Isokinetic Profile of Ankle Joint Muscles in Chronic Non Specific Low Back Pain Patients
15 de julio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
De observación
Inscripción (Estimado)
50
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Mohamed Hazem Abdelhakam Elshafey, Demonstrator (TA)
- Número de teléfono: +201114946552
- Correo electrónico: mohamedhazem3333333333@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Mahmoud Mohamed Nabhan, Lecturer
- Número de teléfono: +201142890404
- Correo electrónico: Mahmoudnabhan37@gmail.com
Ubicaciones de estudio
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Gharbia Governorate
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Tanta, Gharbia Governorate, Egipto, 31511
- Reclutamiento
- Al-Salam University
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Contacto:
- Ayman Mohammed Elmakakey, Associate Professor
- Número de teléfono: +20403386400
- Correo electrónico: info@sue.edu.eg
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Contacto:
- Aya Elkomy, Lecturer
- Número de teléfono: +20 106 603 4330
- Correo electrónico: info@sue.edu.eg
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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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.
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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
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Torque parameters for ankle Isokinetic testing of plantar flexors and dorsi flexors for dominant and non-dominant limbs.
Periodo de tiempo: Baseline (Single assessment session per patient)
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Ankle torque parameters will be tested at velocity of 30°/s, these parameters will include (peak torque - peak torque / BW - Cof of Variance)
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Baseline (Single assessment session per patient)
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Endurance and power parameters for ankle Isokinetic testing of plantar flexors and dorsi flexors for dominant and non-dominant limbs.
Periodo de tiempo: Baseline (single assessment session per patient)
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Ankle torque parameters will be tested at velocity of 180°/s, these parameters will include (fatigue index - Total work - Average Power/reps)
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Baseline (single assessment session per patient)
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Position parameters for ankle Isokinetic testing of plantar flexors and dorsi flexors for dominant and non-dominant limbs.
Periodo de tiempo: Baseline (Single assessment session per patient)
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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)
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Baseline (Single assessment session per patient)
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Time parameters for ankle Isokinetic testing of plantar flexors and dorsi flexors for dominant and non-dominant limbs.
Periodo de tiempo: Baseline (Single assessment session per patient)
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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)
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Baseline (Single assessment session per patient)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Lumbo-sacral angle
Periodo de tiempo: Baseline
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Will be measured by Fergusson's method on Lateral X-ray films of lumbo-sacral region for each patient
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Baseline
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Level of pain intensity
Periodo de tiempo: Baseline
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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.
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Baseline
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Level of functional disability
Periodo de tiempo: Baseline
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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
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Kinesiophobia and fearing of physical activity and work
Periodo de tiempo: Baseline
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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
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Baseline
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Overall body fatiguability status and physical function
Periodo de tiempo: Baseline
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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.
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Baseline
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Assessment of core muscles endurance
Periodo de tiempo: Baseline
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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.
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Baseline
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Core endurance The Sorenson test
Periodo de tiempo: Baseline
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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.
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Baseline
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Core endurance Side Plank test
Periodo de tiempo: Baseline
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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.
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Baseline
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Maha Mostafa Alibeiny, Associate Professor, Cairo University
- Director de estudio: Hany Mohamed Hamed, Associate Professor, Faculty of Medicine, Kafrelsheikh University
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Balague F, Mannion AF, Pellise F, Cedraschi C. Non-specific low back pain. Lancet. 2012 Feb 4;379(9814):482-91. doi: 10.1016/S0140-6736(11)60610-7. Epub 2011 Oct 6.
- Al-Sobayel HI, Al-Hugail HA, AlSaif RM, Albawardi NM, Alnahdi AH, Daif AM, Al-Arfaj HF. Validation of an Arabic version of Fatigue Severity Scale. Saudi Med J. 2016 Jan;37(1):73-8. doi: 10.15537/smj.2016.1.13055.
- Rahimi A, Arab AM, Nourbakhsh MR, Hosseini SM, Forghany S. Lower limb kinematics in individuals with chronic low back pain during walking. J Electromyogr Kinesiol. 2020 Apr;51:102404. doi: 10.1016/j.jelekin.2020.102404. Epub 2020 Feb 17.
- Koch C, Hansel F. Non-specific Low Back Pain and Postural Control During Quiet Standing-A Systematic Review. Front Psychol. 2019 Mar 22;10:586. doi: 10.3389/fpsyg.2019.00586. eCollection 2019.
- Chiarotto A, Maxwell LJ, Terwee CB, Wells GA, Tugwell P, Ostelo RW. Roland-Morris Disability Questionnaire and Oswestry Disability Index: Which Has Better Measurement Properties for Measuring Physical Functioning in Nonspecific Low Back Pain? Systematic Review and Meta-Analysis. Phys Ther. 2016 Oct;96(10):1620-1637. doi: 10.2522/ptj.20150420. Epub 2016 Apr 14.
- Goubert D, De Pauw R, Meeus M, Willems T, Cagnie B, Schouppe S, Van Oosterwijck J, Dhondt E, Danneels L. Lumbar muscle structure and function in chronic versus recurrent low back pain: a cross-sectional study. Spine J. 2017 Sep;17(9):1285-1296. doi: 10.1016/j.spinee.2017.04.025. Epub 2017 Apr 26.
- Claeys K, Dankaerts W, Janssens L, Pijnenburg M, Goossens N, Brumagne S. Young individuals with a more ankle-steered proprioceptive control strategy may develop mild non-specific low back pain. J Electromyogr Kinesiol. 2015 Apr;25(2):329-38. doi: 10.1016/j.jelekin.2014.10.013. Epub 2014 Oct 31.
- Shafshak TS, Elnemr R. The Visual Analogue Scale Versus Numerical Rating Scale in Measuring Pain Severity and Predicting Disability in Low Back Pain. J Clin Rheumatol. 2021 Oct 1;27(7):282-285. doi: 10.1097/RHU.0000000000001320.
- Amundsen PA, Evans DW, Rajendran D, Bright P, Bjorkli T, Eldridge S, Buchbinder R, Underwood M, Froud R. Inclusion and exclusion criteria used in non-specific low back pain trials: a review of randomised controlled trials published between 2006 and 2012. BMC Musculoskelet Disord. 2018 Apr 12;19(1):113. doi: 10.1186/s12891-018-2034-6.
- Gonosova Z, Linduska P, Bizovska L, Svoboda Z. Reliability of Ankle(-)Foot Complex Isokinetic Strength Assessment Using the Isomed 2000 Dynamometer. Medicina (Kaunas). 2018 Jun 4;54(3):43. doi: 10.3390/medicina54030043.
- Wertli MM, Rasmussen-Barr E, Weiser S, Bachmann LM, Brunner F. The role of fear avoidance beliefs as a prognostic factor for outcome in patients with nonspecific low back pain: a systematic review. Spine J. 2014 May 1;14(5):816-36.e4. doi: 10.1016/j.spinee.2013.09.036. Epub 2013 Oct 18.
- Sung PS, Park MS. Ankle reaction times with tray usage following a slip perturbation between subjects with and without chronic low back pain. Gait Posture. 2022 Sep;97:196-202. doi: 10.1016/j.gaitpost.2022.07.260. Epub 2022 Aug 1.
- Shokouhyan SM, Davoudi M, Hoviattalab M, Abedi M, Bervis S, Parnianpour M, Brumagne S, Khalaf K. Distinction of non-specific low back pain patients with proprioceptive disorders from healthy individuals by linear discriminant analysis. Front Bioeng Biotechnol. 2022 Dec 13;10:1078805. doi: 10.3389/fbioe.2022.1078805. eCollection 2022.
- Ruchi., Jagga V., & Pal S. (2024). Prevalence of Non-Specific Chronic Low Back Pain and Its Effects on Activities of Daily Life in College Students. https://www.researchgate.net/publication/381293938.
- McCaskey MA, Schuster-Amft C, Wirth B, Suica Z, de Bruin ED. Effects of proprioceptive exercises on pain and function in chronic neck- and low back pain rehabilitation: a systematic literature review. BMC Musculoskelet Disord. 2014 Nov 19;15:382. doi: 10.1186/1471-2474-15-382.
- Liporaci RF, Saad M, Grossi DB, Riberto M. Clinical Features and isokinetic Parameters in Assessing Injury Risk in elite Football Players. Int J Sports Med. 2019 Dec;40(14):903-908. doi: 10.1055/a-1014-2911. Epub 2019 Oct 15.
- Kahlaee AH, Ghamkhar L, Arab AM. Effect of the Abdominal Hollowing and Bracing Maneuvers on Activity Pattern of the Lumbopelvic Muscles During Prone Hip Extension in Subjects With or Without Chronic Low Back Pain: A Preliminary Study. J Manipulative Physiol Ther. 2017 Feb;40(2):106-117. doi: 10.1016/j.jmpt.2016.10.009. Epub 2016 Dec 22.
- Estrazulas JA, Estrazulas JA, de Jesus K, de Jesus K, da Silva RA, Libardoni Dos Santos JO. Evaluation isometric and isokinetic of trunk flexor and extensor muscles with isokinetic dynamometer: A systematic review. Phys Ther Sport. 2020 Sep;45:93-102. doi: 10.1016/j.ptsp.2020.06.008. Epub 2020 Jul 17.
- Dubois JD, Abboud J, St-Pierre C, Piche M, Descarreaux M. Neuromuscular adaptations predict functional disability independently of clinical pain and psychological factors in patients with chronic non-specific low back pain. J Electromyogr Kinesiol. 2014 Aug;24(4):550-7. doi: 10.1016/j.jelekin.2014.04.012. Epub 2014 May 2.
- Brodke DS, Goz V, Lawrence BD, Spiker WR, Neese A, Hung M. Oswestry Disability Index: a psychometric analysis with 1,610 patients. Spine J. 2017 Mar;17(3):321-327. doi: 10.1016/j.spinee.2016.09.020. Epub 2016 Sep 29.
- Brockett CL, Chapman GJ. Biomechanics of the ankle. Orthop Trauma. 2016 Jun;30(3):232-238. doi: 10.1016/j.mporth.2016.04.015.
- Bosquet L, Gouadec K, Berryman N, Duclos C, Gremeaux V, Croisier JL. The Total Work Measured During a High Intensity Isokinetic Fatigue Test Is Associated With Anaerobic Work Capacity. J Sports Sci Med. 2016 Feb 23;15(1):126-30. eCollection 2016 Mar.
- Bonetti, L. V., Grisa, N. C., Palandi, J., Finger, A. L. T., Marchi, T. de, & Tadiello, G. S. (2018). Isokinetic performance of ankle evertor and invertor muscles in adolescent female volleyball athletes. Motriz: Revista de Educação Física, 24(3). https://doi.org/10.1590/s1980- 657420180003e005018.
- Amin, D., Abdelmegeed, M., Sherif, M., & Soliman, E. (2023). Relationship between Core Muscles Endurance and Functional Lower Limb Performance in Patients with Chronic Mechanical Low Back Pain. Egyptian Journal of Physical Therapy, 16(1), 45-51. https://doi.org/10.21608/ejpt.2023.223299.1147.
- Alizamani S, Ghasemi G, Lenjan Nejadian S. Effects of eight week core stability training on stable- and unstable-surface on ankle muscular strength, proprioception, and dorsiflexion in athletes with chronic ankle instability. J Bodyw Mov Ther. 2023 Apr;34:6-12. doi: 10.1016/j.jbmt.2023.04.005. Epub 2023 Apr 9.
- Abdelmegeed, M., Abdelaziz, W., Abdelmajeed, S., & Elhabashy, H. (2023). Relationship between Scapular Upward Rotation and Gluteus Maximus Activity in Subjects with Chronic Nonspecific Low Back Pain. Egyptian Journal of Physical Therapy. 15. 6-11. https://doi.org/10.21608/ejpt.2022.166395.1103.
- Abdelhaleem, M. D., Abdelhay, M. I., Aly, S. M., Abdallah, E. A., & Neamat Allah, N. H. (2023). Effects of 6 weeks of ankle stability exercises on pain, functional abilities, and flexibility in patients with chronic non-specific low back pain: a randomized controlled trial. Bulletin of Faculty of Physical Therapy, 28(1). https://doi.org/10.1186/s43161-023-00126-x.
- Abdelhaleem, M. D., Grase, M. O., Aly, S. M., & Abdallah, E. A. (2022). Association between unilateral functional ankle instability, limited ankle dorsiflexion range of motion and low back pain. SPORT TK-Revista EuroAmericana de Ciencias Del Deporte, 47. https://doi.org/10.6018/sportk.526661.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
13 de junio de 2026
Finalización primaria (Estimado)
30 de octubre de 2026
Finalización del estudio (Estimado)
1 de diciembre de 2026
Fechas de registro del estudio
Enviado por primera vez
4 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
4 de junio de 2026
Publicado por primera vez (Actual)
9 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
15 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- Ankle Isokinetic in CNSLBP
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .