View older revisions Content changed at 2025-02-06, 1403/11/18

Protocol summary

Study aim
Investigating the effect of motor control exercises with forced respiratory training on core muscles activity of women with postpartum lumbopelvic pain.
Design
RCT, single-blinded, with a factorial design on 48 participants. Randomization is done using the Randomization website.
Settings and conduct
Women are included in the study based on the inclusion and exclusion criteria. After that, ultrasound evaluations will be done. Treatments will be performed in the intervention and the control groups. Reassessment is done after the last treatment session. All assessments and exercises will be done in the laboratory of the Department of Physiotherapy, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran. Blinding: the examiner and the therapist are two people, and the examiner isn't aware of the groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women with a history of vaginal delivery in the past 3-12 months and suffering from CNLBP, and/ or pelvic pain or both back and pelvic pain. The onset of pain must be during pregnancy or after delivery, and the intensity of pain must be between 3 and 7 based on the VAS. Exclusion criteria: History of pathological, neurological, and RA diseases, lumbar spondylolisthesis, urinary incontinence, back, pelvic or ankle surgery, pelvic tumor, spine deformity, uterine and bladder prolapse, gestational diabetes, heart, vascular, kidney disorders and more than 2 deliveries.
Intervention groups
Participants will be assessed in two groups to investigate the additional effect of breathing exercises compared to motor control exercises alone, on the improvement of the study variables, participants will be assessed in two groups: Intervention group (respiratory resistance training + motor control exercises); Control group (motor control exercises)
Main outcome variables
Pain, disability, Core muscles activity

General information

Reason for update
Dear Editor The article protocol has been submitted for publication in a journal. At the request of the journal reviewer, some items in the exclusion criteria have been merged and more explanations have been added to some of the items of the inclusion criteria and sharing plans. Also, in the outcomes section, all outcomes were mistakenly listed as primary outcomes, which was corrected (outcomes have not changed, one outcome is considered as primary and the other outcomes are listed as secondary outcomes). Moreover, minor changes have been made to make the title more concise. For this reason, the protocol has been updated.
Acronym
Active straight leg raise(ASLR), Chronic non-specific low back pain (CNLB), Intraclass Correlation Coefficient (ICC), Minimal Detectable Changes (MDC), Oswestry Disability Index(ODI), International Consultation on Incontinence Question (ICIQ), Randomize
IRCT registration information
IRCT registration number: IRCT20180916041051N2
Registration date: 2024-05-21, 1403/03/01
Registration timing: registered_while_recruiting

Last update: 2025-02-06, 1403/11/18
Update count: 1
Registration date
2024-05-21, 1403/03/01
Registrant information
Name
Shabnam Shahali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2225 8769
Email address
shahali.sh@iums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2025-11-22, 1404/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of motor control training and breathing exercises, on pain, disability, and core muscle activity in women with postpartum lumbopelvic pain based on artificial intelligence algorithms
Public title
Effect of motor control training and breathing exercises, on pain, disability, and core muscle activity in women with postpartum lumbopelvic pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with CNLBP: back pain without specific pathology that occurs between the last rib and the end of the gluteal fold. Women with pelvic pain: Positive active straight leg raise (ASLR) test, and having a positive result on at least three of six sacroiliac provocation tests (including distraction, compression, posterior shear test (thigh-thrust test), Gaenslen provocation test (right), Gaenslen provocation test (left) and sacral thrust test). Women who have back and pelvic pain together. The onset of lumbar, pelvic or lumbopelvic pain is during pregnancy or postpartum. At least 3 months and at most 1 year after postpartum. Age over 20 years The pain intensity of the patients, at the time of the test or during the last two weeks, should be between 3 and 7 on the visual analog scale. Reading and writing literacy (at least cycle level education) Vaginal delivery Body mass index below 30
Exclusion criteria:
Spinal deformity or pathological condition (canal stenosis, scoliosis, spondylolisthesis, fractures, spinal or pelvic tumors…) History of neurological, cardiovascular, respiratory, renal diseases, or rheumatoid arthritis. Postpartum urinary dysfunctions History of surgical intervention in the lumbopelvic region. Urogenital prolapse above grade 3 History of cesarean section or more than two vaginal deliveries Refusal to participate in the study.
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done using the Randomization website. The people of both groups are identical in terms of demographic characteristics and are randomly divided into one of the two treatment groups with a ratio of 1:1. Randomization will be done by variable blocks method, which will consist of 4-letter blocks, made of letters A and B. The obtained treatment allocation is placed in sealed and numbered envelopes in the form of letters A and B. This process will be done by someone outside the research team and before the start of the study. After the initial evaluations by the examiner, the numbered envelopes are presented to him according to the sequential number of each person entered into the study, and the therapeutic intervention is adjusted based on the letters inside the envelope. The examiner is unaware of the letters inside the envelope.
Blinding (investigator's opinion)
Single blinded
Blinding description
The examiner and the therapist are different people and the examiner is not aware of the way of grouping and the patients in each group, therefore the present study is a one-way blind study (blinding of the examiner).
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemet Highway, next to Milad Tower, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2024-04-13, 1403/01/25
Ethics committee reference number
IR.IUMS.REC.1403.017

