Postpartum DisorderNCT06600074
Effect of Retro-walking on Postpartum Low Back Pain
A study testing Back care advice, Postural correction exercises and Retro-walking in people with Postpartum Disorder and Low Back Pain, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be conducted to determine the effect of retro walking on post partum low back pain. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Postpartum Disorder, Low Back Pain
- What is being tested?
- Back care advice, Postural correction exercises and Retro-walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Sep 2024to 1 Dec 2024
- 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 25 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Multi parous women suffering from postpartum low back pain after cesarean delivery (from 6 weeks to 6 months after delivery).
- Their ages will range from 25-35 years old.
- Their body mass index will be less than 30 Kg/m2.
- They should have mild to moderate low back pain as scored on VAS (represented by cut points on the scale recommending mild pain (5- 44mm), moderate pain (45- 74mm))
Who cannot join
- Recent surgeries, trauma or fractures of the lower limb or in the back region.
- Morbid cardiovascular disease.
- Liver or kidney dysfunction.
- Any neurological disorders including balance issues or motor and sensory loss.
- Any musculoskeletal disorders such as disc prolapsed, lumbar canal stenosis and spondylysthesis or severe knee osteoarthritis.
- Taking intra-articular injection for knee for the last 6 months.
- Those having visual dysfunction or refractory errors not corrected with glasses or contact lenses.
Trial locations and contacts
1 site in 1 country.
About this study
This study will be conducted to determine the effect of retro walking on post partum low back pain.
Read the detailed description
Postpartum LBP is a common musculoskeletal disorder. It occurs due to ligament laxity and postural changes that started during pregnancy or within 3 weeks of childbirth and continue for 3 months after delivery. When all forms of non-specific LBP were considered, approximately 33% of postpartum women had some LBP within 3 months after childbirth, and approximately 40% described moderate to severe disability.
Postpartum LBP stresses the sacroiliac joints and lumbosacral spine. Previous studies of Swedish women with postpartum LBP reported impairments to their daily activities with a prevalence ranging between 20-90%, but they seldom sought health care assistance or treatment.
Many researchers and clinicians have suggested that an increase in core strength and improvement in pelvic alignment are keys to resolve or avoid LBP. During backward walking, the typical heel-strike associated with ground contact is eliminated because the toe contacts the ground first and the pelvis is anteriorly aligned. This may open up the facet joints in the vertebral column and help in alleviating the pressure on intervertebral discs and the associated LBP.
Previous studies investigated the effect of retro walking on other types of LBP (non-specific and chronic) but till now, there is no previous study investigate the effect of retro walking on postpartum LBP related to C.S delivery. So, this study will be the first one in this issue. Therefore, this study will be of valuable benefits for medical service organization and increase the body of knowledge in physical therapy field.
- Conditions
- Postpartum Disorder, Low Back Pain
- Being tested
- Back care advice, Postural correction exercises, Retro-walking
- Medical subject headings
- Puerperal Disorders, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Back care adviceBehavioural
All patients in both groups will be advised to use proper lifting techniques, avoid prolonged sitting or standing, maintain a healthy weight, quit smoking, practice good posture, take breaks, spread housekeeping duties over the whole week, and sleep in supportive positions.
Postural correction exercisesOther
All patients in both groups will be instructed to perform postural correction exercise. They will be performed from different positions (crock lying, supine lying, supine, sitting and standing position). They will lie in crock lying position for example and the physical therapist will instruct them to do chin in , open out ribs through costal breathing, contract abdominal muscles, contract glutei, hold for 6 seconds and relax and repeat 10 times.
Retro-walkingOther
Patients in the experimental group only will practice walking backward on a treadmill, starting with a 5-minute warm-up at a self-selected speed, then gradually increasing speed from 1.2 to 1.6 m/s based on comfort and progress.
| Study group | Role | What they receive |
|---|---|---|
| Back care advice + Postural correction exercises | Active comparator | It will include 18 postpartum women who will receive back care advice and postural correction exercises. Receives: Behavioral: Back care advice; Other: Postural correction exercises |
| Back care advice + Postural correction exercises + Retro-walking | Experimental | It will include 18 postpartum women who will receive the same back care advice and postural correction exercises, in addition to retro-walking. Receives: Behavioral: Back care advice; Other: Postural correction exercises; Other: Retro-walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale (VAS)
It will be used to measure the severity of post cesarean low back pain before and after the treatment program for all participants in both groups. The VAS is ten cm horizontal line on which the patients' pain intensity is represented by a point between the extremes of no pain at all (no pain=0) and worst pain imaginable (worst pain=10). Each participating woman will be asked to put a mark on the line at the point indicating her pain level / intensity.
