LordosisNCT05015205
Effects of Muscle Energy Technique and Postural Correction Exercises in Lordotic Females Wearing High Heels
A study testing Muscle Energy Technique and Postural Correction Exercises in people with Lordosis and Low Back Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
The key purpose was to determine the effects of Muscle Energy Technique (MET) and Postural Correction Exercises on low back pain in females wearing high heels. To determine the effects of muscle energy technique \& postural correction exercises in reducing pain, anterior pelvic tilt angle and increasing lumbar range… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lordosis, Low Back Pain
- What is being tested?
- Muscle Energy Technique and Postural Correction Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Apr 2019to 30 Sep 2019
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-45 years
- Low back pain of no more than 12 weeks duration in lordotic females wearing high heel shoes.
- Females wearing 4 to 5 inches high heel shoes 6 hour per day.
- Increased lumbosacral angle
- An initial ODI score of 20 % to 60 %.
- Localized pain in lumbar spine with no radiating pain towards buttocks, hips or legs.
Who cannot join
- Any red flags (tumor, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis, resting blood pressure greater than 140/90 mmHg, prolonged history of steroid use, etc)
- Presented with involvement of nerve compression symptoms like radiating pain, change in normal sensory sensations with significant muscle weakness, or hypo reflexia or hyper reflexia.
- Presented with a diagnosis of Lumbar spinal stenosis.
- Presented with a diagnosis of Lumbar spinal spondylolisthesis.
- Prior surgery to the lumbar region.
- Patients who are already receiving treatment.
Trial locations and contacts
1 site in 1 country.
About this study
The key purpose was to determine the effects of Muscle Energy Technique (MET) and Postural Correction Exercises on low back pain in females wearing high heels.
To determine the effects of muscle energy technique \& postural correction exercises in reducing pain, anterior pelvic tilt angle and increasing lumbar range of motion in subjects with chronic low back pain due to lordotic posture in females wearing high heels.
Read the detailed description
Body segments can be defined as the suitable posture positions. Body segments are placed in a way that center of gravity of each segment lies vertically. By this appropriate alignment, instead of excessive muscular activity, stability can be achieved by the body by the use of bone structures and ligament. Hence, in this way body structures experience the decreased tension. Besides the cosmetic effects of high heels, high heels results in increased risk of fall, fracture of bones particularly bones lower extremity, and also the change in normal kinematics of lower limb especially knee joint, and altered weight bearing on medial and longitudinal arches of foot. High heels change the line of gravity and posture of the body. Use of high heels change the posture which is compensated by the changes in different segments of the body like increased planter flexion of ankle as well as the displacements of the trunk and posterior pelvic tilting. The whole body mechanics gets affected in females wearing high heels. The center of gravity get disturbed with the use of high heel shoes. In body alignment, pelvis is known to have key importance. Any alteration in neutral position of pelvis leads to the compensatory altered movements in different regions, while, the segment which is considered to be the most effect is lumber spine.
- Conditions
- Lordosis, Low Back Pain
- Being tested
- Muscle Energy Technique, Postural Correction Exercises
- Keywords
- Lordosis, METs, Postural Correction Exercise
- Medical subject headings
- Lordosis, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle Energy TechniqueOther
Post isometric relaxation technique MET was applied in two muscle groups; Lumbar Extensors (Erector Spinae) and Hip Flexors (Iliopsoas). The muscle was positioned in position and patient was asked to apply 20% force isometrically and hold the isometric contractions for 7-10 seconds. Then the patient was asked to relax for about seconds. On exhalation, therapist takes muscle to new restriction barrier. Hold this position for 30 seconds at the end barrier as an end-stretch with 3 repetitions.
Postural Correction ExercisesOther
: Postural Correction Exercises was applied to one group. Exercises performed included stretching and strengthening exercises. Hip flexors and back extensors were stretched while hip extensors and abdominals were strengthened. Seated hip flexion used to stretch back extensors while lunge position used to stretch hip flexors. The abdominals were strengthened by using curl up exercises while hip extensors were strengthened by resisted contractions in prone lying.
| Study group | Role | What they receive |
|---|---|---|
| MET Group | Experimental | Post isometric relaxation technique MET was applied in two muscle groups; Lumbar Extensors (Erector Spinae) and Hip Flexors (Iliopsoas). The exercises were performed 3 times per week for 4 weeks. Receives: Other: Muscle Energy Technique |
| Control Group | Experimental | Postural Correction Exercises was applied to one group. Exercises performed included stretching and strengthening exercises. The exercises were performed 3 times per week for 4 weeks. Receives: Other: Postural Correction Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale (NPRS)
This is subjective instrument that is widely used in clinical settings. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Measured: 3 months
Disability Index (DI)
This is subjective instrument that is widely used in clinical settings. 0% to 20%: minimal disability: The patient can cope with most living activities. Usually no treatment is indicated apart from advice on lifting sitting and exercise. 21%-40%: moderate disability: The patient experiences more pain and difficulty with sitting, lifting and standing. Travel and social life are more difficult and they may be disabled from work. Personal care, sexual activity and sleeping are not grossly affected and the patient can usually be managed by conservative means. 41%-60%: severe disability: Pain remains the main problem in this group but activities of daily living are affected. These patients require a detailed investigation. 61%-80%: crippled: Back pain impinges on all aspects of the patient's life. Positive intervention is required. 81%-100%: These patients are either bed-bound or exaggerating their symptoms.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start2 Apr 2019
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LordosisStudies 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
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nosheen Manzoor, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05015205
- Sponsor's protocol ID
- REC/RCRS/18/1003
- Status last verified
- Aug 2021
- First submitted
- 10 Aug 2021
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Muscle Energy Technique and Postural Correction Exercises in Lordotic Females Wearing High Heels
- ClinicalTrials.gov ID
- NCT05015205
- Acronym / sponsor ID
- REC/RCRS/18/1003
- Conditions
- Lordosis, Low Back Pain
- Keywords
- Lordosis, METs, Postural Correction Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 2 Apr 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 20 Aug 2021 (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.
The key purpose was to determine the effects of Muscle Energy Technique (MET) and Postural Correction Exercises on low back pain in females wearing high heels.
To determine the effects of muscle energy technique \& postural correction exercises in reducing pain, anterior pelvic tilt angle and increasing lumbar range of motion in subjects with chronic low back pain due to lordotic posture in females wearing high heels.
Detailed description
Body segments can be defined as the suitable posture positions. Body segments are placed in a way that center of gravity of each segment lies vertically. By this appropriate alignment, instead of excessive muscular activity, stability can be achieved by the body by the use of bone structures and ligament. Hence, in this way body structures experience the decreased tension. Besides the cosmetic effects of high heels, high heels results in increased risk of fall, fracture of bones particularly bones lower extremity, and also the change in normal kinematics of lower limb especially knee joint, and altered weight bearing on medial and longitudinal arches of foot. High heels change the line of gravity and posture of the body. Use of high heels change the posture which is compensated by the changes in different segments of the body like increased planter flexion of ankle as well as the displacements of the trunk and posterior pelvic tilting. The whole body mechanics gets affected in females wearing high heels. The center of gravity get disturbed with the use of high heel shoes. In body alignment, pelvis is known to have key importance. Any alteration in neutral position of pelvis leads to the compensatory altered movements in different regions, while, the segment which is considered to be the most effect is lumber spine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MET Group | Experimental | Other: Muscle Energy TechniquePost isometric relaxation technique MET was applied in two muscle groups; Lumbar Extensors (Erector Spinae) and Hip Flexors (Iliopsoas). The exercises were performed 3 times per week for 4 weeks. |
| Control Group | Experimental | Other: Postural Correction ExercisesPostural Correction Exercises was applied to one group. Exercises performed included stretching and strengthening exercises. The exercises were performed 3 times per week for 4 weeks. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18-45 years
- Low back pain of no more than 12 weeks duration in lordotic females wearing high heel shoes.
- Females wearing 4 to 5 inches high heel shoes 6 hour per day.
- Increased lumbosacral angle
- An initial ODI score of 20 % to 60 %.
Key exclusion criteria (6 listed)
- Any red flags (tumor, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis, resting blood pressure greater than 140/90 mmHg, prolonged history of steroid use, etc)
- Presented with involvement of nerve compression symptoms like radiating pain, change in normal sensory sensations with significant muscle weakness, or hypo reflexia or hyper reflexia.
- Presented with a diagnosis of Lumbar spinal stenosis.
- Presented with a diagnosis of Lumbar spinal spondylolisthesis.
- Prior surgery to the lumbar region.
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 |
|---|---|---|
| Muscle Energy TechniquePost isometric relaxation technique MET was applied in two muscle groups; Lumbar Extensors (Erector Spinae) and Hip Flexors (Iliopsoas). The muscle was positioned in position and patient was asked to apply 20% force isometrically and hold the isometric contractions for 7-10 seconds. Then the patient was asked to relax for about seconds. On exhalation, therapist takes muscle to new restriction barrier. Hold this position for 30 seconds at the end barrier as an end-stretch with 3 repetitions. | Other | MET Group |
| Postural Correction Exercises: Postural Correction Exercises was applied to one group. Exercises performed included stretching and strengthening exercises. Hip flexors and back extensors were stretched while hip extensors and abdominals were strengthened. Seated hip flexion used to stretch back extensors while lunge position used to stretch hip flexors. The abdominals were strengthened by using curl up exercises while hip extensors were strengthened by resisted contractions in prone lying. | Other | Control Group |
Primary outcome
Numeric Pain Rating Scale (NPRS)
Time frame: 3 months
This is subjective instrument that is widely used in clinical settings. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Disability Index (DI)
Time frame: 3 months
This is subjective instrument that is widely used in clinical settings. 0% to 20%: minimal disability: The patient can cope with most living activities. Usually no treatment is indicated apart from advice on lifting sitting and exercise. 21%-40%: moderate disability: The patient experiences more pain and difficulty with sitting, lifting and standing. Travel and social life are more difficult and they may be disabled from work. Personal care, sexual activity and sleeping are not grossly affected and the patient can usually be managed by conservative means. 41%-60%: severe disability: Pain remains the main problem in this group but activities of daily living are affected. These patients require a detailed investigation. 61%-80%: crippled: Back pain impinges on all aspects of the patient's life. Positive intervention is required. 81%-100%: These patients are either bed-bound or exaggerating their symptoms.
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 27 Aug 2021.
- Individual participant dataSharing planned: No
Related trials for Lordosis
RecruitingObservational study
Changes in Cervical Posture, Cervical Function, and Neck Pain After Sleeve Gastrectomy
Morbid Obesity Requiring Bariatric Surgery, Neck Pain Musculoskeletal
Active, not recruitingObservational study
Longitudinal Changes in Spinopelvic Alignment and Sagittal Balance After Bariatric Surgery in Patients With Morbid Obesity: A Prospective Observational Study
Obesity, Spine Condition
Enrolling by invitation
Egoscue and Core Stabilization for Chronic Low Back Pain
Chronic Low Back Pain (CLBP)
Not yet recruitingObservational study
Hamstring Tightness and Lumbar Lordosis Angel Across Functional Sitting Posture.
Hamstring Tightness, Lumbar Lordosis
Active, not recruiting
Restoring Segmental Lumbar Lordosis After Failed Previous Fusion at the Same Level
Failed Back Surgery Syndrome, Degeneration Lumbar Spine
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.
Nosheen Manzoor, MS principal investigator
Riphah International 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 Muscle Energy Technique and Postural Correction Exercises in people with Lordosis and 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 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 27 Aug 2021. 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: 3 months). The study lists 2 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 27 Aug 2021.