Effects of breathing exercises on pain, disability, range of motion and muscle endurance in patients with chronic low back pain: A randomized controlled trial
To compare mean pain, range of motion, disability and endurance in routine physical therapy with and without breathing exercises in patients with mechanical chronic low back pain.
Design
A concealed, randomized, triple blinded clinical trial with 132 patients followed by inclusion and exclusion criteria.
Settings and conduct
study will be conducted in Physical therapy department Gulab Devi Institute of Physiotherapy Lahore
Participants/Inclusion and exclusion criteria
Inclusion Criteria
• Patients with chronic low back pain (>12 weeks),on VAS >3. (30)
• Main complaint of localized lumbar pain and decreased lumbar ROM from L1 to L5.
Exclusion Criteria
• Patients with spinal Tuberculosis
• Patients with Spinal Muscular Atrophy
Intervention groups
Routine Physical Therapy + Breathing Exercises
Total no of sessions will be 12, 3 sessions per week for 4 week
Follow up will be done after 6 weeks
Main outcome variables
• Pain
• Functional Disability
• Range of Motion (ROM)
• Muscle Endurance
• Forced Expiratory Volume in one second (FEV1 )
• Oxygen saturation on pulse oximeter (SpO2 )
General information
Reason for update
Acronym
breathing exercise
IRCT registration information
IRCT registration number:IRCT20200901048579N1
Registration date:2020-11-09, 1399/08/19
Registration timing:prospective
Last update:2020-11-09, 1399/08/19
Update count:0
Registration date
2020-11-09, 1399/08/19
Registrant information
Name
Muhammad Arif
Name of organization / entity
The University of Lahore
Country
Pakistan
Phone
+92 42 35918040
Email address
drarifgdpgmi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-15, 1399/08/25
Expected recruitment end date
2022-05-16, 1401/02/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of breathing exercises on pain, disability, range of motion and muscle endurance in patients with chronic low back pain: A randomized controlled trial
Public title
Effects of breathing exercises on pain, disability, range of motion and muscle endurance in patients with chronic low back pain.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-55 years.
Patients of both Genders.
Patients with chronic low back pain (>12 weeks),on VAS >3.
Main complaint of localized lumbar pain and decreased lumbar ROM from L1 to L5.
Exclusion criteria:
Patients with spinal Tuberculosis
Patients with Spinal Muscular Atrophy
Patient with Mental disability.
Patients with any Systemic Illness(e.g. Rheumatism)
Patients with advanced lumbar spine degenerative changes.
Patients with radiating pain.
Patients with spinal injury.
Patients with leg length discrepancies
Patients having functional and structural disabilities
Lactating and Pregnant females
Age
From 18 years old to 55 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
132
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided in to two groups using random no table. i.e group A with group B
Group-A: Routine Physical Therapy
Group-B: Routine Physical Therapy + Breathing Exercises
Assessor: Assessor will be expert physical therapist
Blinding (investigator's opinion)
Triple blinded
Blinding description
participant, Physiotherapist and investigator are blind. groups selection and tagging information will not open to the participant, therapist and assessor
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
university of lahore pakistan
Street address
1 km Defence road lahore
City
Lahore
Postal code
55150
Approval date
2019-07-25, 1398/05/03
Ethics committee reference number
BOS/UIPT/028-17
Health conditions studied
1
Description of health condition studied
Mechanical low back pain
ICD-10 code
M54
ICD-10 code description
Dorsalgia
Primary outcomes
1
Description
pain
Timepoint
breathing exercises and routine physiotherapy
Method of measurement
VAS
Secondary outcomes
1
Description
endurance, oxygen saturation
Timepoint
breathing exercises
Method of measurement
pulse oximeter, inclinometer
Intervention groups
1
Description
Intervention group: breathing exercises and routine physiotherapy
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Physiotherapy department Gulab Devi hospital lahore
Full name of responsible person
Prof. Dr. Majid Kaleem
Street address
Ferozepur road Lahore
City
Lahore
Postal code
54700
Phone
+92 42 35918040
Email
drarifgdpgmi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
university of Lahore Pakistan
Full name of responsible person
Prof. Dr. Majid Kaleem
Street address
1 Km defense road Lahore
City
Lahore
Postal code
54792
Phone
+92 42 35963424
Email
drarifgdpgmi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
university of Lahore Pakistan
Proportion provided by this source
100
Public or private sector
Private
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
Riphah Institute of rehabilitation sciences
Full name of responsible person
Prof. Dr. Muhammad Salman Bashir
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Rehabilitation management
Street address
Quid e Azam industrial estate lahore
City
Lahore
Province
Punjab
Postal code
54700
Phone
+92 42 35126110
Email
chishtisalman@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Riphah Institute of rehabilitation sciences
Full name of responsible person
Prof. Dr. Muhammad Salman Bashir
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Rehabilitation management
Street address
Quid e Azam industrial estate lahore
City
Lahore
Province
Punjab
Postal code
54700
Phone
+92 42 35126110
Email
chishtisalman@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Riphah Institute of rehabilitation sciences
Full name of responsible person
Prof. Dr. Muhammad Salman Bashir
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Rehabilitation management
Street address
Quid e Azam industrial estate lahore
City
Lahore
Province
Punjab
Postal code
54700
Phone
+92 42 35126110
Email
chishtisalman@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
individual participant data must not be shared while results should shared
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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Effect of breathing exercises on pain, disability, range of motion and muscle endurance in patient with chronic low back pain
When the data will become available and for how long
January 2022
To whom data/document is available
health care provider, PhD students, institutes
Under which criteria data/document could be used
for research purposes, evidence based practice
From where data/document is obtainable
drarifgdpgmi@gmail.com
What processes are involved for a request to access data/document