Low Back PainNCT06461494
Comparison of Egoscue Versus Pilates Exercises in Patient With Mechanical Low Back Pain
A study testing baseline treatment in people with Low Back Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
Mechanical low back pain arises intrinsically from the spine, intervertebral disc,or surrounding soft tissues.It is causes by muscular spasm, and other soft tissue injuries. The aim of the study will be to compare the effect of Egoscue versus Pilates exercises on pain, range of motion and muscle endurance in patient… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- baseline treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Jun 2024to 10 Oct 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 to 40 years
- Both gender
- Patient with non-radiating pain
- Pain NPRS <7
- Positive McGill Extensor Endurance Test ( <101 seconds)
- Positive McGill lateral flexor endurance test (<54 sec Right side, <55sec left side)
Show all 10Show fewer
- Positive McGill flexor endurance test < 120 seconds
- Positive Finger to Floor Test : > 48cm in males, >50cm for females
- Patient with Oswestry disability index (ODI) < 40 ODI score
- Decrease lumbar ROM; Lateral flexion, Extension, Flexion
Who cannot join
- Sacroiliac Joint Dysfunction (SIJD)
- Coccydynia
- Lumber disc pathology
- Malignancy
- Recent fractures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effect of Egoscue Versus Pilates Exercises on Pain, Range of Motion, Flexibility and Muscles Endurance in Patients With Mechanical Low Back Pain
Mechanical low back pain arises intrinsically from the spine, intervertebral disc,or surrounding soft tissues.It is causes by muscular spasm, and other soft tissue injuries. The aim of the study will be to compare the effect of Egoscue versus Pilates exercises on pain, range of motion and muscle endurance in patient with mechanical low back pain.
Read the detailed description
A Randomized Clinical Trial will be conducted at Riphah Clinic Lahore through consecutive sampling technique on 30 patients which will be allocated using simple random sampling through sealed opaque enveloped into Group A and Group B. Group A will be treated with Pilates exercises at frequency 2 sets 5 repetitions 5 days a week and Group B will be treated with Egoscue exercises at the frequency of 2 sets with 5 repetitions 5 days a week. Outcome measures will be conducted through pain, disability,lumber range of motion, Muscle flexibility, Extensor muscle endurance, Lateral muscle endurance, Flexors muscle endurance questionnaires after 4 weeks. Data will be analyzed during SPSS software version 21. After assessing normality of data by ANOVA test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.
- Conditions
- Low Back Pain
- Being tested
- baseline treatment
- Keywords
- muscle endurance, pain, range of motion, muscle flexibility
- Medical subject headings
- Low Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
baseline treatmentOther
hot pack will be applied for 10 minutes
| Study group | Role | What they receive |
|---|---|---|
| Group A: Pilates exercise | Active comparator | Group A received the pilates exercise. It doesn't require any special equipment and can be done in any training center.
Week 1: Leg slides, hip release, knee to chest, spinal rotation, single knee extension, cat stretch, neutral to imprint Week 2: Imprint table top position, ab prep, Imprint table top toe touching floor, imprint table top knee extensions, spine twist, Ab prep in table top position, bridging Week 3: Half roll back, pull up; pull up with leg extension, swimming exercise, single leg extension, leg circles, and single leg stretch Week 4: Bridging on the ball, spine stretch forward, single leg lift, double knee lifts, upward dog, and shell stretch Each exercise was performed for 5 times Receives: Other: baseline treatment |
| Group B: Egoscue exercise | Experimental | Static back and static back with breathing, abdominal contraction while in the static back position, abductor press, overhead extension, elbow curls on wall, static wall, upper spinal twist, pelvic tilts, supine groin progressive, and air bench Week 1: 3 times with 30 s hold time Week 2: 5 times with 30 s hold time Week 3: 15 times with 30 s hold time Week 4: 20 times with 30 s hold time Receives: Other: baseline treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric pain rating scale (NPRS)
Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. where 0 indicate no pain and 10 indicate severe pain.The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Measured: upto 4 weeks
Muscle flexibility (Finger to floor test)
- The patient is asked to bend forward and attempt to reach for the floor with their fingertips.