Measured: 6 weeks
Lumbar flexion range of motion (ROM)
It will be assessed by the Modified Schober test before and after the treatment program for all participants in both groups. The therapist will mark the lumbar spine at the posterior superior iliac spines, with another mark 15 cm above it. A tape measure will be used to record the distance between the marks in a standing position, then again after the patient bends forward into full lumbar flexion. The difference indicates the lumbar flexion ROM. This test will be repeated three times, and the average value will be taken as the lumbar flexion ROM.
Measured: 6 weeks
Lumbar extension range of motion (ROM)
It will be assessed by the Modified Schober test before and after the treatment program for all participants in both groups. The therapist will mark the lumbar spine at the posterior superior iliac spines, then place another mark 15 cm above. A tape measure will record the distance between the marks while the patient is standing. The patient will then bend backward into full lumbar extension, and the new distance between the marks will be measured. The difference represents the lumbar extension ROM. This process will be repeated three times, with the average value taken as the lumbar extension ROM.
Measured: 6 weeks
Secondary outcomes (1)
Oswestry disability questionnaire
It will be used to assess functional disability for all women in both groups before and after the end of the treatment program. The Oswestry disability questionnaire is considered the "gold standard" tool for low back functional outcome It is consisted of 50 questions covering 10 sections (personal care, lifting, sitting, standing, walking, sex life, sleeping, social life and travelling). Each question is scored from 0-5, giving maximum score of 50 if one section is missed, the total score will be 45 and then the score is converted into percentage. scores are classified according to severity into minimal disability (10-20%), moderate disability (21-40%), sever disability (41-60%) crippled (61-80%) and bed bound (81-100%).
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 posted19 Sep 2024
- Study start16 Sep 2024
- Primary completion22 Nov 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum DisorderStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Safa Magdy Mohamed, Cairo University
- Investigators
- Afaf Mohamed Mahmoud Botla, PhD, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06600074
- Sponsor's protocol ID
- P.T.REC/012/004491
- Status last verified
- Dec 2024
- First submitted
- 12 Sep 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Retro-walking on Postpartum Low Back Pain
- ClinicalTrials.gov ID
- NCT06600074
- Acronym / sponsor ID
- P.T.REC/012/004491
- Conditions
- Postpartum Disorder, Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 16 Sep 2024 (actual)
- Primary completion
- 22 Nov 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 19 Sep 2024 (actual)
- 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.
This study will be conducted to determine the effect of retro walking on post partum low back pain.
Detailed description
Postpartum LBP is a common musculoskeletal disorder. It occurs due to ligament laxity and postural changes that started during pregnancy or within 3 weeks of childbirth and continue for 3 months after delivery. When all forms of non-specific LBP were considered, approximately 33% of postpartum women had some LBP within 3 months after childbirth, and approximately 40% described moderate to severe disability.
Postpartum LBP stresses the sacroiliac joints and lumbosacral spine. Previous studies of Swedish women with postpartum LBP reported impairments to their daily activities with a prevalence ranging between 20-90%, but they seldom sought health care assistance or treatment.
Many researchers and clinicians have suggested that an increase in core strength and improvement in pelvic alignment are keys to resolve or avoid LBP. During backward walking, the typical heel-strike associated with ground contact is eliminated because the toe contacts the ground first and the pelvis is anteriorly aligned. This may open up the facet joints in the vertebral column and help in alleviating the pressure on intervertebral discs and the associated LBP.
Previous studies investigated the effect of retro walking on other types of LBP (non-specific and chronic) but till now, there is no previous study investigate the effect of retro walking on postpartum LBP related to C.S delivery. So, this study will be the first one in this issue. Therefore, this study will be of valuable benefits for medical service organization and increase the body of knowledge in physical therapy field.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Back care advice + Postural correction exercises | Active comparator | Behavioral: Back care advice, Other: Postural correction exercisesIt will include 18 postpartum women who will receive back care advice and postural correction exercises. |
| Back care advice + Postural correction exercises + Retro-walking | Experimental | Behavioral: Back care advice, Other: Postural correction exercises, Other: Retro-walkingIt will include 18 postpartum women who will receive the same back care advice and postural correction exercises, in addition to retro-walking. |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Multi parous women suffering from postpartum low back pain after cesarean delivery (from 6 weeks to 6 months after delivery).
- Their ages will range from 25-35 years old.
- Their body mass index will be less than 30 Kg/m2.
- They should have mild to moderate low back pain as scored on VAS (represented by cut points on the scale recommending mild pain (5- 44mm), moderate pain (45- 74mm))
Key exclusion criteria (7 listed)
- Recent surgeries, trauma or fractures of the lower limb or in the back region.
- Morbid cardiovascular disease.
- Liver or kidney dysfunction.
- Any neurological disorders including balance issues or motor and sensory loss.
- Any musculoskeletal disorders such as disc prolapsed, lumbar canal stenosis and spondylysthesis or severe knee osteoarthritis.
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 |
|---|---|---|
| Back care adviceAll patients in both groups will be advised to use proper lifting techniques, avoid prolonged sitting or standing, maintain a healthy weight, quit smoking, practice good posture, take breaks, spread housekeeping duties over the whole week, and sleep in supportive positions. | Behavioural | Back care advice + Postural correction exercises, Back care advice + Postural correction exercises + Retro-walking |
| Postural correction exercisesAll patients in both groups will be instructed to perform postural correction exercise. They will be performed from different positions (crock lying, supine lying, supine, sitting and standing position). They will lie in crock lying position for example and the physical therapist will instruct them to do chin in , open out ribs through costal breathing, contract abdominal muscles, contract glutei, hold for 6 seconds and relax and repeat 10 times. | Other | Back care advice + Postural correction exercises, Back care advice + Postural correction exercises + Retro-walking |
| Retro-walkingPatients in the experimental group only will practice walking backward on a treadmill, starting with a 5-minute warm-up at a self-selected speed, then gradually increasing speed from 1.2 to 1.6 m/s based on comfort and progress. | Other | Back care advice + Postural correction exercises + Retro-walking |
Primary outcome
Visual analog scale (VAS)
Time frame: 6 weeks
It will be used to measure the severity of post cesarean low back pain before and after the treatment program for all participants in both groups. The VAS is ten cm horizontal line on which the patients' pain intensity is represented by a point between the extremes of no pain at all (no pain=0) and worst pain imaginable (worst pain=10). Each participating woman will be asked to put a mark on the line at the point indicating her pain level / intensity.
Lumbar flexion range of motion (ROM)
Time frame: 6 weeks
It will be assessed by the Modified Schober test before and after the treatment program for all participants in both groups. The therapist will mark the lumbar spine at the posterior superior iliac spines, with another mark 15 cm above it. A tape measure will be used to record the distance between the marks in a standing position, then again after the patient bends forward into full lumbar flexion. The difference indicates the lumbar flexion ROM. This test will be repeated three times, and the average value will be taken as the lumbar flexion ROM.
Lumbar extension range of motion (ROM)
Time frame: 6 weeks
It will be assessed by the Modified Schober test before and after the treatment program for all participants in both groups. The therapist will mark the lumbar spine at the posterior superior iliac spines, then place another mark 15 cm above. A tape measure will record the distance between the marks while the patient is standing. The patient will then bend backward into full lumbar extension, and the new distance between the marks will be measured. The difference represents the lumbar extension ROM. This process will be repeated three times, with the average value taken as the lumbar extension ROM.
1 secondary outcome
Oswestry disability questionnaire
Time frame: 6 weeks
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 20 Dec 2024.
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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.
Afaf Mohamed Mahmoud Botla, PhD study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Back care advice, Postural correction exercises and Retro-walking in people with Postpartum Disorder and Low Back Pain, run by Cairo University at 1 site in Egypt.
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 7 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 20 Dec 2024. 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 Egypt. 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?
Visual analog scale (VAS) (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Dec 2024.