Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000008820
Ethics application status
Approved
Date submitted
28/11/2011
Date registered
4/01/2012
Date last updated
5/01/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of the thoracic diaphragm stretching technique in shoulder pain.
Scientific title
Effectiveness of the thoracic diaphragm stretching technique in shoulder pain.
Secondary ID [1] 273476 0
None
Universal Trial Number (UTN)
U1111-1126-1114
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shoulder pain 279264 0
Condition category
Condition code
Physical Medicine / Rehabilitation 279462 279462 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The technique used in the intervention consists in stretching the muscular fibres of the thoracic diaphragm. The patient lies on a stretcher in supine position with the legs bent and together, the soles of the feet leaning on the stretcher, the arms relaxed in parallel with the body and a little pillow under the head (it improves patient's comfort). The physiotherapist stands at the head of the stretcher in a front stance looking towards the feet of the patient. The contact is made using both hands with the pisiform bone and the cubital edge of the fingers (2nd to 5th) on the side edge comprising the common cartilage between the 7th and the 10th rib and facing the forearm towards the corresponding shoulder of the patient. Swinging both hands to penetrate the internal area of the side cartilage and the ribs. The physioterapist makes a cephalic traction using his hands and the weight of his body while the patient inhales. The traction is held while the patient exhales in order to maintain the side position and avoid the descent of the ribs. The technique is carried out in a single session, making a succession of 10 breathing cycles (each cycle consists of one inhalation phase and one exhalation phase).
Intervention code [1] 283792 0
Rehabilitation
Comparator / control treatment
Same technique but without making the cephalic traction. This way, the patient's breathing cycle continues with no influence. The technique is carried out in a single session, making a succession of 10 breathing cycles (each cycle consists of one inhalation phase and one exhalation phase).
Control group
Placebo

Outcomes
Primary outcome [1] 286036 0
Pain reduction in active movement. Measured by VAS.
Timepoint [1] 286036 0
Measurement before and after intervention.
Primary outcome [2] 286037 0
Increase of active mobility. Measured by goniometry.
Timepoint [2] 286037 0
Measurement before and after intervention.
Primary outcome [3] 286038 0
Increase of pain threshold by pressing the following trigger points: medial supraspinatus, upper medial infraspinatus and central levator escapula. Measured by algometry.
Timepoint [3] 286038 0
Measurement before and after intervention.
Secondary outcome [1] 295024 0
Medical diagnosis.
Timepoint [1] 295024 0
Before intervention.

Eligibility
Key inclusion criteria
-Subjects from 18 to 70 years. Both male and female.
-Pain during movement and lack of mobility in one or both of the shoulders.
-Voluntary participation.
-Signature of informed consent.
-Not fulfilling any of the exclusion criteria.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Subjects under 18 and over 70 years.
-Patient situations with contraindications to intervention: neurological pathologies (paraplegia, tetraplegia, Parkinson's Disease, Alzheimer's Disease...), rheumatic diseases, fever, upper limb and rib fracture in recovery phase, tumoral process whether in trunk or in an upper limb, aortic aneurysm, radicular cervicobrachial pain.
-Subjects who are unable to bear the technique due to hypersensitivity in the abdominal region.
-Subjects who are unable to maintain the posture in order to execute the evaluation or the intervention.
-Subjects who have received osteopathic treatment in the last 3 weeks.
-Subjects who have received analgesics or anti-inflamatory drugs in the last 12 hours.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 3978 0
Spain
State/province [1] 3978 0

Funding & Sponsors
Funding source category [1] 284267 0
Self funded/Unfunded
Name [1] 284267 0
none
Country [1] 284267 0
Spain
Primary sponsor type
Individual
Name
Jorge Rodriguez Jimenez
Address
Avda. Huerta Grande, Numero 2, Portal E, 2o C. Pozuelo de Alarcon (Madrid) 28224.
Country
Spain
Secondary sponsor category [1] 283219 0
None
Name [1] 283219 0
Address [1] 283219 0
Country [1] 283219 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286235 0
Comite Etico de Experimentacion (Experimentation Ethics) Committee).
Ethics committee address [1] 286235 0
Ethics committee country [1] 286235 0
Spain
Date submitted for ethics approval [1] 286235 0
Approval date [1] 286235 0
19/11/2011
Ethics approval number [1] 286235 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33444 0
Address 33444 0
Country 33444 0
Phone 33444 0
Fax 33444 0
Email 33444 0
Contact person for public queries
Name 16691 0
Jorge Rodriguez Jimenez
Address 16691 0
Avda. Huerta Grande. Numero 2. Portal E. 2o C. Pozuelo de Alarcon. 28223 (Madrid).
Country 16691 0
Spain
Phone 16691 0
+34606530423
Fax 16691 0
None
Email 16691 0
[email protected]
Contact person for scientific queries
Name 7619 0
Jorge Rodriguez Jimenez
Address 7619 0
Avda. Huerta Grande. Numero 2. Portal E. 2o C. Pozuelo de Alarcon. 28223 (Madrid).
Country 7619 0
Spain
Phone 7619 0
+34606530423
Fax 7619 0
Email 7619 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.