Low Back PainNCT06427434
Effect of Modified Lumbar Sustained Natural Apophyseal Glide on Postnatal Low Back Pain
A study testing Strengthening and stretching exercises to the back and abdominal muscles and Modified Lumbar Sustained Natural Apophyseal Glide in people with Low Back Pain, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Strengthening and stretching exercises to the back and abdominal muscles and Modified Lumbar Sustained Natural Apophyseal Glide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2024to 30 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Modified Lumbar Sustained Natural Apophyseal Glide on Low Back Pain in Postnatal Women
This study will be carried out to evaluate the effect of modified lumbar Sustained Natural Apophyseal Glide on low back pain in postnatal women.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- Strengthening and stretching exercises to the back and abdominal muscles, Modified Lumbar Sustained Natural Apophyseal Glide
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strengthening and stretching exercises to the back and abdominal musclesOther
Strengthening and stretching exercises to the back and abdominal muscles will be performed for 30 min, three times per week for 4 weeks.
Modified Lumbar Sustained Natural Apophyseal GlideOther
Modified Sustained Natural Apophyseal Glide will be applied on the affected lumbar level for 30 sec three times per week for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Strengthening and stretching exercises | Active comparator | 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. Receives: Other: Strengthening and stretching exercises to the back and abdominal muscles |
| Modified Lumbar Sustained Natural Apophyseal Glide | Experimental | 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 Receives: Other: Strengthening and stretching exercises to the back and abdominal muscles; Other: Modified Lumbar Sustained Natural Apophyseal Glide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: within 4 weeks
Secondary outcomes (1)
Functional disability
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.
Measured: within 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start1 Jun 2024
- Primary completion15 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Nageib Soliman, Cairo University
- Investigators
- Azza Kassab, professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06427434
- Sponsor's protocol ID
- P.T.REC/012/004494
- Status last verified
- May 2024
- First submitted
- 19 May 2024
- Last updated
- 30 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Modified Lumbar Sustained Natural Apophyseal Glide on Low Back Pain in Postnatal Women
- ClinicalTrials.gov ID
- NCT06427434
- Acronym / sponsor ID
- P.T.REC/012/004494
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 23 May 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 carried out to evaluate the effect of modified lumbar Sustained Natural Apophyseal Glide on low back pain in postnatal women.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strengthening and stretching exercises | Active comparator | Other: Strengthening and stretching exercises to the back and abdominal musclesThe 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 | Experimental | Other: Strengthening and stretching exercises to the back and abdominal muscles, Other: Modified Lumbar Sustained Natural Apophyseal GlideThe 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 |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Strengthening and stretching exercises to the back and abdominal musclesStrengthening and stretching exercises to the back and abdominal muscles will be performed for 30 min, three times per week for 4 weeks. | Other | Modified Lumbar Sustained Natural Apophyseal Glide, Strengthening and stretching exercises |
| Modified Lumbar Sustained Natural Apophyseal GlideModified Sustained Natural Apophyseal Glide will be applied on the affected lumbar level for 30 sec three times per week for 4 weeks. | Other | Modified Lumbar Sustained Natural Apophyseal Glide |
Primary outcome
Pain intenesity
Time frame: within 4 weeks
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.
Lumbar flexion range of motion
Time frame: within 4 weeks
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).
Lumbar extension range of motion
Time frame: within 4 weeks
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).
Lumbar lateral flexion range of motion
Time frame: within 4 weeks
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.
1 secondary outcome
Functional disability
Time frame: within 4 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 30 May 2025.
- Individual participant dataSharing planned: Yes
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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.
Azza Kassab, professor study director
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 Strengthening and stretching exercises to the back and abdominal muscles and Modified Lumbar Sustained Natural Apophyseal Glide in people with 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 6 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 30 May 2025. 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?
Pain intenesity (time frame: within 4 weeks). The study lists 4 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 30 May 2025.