NCT04562701

Brief Summary

The aim of this study was to determine the correlation between hamstring length and gluteus maximus strength with and without normalization 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 Sep 2018

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

September 10, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 24, 2020

Completed
Last Updated

October 6, 2020

Status Verified

September 1, 2020

Enrollment Period

1.3 years

First QC Date

September 18, 2020

Last Update Submit

October 4, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Gluteus muscle torque

    The gluteus maximus strength was evaluated by using hand-held dynamometer (HHD). The patient was asked to lie in the prone position. Belt was used to support the pelvis, then the patient was asked to maximally extend the hip joint with the knee joints flexed to 90°). Resistance belt (non-elastic strap) was placed 15 cm above the knee joint above popliteal fossa with the Hand-held dynamometer below it. Each subject was instructed to perform maximal isometric hip extension for 5 seconds. Measurement was done three times, with 2-minutes rest between trials. Subject's hand was places behind waist to control the substitute motions of arm or hand. The peak force for each trial was recorded, and the average value was calculated

    20 minutes

  • Hamstring length

    Patient was positioned supine with the non-tested limb flat with knee extended and supported with strap over the mid-thigh to eliminate any substitutive movement. An another strap was rapped over the pelvis for fixation, to maintain 90 degrees of the hip joint, a wooden frame was then placed on the plinth in line with the participant's anterior superior iliac spine of the pelvis. The participant was asked to flex the hip of the test leg so that their thigh touching the wooden apparatus all over test time

    20 minutes

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

* Male and female patients * Age ranged from 18-40 years * Body mass index ranged from 25-30 kg/m2

You may qualify if:

  • Patients diagnosed as mechanical low back pain (MLBP) with very high grade mechanical inflammatory low back pain (MIL) index.
  • Age ranged from 18 to 40 years.
  • Body mass index ranged from 25 to 30 kg/m2

You may not qualify if:

  • History of previous fractures, surgeries, malignancies, trauma, rheumatoid arthritis, spondylosis, and spondylolisthesis.
  • History of lower limb injuries in the last six months before the study.
  • Inability to correctly produce maximal Gluteus Maximus contraction in a pain-free ROM.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university

Giza, Egypt

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

September 18, 2020

First Posted

September 24, 2020

Study Start

September 10, 2018

Primary Completion

January 5, 2020

Study Completion

August 31, 2020

Last Updated

October 6, 2020

Record last verified: 2020-09

Locations