Low Back PainNCT06634550
Effect of Mulligan Technique Versus Core Stability Exercises on Low Back Pain in Post Menopausal Women
A study testing Mulligan technique, Core stability exercise and Lifestyle modification advice in people with Low Back Pain, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be conducted to compare the effect of Mulligan technique and core stability exercises on low back pain in post menopausal women. Read more about this study
- Who is it for?
- Ages 50 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Mulligan technique, Core stability exercise and Lifestyle modification advice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2024to 30 Jan 2025
- 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 50 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sixty postmenopausal women (at least one year after stoppage of menses).
- Their age will be ranged from 50 to 60 years.
- All of them are diagnosed with chronic low back pain.
- Their BMI will be less than 30 kg/ m2.
- All of them are of sedentary lifestyle.
- The score of pain will be 2 or more in a VAS.
Who cannot join
- Participants will be excluded from the study if they have:
- Spinal fractures or any other neurological disorders.
- Lumber disc herniation or spondylolithesis
- Body mass index more than 30 kg/m2.
- Pelvic pathology
- Gynecological diseases as chronic pelvic pain, uterine prolapse or retroversion flexion of the uterus.
Trial locations and contacts
1 site in 1 country.
About this study
This study will be conducted to compare the effect of Mulligan technique and core stability exercises on low back pain in post menopausal women.
Read the detailed description
Low back pain is a major health problem affecting majority of the people at some point of their life.
Mulligan techniques can correct positional faults that occur in the spine and, thus, once the pain generator is released, normal function returns and the muscle guarding around the affected joint is resolved. Several studies have reported that along with the biomechanical changes, certain neurophysiological changes exist that occur at the spinal level after applying Mulligan techniques, including changes in descending pain inhibitory systems and changes in central pain processing mechanisms.
Core stability exercises are usually used to strengthen the muscles around the abdominal, lumbar, and pelvic regions, because the muscles of these regions play an important role in stability as well as in controlling the lumbar posture by using tonic or postural muscles during whole-body exercises.
So, this study will be conducted to provide new evidence and information about the efficacy of Mulligan technique versus core stability exercises on low back pain in postmenopausal women, to manage this problem for these women and add new information to the field of physical therapy.
- Conditions
- Low Back Pain
- Being tested
- Mulligan technique, Core stability exercise, Lifestyle modification advice
- 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.
Mulligan techniqueOther
The participants will receive Mulligan technique (modified SNAGs) (10 rep. / 3 sets with 5 min rest in between) for 30 minutes, 3 sessions / week in addition to lifestyle modification advice for 4 weeks.
Core stability exerciseOther
The participants will perform core stability exercises (spinus multifiduse ex, diaphragmatic strengthening ex, frontal plank, pelvic floor ex,) 3 sessions / week for 30 min each session in addition to lifestyle modification advice for 4 weeks
Lifestyle modification adviceOther
The participants will receive lifestyle modification advice only for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Mulligan technique group | Experimental | The participants will receive Mulligan technique and lifestyle modification advice for 4 weeks Receives: Other: Mulligan technique; Other: Lifestyle modification advice |
| Core stability exercise group | Experimental | The participants will receive core stability exercises and lifestyle modification advice for 4 weeks Receives: Other: Core stability exercise; Other: Lifestyle modification advice |
| Lifestyle modification advice group | Active comparator | The participants will receive lifestyle modification advice only for 4 weeks Receives: Other: Lifestyle modification advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity level
The intensity of postmenopausal low back pain will be assessed using a visual analogue scale (VAS) for all participants in the three groups before and after treatment, which is a method of representing subjects' pain on a 10 cm linear scale. A score of 0 means " no pain" and 10 means " very high degree of pain
Measured: 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: 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 1cm should be considered abnormal).
Measured: 4 weeks
Assessment of 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: 4 weeks
Secondary outcomes (1)
Functional disability
Functional disability will be assessed by the Oswestry Disability Index, it was developed as 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: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start15 Oct 2024 (estimated)
- Primary completion15 Jan 2025 (estimated)
- Study completion30 Jan 2025 (estimated)
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 (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hala Ali Mohamed, Cairo University
- Investigators
- Azza B Kassab, professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06634550
- Sponsor's protocol ID
- P.T.REC/012/005170
- Status last verified
- Oct 2024
- First submitted
- 8 Oct 2024
- Last updated
- 10 Oct 2024
- 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 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mulligan Technique Versus Core Stability Exercises on Low Back Pain in Post Menopausal Women
- ClinicalTrials.gov ID
- NCT06634550
- Acronym / sponsor ID
- P.T.REC/012/005170
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Oct 2024 (estimated)
- Primary completion
- 15 Jan 2025 (estimated)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 10 Oct 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 compare the effect of Mulligan technique and core stability exercises on low back pain in post menopausal women.
Detailed description
Low back pain is a major health problem affecting majority of the people at some point of their life.
Mulligan techniques can correct positional faults that occur in the spine and, thus, once the pain generator is released, normal function returns and the muscle guarding around the affected joint is resolved. Several studies have reported that along with the biomechanical changes, certain neurophysiological changes exist that occur at the spinal level after applying Mulligan techniques, including changes in descending pain inhibitory systems and changes in central pain processing mechanisms.
Core stability exercises are usually used to strengthen the muscles around the abdominal, lumbar, and pelvic regions, because the muscles of these regions play an important role in stability as well as in controlling the lumbar posture by using tonic or postural muscles during whole-body exercises.
So, this study will be conducted to provide new evidence and information about the efficacy of Mulligan technique versus core stability exercises on low back pain in postmenopausal women, to manage this problem for these women and add new information to the field of physical therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mulligan technique group | Experimental | Other: Mulligan technique, Other: Lifestyle modification adviceThe participants will receive Mulligan technique and lifestyle modification advice for 4 weeks |
| Core stability exercise group | Experimental | Other: Core stability exercise, Other: Lifestyle modification adviceThe participants will receive core stability exercises and lifestyle modification advice for 4 weeks |
| Lifestyle modification advice group | Active comparator | Other: Lifestyle modification adviceThe participants will receive lifestyle modification advice only for 4 weeks |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Sixty postmenopausal women (at least one year after stoppage of menses).
- Their age will be ranged from 50 to 60 years.
- All of them are diagnosed with chronic low back pain.
- Their BMI will be less than 30 kg/ m2.
- All of them are of sedentary lifestyle.
Key exclusion criteria (6 listed)
- Participants will be excluded from the study if they have:
- Spinal fractures or any other neurological disorders.
- Lumber disc herniation or spondylolithesis
- Body mass index more than 30 kg/m2.
- Pelvic pathology
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 |
|---|---|---|
| Mulligan techniqueThe participants will receive Mulligan technique (modified SNAGs) (10 rep. / 3 sets with 5 min rest in between) for 30 minutes, 3 sessions / week in addition to lifestyle modification advice for 4 weeks. | Other | Mulligan technique group |
| Core stability exerciseThe participants will perform core stability exercises (spinus multifiduse ex, diaphragmatic strengthening ex, frontal plank, pelvic floor ex,) 3 sessions / week for 30 min each session in addition to lifestyle modification advice for 4 weeks | Other | Core stability exercise group |
| Lifestyle modification adviceThe participants will receive lifestyle modification advice only for 4 weeks | Other | Core stability exercise group, Lifestyle modification advice group, Mulligan technique group |
Primary outcome
Pain intensity level
Time frame: 4 weeks
The intensity of postmenopausal low back pain will be assessed using a visual analogue scale (VAS) for all participants in the three groups before and after treatment, which is a method of representing subjects' pain on a 10 cm linear scale. A score of 0 means " no pain" and 10 means " very high degree of pain
Lumbar flexion range of motion
Time frame: 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: 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 1cm should be considered abnormal).
Assessment of lateral flexion range of motion
Time frame: 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: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- 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 B Kassab, professor 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 Mulligan technique, Core stability exercise and Lifestyle modification advice 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: status not confirmed, as of the sponsor's last update on 10 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hala A. Mohamed, Master (+200103611530, halaali23995@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity level (time frame: 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 10 Oct 2024.