The effect of exercise on lower back pain during pregnancy
| ISRCTN | ISRCTN73252556 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN73252556 |
| Secondary identifying numbers | 7/29/3634 - University of Raparin/ Vice-President for scientific Affairs and Higher Education Directorate of Higher Education and Continuing Education. |
- Submission date
- 20/08/2022
- Registration date
- 15/09/2022
- Last edited
- 08/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English Summary
Background and study aim
Lower back pain during pregnancy is a common problem that can affect women's day-to-day activities and may worsen as the pregnancy progresses. Some women ask for advice from their healthcare provider. Pregnant women may wish to avoid medication and seek other ways to manage their symptoms. This study looks at the effect of appropriate, personalized exercises on these women.
Who can participate?
Women aged 18 years or over who were between 14 and 30 weeks pregnant when they joined the study. They had to be experiencing lower back pain.
What does the study involve?
Women were assessed by a physiotherapist who asked them about their symptoms and physically examined them. The women answered questions used in previous scientific research into back pain during pregnancy. The women were then allocated to one of two groups. One group continued with routine antenatal care. The other group undertook 12 weeks of exercises. The women had a weekly one-to-one clinic appointment with the physiotherapist for the first four weeks. The exercise program was personalized to suit the needs of each individual and included appropriate stabilizing and stretching exercises. At the end of the first four weeks, the woman decided on a personal plan of exercises to carry out once a day at home for the following eight weeks.
What are the possible benefits and risks of participating?
Past research has shown that specific exercises can reduce symptoms for women experiencing lower back pain during pregnancy. The exercises in this study have been used safely (for both mother and baby) in previous research and clinical practice. In addition, women were advised against continuing any exercise that increased their symptoms as the aim of all the exercises was to reduce pain.
Where is the study run from?
This study is part of the principal investigator's PhD studies and is the property of the Nursing College, the University of Raparin in the Kurdistan region/north Iraq.
When is the study starting, and how long is it expected to run?
September 2020 to February 2022
Who is funding the study?
Investigator initiated and funded
Who is the primary contact?
Begard Othman Muhammad, begard.othman@uor.edu.krd
Contact information
Principal Investigator
Zargatay Kon
Slemani
-
Iraq
 ORCID ID |
0000-0002-1610-3472 |
|---|---|
| Phone | +964 7701993036 |
| begard.othman@uor.edu.krd |
Scientific
College of Health Sciences/Hawler Medical University
Hawler
-
Iraq
| ORCID ID |
0000-0002-4952-7108 |
|---|---|
| Phone | +964 7504478625 |
| hamdia.ahmed@hmu.edu.krd |
Scientific
College of Medicine, Hawler Medical University
Hawler
-
Iraq
| ORCID ID |
0000-0002-8921-9687 |
|---|---|
| Phone | +964 7505190000 |
| mediashwan@hotmail.com |
Study information
| Study design | Interventional non-randomized study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a (Kurdish language) participant information sheet. |
| Scientific title | Effect of therapeutic exercise on lumbopelvic pain among pregnant women. |
| Study hypothesis | Does therapeutic exercise reduce pregnancy-related lumbopelvic pain and improve functional capability in performing daily activities? |
| Ethics approval(s) | Approved 08/11/2020, University of Raparin Scientific and Ethical Committee (Humanities Building, 3rd Floor, Main Street, Rania City, 46012, Iraq; +964 772208398; dr.sanaa@uor.edu.krd), ref: 7/29/3634 |
| Condition | Lumbopelvic pain during pregnancy |
| Intervention | A quasi-experimental study involving 110 pregnant women with lumbopelvic pain, recruited from six primary healthcare clinics in Slemani city, Kurdistan region of Iraq. Stability exercises to strengthen muscles around the lumbar and pelvic region and focused stretching exercises to increase flexibility at the lumbar spine, hip, knee, and ankle joints. The course of the study comprised: - Clinic-based exercise program (CBEP), once a week for 4 weeks. - Home-based exercise program (HBEP), one session of personalized exercises per day for 8 weeks. At recruitment, women are allocated a number in sequential order (1,2,3 etc.) All who obtain odd numbers are assigned to the intervention group, and all with even numbers are assigned to the control group |
| Intervention type | Behavioural |
| Primary outcome measure | Pain intensity measured using the Numeric Rating Scale (NRS) at baseline and follow up (12 weeks) |
| Secondary outcome measures | Functional ability measured using modified pregnancy mobility index, incorporating the Oswestry disability index (ODI), pregnancy mobility index (PMI) and pelvic girdle questionnaire (PGQ) at at baseline and follow up (12 weeks) |
| Overall study start date | 20/09/2020 |
| Overall study end date | 28/02/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | In non-probability convenient sampling, the target number was 140 subjects (n=70 therapeutic and n=70 control) groups. But at the end of the study, the analyzed subjects were n=60 in the therapeutic and n=50 in the control group. |
| Total final enrolment | 110 |
| Participant inclusion criteria | 1. Pregnant women complaining of lower back pain (LBP) between the costal margin and inferior gluteal folds, with or without leg pain 2. Singleton pregnancy 3. Gestational stage 14 - 30 weeks 4. No previous treatment for current symptoms |
| Participant exclusion criteria | 1. With reference to the American College of Obstetricians and Gynecologists (ACOG) guidelines on exercise during pregnancy, any woman for whom exercise is contraindicated. 2. Indications for high-risk pregnancy, e.g., placenta previa, pre-eclampsia. 3. History of disc prolapse, spine or pelvic trauma, or spinal surgery. 4. Body Mass Index greater than 40 kg/m² 5. Unexplained weight loss |
| Recruitment start date | 16/01/2021 |
| Recruitment end date | 31/10/2021 |
Locations
Countries of recruitment
- Iraq
Study participating centre
Slemani
-
Iraq
Sponsor information
University/education
Main Street
University Campus
Rania - Sulamani
46012
Iraq
| Phone | +964 7502659191 |
|---|---|
| relations@uor.edu.krd | |
| Website | https://www.uor.edu.krd/en/ |
"ROR" |
https://ror.org/00fs9wb06 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 07/09/2022 | No | No | ||
| Basic results | version 22 | 08/11/2022 | 08/11/2022 | No | No |
Additional files
Editorial Notes
08/11/2022: Basic results uploaded.
07/09/2022: Trial's existence confirmed by University of Raparin Scientific and Ethical Committee
