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NCT Number: NCT07636967

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

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.

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Key information

Age range

20 year–25 year

Sex eligibility

Male

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Unexplained weight loss.
  • History of malignancy.
  • Recent trauma within last 12 months.
  • Osteoporosis.
  • Cauda Equina Symptoms.
  • Herniated discs.
  • Radicular signs.
  • Spine fractures.
  • Spinal Canal Stenosis.
  • Myofascial Pain Syndrome.
  • Spondylolisthesis.
  • Rheumatological history.
  • CVS manifestations.
  • GIT manifestations.
  • Psychiatric disorders.
  • Weakness or parathesis in L.L.
  • History of back surgery.
  • Chronic Ankle Instability.
  • Scoliosis or leg length discrepancies.
  • Neurological and systemic manifestations such Epilepsy, muscular diseases, or seziures.
  • Mechanical back pain

Treatment and study plan

Humac Isokinetic 2015 System 2

Device

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

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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.

  5. 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

  6. 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.

  7. Core endurance The Sorenson test

    Time frame: Baseline

    The Sorenson test will be carried out with the individuals' upper bodies off the end of the test bench and their pelvises, knees, and hips restrained. Hands were placed on opposite shoulders while the subjects' upper bodies were held across their chests. Failure is defined as the moment that a subject's upper body deviated from the horizontal position, and the researcher will note the amount of time that a subject typically maintained a straight posture for between one and two minutes.

  8. Core endurance Side Plank test

    Time frame: Baseline

    Side plank test will be conducted with subjects lied on side, then researcher will ask to lift body on elbow, forearm, and feet will be stacked to create a straight line from head to toes. Thus, failure will be determined when subjects' body would be dropped; and researcher will record time that subjects has hold body straight with normal range of one and two minutes.

Study contacts

Contact information is provided by the study sponsor or research team.

Mahmoud Mohamed Nabhan, Lecturer

CONTACT

[email protected]

+201142890404

Mohamed Hazem Abdelhakam Elshafey, Demonstrator (TA)

CONTACT

[email protected]

+201114946552

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 9, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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