- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05015205
Effects of Muscle Energy Technique and Postural Correction Exercises in Lordotic Females Wearing High Heels
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
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Faisalābad, Punjab, Pakistan, 3800
- Nosheen Manzoor
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: MET Group
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.
|
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.
|
|
Experimental: Control Group
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.
|
: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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").
|
3 months
|
|
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.
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nosheen Manzoor, MS, Riphah International 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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCRS/18/1003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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