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
-
-
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
-
-
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
-
Ethics committees
1
-
Ethics committee
-
-
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
1
-
Sponsor
-
-
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
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
-