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Measurements of lumbar multifidus muscle thickness using ultrasound in chronic low back pain patients, before and after physical therapy exercises

Protocol summary

Study aim
To study whether strengthening of the lumbar multifidus muscles can be more effective than the MF muscle stabilization in restoration of the muscle size.
Design
Two parallel groups (one as control and one as intervention) with random assignment of the subjects into two groups of 12.
Settings and conduct
For all subjects of each group, the trials continued in 24 sessions distributed over 8 weeks and the MF muscles were measured in the beginning of the first session and at the end of the last session
Participants/Inclusion and exclusion criteria
only those CLBP patients with a pain intensity above 3 were selected. Oppositely, patients with a history of sacroiliac dysfunction, invasive surgical operations with alteration of the normal anatomy of the patient (e.g., implant) on abdomen, pelvis, and lower extremity, respiratory diseases, neurological disorders, pelvic fracture and dislocation, scoliosis and structural deformities of spine, spine surgery, malignancies, rheumatic diseases, or other systemic diseases, acute back trauma, spondylolysis and spondylolisthesis, and pregnancy or caesarian section in the last two months were excluded.
Intervention groups
12-person group of chronic low back pain patients who underwent hip abductor strengthening exercises
Main outcome variables
Statistical significance (p-value) of the change in the average MF muscle thickness, pain, and disability scores along with for each group

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201119049444N1
Registration date: 2020-12-13, 1399/09/23
Registration timing: retrospective

Last update: 2020-12-13, 1399/09/23
Update count: 0
Registration date
2020-12-13, 1399/09/23
Registrant information
Name
Mahnaz Aboufazeli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 86709
Email address
m.aboufazeli111@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-10, 1396/10/20
Expected recruitment end date
2018-01-24, 1396/11/04
Actual recruitment start date
2018-02-20, 1396/12/01
Actual recruitment end date
2018-02-27, 1396/12/08
Trial completion date
2018-05-19, 1397/02/29
Scientific title
Measurements of lumbar multifidus muscle thickness using ultrasound in chronic low back pain patients, before and after physical therapy exercises
Public title
Recovery of muscle size and pain improvement in patients with a chronic low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Female chronic low back pain patients with a pain intensity above 3 score when using Visual Analog Scale
Exclusion criteria:
patients with a history of sacroiliac dysfunction, invasive surgical operations with alteration of the normal anatomy of the patient (e.g., implant)major surgeries on abdomen, pelvis, and lower extremity, respiratory diseases, neurological disorders, pelvic fracture and dislocation, scoliosis and structural deformities of spine, spine surgery, malignancies, rheumatic diseases, or other systemic diseases, acute back trauma, spondylolysis and spondylolisthesis, and pregnancy or caesarian section in the last two months were excluded.
Age
From 20 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 24
Actual sample size reached: 24
Randomization (investigator's opinion)
Randomized
Randomization description
With consideration of the minimum subjects needed for a reliable statistical analysis, a total of 24 participants who were eligible for random allocation between two groups, were selected. To avoid potential bias in allocation of the participants, their hospital admission IDs were shuffled using MicroSoft Office Excel software package. Then, the first 12 participants appeared in the resultant output column of the software were allocated to the first group (control group) and the second 12 participants appeared in that column were allocated to the second group (intervention group).
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients did not know whether they are receiving the conventional treatment or the interventional treatment. The radiologist who performed muscle thickness measurements also did not the group a patient was coming from. The data analyst knew the group as 1 and 2, so he also did not know which group is conventional and which one is interventional.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of the Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
14496-14535
Approval date
2016-12-10, 1395/09/20
Ethics committee reference number
IR.IUMS.REC 1395.9211342209

Health conditions studied

1

Description of health condition studied
Chronic low back pain
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Thickness of the lumbar multifidus muscle, pain intensity, and disability index
Timepoint
8 weeks with 3 sessions each (24 sessions)
Method of measurement
An ultrasound device is used for muscle thickness measurements, a linear scale is used for marking the pain intensity by patients (Visual Analog Scale), and finally a questionnaire is used to record the disability index (Oswestry).

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: hip abductor strengthening exercises 3 times a week and total period of 8 weeks (24 sessions). Each session started with 10 min warm-up period consisted of 5 min stationary biking at a moderate pace and 5 min back stretching exercises. During the back stretching, the low back sustained rotation from supine position, single and double knee to chest from supine position, alternate spinal flexion-extension from 4-point kneeling position, trunk forward stretching while sitting on the heels and with trunk parallel to the floor, side bending in standing position with and without contralateral arm elevation. Then, the patients received the hip abductor strengthening exercises consisting of abduction during four separate positions: supine, side lying, and standing.
Category
Rehabilitation

2

Description
Control group: Stabilization exercises 3 times a week and total period of 8 weeks (24 sessions). The stabilization exercises were performed in 6 steps including: 1) segmental control exercises (SCE) with emphasis on training of isolated contraction of the transversus abdominis, multifidus, and pelvic floor muscles, 2) SCE with emphasis on co-contractions of the above-mentioned muscles in the prone, supine, and four-point kneeling positions, 3) SCE as a closed kinematic chain, 4) SCE extension by adding a low weight (0.5-1.5 kg) to create leverage of the limbs, 5) application of SCE in functional situation, and 6) co-contraction of the transversus abdominis and multifidus, muscles during application of an external load, complication of movements, increased load with the lumbar spine in the correct position, and addition of a co-contraction pattern to light aerobic activities such as walking.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Mahnaz Aboufazeli
Street address
Tajjeddin Street, ChaharBagh-e-Baalaa Ave., Shariati Hospital
City
Isfahan
Province
Isfehan
Postal code
4538481737
Phone
+98 31 3627 2001
Email
mahnaz.aboufazeli111@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Akbari
Street address
Iran University of Medical Sciences, School of Rehabilitation Sciences, Maddadkaran St., Shahid Nazari St., Mirdamad Blvd. Mother Square
City
Tehran
Province
Tehran
Postal code
14496-14535
Phone
+98 21 2222 7124
Email
akbari.mo@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Mahnaz Aboufazeli
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Iran University of Medical Sciences, School of Rehabilitation Sciences, Maddadkaran St., Shahid Nazari St., Mirdamad Blvd., Mother Square
City
Tehran
Province
Tehran
Postal code
1348715459
Phone
+98 21 2222 7124
Email
m.aboufazeli111@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahnaz Aboufazeli
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Iran University of Medical Sciences, School of Rehabilitation Sciences, Maddadkaran St., Shahid Nazari St., Mirdamad Blvd., Mother Square
City
Tehran
Province
Tehran
Postal code
15459-13487
Phone
+98 21 2222 2059
Email
m.aboufazeli111@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahnaz Aboufazeli
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Iran University of Medical Sciences, School of Rehabilitation Sciences, Maddadkaran St., Shahid Nazari St., Mirdamad Blvd. Mother Square
City
Tehran
Province
Tehran
Postal code
15459-13487
Phone
+98 21 2222 2059
Email
m.aboufazeli111@gmail.com

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
Undecided - It is not yet known if there will be 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
Results of multifidus muscle size measurements and pain intensity in chronic low back pain patients before and after stabilization and hip abductor strengthening treatments
When the data will become available and for how long
From January 2021
To whom data/document is available
Public but mainly medical scientists and healthcare providers
Under which criteria data/document could be used
Non-profit
From where data/document is obtainable
Email corresponding author
What processes are involved for a request to access data/document
Within 2 business days after receiving the email request
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