Submit

May 27, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in thoracic rotation mobility

    Change from baseline rotation, left and right, to rotation immediately after the test

    Before and immediately after the test

Study Arms (2)

Stretching of intrathoracic fascia

EXPERIMENTAL

A technique will be used to stretch the intrathoracic fascia. The subject lies in his/her back, and a flexion of the upper cervical spine is combined with a retraction movement of the lower cervical and upper thoracic spine, this in combination with inspiration.

Other: Measuring thoracic rotation mobility

Test without stretching

PLACEBO COMPARATOR

A placebo technique is performed by positioning the hands of the therapist on the thorax without pressure or performing a technique. Similar as the stretching technique, a deep inspiration is performed by the patient, for each of the intrathoracic cilinders. This without performing a retraction of the lower cervical and upper thoracic spine.

Other: Measuring thoracic rotation mobility

Interventions

Measuring the thoracic rotation mobility with a goniometer, from a standardized position

Stretching of intrathoracic fasciaTest without stretching

Eligibility Criteria

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

You may qualify if:

  • Subjects between the age of 18 and 65
  • Both men and women

You may not qualify if:

  • Structural disease of cervical or/and thoracic spine and/or head and/or thorax
  • Acute mobility restriction of cervical and/or thoracic spine
  • Acute and/or intense pain
  • A history of trauma and/or operation on cervical and/or thoracic spine
  • Treatment for cancer like chemo or radiation
  • Baby's and children
  • Elderly people

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Practice for fysiotherapy and osteopathy

Scherpenheuvel, Vlaams-brabant, 3270, Belgium

Location

MeSH Terms

Conditions

Fasciitis

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Study Officials

  • IAO Administration

    The International Academy of Osteopathy

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2020

First Posted

June 2, 2020

Study Start

February 28, 2020

Primary Completion

April 1, 2020

Study Completion

April 1, 2020

Last Updated

June 2, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations