Protocol summary

Study aim
The aim of this study was to investigate the effect of progressive diaphragmatic breathing exercises on reducing pain, improving function and balance in the population of non-specific low back pain patients.
Design
Phase 3 clinical trial with control group, with parallel group, one-way blind, randomized, 10 patients in each group, simple random sampling with papers written by control or intervention group.
Settings and conduct
20 patients were selected from 26 patients referred to Ramten and Hirad private clinics , then were randomly divided into control and intervention groups. Preliminary assessments were evaluated by a co-worker physiotherapist, including pain measurement based on visual analogue scale, static balance based on unilateral hip bridge test, and dynamic balance based on star test, and data were recorded.The examiner started treatment based on a sheet selected by the patient. in control group patients were received TENS and interfrential modalities for 4 weeks and every other day. The intervention group were received breathing exercises in addition to modalities. At the end of 4 weeks, the outcomes were measured again and the person measuring the outcomes was not aware of the type of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with nonspecific back pain Patients 20 to 50 years People who exercise at least 3 times a week for a total of 6 hours History of back pain for more than 12 weeks (chronic back pain) Patients with VAS low back pain have less than 7 and more than 3 Exclusion criteria: Having any musculoskeletal disease or neurology Pregnancy
Intervention groups
Control group received TENS and interferential modalities intervention group received breathing exercises in addition to TENS and interferential, for 4 weeks
Main outcome variables
Pain, Static balance, Dynamic balance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20090228001719N8
Registration date: 2020-09-10, 1399/06/20
Registration timing: retrospective

Last update: 2020-09-10, 1399/06/20
Update count: 0
Registration date
2020-09-10, 1399/06/20
Registrant information
Name
khadije Otadi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7753 6134
Email address
k_otadi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-20, 1398/02/30
Expected recruitment end date
2019-10-22, 1398/07/30
Actual recruitment start date
2019-06-10, 1398/03/20
Actual recruitment end date
2019-11-21, 1398/08/30
Trial completion date
2019-11-21, 1398/08/30
Scientific title
Effects of Diaphragmatic Breathing Exercise on Pain, Balance and Function in athletes with Chronic Non-specific Low Back Pain
Public title
Effects of Diaphragmatic Breathing Exercise on improving of Chronic Low Back Pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with nonspecific low back pain Age between 20 to 50 Training at least 3 times a week for a total of 6 hours History of back pain for more than 12 weeks (chronic back pain) Pain between 3 to 7 based on VAS( visual analogue scale)
Exclusion criteria:
Other musculoskeletal or neurological disorders Pregnancy
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 10
Actual sample size reached: 10
Randomization (investigator's opinion)
Randomized
Randomization description
Samples were selected by simple randomization from athletes with low back pain based on inclusion criteria, then samples were asked randomly select a piece of paper among 20 papers that was written on control group or breathing exercise group (10 control group and 10 breathing exercise group).
Blinding (investigator's opinion)
Single blinded
Blinding description
The person evaluating the outcome measures did not know the type of treatment.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Seiences
Street address
Keshavarz Blv, Qudes Sreet
City
Tehran
Province
Tehran
Postal code
1419934146
Approval date
2019-12-06, 1398/09/15
Ethics committee reference number
IR.TUMS.FNM.REC.1398.138

Health conditions studied

1

Description of health condition studied
Non specific low back pain
ICD-10 code
G89.4
ICD-10 code description
Chronic pain syndrome

Primary outcomes

1

Description
Pain
Timepoint
Before and after 4 weeks of treatment
Method of measurement
Visual Analogue Scale

2

Description
Static balance
Timepoint
Before and after 4 weeks of treatment
Method of measurement
Unilateral Hip Bridge Endurance

3

Description
Dynamic balance
Timepoint
Before and after 4 weeks of treatment
Method of measurement
Star balance test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The patients in the breathing exercise group also came on the clinic three days a week for four weeks. In each session, the patients received electrotherapy treatment same as control group. In addition to patients were required to perform two types of breathing exercises daily for 4 weeks. These breathing exercises were taught to the patient at the beginning of each week by the physiotherapist and practiced with him to ensure that the exercise was performed correctly. It lasted 5 minutes and was done twice a day, and considering that there were two types of exercises per day (days and times that did not go to the clinic at home), a total of 20 minutes a day. When patients went to the physiotherapy clinic, one set of these breathing exercises was performed with the therapist after electrotherapy. Exercises for each week are as follows: First week: Supine breathing+ Crocodile breathing Second week: Supine breathing+ Crocodile breathing with Theraband Third week: Seated Breathing+ 90/90/90 Breathing Forth week: Seated Breathing+ 90/90/90 Breathing with Theraband. Outcomes were measured before treatment and after 4 weeks of treatment. They received a total of 12 sessions of physiotherapy.
Category
Rehabilitation

2

Description
Control group: In this group, the patients came on the clinic 4 weeks , every weeks 3 days with every other day and received TENS and Interferential. In each session the patients received 30 minutes of conventional TENS with a pulse duration of 100 microseconds and 20 minutes of Interferential with a base frequency of 4000 Hz and a variable frequency of 50 to 100 Hertz . Outcomes were measured before treatment and after 4 weeks of treatment. There was no exercise therapy in this group. They received a total of 12 sessions of physiotherapy.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Private physiotherapy clinics
Full name of responsible person
Shariar Sharify
Street address
Enghlab Ave, Pich e Shemiran, Faculty of Rehabilitation
City
Tehran
Province
Tehran
Postal code
1419934146
Phone
+98 21 7753 3939
Email
sharifi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Amirali Sohrabpour
Street address
Keshavarz Blvd.-Ghodss Street-Nbash- Central University
City
Tehran
Province
Tehran
Postal code
1419934146
Phone
+98 21 8163 3786
Email
k_otadi@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
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
Tehran University of Medical Sciences
Full name of responsible person
Khadijeh Otadi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Pich- e- Shemiran, Faculty of Rehabilitation
City
Tehran
Province
Tehran
Postal code
1366718661
Phone
+98 21 7753 3939
Email
k_otadi@sina.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Khadijeh Otadi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Pich- e-Shemiran, Faculty of Rehabilitation
City
Tehran
Province
Tehran
Postal code
1366718661
Phone
+98 21 7753 3939
Email
k_otadi@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Khadijeh Otadi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Pich-E- Shemiran, Faculty of Rehabilitation
City
Tehran
Province
Tehran
Postal code
1366718661
Phone
+98 21 7753 3939
Email
k_otadi@sina.tums.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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only information about the effect of treatment on outcomes will be made available to faculty and students through the publication of articles and dissertations.
When the data will become available and for how long
After paper publishing
To whom data/document is available
Teachers, students, patients
Under which criteria data/document could be used
No condition
From where data/document is obtainable
My e-mail
What processes are involved for a request to access data/document
Sending message to my e-mail with specific cause of request
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