Effect of Modified Lumbar Sustained Natural Apophyseal Glide on Postnatal Low Back Pain
1 other identifier
interventional
60
1 country
1
Brief Summary
This study will be carried out to evaluate the effect of modified lumbar Sustained Natural Apophyseal Glide on low back pain in postnatal women.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable low-back-pain
Started Jun 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2024
CompletedFirst Posted
Study publicly available on registry
May 23, 2024
CompletedStudy Start
First participant enrolled
June 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2024
CompletedMay 30, 2025
May 1, 2024
7 months
May 19, 2024
May 26, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
Pain intenesity
The visual analogue scale is a 10 cm calibrated line with 0 representing no pain and 10 representing the worst pain; will be used to assess the severity of pain before and after treatment for all participants in both groups.
within 4 weeks
Lumbar flexion range of motion
The modified Schober test will be used to measure the lumbar flexion range of motion (ROM) by using the tape measurement. Each participant will be asked to stand erect with her feet about shoulder-width apart to stabilize the pelvis. Then, the posterior superior iliac spines(PSIS) will be determined by the therapist's both thumbs, and then an ink line will be drawn along the midline of the lumbar spines horizontal to the PSIS to mark the midpoint between the two PSIS. Then tape will be used to identify and mark two points: one is 10 cm superior to the midpoint (A), and another is 5 cm inferior to the midpoint (B). The participant will be instructed to bend forward as much as she can while keeping both knees straight, the new distance between superior and inferior skin marking will be measured in centimeters. The increased distance along the tape due to lumbar flexion is normally about 6-7 cm (less than 5 cm should be considered abnormal).
within 4 weeks
Lumbar extension range of motion
The modified Schober test will be used to measure the lumbar extension range of motion (ROM) by using the tape measurement while the patient is in a standing position. The participant will be instructed to put her hands on her buttocks and bend backward into full lumbar extension and the new distance between the superior and inferior skin markings will be measured in centimeters by the tape measurement. The change in the difference between the marks is used to indicate the amount of lumbar extension. The increased distance along the tape due to the extension of the lumbar spine is normally about 2-3 cm (less than 1 cm should be considered abnormal).
within 4 weeks
Lumbar lateral flexion range of motion
The participant will be asked to stand erect with her feet about shoulder-width apart. Both right and left lateral flexion will be measured by the tape as the distance from the tip of the index finger to the floor at maximal comfortable lateral flexion. The participant will be instructed to bend her trunk laterally as much as she can. The normal value of lateral spinal flexion is 16.2-28.0 cm.
within 4 weeks
Secondary Outcomes (1)
Functional disability
within 4 weeks
Study Arms (2)
Strengthening and stretching exercises
ACTIVE COMPARATORThe participants will be asked to perform strengthening and stretching exercises to the back and abdominal muscles for 30 min, three times per week for 4 weeks.
Modified Lumbar Sustained Natural Apophyseal Glide
EXPERIMENTALThe participants will receive Modified Sustained Natural Apophyseal Glide on the affected lumbar level for 30 sec three times per week for 4 weeks. In addition to strengthening and stretching exercises to the back and abdominal muscles for 30 min, three times per week for 4 weeks
Interventions
Strengthening and stretching exercises to the back and abdominal muscles will be performed for 30 min, three times per week for 4 weeks.
Modified Sustained Natural Apophyseal Glide will be applied on the affected lumbar level for 30 sec three times per week for 4 weeks.
Eligibility Criteria
You may qualify if:
- All participants will be diagnosed as chronic postnatal low back pain.
- Their ages will be ranged from 20 to 35 years old.
- Their body mass index (BMI) will not exceed 30 kg/m2.
- All participants have the same social level.
- All participants have the same lifestyle.
- Their number of parity will be ranged from 2-4 children.
You may not qualify if:
- Spinal fracture or any other neurological disorders.
- Lumbar spinal stenosis from lumbar disc herniation, degenerative joint diseases, or spondylolisthesis.
- Women with BMI \> 30 kg/m2.
- Participants who had pelvic pathology.
- Skin disease interferes with mobilization application.
- Gynecological diseases (chronic pelvic pain, uterine prolapse and retroversion flexion of the uterus).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Mina Nageb Soliman
Cairo, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Azza Kassab, professor
Cairo University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
May 19, 2024
First Posted
May 23, 2024
Study Start
June 1, 2024
Primary Completion
December 15, 2024
Study Completion
December 30, 2024
Last Updated
May 30, 2025
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL