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Effect of Opposite Leg Position on Hamstring Flexibility in Patients With Mechanical Low Back Pain

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ClinicalTrials.gov Identifier: NCT04082013
Recruitment Status : Completed
First Posted : September 9, 2019
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
HAhmed, Cairo University

Tracking Information
First Submitted Date September 5, 2019
First Posted Date September 9, 2019
Last Update Posted Date September 23, 2019
Actual Study Start Date April 1, 2019
Actual Primary Completion Date June 27, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 20, 2019)
Knee extension ROM [ Time Frame: 30 minutes ]
measuring knee extension ROM from 90 degrees hip flexion with opposite-leg flexed and extended
Original Primary Outcome Measures
 (submitted: September 5, 2019)
Knee extension ROM [ Time Frame: 4 months ]
measuring knee extension ROM from 90 degrees hip flexion with opposite-leg flexed and extended
Change History Complete list of historical versions of study NCT04082013 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effect of Opposite Leg Position on Hamstring Flexibility in Patients With Mechanical Low Back Pain
Official Title Effect of Opposite Leg Position on Hamstring Flexibility in Patients With Mechanical Low Back Pain
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?

Detailed Description
  • 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 recorded used as the hamstring muscle length for the data analysis (Dong-Kyu Lee, et al., 2018).
  • This test will be done for the same limb with opposite leg extended and with opposite flexed.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population
  • Male and female
  • Age range from 18-40 years old
  • With previous mentioned inclusion criteria
Condition Flexibility
Intervention Other: Hamstring Flexibility

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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 20, 2019)
73
Original Actual Enrollment
 (submitted: September 5, 2019)
60
Actual Study Completion Date July 25, 2019
Actual Primary Completion Date June 27, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  1. Previous trauma, fractures or surgery of the back.
  2. Malignancy of the back.
  3. Rheumatoid arthritis
  4. Spondylolysis or spondylolithesis
  5. History of lower extremity injury within 6 months prior to the study
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Egypt
Removed Location Countries  
 
Administrative Information
NCT Number NCT04082013
Other Study ID Numbers P.T.REC/012/002301
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party HAhmed, Cairo University
Study Sponsor Cairo University
Collaborators Not Provided
Investigators
Principal Investigator: Nasr A. Abdelkader, PhD Lecturer,Cairo University
PRS Account Cairo University
Verification Date March 2019