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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age20-25
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Unexplained weight loss.

History of malignancy.

Recent trauma within last 12 months.

Osteoporosis.

Trial 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.

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

  • 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

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Study Group1 intervention

Trial outcomes

Primary outcomes

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)

Time frame
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)

Time frame
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)

Time frame
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)

Time frame
Baseline (Single assessment session per patient)

Secondary outcomes

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.

Time frame
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

Time frame
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

Time frame
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.

Time frame
Baseline

Other outcomes

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