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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
only biological males who self-identify as men are eligible to participate in this study
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohamed Hazem Abdelhakam Elshafey, Demonstrator (TA) | Contact | +201114946552 | mohamedhazem3333333333@gmail.com | |
| Mahmoud Mohamed Nabhan, Lecturer | Contact | +201142890404 | Mahmoudnabhan37@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Maha Mostafa Alibeiny, Associate Professor | Cairo University | Study Director |
| Hany Mohamed Hamed, Associate Professor | Faculty of Medicine, Kafrelsheikh University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Al-Salam University | Recruiting | Tanta | Gharbia Governorate | 31511 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24412032 | Background | 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. | |
| 35988435 | Background |
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| Baseline |
| 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 | Baseline |
| 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 | Baseline |
| 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. | Baseline |
| Lumbo-sacral angle | Will be measured by Fergusson's method on Lateral X-ray films of lumbo-sacral region for each patient | Baseline |
| 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. | Baseline |
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| 31614383 | 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. |
| 30967811 | 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. |
| 28017604 | 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. |
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