- The physical therapist then measures the distance between the patient's right long finger and the floor using a standard measuring tape
- Ask the client whether pain, stiffness or both limit the movement(Fingertips to floor (FTF) test).
- If the FTF test is limited by pain, the location and pain score out of 10 should be documented.
- If the FTF test is 0cm or the patient is able to place their palms to the floor with no pain, a different outcome measure should be considered.
Measured: upto 4 weeks
Trunk Flexor Endurance Test
The flexor endurance test is the first in the battery of three tests that assesses muscular endurance of the deep core muscles (i.e., transverse abdominis, quadratus lumborum, and erector spinae). It is a timed test involving a static, isometric contraction of the anterior muscles, stabilizing the spine until the individual exhibits fatigue and can no longer hold the assumed position.
Measured: upto 4 weeks
Trunk Lateral Endurance Test
The trunk lateral endurance test, also called the side-bridge test, assesses muscular endurance of the lateral core muscles (i.e., transverse abdominis, obliques, quadratus lumborum, and erector spinae). Similar to the trunk flexor endurance test, this timed test involves static, isometric contractions of the lateral muscles on each side of the trunk that stabilize the spine.
Measured: upto 4 weeks
Trunk Extensor Endurance Test
The trunk extensor endurance test is generally used to assess muscular endurance of the torso extensor muscles (i.e., erector spinae, longissimus, iliocostalis, and multifidi). This is a timed test involving a static, isometric contraction of the trunk extensor muscles that stabilize the spine.
Measured: upto 4 weeks
universal goniometer
The purpose of goniometry is to measure the joint angle or range of motion. It is assumed that the angle created by aligning the arms of a universal goniometer with bony landmarks truly represents the angle created by the proximal and distal bones composing the joint.
Measured: upt0 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start30 Jun 2024
- Primary completion30 Aug 2024
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ghazala Arshad, MSPT*, Principal investigator, Riphah International University,Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06461494
- Sponsor's protocol ID
- REC/RCR & AHS/23/ 0195 Ghazala
- Status last verified
- Oct 2024
- First submitted
- 11 Jun 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kudchadkar GS, Gurudut P, Welling AJIJoPT, Research. Comparative effect of mat pilates and egoscue exercises in asymptomatic individuals with lumbar hyperlordosis: A randomized controlled trial. 2019;1(2):79-88.
Baillie L, Bacon CJ, Hewitt CM, Moran RW. Predictors of functional improvement in people with chronic low back pain following a graded Pilates-based exercise programme. J Bodyw Mov Ther. 2019 Jan;23(1):211-218. doi: 10.1016/j.jbmt.2018.06.007. Epub 2018 Jun 30.
PubMed 30691755Altinbilek T, Murat S. A comparison of application frequency of physical therapy modalities in patients with chronic mechanical low back pain. Turk J Phys Med Rehabil. 2020 May 18;66(2):201-209. doi: 10.5606/tftrd.2020.4192. eCollection 2020 Jun.
PubMed 32760898Jerome EJIJoP. Effects of core stabilization program and conventional exercises in the management of patients with chronic mechanical low back pain. 2015:441-7.
Caglayan M, Tacar O, Demirant A, Oktayoglu P, Karakoc M, Cetin A, et al. Effects of lumbosacral angles on development of low back pain. 2014;22(3):251-5.
Kumar SP. Efficacy of segmental stabilization exercise for lumbar segmental instability in patients with mechanical low back pain: A randomized placebo controlled crossover study. N Am J Med Sci. 2011 Oct;3(10):456-61. doi: 10.4297/najms.2011.3456.
PubMed 22363083Russo M, Deckers K, Eldabe S, Kiesel K, Gilligan C, Vieceli J, Crosby P. Muscle Control and Non-specific Chronic Low Back Pain. Neuromodulation. 2018 Jan;21(1):1-9. doi: 10.1111/ner.12738. Epub 2017 Dec 12.
PubMed 29230905Vining R, Potocki E, Seidman M, Morgenthal AP. An evidence-based diagnostic classification system for low back pain. J Can Chiropr Assoc. 2013 Sep;57(3):189-204.
PubMed 23997245
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effect of Egoscue Versus Pilates Exercises on Pain, Range of Motion, Flexibility and Muscles Endurance in Patients With Mechanical Low Back Pain
- ClinicalTrials.gov ID
- NCT06461494
- Acronym / sponsor ID
- REC/RCR & AHS/23/ 0195 Ghazala
- Conditions
- Low Back Pain
- Keywords
- muscle endurance, pain, range of motion, muscle flexibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 Jun 2024 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 17 Jun 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.
Mechanical low back pain arises intrinsically from the spine, intervertebral disc,or surrounding soft tissues.It is causes by muscular spasm, and other soft tissue injuries. The aim of the study will be to compare the effect of Egoscue versus Pilates exercises on pain, range of motion and muscle endurance in patient with mechanical low back pain.
Detailed description
A Randomized Clinical Trial will be conducted at Riphah Clinic Lahore through consecutive sampling technique on 30 patients which will be allocated using simple random sampling through sealed opaque enveloped into Group A and Group B. Group A will be treated with Pilates exercises at frequency 2 sets 5 repetitions 5 days a week and Group B will be treated with Egoscue exercises at the frequency of 2 sets with 5 repetitions 5 days a week. Outcome measures will be conducted through pain, disability,lumber range of motion, Muscle flexibility, Extensor muscle endurance, Lateral muscle endurance, Flexors muscle endurance questionnaires after 4 weeks. Data will be analyzed during SPSS software version 21. After assessing normality of data by ANOVA test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Pilates exercise | Active comparator | Other: baseline treatmentGroup A received the pilates exercise. It doesn't require any special equipment and can be done in any training center. Week 1: Leg slides, hip release, knee to chest, spinal rotation, single knee extension, cat stretch, neutral to imprint Week 2: Imprint table top position, ab prep, Imprint table top toe touching floor, imprint table top knee extensions, spine twist, Ab prep in table top position, bridging Week 3: Half roll back, pull up; pull up with leg extension, swimming exercise, single leg extension, leg circles, and single leg stretch Week 4: Bridging on the ball, spine stretch forward, single leg lift, double knee lifts, upward dog, and shell stretch Each exercise was performed for 5 times |
| Group B: Egoscue exercise | Experimental | Other: baseline treatmentStatic back and static back with breathing, abdominal contraction while in the static back position, abductor press, overhead extension, elbow curls on wall, static wall, upper spinal twist, pelvic tilts, supine groin progressive, and air bench Week 1: 3 times with 30 s hold time Week 2: 5 times with 30 s hold time Week 3: 15 times with 30 s hold time Week 4: 20 times with 30 s hold time |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Age 18 to 40 years
- Both gender
- Patient with non-radiating pain
- Pain NPRS <7
- Positive McGill Extensor Endurance Test ( <101 seconds)
Key exclusion criteria (5 listed)
- Sacroiliac Joint Dysfunction (SIJD)
- Coccydynia
- Lumber disc pathology
- Malignancy
- Recent fractures
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 |
|---|---|---|
| baseline treatmenthot pack will be applied for 10 minutes | Other | Group A: Pilates exercise, Group B: Egoscue exercise |
Primary outcome
Numeric pain rating scale (NPRS)
Time frame: upto 4 weeks
Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. where 0 indicate no pain and 10 indicate severe pain.The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Muscle flexibility (Finger to floor test)
Time frame: upto 4 weeks
* The patient is asked to bend forward and attempt to reach for the floor with their fingertips. * The physical therapist then measures the distance between the patient's right long finger and the floor using a standard measuring tape * Ask the client whether pain, stiffness or both limit the movement(Fingertips to floor (FTF) test). * If the FTF test is limited by pain, the location and pain score out of 10 should be documented. * If the FTF test is 0cm or the patient is able to place their palms to the floor with no pain, a different outcome measure should be considered.
Trunk Flexor Endurance Test
Time frame: upto 4 weeks
The flexor endurance test is the first in the battery of three tests that assesses muscular endurance of the deep core muscles (i.e., transverse abdominis, quadratus lumborum, and erector spinae). It is a timed test involving a static, isometric contraction of the anterior muscles, stabilizing the spine until the individual exhibits fatigue and can no longer hold the assumed position.
Trunk Lateral Endurance Test
Time frame: upto 4 weeks
The trunk lateral endurance test, also called the side-bridge test, assesses muscular endurance of the lateral core muscles (i.e., transverse abdominis, obliques, quadratus lumborum, and erector spinae). Similar to the trunk flexor endurance test, this timed test involves static, isometric contractions of the lateral muscles on each side of the trunk that stabilize the spine.
Trunk Extensor Endurance Test
Time frame: upto 4 weeks
The trunk extensor endurance test is generally used to assess muscular endurance of the torso extensor muscles (i.e., erector spinae, longissimus, iliocostalis, and multifidi). This is a timed test involving a static, isometric contraction of the trunk extensor muscles that stabilize the spine.
universal goniometer
Time frame: upt0 4 weeks
The purpose of goniometry is to measure the joint angle or range of motion. It is assumed that the angle created by aligning the arms of a universal goniometer with bony landmarks truly represents the angle created by the proximal and distal bones composing the joint.
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 15 Oct 2024.
- BackgroundKudchadkar GS, Gurudut P, Welling AJIJoPT, Research. Comparative effect of mat pilates and egoscue exercises in asymptomatic individuals with lumbar hyperlordosis: A randomized controlled trial. 2019;1(2):79-88.
- Background: PubMed 30691755Baillie L, Bacon CJ, Hewitt CM, Moran RW. Predictors of functional improvement in people with chronic low back pain following a graded Pilates-based exercise programme. J Bodyw Mov Ther. 2019 Jan;23(1):211-218. doi: 10.1016/j.jbmt.2018.06.007. Epub 2018 Jun 30.
- Background: PubMed 32760898Altinbilek T, Murat S. A comparison of application frequency of physical therapy modalities in patients with chronic mechanical low back pain. Turk J Phys Med Rehabil. 2020 May 18;66(2):201-209. doi: 10.5606/tftrd.2020.4192. eCollection 2020 Jun.
- BackgroundJerome EJIJoP. Effects of core stabilization program and conventional exercises in the management of patients with chronic mechanical low back pain. 2015:441-7.
- BackgroundCaglayan M, Tacar O, Demirant A, Oktayoglu P, Karakoc M, Cetin A, et al. Effects of lumbosacral angles on development of low back pain. 2014;22(3):251-5.
- Background: PubMed 22363083Kumar SP. Efficacy of segmental stabilization exercise for lumbar segmental instability in patients with mechanical low back pain: A randomized placebo controlled crossover study. N Am J Med Sci. 2011 Oct;3(10):456-61. doi: 10.4297/najms.2011.3456.
- Background: PubMed 29230905Russo M, Deckers K, Eldabe S, Kiesel K, Gilligan C, Vieceli J, Crosby P. Muscle Control and Non-specific Chronic Low Back Pain. Neuromodulation. 2018 Jan;21(1):1-9. doi: 10.1111/ner.12738. Epub 2017 Dec 12.
- Background: PubMed 23997245Vining R, Potocki E, Seidman M, Morgenthal AP. An evidence-based diagnostic classification system for low back pain. J Can Chiropr Assoc. 2013 Sep;57(3):189-204.
- Individual participant dataSharing planned: No
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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.
Ghazala Arshad, MSPT* principal investigator
Riphah International University,Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing baseline treatment in people with Low Back Pain, run by Riphah International University at 1 site in Pakistan.
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 10 inclusion and 5 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 15 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 Pakistan. 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?
Numeric pain rating scale (NPRS) (time frame: upto 4 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06461494, which also lists 8 linked publications.
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 15 Oct 2024.