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

NCT07636967 | Not Yet Recruiting DMC

• 1 other identifier: Ankle Isokinetic in CNSLBP
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Non-specific Low Back Pain

Keywords

Isokinetics; Muscle Performance; power parameter; Torque parameter; Time Parameter

Outcome Measures

Primary Outcomes (4)

• Torque parameters for ankle Isokinetic testing of plantar flexors and dorsi flexors for dominant and non-dominant limbs.

  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.

  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.

  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 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 Outcomes (6)

• Level of pain intensity

  Baseline

• Level of functional disability

  Baseline

• Kinesiophobia and fearing of physical activity and work

  Baseline

• Overall body fatiguability status and physical function

  Baseline

• Lumbo-sacral angle

  Baseline

Study Arms (1)

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

Interventions

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

Study Group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: only biological males who self-identify as men are eligible to participate in this study
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Al-Salam University

Tanta, Gharbia Governorate, 31511, Egypt

Location

Related Publications (28)

• 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.

  PMID: 24412032 BACKGROUND

• 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.

  PMID: 35988435 BACKGROUND

• 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.

  PMID: 36582840 BACKGROUND

• 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.

  PMID: 31985722 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 32120055 BACKGROUND

• 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.

  PMID: 25409985 BACKGROUND

• 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.

  PMID: 31614383 BACKGROUND

• 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.

  PMID: 30967811 BACKGROUND

• 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.

  PMID: 28017604 BACKGROUND

• 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.

  PMID: 28456669 BACKGROUND

• 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.

  PMID: 30344274 BACKGROUND

• 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.

  PMID: 32726732 BACKGROUND

• 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.

  PMID: 24837629 BACKGROUND

• 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.

  PMID: 25467548 BACKGROUND

• 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.

  PMID: 27081203 BACKGROUND

• 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.

  PMID: 27693732 BACKGROUND

• Brockett CL, Chapman GJ. Biomechanics of the ankle. Orthop Trauma. 2016 Jun;30(3):232-238. doi: 10.1016/j.mporth.2016.04.015.

  PMID: 27594929 BACKGROUND

• 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.

  PMID: 26957935 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 21982256 BACKGROUND

• 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.

  PMID: 29650015 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 26739978 BACKGROUND

• 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.

  PMID: 37301558 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

Study Officials

• Maha Mostafa Alibeiny, Associate Professor

  Cairo University

  STUDY DIRECTOR

• Hany Mohamed Hamed, Associate Professor

  Faculty of Medicine, Kafrelsheikh University

  STUDY DIRECTOR

Central Study Contacts

Mohamed Hazem Abdelhakam Elshafey, Demonstrator (TA)

CONTACT

+201114946552; mohamedhazem3333333333@gmail.com

Mahmoud Mohamed Nabhan, Lecturer

CONTACT

+201142890404; Mahmoudnabhan37@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Demonstrator of Biomechanics department, Faculty of Physical Therapy

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 9, 2026
• Study Start: June 7, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)