NCT05015205

Brief 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 of motion in subjects with chronic low back pain due to lordotic posture in females wearing high heels.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 2, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 20, 2021

Completed
Last Updated

August 27, 2021

Status Verified

August 1, 2021

Enrollment Period

6 months

First QC Date

August 10, 2021

Last Update Submit

August 23, 2021

Conditions

Keywords

LordosisMETsPostural Correction Exercise

Outcome Measures

Primary Outcomes (2)

  • 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").

    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.

    3 months

Study Arms (2)

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.

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.

Other: Postural Correction Exercises

Interventions

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.

MET Group

: 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.

Control Group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemales wearing high heels
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nosheen Manzoor

Faisalābad, Punjab Province, 3800, Pakistan

Location

MeSH Terms

Conditions

LordosisLow Back Pain

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal DiseasesBack PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nosheen Manzoor, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2021

First Posted

August 20, 2021

Study Start

April 2, 2019

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

August 27, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations