HealthyNCT01753726
Diaphragm Stretching Increases Spine and Thoracic Mobility
A study testing Diaphragm stretching. in people with Healthy, run by Universidad de Granada at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Diaphragm stretching.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2012to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects
- Age: between 18 and 65 years old.
Who cannot join
- Pathological subjects
Trial locations and contacts
1 site in 1 country.
Spain1 site
Faculty of Health Sciences. University of Granada.
Granada, Granada, 18071
About this study
Official title: Diaphragm Stretching Technique Increases Spine Mobility and Thoracic Movement: a Randomized Controlled Trial
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.
Read the detailed description
Spinal pain is a well recognized condition associated with significant personal and community burdens. Recent studies estimated the prevalence between 6 and 22% in neck pain, from 4-72% in thoracic pain and from 1.0% to 58.1% in low back pain, which increases with age. During the last decades numerous researches have been conducted on stretching effects, evidencing an increased muscle control, flexibility and range of motion. The main purpose of this investigation is to examine the effects of diaphragm stretching in spine and thoracic mobility in healthy subjects in order to apply the results in a specifics pathologies in future studies.
- Conditions
- Healthy
- Being tested
- Diaphragm stretching., Placebo.
- Keywords
- stretching, diaphragm, spinal movement, thoracic movement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragm stretching.Other
Also called Manual technique
A manual technique of diaphragm stretching during 7 minutes. The participants were situated in a seated position.
Placebo.Other
Also called Placebo
Disconnected ultrasound was used for the 7 min as sham treatment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Diaphragm stretching. |
| Placebo group | Placebo comparator | 37 healthy people were recruited in order to the inclusion criteria. Receives: Other: Placebo. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 2 months
Secondary outcomes (3)
Assessment of trunk mobility
In Finger to floor test, the subjects were stood on a stool and asked to flex the trunk forward in order to reach as far as possible with both hands, without blending their knees.
Measured: baseline, 2 months
Cervical mobility
A Baseline Bubble Inclinometer, Fabrication Enterprises Incorporated, New York. USA, was used to measure de active range of motion of the cervical spine. The measurements were performed in two planes of movement, lateral flexion (frontal plane) the right and left side; and flexion-extension (sagittal plane)
Measured: baseline, 2 months.
Abdominal and Thoracic Dimensions and Kinematics
Abdominal and thoracic dimensions and kinematics measurements can be used as an evaluative method for diaphragmatic breathing excursion to quantify possible alterations in thoracic capacity and abdominal and chest wall compliance as achieved by all expiratory and inspiratory muscles
Measured: baseline, 2 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2012 (estimated)
- Study startJun 2012
- Primary completionJan 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Carmen Valenza, Universidad de Granada
- Investigators
- M. Carmen Valenza, PH MD, Principal investigator, Department of Physical Therapy. University of Granada.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01753726
- Sponsor's protocol ID
- DF0037UG
- Status last verified
- Oct 2016
- First submitted
- 17 Dec 2012
- Last updated
- 1 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 27333481
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diaphragm Stretching Technique Increases Spine Mobility and Thoracic Movement: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01753726
- Acronym / sponsor ID
- DF0037UG
- Conditions
- Healthy
- Keywords
- stretching, diaphragm, spinal movement, thoracic movement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 20 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Spinal pain is a well recognized condition associated with significant personal and community burdens. Recent studies estimated the prevalence between 6 and 22% in neck pain, from 4-72% in thoracic pain and from 1.0% to 58.1% in low back pain, which increases with age. During the last decades numerous researches have been conducted on stretching effects, evidencing an increased muscle control, flexibility and range of motion. The main purpose of this investigation is to examine the effects of diaphragm stretching in spine and thoracic mobility in healthy subjects in order to apply the results in a specifics pathologies in future studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Diaphragm stretching.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. |
| Placebo group | Placebo comparator | Other: Placebo.37 healthy people were recruited in order to the inclusion criteria. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy subjects
- Age: between 18 and 65 years old.
Key exclusion criteria (1 listed)
- Pathological subjects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diaphragm stretching.Also: Manual techniqueA manual technique of diaphragm stretching during 7 minutes. The participants were situated in a seated position. | Other | Experimental group |
| Placebo.Also: PlaceboDisconnected ultrasound was used for the 7 min as sham treatment | Other | Placebo group |
Primary outcome
Assessment of lumbar mobility
Time frame: up to 2 months
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.
3 secondary outcomes
Assessment of trunk mobility
Time frame: baseline, 2 months
Cervical mobility
Time frame: baseline, 2 months.
Abdominal and Thoracic Dimensions and Kinematics
Time frame: baseline, 2 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2016.
- Derived from this study: PubMed 27333481Gonzalez-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.
- González-ÁlvarezFJ, ValenzaMC, Torres-SánchezI, Cabrera-MartosI, Rodríguez-TorresJ, CastelloteY.Effects of diaphragm stretching on posterior chain muscle kinematics and rib cage and abdominal excursion: a randomized controlled trial. BrazJPhysTher.2016Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M. Carmen Valenza, PH MD principal investigator
Department of Physical Therapy. University of Granada.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diaphragm stretching. in people with Healthy, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of lumbar mobility (time frame: up to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01753726, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2016.