To compare the effect of Diaphragm training and myofascial release back pain patients with non- specific chronic low back pain.
Design
A concealed, randomized, blinded, clinical trial with a parallel group design of 44 patients, enrolled between April 2025 and June 2025
Settings and conduct
The study was held at Arif Memorial Teaching hospital and Hameed Latif Hospital Lahore. The blinding is achieved by concealment in which the treatment allocation for each patient. This is done to avoid biasness
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Participants were included if they had intermittent nonspecific CLBP for ≥12 weeks, with VAS between 3 to 7. All participants were active at a recreational level, for 2–4 times per week, since at least 3 years. Patients with low back pain without radiculopathy. Individual willing to participate in study
Exclusion Criteria:
Upper abdominal surgery, lumbar surgery experience, inflammatory spinal disease, spinal deformities, neurologic radiating pain
Intervention groups
Group A: Diaphragm Training
Group B: Myofascial Release technique
Main outcome variables
Numeric pain rating scale was used to measure the intensity of pain, Oswestry Disability Index for the measurement of disability and Schober’s test for lumbar flexibility
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220604055072N3
Registration date:2025-04-16, 1404/01/27
Registration timing:prospective
Last update:2025-04-16, 1404/01/27
Update count:0
Registration date
2025-04-16, 1404/01/27
Registrant information
Name
Aleena Waheed
Name of organization / entity
Rashid Latif Medical College
Country
Pakistan
Phone
+92 321 4883868
Email address
alwaheed28@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-04-20, 1404/01/31
Expected recruitment end date
2025-07-20, 1404/04/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effect of diaphragmatic training and myofascial release on patients with chronic non-specific low back pain
Public title
Comparative effect of diaphragmatic training and myofascial release on pain, flexibility and disability in patients with chronic non-specific low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Participants were included if they had intermittent nonspecific CLBP for ≥12 weeks, with VAS between 3 to 7. All participants were active at a recreational level, for 2–4 times per week, since at least 3 years.
Patients with low back pain without radiculopathy
Individual willing to participate in study
Exclusion criteria:
Upper abdominal surgery
Lumbar surgery experience
Inflammatory spinal disease
Spinal deformities
Neurologic radiating pain
Age
From 20 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were allocated randomly to study groups using the lottery method. Each patient was asked to draw a closed slip marked with number 1 or 2 from a box. Group A include participants in box number one, while group B include participants of box number two. 48 patients were allocated based on randomization in two groups equally, i.e., 24 in each group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The interventions were based on outpatient rehabilitation program in both groups. The study participants were blind about groups a treatment protocol.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Institutional Review Board of Rashid Latif Medical College
Street address
25-Km Ferozepur road Lahore
City
Lahore
Postal code
54600
Approval date
2024-12-12, 1403/09/22
Ethics committee reference number
IRB/2024/213
Health conditions studied
1
Description of health condition studied
Chronic non-specific Low Back Pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Pain
Timepoint
Pre-intervention and Post-4 week intervention
Method of measurement
Pain level was assessed by the Numerical Rating Scale (NRS). The participants rated their pain on a defined 0–10 scale, where 0 is no pain, and 10 is the worst pain imaginable.
2
Description
Disability
Timepoint
Pre-intervention and Post-4 week intervention
Method of measurement
The ODI is one of the most common scoring systems used for patients with LBP. The total score ranges from 0 to 100, where a higher score indicates a higher level of disability.
3
Description
Flexibility
Timepoint
Pre-intervention and Post-4 week intervention
Method of measurement
The examiner puts his thumbs on the inferior margin of the subject’s PSIS. An ink mark is drawn along the midline of the lumbar spine horizontal to the PSIS (lower landmark). While the examiner holds the tape firmly against the subject’s skin, he marks a second line 15 cm above the original one (higher landmark). Then the subject is asked to do an active anterior flexion of the trunk without increasing the pain. The new distance between the lower and higher landmarks is then measured. The subject returns to the neutral position. The difference in the initial distance between the skin markings in the neutral position and the new measurements made in the flexion position is used to indicate the amount of lumbar flexion.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Diaphragm Training. The diaphragm has a dual role of respiration and postural control. However, the role of the diaphragm is often overlooked in core stability exercise regime low back pain rehabilitation. Abdominal hollowing exercise, also known as the ‘tummy tuck’ exercise focusing on TrA and lumbar multifidus. Diaphragmatic breathing on activation of trunk muscles of patients with low back pain. Diaphragmatic breathing may affect activation of trunk muscles. Diaphragmatic breathing increases intra-abdominal pressure, and the increased intra-abdominal pressure may contribute to the lumbar stability. Experimental group performed diaphragmatic breathing exercise with six breathing positions. First week: Supine breathing + Crocodile breathing. Second week: Supine breathing with TheraBand + Crocodile breathing with TheraBand. Third week: Seated breathing + 90/90/90 breathing Fourth week: Seated breathing with TheraBand + TheraBand.
Category
Treatment - Other
2
Description
Comparative Intervention group: Myofascial Release technique. Myofascial release technique diaphragm performed as follow: The participant lay supine with relaxed limbs. Positioned at the head of the participant, the therapist made manual contact with the pisiform, hypothenar region and the last three fingers bilaterally to the underside of the seventh to tenth rib costal cartilages, with the therapist's forearms aligned toward the participant's shoulders. In the inspiratory phase, the therapist gently pulled the points of contact with both hands in the direction of the head and slightly laterally, accompanying the elevation of the ribs. During exhalation, the therapist deepened contact toward the inner costal margin, maintaining resistance. The manoeuvre was performed in two sets of 10 deep breaths, with a 1-minute interval between them.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Arif Memorial Teaching Hospital
Full name of responsible person
Sadia
Street address
25-Km Ferozepur road Lahore
City
Lahore
Postal code
54600
Phone
+92 305 4501212
Email
areejsaadia@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rashid Latif Medical College
Full name of responsible person
Aleena Waheed
Street address
25-Km Ferozepur road Lahore
City
Lahore
Postal code
54900
Phone
+92 321 4883868
Email
alwaheed28@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rashid Latif Medical College
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Rashid Latif Medical College
Full name of responsible person
Sadia Ahmed
Position
Physiotherapist
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
25-Km Ferozepur road Lahore
City
Lahore
Province
Punjab
Postal code
54600
Phone
+92 305 4501212
Email
areejsaadia@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rashid Latif Medical College
Full name of responsible person
Sadia Ahmed
Position
Physiotherapist
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
25-Km Ferozepur road Lahore
City
Lahore
Province
Punjab
Postal code
54900
Phone
+92 305 4501212
Email
areejsaadia@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rashid Latif Medical College
Full name of responsible person
Aleena Waheed
Position
Senior Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
25-Km Ferozepur road Lahore
City
Lahore
Province
Punjab
Postal code
54900
Phone
+92 321 4883868
Email
alwaheed28@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available