- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06427434
Effect of Modified Lumbar Sustained Natural Apophyseal Glide on Postnatal Low Back Pain
Effect of Modified Lumbar Sustained Natural Apophyseal Glide on Low Back Pain in Postnatal Women
Study Overview
Status
Conditions
Detailed Description
In fact, up to 75% of women who suffer from pregnancy-related back pain may continue to have pain after giving birth. Women who experience LBP or pelvic girdle pain (PGP) at 3 months postpartum were found to be at higher risk for persistent or chronic LBP. Of these women, only 6% recover within 6-18 months after giving birth.
A modified lumbar Sustained Natural Apophyseal Glide (SNAG) is an existing Mulligan mobilization technique performed with a combination of joint glide and physiological spinal movement. The glide can be applied to the spinous processes, facets, or unilaterally over the transverse processes while the patient performs the active exercise.
Few studies have been concerned with the effects of modified "SNAGS" on the lumbar spine . So, this study will be done to investigate its effect on low back pain in postnatal women aiming to improve their function to accomplish their daily living activities and reduce the side effects of medical treatment.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Cairo, Egypt
- Mina Nageb Soliman
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Strengthening and stretching exercises
The 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.
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Strengthening and stretching exercises to the back and abdominal muscles will be performed for 30 min, three times per week for 4 weeks.
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Experimental: Modified Lumbar Sustained Natural Apophyseal Glide
The 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
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intenesity
Time Frame: within 4 weeks
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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.
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within 4 weeks
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Lumbar flexion range of motion
Time Frame: within 4 weeks
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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).
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within 4 weeks
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Lumbar extension range of motion
Time Frame: within 4 weeks
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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
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Lumbar lateral flexion range of motion
Time Frame: within 4 weeks
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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.
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within 4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Functional disability
Time Frame: within 4 weeks
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Functional disability will be assessed by the Oswestry Disability Index, it was developed as a clinical valid and reliable assessment tool that would provide an estimate of disability expressed as a percentage score.
It is composed of 10 questions and it takes around 5min for a patient to complete.
Each of the 10 questions is scored from 0 to 5, giving a maximum score of 50.
The total score is then converted into a percentage by multiplying it by 2. Scores are stratified into severity: 0-20, minimal disability; 21-40, moderate disability; 41-60, severe disability; 61-80, crippling back pain; 81-100, bed-bound.
A low score = low degree of disability, a high score = high degree of disability.
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within 4 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Azza Kassab, professor, Cairo university
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/004494
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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