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Recruiting NCT07636967

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

— Observational Chronic Non-specific Low Back Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Humac Isokinetic 2015 System 2.
Who it may be relevant to
Registry conditions: Chronic Non-specific Low Back Pain. Basic parameters: 20 years — 25 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Interventions

  • 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

Primary outcome measures

  • 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)]
  • 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)]
  • 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)]
  • 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)]
Secondary outcome measures (8)
  • Level of pain intensity [Time frame: Baseline]
  • Level of functional disability [Time frame: Baseline]
  • Kinesiophobia and fearing of physical activity and work [Time frame: Baseline]
  • Overall body fatiguability status and physical function [Time frame: Baseline]
  • Lumbo-sacral angle [Time frame: Baseline]
  • Assessment of core muscles endurance [Time frame: Baseline]
  • Core endurance The Sorenson test [Time frame: Baseline]
  • Core endurance Side Plank test [Time frame: Baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Egypt · 1 center
  • Al-Salam University — Tanta

Publications

  • 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
  • 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
  • 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
  • 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
  • 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.
  • 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
  • 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
  • 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

Identifiers

NCT: NCT07636967 · Ankle Isokinetic in CNSLBP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