IRCT | Effect of combined suspension and core stability exercises on structural characteristic of intervertebral disc and functional disability in office workers with disc herniation.

Protocol summary

Study aim: Comparison of the effect of 8 weeks of suspension and central stabilizer training on functional limitation (pain severity, personal hygiene, lifting of objects, walking, sitting, standing, sleeping, sexual activity, social life and travel) and structural features of lumbar disc (Intervertebral disk height and disk hernia index) in the administrative staff with herniated discs.
Design: Clinical trial with two experimental groups in parallel and without a control group and one blinded
Settings and conduct: This project was conducted in the form of a Ph.D. thesis of sport pathology and corrective movements in the University of Isfahan and in Mashhad, under the supervision of Mashhad University of medical sciences, with one-way blindness (supervisors and evaluators are not familiar with the research routine).
Participants/Inclusion and exclusion criteria: Employees with chronic lumbar disc herniation
Intervention groups: Experimental group 1 conventional exercises and experimental group 2 suspension exercises
Main outcome variables: Conventional and suspended central stabilizer exercises, structural features of intervertebral disc, functional limitation

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20190115042365N1

Registration date: 2019-04-28, 1398/02/08

Registration timing: retrospective

Last update: 2019-04-28, 1398/02/08

Update count: 0
Registration date: 2019-04-28, 1398/02/08

Registrant information: Name

Reza Khanzadeh

Name of organization / entity

Isfahan university

Country

Iran (Islamic Republic of)

Phone

+98 51 3891 8630

Email address

r.khanzadeh84@spr.ui.ac.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2018-09-23, 1397/07/01
Expected recruitment end date: 2019-01-21, 1397/11/01
Actual recruitment start date: 2018-09-23, 1397/07/01
Actual recruitment end date: 2019-02-20, 1397/12/01
Trial completion date: 2019-02-20, 1397/12/01

Scientific title: Effect of combined suspension and core stability exercises on structural characteristic of intervertebral disc and functional disability in office workers with disc herniation.

Public title: The effect of suspension and traditional exercises on intervertebral disc herniation
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

the People who sitting on the chair about 6 to 7 hours a day during the day. the People without history of trauma of the lumbar region. People without a history of surgery in the lumbar region. People with lateral posterior hernia in the L4-L5 and L5-S1 regions with orthopedic surgeon diagnosis. People who are authorized to perform exercises with orthopedic diagnosis

Exclusion criteria:

Individual desire to leave the research Failure to observe disciplinary during the training period The occurrence of medical problems or any kind of problem that prevents the continuation of the workout.
Age: From 30 years old to 50 years old
Gender: Male

Phase

N/A

Groups that have been masked

Care provider
Outcome assessor
Data analyser

Sample size

Target sample size: 30

Actual sample size reached: 25

Randomization (investigator's opinion)

Randomized

Randomization description

After determining the patients list and their numbering, randomly, the odd numbers in the first intervention group and the couples in the second intervention group were placed. This method is described in statistical books as one of the methods of random selection.

Blinding (investigator's opinion)

Single blinded

Blinding description

In this research, both groups (experimental 1 and 2) received intervention and the control group (without intervention therapy) was absent due to ethical considerations. meanwhile, those who supervised the exercises and the Doctor responsible for reviewing the results were not aware of the results of the job title. And solely on the correct way of exercising and evaluating.

Placebo

Not used

Assignment

Parallel

Other design features

In this study, in collaboration with the Physical Education and Orthopedic Department, a chair was designed to perform suspended exercises.

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics Committee of the University of Isfahan

Street address

Isfahan, Azadi Square, Isfahan University

City

isfahan

Province

Isfehan

Postal code

۸۱۷۴۶۷۳۴۴۱
Approval date: 2017-08-25, 1396/06/03
Ethics committee reference number: IR.UI.REC.1396.063 نامه ارسالی از طرف کمیته اخلاق دانشگاه اصفهان نیز به ایمیل ذیل که توسط داور محترم ذکر شده است ارسال شد. با سلام مجدد من به ایمیل ارسالی توسط ادمین محترم پاسخ دادم و شماره عضویت و کارآزمایی به ایشان اعلام شد.

Health conditions studied

1

Description of health condition studied: Intervertebral disc herniation
ICD-10 code: M51.1†
ICD-10 code description: M51.1†Lumbar and other intervertebral disc disorders with radiculopathy (G55.1*)

Primary outcomes

1

Description: Change the level of functional limitation of individuals and change the structural characteristics of the intervertebral disc
Timepoint: 8 weeks after exercises
Method of measurement: MRI imaging apparatus and Oswestry questionnaire and functional tests

Secondary outcomes

empty

Intervention groups

1

Description: The conventional stabilizer exercises included abdominal and pelvic floor exercises in 24 sessions of 30 minutes, based on previous studies.
Category: Treatment - Devices

2

Description: Intervention group: The group performed the conventional stabilizer exercises in the first intervention group in a suspended state with the help of a device designed in which case the individual seat was suspended and exercised.
Category: Treatment - Devices

Recruitment centers

1

Recruitment center: Name of recruitment center

Therapeutic Clinic of Khorasan Razavi Oil and Gas Co.

Full name of responsible person

dr Mohammad Bagheri Ghouzhdi

Street address

Sazeman Ab Boulevard, Oil and Gas Company Therapeutic Clinic

City

Mashhad

Province

Razavi Khorasan

Postal code

1111111111

Phone

+98 51 3726 6045

Email

asndr70267@yahoo.com

1

Sponsor: Name of organization / entity

Isfahan University

Full name of responsible person

Reza Mahdavinezhad

Street address

Azadi Square Isfahan University

City

Isfahan

Province

Isfehan

Postal code

۸۱۷۴۶۷۳۴۴۱

Phone

+98 31 3793 2128

Email

r.mahdavinejad@spr.ui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Isfahan University
Proportion provided by this source: 100
Public or private sector: Public
Domestic or foreign origin: Domestic
Category of foreign source of funding: empty
Country of origin
Type of organization providing the funding: Academic

Person responsible for general inquiries

Contact: Name of organization / entity

Isfahan University

Full name of responsible person

Reza Khanzadeh

Position

Phd student

Latest degree

Master

Other areas of specialty/work

Sport Pathology and Corrective Exercises

Street address

Azadi Square Isfahan University

City

Isfahan

Province

Isfehan

Postal code

8174673441

Phone

+98 31 3973 2128

Email

r.khanzadeh84@spr.ui.ac.ir

Person responsible for scientific inquiries

Contact: Name of organization / entity

University of Isfahan

Full name of responsible person

Reza Mahdavinejad

Position

Associate Professor

Latest degree

Ph.D.

Other areas of specialty/work

Sport Pathology and Corrective Exercises

Street address

Azadi Square Isfahan University

City

Isfahan

Province

Isfehan

Postal code

8174673441

Phone

+98 31 3793 2128

Email

r.mahdavinejad@spr.ui.ac.ir

Person responsible for updating data

Contact: Name of organization / entity

Isfahan University

Full name of responsible person

Reza Khaanzadeh

Position

Phd student

Latest degree

Master

Other areas of specialty/work

Sport Pathology and Corrective Exercises

Street address

Azadi Square University of Isfahan

City

Isfahan

Province

Isfehan

Postal code

۸۱۷۴۶۷۳۴۴۱

Phone

+98 31 3793 2128

Email

r.khanzadeh84@spr.ui.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD): Yes - There is a plan to make this available
Study Protocol: Yes - There is a plan to make this available
Statistical Analysis Plan: Yes - There is a plan to make this available
Informed Consent Form: Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report: Yes - There is a plan to make this available
Analytic Code: Not applicable
Data Dictionary: Not applicable
Title and more details about the data/document: The effects of these exercises will be presented in the form of scientific papers and PhD theses
When the data will become available and for how long: Starting the access period from 1398
To whom data/document is available: Usability will be free to the public
Under which criteria data/document could be used: All data will be accessible to patients except personal information.
From where data/document is obtainable: They can be contacted by email
What processes are involved for a request to access data/document: After receiving the email from the applicants and checking their requests, they will be answered promptly
Comments

Effect of combined suspension and core stability exercises on structural characteristic of intervertebral disc and functional disability in office workers with disc herniation.