Isokinetic Profile of Ankle Joint Muscles in Chronic Non Specific Low Back Pain Patients

June 13, 2026 updated by: Mohamed Hazem Abdelhakam Elshafey, Cairo University

The Relationship Between Chronic Non-Specific Low Back Pain and Isokinetic Performance of Ankle Joint Muscles

Chronic non-specific low back pain and its resulting infirmity have become a huge health and socioeconomic burden. Low back pain is reportedly associated with decreased activities of daily living and quality of life. Previous literature supports the presence of a link between CLBP and lower limb kinematics that can contribute to functional limitations and disability. For example, CLBP commonly coexist with postural and structural asymmetry. Ankle muscle performance of individuals with LBP during gait becomes more clinically important as it may provide insights into the mechanisms of ankle strategies. The isokinetic testing is an assessment method of high effectivity and trustworthiness that can be used to compare bilateral and agonist/ antagonist ankle muscles strength of normal subjects and athletes. It can be used to analyze muscular performance and differences in muscle performance between dominant and non-dominant limbs.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will involve 50 male patients diagnosed with CNSLBP and will correlate between level of pain, disability, psychological status, and overall body fatiguability, core muscles endurance with the strength, endurance, joint angle position, and time parameters of isokinetic testing profile of ankle joint.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Gharbia Governorate
      • Tanta, Gharbia Governorate, Egypt, 31511
        • Recruiting
        • Al-Salam University
        • Contact:
          • Ayman Mohammed Elmakakey, Associate Professor
          • Phone Number: +20403386400
          • Email: info@sue.edu.eg
        • Contact:
          • Aya Elkomy, Lecturer
          • Phone Number: +20 106 603 4330
          • Email: info@sue.edu.eg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

50 male patients aged 20-40 years, diagnosed with CNSLBP through direct referral from their orthopedic surgeon after excluding the previous criteria.

Medical assessment for recruiting, diagnosis, and including or excluding will be done at Kafrelsheikh University Hospitals.

Description

Inclusion Criteria:

  1. 50 male patients diagnosed with Chronic non-specific low back pain through direct referral from their orthopedic surgeon.
  2. Each patient will be diagnosed by "Waddle sign"
  3. Age limit 20-40 years.
  4. BMI: less than 30.
  5. Pain duration: chronic more than 3 months or 12 weeks.
  6. Pain location: Between T12- and lower gluteal folds.
  7. Pain Intensity: At least have 3 out of 10 on VAS.
  8. Level of functional disability: 21%-40% on MODI.
  9. Each patient sign an informed consent.

Exclusion Criteria:

  1. Unexplained weight loss.
  2. History of malignancy.
  3. Recent trauma within last 12 months.
  4. Osteoporosis.
  5. Cauda Equina Symptoms.
  6. Herniated discs.
  7. Radicular signs.
  8. Spine fractures.
  9. Spinal Canal Stenosis.
  10. Myofascial Pain Syndrome.
  11. Spondylolisthesis.
  12. Rheumatological history.
  13. CVS manifestations.
  14. GIT manifestations.
  15. Psychiatric disorders.
  16. Weakness or parathesis in L.L.
  17. History of back surgery.
  18. Chronic Ankle Instability.
  19. Scoliosis or leg length discrepancies.
  20. Neurological and systemic manifestations such Epilepsy, muscular diseases, or seziures.
  21. Mechanical back pain

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study Group
50 patient diagnosed with Chronic non-specific low back pain will be evaluated and assessed by humac isokinetic for ankle profile, Mcgill core endurance tests, level of pain, disability, fatiguability through questionnaires and measuring Lumbosacral angle for each patient, and correlate all variables with each others.
Device: Humac Isokinetic 2015 System 2
Humac isokinetic device will be used for testing and assessing ankle joint profile including torque, endurance, joint position, and time parameters for both limbs for 50 patients diagnosed with chronic non specific low back pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Torque parameters for ankle Isokinetic testing of plantar flexors and dorsi flexors for dominant and non-dominant limbs.
Time Frame: Baseline (Single assessment session per patient)
Ankle torque parameters will be tested at velocity of 30°/s, these parameters will include (peak torque - peak torque / BW - Cof of Variance)
Baseline (Single assessment session per patient)
Endurance and power parameters for ankle Isokinetic testing of plantar flexors and dorsi flexors for dominant and non-dominant limbs.
Time Frame: Baseline (single assessment session per patient)
Ankle torque parameters will be tested at velocity of 180°/s, these parameters will include (fatigue index - Total work - Average Power/reps)
Baseline (single assessment session per patient)
Position parameters for ankle Isokinetic testing of plantar flexors and dorsi flexors for dominant and non-dominant limbs.
Time Frame: Baseline (Single assessment session per patient)
Position torque parameters will be tested at two velocities of 30°/s, and 180°/s these parameters will include (Joint angle at peak torque - Range of motion)
Baseline (Single assessment session per patient)
Time parameters for ankle Isokinetic testing of plantar flexors and dorsi flexors for dominant and non-dominant limbs.
Time Frame: Baseline (Single assessment session per patient)
Time torque parameters will be tested at two velocities of 30°/s, and 180°/s these parameters will include (Time to peak torque - Force decay time - Delay time)
Baseline (Single assessment session per patient)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lumbo-sacral angle
Time Frame: Baseline
Will be measured by Fergusson's method on Lateral X-ray films of lumbo-sacral region for each patient
Baseline
Level of pain intensity
Time Frame: Baseline
Will be measured through Visual Analogue Scale (VAS) VAS is a proven, evaluative tool for measuring both acute and chronic pain as scores is recorded by placing a handwriting mark along a 10-cm line that represents a pain spectrum between "no pain" and "worst pain" as the word descriptions "no pain" on the left and "worst imaginable pain" on the right serve as anchors for the 100-mm long horizontal line.
Baseline
Level of functional disability
Time Frame: Baseline

Will be assessed through Arabic version of Modified Oswestry Disability Index (MODI).

The Oswestry Low Back Pain Disability Index is a 10-item self-assessment questionnaire with 6 levels of answers ranging from 0 to 5. Pain, personal care, lifting and moving objects, walking, sitting, standing, sleep disorders caused by LBP, sex life, social life, and traveling are among these items. A total score is computed, and the percentage of disability (score obtained divided by 50 and multiplied by 100) ranges from 0% (no disability) to 100% (complete disability) (complete disability). The following scores are used to interpret this scale: 0 to 20%: minimal disability; 20 to 40%: moderate disability; 40 to 60%: severe disability; 60 to 80%: crippling low back pain; and above 80%: the person is confined to bed. To obtain the score, the sum of the scores is divided by the total possible score (i.e., 50). To obtain the percentage of a patient's disability, the resulting total is multiplied by 100
Baseline
Kinesiophobia and fearing of physical activity and work
Time Frame: Baseline
Will be assessed through Fear Avoidance Beliefs Questionnaire (FABQ) The questionnaire consists of 16 items in which a patient rates their agreement with each statement on a 7-point Likert scale. Where 0= completely disagree, 6=completely agree. There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs. There are two subscales within the FABQ; the work subscale (FABQw) with 7 questions (maximum score of 42) and the physical activity subscale (FABQpa) with 4 questions (maximum score of 24). The numbers in parentheses below designate which items from the FABQ are included in each subscale. The questionnaire takes approximately 10 minutes to complete. The higher the score, the higher the subject's fear-avoidance beliefs
Baseline
Overall body fatiguability status and physical function
Time Frame: Baseline
Will be assessed through Fatigue Severity Scale (FSS) Arabic version of the FSS is a 9-item scale which measures the severity of fatigue and its effect on a person's activities. Answers are scored on a seven- point scale where 1 = strongly disagree and 7 = strongly agree. This means the minimum score possible is nine and the highest is 63. The higher the score, the more severe the fatigue is and the more it affects the person's activities.
Baseline
Assessment of core muscles endurance
Time Frame: Baseline
Will be assessed through McGill endurance test For the McGill test, the participant back leaned against a jig in a sit-up position that will be 60 degrees (degrees) off the ground, their knees bent 90 degrees, their hips folded over their chests, their hands on the shoulder across from them, and their feet fastened. The patient will be instructed to maintain isometric posture for the longest period of time feasible before the researcher pushed the jig back 10 centimeters. Thus, when the patients' backs touched the jig, it was considered a failure. The researcher also will note how long the subjects maintained an isometric stance, which is typically between one and two minutes.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Maha Mostafa Alibeiny, Associate Professor, Cairo University
  • Study Director: Hany Mohamed Hamed, Associate Professor, Faculty of Medicine, Kafrelsheikh University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2026

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

June 4, 2026

First Submitted That Met QC Criteria

June 4, 2026

First Posted (Actual)

June 9, 2026

Study Record Updates

Last Update Posted (Actual)

June 16, 2026

Last Update Submitted That Met QC Criteria

June 13, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Ankle Isokinetic in CNSLBP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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