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Chronic Non-specific Low Back PainNCT07636967

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

An observational study of Chronic Non-specific Low Back Pain, run by Cairo University at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 25 years, men only
Conditions the study is for
Chronic Non-specific Low Back Pain
What is being tested?
Humac Isokinetic 2015 System 2
Type of treatment
Medical device
How many people
50 participants
Where
1 siteEgypt
Study dates
13 Jun 2026to 1 Dec 2026
How long will I take part?
1 Day
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 25 years
  • Men only
  • No healthy volunteers
  • Adult

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.

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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.

Who cannot join

  • Unexplained weight loss.
  • History of malignancy.
  • Recent trauma within last 12 months.
  • Osteoporosis.
  • Cauda Equina Symptoms.
  • Herniated discs.
Show all 21Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mohamed Hazem Abdelhakam Elshafey, Demonstrator (TA) contact

+201114946552

mohamedhazem3333333333@gmail.com

Mahmoud Mohamed Nabhan, Lecturer contact

+201142890404

Mahmoudnabhan37@gmail.com

Egypt1 site, 1 recruiting

  • Al-Salam University

    Tanta, Gharbia Governorate, 31511

    Ayman Mohammed Elmakakey, Associate Professor, +20403386400, info@sue.edu.eg

    Aya Elkomy, Lecturer, +20 106 603 4330, info@sue.edu.eg

    Recruiting

Other trials in Egypt

About this study

Official title: 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.

Read the 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.

Being tested
Humac Isokinetic 2015 System 2
Keywords
Isokinetics, Muscle Performance, power parameter, Torque parameter, Time Parameter

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Humac Isokinetic 2015 System 2Device

    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 groups in NCT07636967
Study groupRoleWhat they receive
Study Group50 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.
Receives: Device: Humac Isokinetic 2015 System 2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Baseline (Single assessment session per patient)

  2. 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)

    Measured: Baseline (single assessment session per patient)

  3. 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)

    Measured: Baseline (Single assessment session per patient)

  4. 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)

    Measured: Baseline (Single assessment session per patient)

Secondary outcomes (8)

  1. Level of pain intensity

    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.

    Measured: Baseline

  2. Level of functional disability

    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

    Measured: Baseline

  3. Kinesiophobia and fearing of physical activity and work

    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

    Measured: Baseline

  4. Overall body fatiguability status and physical function

    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.

    Measured: Baseline

  5. Lumbo-sacral angle

    Will be measured by Fergusson's method on Lateral X-ray films of lumbo-sacral region for each patient

    Measured: Baseline

  6. Assessment of core muscles endurance

    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.

    Measured: Baseline

  7. Core endurance The Sorenson test

    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.

    Measured: Baseline

  8. Core endurance Side Plank test

    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.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2026
  2. Study start13 Jun 2026
  3. Primary completion30 Oct 2026 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
50 participants (estimated)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT07636967
Sponsor's protocol ID
Ankle Isokinetic in CNSLBP
Status last verified
Jul 2026
First submitted
4 Jun 2026
Last updated
17 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 31614383

  • 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.

    PubMed 30967811

  • 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.

    PubMed 28017604

  • 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.

    PubMed 28456669

  • 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.

    PubMed 30344274

  • 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.

    PubMed 32726732

  • 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.

    PubMed 24837629

  • 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.

    PubMed 25467548

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Non-specific Low Back Pain, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mohamed Hazem Abdelhakam Elshafey, Demonstrator (TA) (+201114946552, mohamedhazem3333333333@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07636967, which also lists 28 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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