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Trial registered on ANZCTR


Registration number
ACTRN12616000216415
Ethics application status
Approved
Date submitted
30/10/2015
Date registered
17/02/2016
Date last updated
17/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of selected osteopathic lymphatic techniques on immune system in healthy subjects
Scientific title
Effect of selected osteopathic lymphatic techniques on immune system in healthy subjects
Secondary ID [1] 287750 0
NIL KNOWN
Universal Trial Number (UTN)
U1111-1175-9752
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy subjects 296620 0
Condition category
Condition code
Physical Medicine / Rehabilitation 296861 296861 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group one ( study group 1 ) : will receive group of techniques (thoracic lymphatic pump , liver pump , splenic pump techniques) will be done for 15 min , 5 min each technique.
1-thoracic lymphatic pump technique: The patient lies supine with the head turned to one side (to avoid breathing or coughing into the face of the therapist) and with the hips and knees flexed and the feet flat on the table, The therapist stands at the head of the table with one foot in front of the other ,The therapist places the thenar eminences inferior to the patient’s clavicles with the fingers spreading out over the upper rib cage . For female patients, the therapist may place the hands more midline over the sternum , The patient is instructed to take a deep breath and exhale fully,During exhalation, the therapist increases the pressure on the anterior rib cage, exaggerating the exhalation motion, At end exhalation, the therapist imparts a vibratory motion to the rib cage at two compressions per second,Should the patient need to breathe, pressure is relaxed slightly,
2-splenic pump technique: The patient is in the supine position, legs bent. The therapist stands on the patient's right side.Place the fingers of your right hand with the side of the little finger below the left costal arch. Place the left hand on top of the right hand. With both hands, oscillate in the direction of the spleen, i.e., press lightly and intermittently in a cranial-lateral direction.
3-liver pump technique :The patient breaths through her mouth. While breathing out, slight pressure is applied to the liver, which remains constant until the start of breathing in. At the end of breathing out, the pressure is suddenly released without losing contact to the skin.

Group two ( study group 2) : will receive group of techniques ( sternal pump , sternal oscillation and sternal rebound techniques ) will be done for 15 min , 5 min each technique
1-sternal pump technique:The patient is in the supine position. The therapist stands at the head of the table. Place both hands on top of each other on the sternum, with the thenar eminence on the sternal angle. Ask the patient to inhale deeply. During the deep exhalation, apply pressure with both hands caudally and posteriorly. Release the pressure on the next inhalation.
2-sternal rebound technique :The patient is in the supine position. The therapist stands at the head of the table. Place both hands on top of each other on the sternum, with the thenar eminence on the sternal angle. Ask the patient to inhale deeply. During the deep exhalation, apply pressure with both hands caudally and posteriorly. Release the pressure on the next inhalation rapidly with recoil.
3-sternal oscillation technique:The patient is in the supine position. The therapist stands to the side of the patient. Place both hands on top of each other on the sternum, with the thenar eminence on the sternal angle. Both hands apply rhythmic pressure to the sternum in a caudal-posterior direction.

Group three ( control group ): will receive placebo ( subjects will be handled in light touch ) , will be done for 15 min
all the three study groups will be applied for 4 weeks / three times per week / delivered by qualified physiotherapist also he is osteopathic student third year.
Intervention code [1] 293144 0
Rehabilitation
Intervention code [2] 293409 0
Treatment: Devices
Intervention code [3] 293410 0
Treatment: Other
Comparator / control treatment
Group one ( study group 1 ) : will receive group of techniques ( lymphatic pump , liver pump , splenic pump techniques)
Group two ( study group 2) : will receive group of techniques ( sternal pump , sternal oscillation and sternal rebound techniques )
Group three ( control group ) :will receive placebo ( subjects will be handled in light touch )
will be applied for 4 weeks / three times per week / delivered by qualified physiotherapist also he is osteopathic student third year.
Control group
Placebo

Outcomes
Primary outcome [1] 296464 0
Blood samples will be collected before the 1st session of manipulation techniques and after the last session. Lymphocyte percent of (CD4+) will be detected in each blood sample using flow cytometry.
Timepoint [1] 296464 0
before the 1st session of manipulation techniques and after the last session
Primary outcome [2] 297308 0
Blood samples will be collected before the 1st session of manipulation techniques and after the last session. Lymphocyte percent of (CD8+) will be detected in each blood sample using flow cytometry.
Timepoint [2] 297308 0
before the 1st session of manipulation techniques and after the last session
Primary outcome [3] 297337 0
Blood samples will be collected before the 1st session of manipulation techniques and after the last session. complete blood count (CBC) will be detected in each blood sample .
Timepoint [3] 297337 0
before the 1st session of manipulation techniques and after the last session
Secondary outcome [1] 318507 0
validated common cold questionnaire (CCQ) for common infections ( sore throat , common cold ) 1 months after the interventions is completed..
Timepoint [1] 318507 0
one month after the intervention is completed

Eligibility
Key inclusion criteria
1. forty five healthy subjects.
2. Both genders male and female.
3. Age ranged between 20-50 years.
Minimum age
20 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Thoracic trauma.
2. Inflammatory or systemic diseases.
3. Malignancy.
4. Osteoporosis.
5. Pregnancy.
6. Skeletal disorders.
7. Autoimmune diseases.

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)
sample will be randomly allocated by sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedures like coin-tossing and dice-rolling
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
Descriptive analysis:
1. Included X (mean), SD (standard deviation) and MD (mean difference) to measure the central tendency of data and the distribution of data and mean.
Inferential analysis:
2. One way ANOVA statistics using SPSS version 20.
3. The level of significance was settled at (p= 0.05).
4. Number is statistically detected by power analysis with 95 % power and alpha 0.05 with effect size 0.56


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment outside Australia
Country [1] 7280 0
Egypt
State/province [1] 7280 0
Al Iskandarîyah

Funding & Sponsors
Funding source category [1] 292290 0
Self funded/Unfunded
Name [1] 292290 0
ahmed samir abdelfattah
Country [1] 292290 0
Egypt
Primary sponsor type
Individual
Name
ahmed samir abdelfattah
Address
Faculty of Physical Therapy - Cairo university
7 Ahmed elzayat st, Giza
postcode: 12624
Country
Egypt
Secondary sponsor category [1] 290977 0
None
Name [1] 290977 0
Address [1] 290977 0
Country [1] 290977 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293769 0
Ethical committe of faculty of physical therapy - cairo university
Ethics committee address [1] 293769 0
Ethics committee country [1] 293769 0
Egypt
Date submitted for ethics approval [1] 293769 0
10/06/2015
Approval date [1] 293769 0
24/06/2015
Ethics approval number [1] 293769 0
404-2015

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

Contacts
Principal investigator
Name 61046 0
Mr Ahmed Samir Ibrahim Abdelfattah
Address 61046 0
Faculty of Physical Therapy - Cairo university
7 Ahmed elzayat st, Giza
postcode: 12624
Country 61046 0
Egypt
Phone 61046 0
+201096483843
Fax 61046 0
Email 61046 0
dr.ahmedsamer21@yahoo.com
Contact person for public queries
Name 61047 0
Hisham Mohamed Abdelraheem Hussien
Address 61047 0
Faculty of Physical Therapy - Cairo university
7 Ahmed elzayat st, Giza
postcode: 12624
Country 61047 0
Egypt
Phone 61047 0
+201020936303
Fax 61047 0
Email 61047 0
drhisham3000@cu.edu.eg
Contact person for scientific queries
Name 61048 0
dr_neveen_69@yahoo.com
Address 61048 0
Faculty of Physical Therapy - Cairo university
7 Ahmed elzayat st, Giza
postcode: 12624
Country 61048 0
Egypt
Phone 61048 0
+201064615553
Fax 61048 0
Email 61048 0
dr_neveen_69@yahoo.com

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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes 18/11/2018 369497-(Uploaded-26-12-2020-23-25-47)-Journal results publication.pdf

Documents added automatically
No additional documents have been identified.