Health conditions studied

1

Description of health condition studied
Postpartum lumbopelvic pain
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Excursion of the diaphragm muscle: The diaphragm muscle is the main respiratory muscle and is responsible for 75% of the air flow to the lungs. It plays a role in spinal stability, and its inappropriate function causes lumbopelvic pain. During the activity of the diaphragm muscle, the position of this muscle changes, and in people with back pain, this position change or displacement is less than in people without lumbopelvic pain.
Timepoint
Excursion of the diaphragm muscle is measured at the beginning of the study (before the exercise therapy) and 8 weeks later (after the final session of the exercise therapy).
Method of measurement
The excursion of the right hemidiaphragm will be recorded during deep respiration and ASLR by ultrasound imaging.

Secondary outcomes

1

Description
Pain intensity: Pain intensity is a type of diagnostic information that, in order to check the patient's pain level, will be measured by the visual pain criterion.
Timepoint
Pain intensity will be measured at the beginning of the study (before therapeutic exercise) and 8 weeks later (after the final session of therapeutic exercise)
Method of measurement
Pain intensity will be measured using the visual analog scale

2

Description
Disability: Disability refers to any condition in the body and mind that creates limitations for individuals to perform a series of activities.
Timepoint
Disability will be measured at the beginning of the study (before exercise therapy) and 8 weeks later (after the final session of exercise therapy).
Method of measurement
The Persian version of the ODI, which has demonstrated reliability and validity properties in individuals with low back pain, will be used.

3

Description
Pelvic floor muscle activity: the contraction of the pelvic floor muscles causes upward and inward forces in the pelvic floor and closes the urinary tract; which can play a role in creating stability in the lumbopelvic region.
Timepoint
Pelvic floor muscle activity will be measured at the beginning of the study (before exercise therapy) and 8 weeks later (after the final session of exercise therapy).
Method of measurement
Ultrasound imaging will be used to assess pelvic floor muscle activity. The vertical distance of bladder base displacement, defined as the difference between the maximum displacement of the bladder base during deep expiration/ following a 10-second hold of the ASLR and the initial position of the bladder base at rest, will be regarded as an indicator of PFMs activity.

4

Description
Abdominal muscle activity: Abdominal muscles play a role in stabilizing the spine, pelvic bone, and sacroiliac joint. These muscles create a brace around the abdomen
Timepoint
Abdominal muscle activity will be measured at the beginning of the study (before exercise therapy) and 8 weeks later (after the final session of exercise therapy).
Method of measurement
Using ultrasound imaging, the thickness of abdominal muscles will be measured at rest and then compared with the measurements obtained at the end of deep respiration and after a 10-second hold of the ASLR.

Intervention groups

1

Description
Intervention group: This group includes postpartum women with lumbopelvic pain who receive motor control exercises along with respiratory resistance training for 8 weeks and 3 times a week.
Category
Rehabilitation

2

Description
Control group: This group includes postpartum women with lumbopelvic pain who receive only motor control exercises for 8 weeks and 3 times a week.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Iran University of Medical Sciences
Full name of responsible person
Shabnam ShahAli
Street address
School of Rehabilitation Sciences, Iran University of Medical Sciences, Maddadkaran St., Shahid Nazari St., Mother Square, Mirdamad Blvd, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1431793163
Phone
+98 912 074 9932
Email
shabnamshahali@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Reza Falak
Street address
Iran University of Medical Sciences, Hemet Highway, next to Milad Tower, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
Falak.r@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
Shabnam Shahali
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Madder Square, Maddkaran St., Faculty of Rehabilitation, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۵۴۵۹۱۳۴۸۷
Phone
+98 21 2222 8051
Email
shabnamshahali@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mehdi Dadgoo
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Madder Square, Maddkaran St., Faculty of Rehabilitation, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۵۶۸۶۴۸۵۱۱
Phone
+98 21 2222 8051
Email
dadgoo.m@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Shabnam Shahali
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Madder Square, Maddkaran St., Faculty of Rehabilitation, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۵۶۸۶۴۸۵۱۱
Phone
+98 21 2222 8051
Email
shabnamshahali@yahoo.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
The final trial dataset will be available upon reasonable request from the corresponding author
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
Data, the full protocol, and statistical code are available upon reasonable request. All inquiries about data sharing should be directed to: shabnamshahali@yahoo.com
When the data will become available and for how long
After publishing the results, The final trial dataset will be available upon reasonable request from the corresponding author
To whom data/document is available
Researchers working in academic institutions.
Under which criteria data/document could be used
Use of the data can be done for further research work in the future.
From where data/document is obtainable
Iran University of Medical Sciences, Faculty of Rehabilitation, Madadkaran St., Madar Square, Tehran. Postal code: 1545913487. shabnamshahali@yahoo.com.
What processes are involved for a request to access data/document
Initially, the researcher or institution requesting access to the data should email the corresponding author. The corresponding author, after necessary checks, will provide the requested information.
Comments
Loading...