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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]

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

Condition category

Condition code

Physical Medicine / Rehabilitation

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]

Rehabilitation

Intervention code [2]

Treatment: Devices

Intervention code [3]

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]

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]

before the 1st session of manipulation techniques and after the last session

Primary outcome [2]

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]

before the 1st session of manipulation techniques and after the last session

Primary outcome [3]

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]

before the 1st session of manipulation techniques and after the last session

Secondary outcome [1]

validated common cold questionnaire (CCQ) for common infections ( sore throat , common cold ) 1 months after the interventions is completed..

Timepoint [1]

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Egypt

State/province [1]

Al Iskandarîyah

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

ahmed samir abdelfattah

Address [1]

Faculty of Physical Therapy - Cairo university
7 Ahmed elzayat st, Giza
postcode: 12624

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethical committe of faculty of physical therapy - cairo university

Ethics committee address [1]

7 Ahmed Elzayat st , Giza , Egypt
postcode: 12624

Ethics committee country [1]

Egypt

Date submitted for ethics approval [1]

10/06/2015

Approval date [1]

24/06/2015

Ethics approval number [1]

404-2015

Summary

Brief summary

This study will investigate the effect of selected osteopathic lymphatic techniques on immune system in healthy subjects. the subjects will have consent form prior to participation in the study.
its purpose will be
 :1-To compare the efficacy of selected osteopathic lymphatic techniques on the (CD4+) and (CD8+) T- Helper lymphocytes percentage in healthy subjects.
2-To determine the most effective technique that able to enhance the (CD4+) and (CD8+) T- Helper lymphocytes percentage in healthy subjects.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mr Ahmed Samir Ibrahim Abdelfattah

Address

Faculty of Physical Therapy - Cairo university
7 Ahmed elzayat st, Giza
postcode: 12624

Country

Egypt

Phone

+201096483843

Fax

[email protected]

Contact person for public queries

Name

Hisham Mohamed Abdelraheem Hussien

Address

Faculty of Physical Therapy - Cairo university
7 Ahmed elzayat st, Giza
postcode: 12624

Country

Egypt

Phone

+201020936303

Fax

[email protected]

Contact person for scientific queries

Name

[email protected]

Address

Faculty of Physical Therapy - Cairo university
7 Ahmed elzayat st, Giza
postcode: 12624

Country

Egypt

Phone

+201064615553

Fax

[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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		18/11/2018	369497-(Uploaded-26-12-2020-23-25-47)-Journal results publication.pdf

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically