NCT04082013

Brief Summary

PURPOSE: this study aimed to investigate the effect of opposite knee position on hamstring flexibility BACKGROUND Hamstrings tightness is one of the most common findings in patients with LBP. It is thought that, due to the attachments of hamstrings to the ischial tuberosity, hamstrings tightness generates posterior pelvic tilt and decreases lumbar lordosis, which can result in LBP. HYPOTHESES There will be significant difference in the hamstring flexibility with changing position of opposite knee (flexed or extended) in patients with mechanical low back pain. RESEARCH QUESTION: Will changing position of opposite knee (flexed or extended) affect the hamstring flexibility in patients with mechanical low back pain?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2019

Shorter than P25 for all trials

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 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2019

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 5, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 9, 2019

Completed
Last Updated

July 29, 2021

Status Verified

March 1, 2019

Enrollment Period

3 months

First QC Date

September 5, 2019

Last Update Submit

July 26, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Knee extension ROM

    measuring knee extension ROM from 90 degrees hip flexion with opposite-leg flexed and extended

    30 minutes

Interventions

The active knee extension test has been proposed as the gold standard for assessment of hamstring flexibility, as it utilizes readily available equipment and offers a quick, reliable, and low-cost alternative for measurement of hamstring flexibility (Connor et al; 2015). * The subject will be instructed to maintain 90° hip flexion in the supine position. * Then asked to actively extend the knee joint. * The degree of achieving active knee extension will be measured using a universal goniometer. * The average of three active knee extension measurements will be used as the hamstring muscle length for the data analysis (Dong-Kyu Lee, et al; 2018). * the procedures will be done with opposite-leg flexed, then repeated with opposite-leg extended.

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

* Male and female * Age range from 18-40 years old * With previous mentioned inclusion criteria

You may qualify if:

  • Patients with history of back pain and assessed with Mechanical inflammatory low back pain index and have very high grade for mechanical component.
  • Age ranges from 18-40 years.
  • The body mass index of the subject is ≤25 kg/meter square.

You may not qualify if:

  • Previous trauma, fractures or surgery of the back.
  • Malignancy of the back.
  • Rheumatoid arthritis
  • Spondylolysis or spondylolithesis
  • History of lower extremity injury within 6 months prior to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university

Giza, Egypt

Location

Study Officials

  • Nasr A. Abdelkader, PhD

    Lecturer,Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of physical therapy for musculoskeletal Disorders

Study Record Dates

First Submitted

September 5, 2019

First Posted

September 9, 2019

Study Start

April 1, 2019

Primary Completion

June 27, 2019

Study Completion

July 25, 2019

Last Updated

July 29, 2021

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations