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

15 lipca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

50

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Egipt
    • Gharbia Governorate
      • Tanta, Gharbia Governorate, Egipt, 31511
        • Rekrutacyjny
        • Al-Salam University
        • Kontakt:
          • Ayman Mohammed Elmakakey, Associate Professor
          • Numer telefonu: +20403386400
          • E-mail: info@sue.edu.eg
        • Kontakt:
          • Aya Elkomy, Lecturer
          • Numer telefonu: +20 106 603 4330
          • E-mail: info@sue.edu.eg

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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.

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
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.
Urządzenie: 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

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Torque parameters for ankle Isokinetic testing of plantar flexors and dorsi flexors for dominant and non-dominant limbs.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Lumbo-sacral angle
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Core endurance The Sorenson test
Ramy czasowe: 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.
Baseline
Core endurance Side Plank test
Ramy czasowe: 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.
Baseline

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Cairo University

Śledczy

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

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

13 czerwca 2026

Zakończenie podstawowe (Szacowany)

30 października 2026

Ukończenie studiów (Szacowany)

1 grudnia 2026

Daty rejestracji na studia

Pierwszy przesłany

4 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

4 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

9 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

17 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

15 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Inne numery identyfikacyjne badania

  • Ankle Isokinetic in CNSLBP

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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