Postpartum Lumbopelvic PainNCT03030846
Investigation the Effects of Stabilization Exercises on Pain, Disability and Activity of Pelvic Floor Muscles in Patients With Postpartum Lumbopelvic Pain
A study testing Stabilization exercise in people with Postpartum Lumbopelvic Pain, run by Zahedan University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study was to evaluate the effects of stabilization exercises on pain, disability and pelvic floor muscles function in patients with lumbopelvic pain. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Lumbopelvic Pain
- What is being tested?
- Stabilization exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteIran
- Study dates
- Sep 2015to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- age more than 18 years old
- pain located between costal margin to gluteal fold with or without radiation to lower limbs
- onset of pain during pregnancy or after delivery
- history of delivery at least 3 months ago.
Who cannot join
- known chronic rheumatologic or Orthopedic disorders
- systemic locomotor disease
- history of fracture, neoplasm,intervertebral disk pathology or radiculopathy, spondylolysis or spondylolysthesis
- contraindication of exercises, heart disease, diabetes, thrombophlebitis, uncontrolled epilepsy
- ongoing pregnancy
- treatment with specific stabilisation exercise during previous 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Zahra Teymuri, Zahedan University of Medical Sciences
The purpose of this study was to evaluate the effects of stabilization exercises on pain, disability and pelvic floor muscles function in patients with lumbopelvic pain.
Read the detailed description
Pregnancy is a specific experience that leads to several physical changes in women's body and influence most aspects of their lives. Pregnancy and delivery can cause serious complications such as urinary incontinence, pelvic organ prolapse, fecal incontinence, and low back pain (LBP) that have negative effects on women's sexual, physical, social and psychological health.
Based on Wu et al. systematic review, prevalence of pregnancy related low back pain (PLBP) during pregnancy and postpartum is 45% and 25% respectively.
LBP is one of the most current causes of disability and sick leave after delivery.Abnormal load transfer in the lumbopelvic region has been considered as one possible explanation to lumbopelvic pain.The local stabilizing muscles, i.e. the transversely oriented abdominal, diaphragm, the lumbar MF and the PFM Play an important role in load transfer in the lumbopelvic region.so, we considered that an exercise program that addresses muscular dysfunction, such as lumbar stabilization exercise can improve motor pattern of local stabilizing muscles and can use in management of postpartum lumbopelvic pain.
- Conditions
- Postpartum Lumbopelvic Pain
- Being tested
- Stabilization exercise, Control group
- Keywords
- pregnancy, pelvic floor muscles, Lumbo-pelvic pain, Stabilization exercises, abdominal muscles thickness, Multifidus muscles thickness, Multifidus muscles cross section area
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stabilization exerciseOther
18 sessions during 6 consecutive weeks, three times per week, 30 or 40 minutes per session including: Twenty minutes for receiving hot pack and TENS and 10 or 20 minutes for training the exercises in 7 level : 1.Train the specific contraction of the deep abdominal muscles, multifidus and pelvic floor muscles(PFM). 2.Train the specific contraction of deep abdominal muscles with coactivation of multifidus and PFM in supine, prone, sitting, standing and quadruped position. 3. Segmental control exercises in close kinematic chain. 4. Segmental control exercises in open kinematic chain with limb loading, emphasis on abdominal muscles. 5. Segmental control exercises in open kinematic chain with limb loading, emphasis on back extensor muscles. 6. Progress exercises to functional task. 7. Coactivation of abdominal and multifidus muscles with limb loading in aerobic tasks.
Control groupOther
8 sessions during 6 consecutive weeks, three times per week, per session including: Twenty minutes for receiving hot pack and TENS
| Study group | Role | What they receive |
|---|---|---|
| stabilization exercises | Experimental | stabilization exercises for 6 weeks, 3 sessions per week and each session was 40 minutes for the training group. Receives: Other: Stabilization exercise |
| control group | Experimental | electrotherapy include of 20 minutes TENS conventional and Ultrasound pulse for 10 minutes without any exercises for the control group. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain
Visual Analog Scale(VAS) questionnaire
Measured: 6 weeks
Disability
Oswestry Disability Index(ODI) questionnaire
Measured: 6 weeks
Pelvic Floor Muscle activity
Transabdominal approach of Ultrasound imaging
Measured: 6 weeks
Abdominal muscles(Transverse Abdominis,Internal Oblique,External Oblique) thickness
Ultrasound imaging
Measured: 6 weeks
Multifidus muscle thickness and crass section area(S1 level)
Ultrasound imaging
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2017 (estimated)
- Study startSep 2015
- Primary completionMar 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum Lumbopelvic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zahedan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Teymuri, Zahedan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03030846
- Sponsor's protocol ID
- ZAUMS
- Status last verified
- Jan 2017
- First submitted
- 15 Jan 2017
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Teymuri Z, Hosseinifar M, Sirousi M. The Effect of Stabilization Exercises on Pain, Disability, and Pelvic Floor Muscle Function in Postpartum Lumbopelvic Pain: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2018 Dec;97(12):885-891. doi: 10.1097/PHM.0000000000000993.
PubMed 29979205
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zahra Teymuri, Zahedan University of Medical Sciences
- ClinicalTrials.gov ID
- NCT03030846
- Acronym / sponsor ID
- ZAUMS
- Conditions
- Postpartum Lumbopelvic Pain
- Keywords
- pregnancy, pelvic floor muscles, Lumbo-pelvic pain, Stabilization exercises, abdominal muscles thickness, Multifidus muscles thickness, Multifidus muscles cross section area
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Zahedan University of Medical SciencesUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 25 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to evaluate the effects of stabilization exercises on pain, disability and pelvic floor muscles function in patients with lumbopelvic pain.
Detailed description
Pregnancy is a specific experience that leads to several physical changes in women's body and influence most aspects of their lives. Pregnancy and delivery can cause serious complications such as urinary incontinence, pelvic organ prolapse, fecal incontinence, and low back pain (LBP) that have negative effects on women's sexual, physical, social and psychological health.
Based on Wu et al. systematic review, prevalence of pregnancy related low back pain (PLBP) during pregnancy and postpartum is 45% and 25% respectively.
LBP is one of the most current causes of disability and sick leave after delivery.Abnormal load transfer in the lumbopelvic region has been considered as one possible explanation to lumbopelvic pain.The local stabilizing muscles, i.e. the transversely oriented abdominal, diaphragm, the lumbar MF and the PFM Play an important role in load transfer in the lumbopelvic region.so, we considered that an exercise program that addresses muscular dysfunction, such as lumbar stabilization exercise can improve motor pattern of local stabilizing muscles and can use in management of postpartum lumbopelvic pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stabilization exercises | Experimental | Other: Stabilization exercisestabilization exercises for 6 weeks, 3 sessions per week and each session was 40 minutes for the training group. |
| control group | Experimental | Other: Control groupelectrotherapy include of 20 minutes TENS conventional and Ultrasound pulse for 10 minutes without any exercises for the control group. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age more than 18 years old
- pain located between costal margin to gluteal fold with or without radiation to lower limbs
- onset of pain during pregnancy or after delivery
- history of delivery at least 3 months ago.
Key exclusion criteria (6 listed)
- known chronic rheumatologic or Orthopedic disorders
- systemic locomotor disease
- history of fracture, neoplasm,intervertebral disk pathology or radiculopathy, spondylolysis or spondylolysthesis
- contraindication of exercises, heart disease, diabetes, thrombophlebitis, uncontrolled epilepsy
- ongoing pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stabilization exercise18 sessions during 6 consecutive weeks, three times per week, 30 or 40 minutes per session including: Twenty minutes for receiving hot pack and TENS and 10 or 20 minutes for training the exercises in 7 level : 1.Train the specific contraction of the deep abdominal muscles, multifidus and pelvic floor muscles(PFM). 2.Train the specific contraction of deep abdominal muscles with coactivation of multifidus and PFM in supine, prone, sitting, standing and quadruped position. 3. Segmental control exercises in close kinematic chain. 4. Segmental control exercises in open kinematic chain with limb loading, emphasis on abdominal muscles. 5. Segmental control exercises in open kinematic chain with limb loading, emphasis on back extensor muscles. 6. Progress exercises to functional task. 7. Coactivation of abdominal and multifidus muscles with limb loading in aerobic tasks. | Other | stabilization exercises |
| Control group8 sessions during 6 consecutive weeks, three times per week, per session including: Twenty minutes for receiving hot pack and TENS | Other | control group |
Primary outcome
pain
Time frame: 6 weeks
Visual Analog Scale(VAS) questionnaire
Disability
Time frame: 6 weeks
Oswestry Disability Index(ODI) questionnaire
Pelvic Floor Muscle activity
Time frame: 6 weeks
Transabdominal approach of Ultrasound imaging
Abdominal muscles(Transverse Abdominis,Internal Oblique,External Oblique) thickness
Time frame: 6 weeks
Ultrasound imaging
Multifidus muscle thickness and crass section area(S1 level)
Time frame: 6 weeks
Ultrasound imaging
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2017.
- Derived from this study: PubMed 29979205Teymuri Z, Hosseinifar M, Sirousi M. The Effect of Stabilization Exercises on Pain, Disability, and Pelvic Floor Muscle Function in Postpartum Lumbopelvic Pain: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2018 Dec;97(12):885-891. doi: 10.1097/PHM.0000000000000993.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stabilization exercise in people with Postpartum Lumbopelvic Pain, run by Zahedan University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain (time frame: 6 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03030846, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2017.