Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001700426
Ethics application status
Approved
Date submitted
21/10/2016
Date registered
9/12/2016
Date last updated
9/12/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Impact of osteopathy on the Peak Expiratory Flow (PEF) of asthmatic patients.
Scientific title
Impact of the Dog-Technic for D1-D4 and Longitudinal Stroke Technique for Diaphragm on Peak Expiratory Flow (PEF) in asthmatic patients.
Secondary ID [1] 290368 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 300662 0
Pain 300663 0
Condition category
Condition code
Respiratory 300514 300514 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We used the dog technique, which is a type of thrust. This is a high-velocity, low-amplitude thrust to restore specific joint motion .This technique was used in the D1 through D4 vertebrae. ( Group 1 )

The other technique was the longitudinal stroke, which treats the myofascial tissue. Here the force is constant until the dysfunctional tissues are guided along a path of least resistance and free movement is achieved. (Group 2 )

These techniques were utilized to see if the vertebral pain and dyspnoea diminished, and if the peak expiratory flow (PEF) increased.

This study was performed by an osteopath and physiotherapist.
The entire treatment lasted approximately 10 minutes, but data was collected immediately after each manipulation within that time frame..
Every participant was treated only one time and in only one group ( in Group 1 or Group 2)
No adherence monitoring was necessary.

When participants enter, they breath into the spirometer, and the data is recorded. Then they immediately perform a physical activity, consisting of performing 30 complete leg pressings with the torso erected in 45 seconds, and then returning to the standing position. Immediately after this physical activity, the participant breathes into the spirometer again. Next, participants rested for a mean time of 30 seconds. After rest, the physiotherapist performs the treatment (physical manipulation according to group) and immediately the participant breathes into the spirometer and data is measured. Following this, the participant performs the physical activity for a second time, and immediately following, they breath into the spirometer, and the study ends for that individual.
Intervention code [1] 296185 0
Treatment: Other
Comparator / control treatment
Control group is the Group 2 which aplicated Longitudinal Stroke.
Control group
Active

Outcomes
Primary outcome [1] 299938 0
Peak Expiratory Flow (PEF) is measured with the spirometer Datospir Peak-10. This measures the intensity of the airflow that passes through the airways when the participant gives a fast and intense breath.
Timepoint [1] 299938 0
The Peak Expiratory Flow (PEF) was measured four times.

First, at rest, before treatment was started.

Second, immediately after the first physical activity prior to treatment (manipulation by physiotherapist according to the group).

Third, after the participant has rested for about 30 seconds, and the physiotherapist performs the treatment (manipulation according to group)..

And finally, following treatment after participant has performed the physical activity a second time.
Secondary outcome [1] 328587 0
The pain was evaluated using an algometer. The location where pain was measured was the spinous processes of the D1-D4 vertebrae.
Timepoint [1] 328587 0
Pain was evaluated after the manipulation of the vertebrae, immediately following treatment
Secondary outcome [2] 328588 0
Dyspnea was calculated using the Borg scale.
Timepoint [2] 328588 0
The Dyspnea was calculated before treatment and immediately after physical activity. Moreover then immediately after the treatment and immediately after physical activity

Eligibility
Key inclusion criteria
Must have asthma;
Must have had more than one asthma attack;
Must sign an informed consent form
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Less than 18 years old;
Suffers from some form of bone disorder;
Is depressed;
Suffers from chronic obstructive respiratory disease (COPD);
Suffers from a pulmonary edema;
Older than 65;
Has received phsyical therapy treatment in the last 3 weeks;

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedures like coin-tossing
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
Actual
15/12/2015
Date of last participant enrolment
Anticipated
Actual
20/05/2016
Date of last data collection
Anticipated
Actual
20/05/2016
Sample size
Target
18
Accrual to date
Final
18
Recruitment outside Australia
Country [1] 8341 0
Spain
State/province [1] 8341 0
Madrid

Funding & Sponsors
Funding source category [1] 294754 0
Self funded/Unfunded
Name [1] 294754 0
Unfunded
Country [1] 294754 0
Primary sponsor type
University
Name
Camilo Jose Cela
Address
C/Castillo de Alarcon, 49
Urb. Villafranca del Castillo 28692,
Villanueva de la Canada, Madrid, Espana
Country
Spain
Secondary sponsor category [1] 293604 0
None
Name [1] 293604 0
Address [1] 293604 0
Country [1] 293604 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296264 0
Universidad Camilo Jose Cela
Ethics committee address [1] 296264 0
Urb. Villafranca del Castillo, Calle Castillo de Alarcon, 49, 28692 Villanueva de la Canada, Madrid
Ethics committee country [1] 296264 0
Date submitted for ethics approval [1] 296264 0
20/11/2015
Approval date [1] 296264 0
20/11/2015
Ethics approval number [1] 296264 0
See public notes

Summary
Brief summary
Results:12 Group 1 (Dog Technic and Longitudinal Stroke) patients responded positively to treatment, there was an increase of 5.1% and 6.1% of the post-intervención PEF and post-intervención, and effort. The results of the scale of Borg by which we measure the level of Dyspnea were positive, a % 54,95, patients noted an improvement in breathing. In addition was confirmed through the means of both groups group 1 in which two techniques were applied was 34,05% more effective than group 2 in which applied only a. After handling pain fell by 38% of the cases.
Conclusions:The impact of the technique of Dog-Technic for D1-D4 and the Longitudinal Stroke technique for diaphragm in the volumes of peak expiratory flow (PEF) in asthmatic patients were positive, there was a change of the PEF Post intervention and post-intervención, and effort and showed the most effective group in which only a technique was applied. Furthermore this type of treatment decreased facilitated vertebrae pain and was efficient in the improvement of Dyspnea and the general well-being of the patient.
Trial website
Trial related presentations / publications
Public notes
With reference to the ethics application status, there is no committee that formally gave permission. Rather, my university approved the study, and all participants signed an informed consent.
Attachments [1] 1192 1192 0 0
/AnzctrAttachments/371694-Repercusiones de la técnica dog and stroke ( 17-05-2016) FINAL TIPO 2.pdf (Publication)

Contacts
Principal investigator
Name 69834 0
Mr Angelo Michele Vagali
Address 69834 0
Universidad Camilo Jose Cela
Calle Altamirano 3 4E
Madrid, Madrid, 28008
Spain
Country 69834 0
Spain
Phone 69834 0
+34 603337919
Fax 69834 0
Email 69834 0
angelovagali93@gmail.com
Contact person for public queries
Name 69835 0
Mr Angelo Michele Vagali
Address 69835 0
Universidad Camilo Jose Cela
Calle Altamirano 3 4E
Madrid, Madrid, 28008
Spain
Country 69835 0
Spain
Phone 69835 0
+34 603337919
Fax 69835 0
Email 69835 0
angelovagali93@gmail.com
Contact person for scientific queries
Name 69836 0
Mr Angelo Michele Vagali
Address 69836 0
Universidad Camilo Jose Cela.
Calle Altamirano 3 4E
Madrid, Madrid, 28008
Spain
Country 69836 0
Spain
Phone 69836 0
+34 603337919
Fax 69836 0
Email 69836 0
angelovagali93@gmail.com

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