Clinical trial NCT03753165: Effect of High Intensity Interval Exercise on Chronic Low Back Pain Patients
Official title: Effect of High Intensity Interval Exercise on Pain,Disability, and Autonomic Nervous System on Chronic Low Back Pain Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: Chronic low back pain, Heart rate variability
Lead sponsor: Imam Abdulrahman Bin Faisal University
Sponsor class: OTHER
First posted: 2018-11-26
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It is a single blinded randomised clinical trial
Primary purpose: TREATMENT

Brief summary: Patients with low back pain (LBP) often report an overall reduced physical activity and fitness that could consequently lead to an altered autonomic balance. Dysregulation of autonomic nervous system (ANS) is also implicated to be an underlying cause in the initiation and persistence of chronic muscle pain.High intensity interval exercise (HIIE) is a newer modality where short bursts of high intensity exercise are interspersed with rest intervals.

Method:Study Design: It is a single blinded randomised clinical trial.Sample Size:

Experimental Group (HIIE+ standard regular physiotherapy) = 40 Positive Control Group (standard regular physiotherapy) = 40 After the ethical approval of Imam Abdulrahman Bin Faisal University, Dammam, eighty (80) patients with nonspecific CLBP (either sex, age range 18-65 years years) will be recruited. These patients, with mild to moderate disability/pain according to Oswestry index, will be referred from the orthopedics clinic, rheumatologist, neurology, rehabilitation specialist, to the physiotherapy department.

Oswestry Disability Index (ODI) will be completed for all CLBP patients. Pre and post assessment includes pain intensity, disability, resting heart rate (HRrest) and blood pressure, maximum heart rate (HRmax) after graded maximal exercise, heart rate recovery after graded maximal exercise (HRR).

Tests of autonomic function will be done by recording ECG and analyzing he ECG for variability in heart rate (HRV), the Expiratory/inspiratory ratio in deep breathing (HRVdb) and baroreceptor sensitivity (BRS) at rest. Additionally each subject will be exposed to an orthostatic challenge and his responses will be evaluated. The recording will be done first in supine position and then asking the patient to quickly stand up and remain standing for 5 min. Data will be entered in Microsoft excel and comparisons and correlations will be done using either excel or SPSS version 20.

Detailed description: Effect of High Intensity Interval Exercise on pain, disability and autonomic balance in patients with chronic low back pain

Chronic low back pain (CLBP) is a clinical problem of large magnitude with great socio-economical effect. About 80% of people may complain of low back pain in their life.

Patients with low back pain (LBP) often report an overall reduced physical activity and fitness that could consequently lead to an altered autonomic balance. Dysregulation of autonomic nervous system (ANS) is also implicated to be an underlying cause in the initiation and persistence of chronic muscle pain. Different types of exercises can be prescribed to patients with CLBP to improve pain, disability and physical fitness. High intensity interval exercise (HIIE) is a newer modality where short bursts of high intensity exercise are interspersed with rest intervals.it is more time efficient, enjoyable, and superior to mild or moderate intensity continuous exercise in improving the physical fitness, peak performance, autonomic balance, muscle strength and coordination in athletes. HIIE might prove more useful and effective for individuals with nonspecific CLBP and could have a better adherence rate in the long run.

Methods: After the ethical approval of Imam Abdulrahman Bin Faisal University, Dammam, KSA, eighty (80) patients with nonspecific CLBP (either sex, age: 18-65 years) will be recruited. These patients, with mild to moderate disability/pain according to Oswestry index, will be referred from relevant clinics to the physiotherapy department of King Fahd Hospital of the University, AlKhobar (KFHU). After full explanation of the study, the patients will be required to sign an informed consent form and then they will be randomly assigned to one of the two groups.

Experimental Group (GE: n= 40) will be assigned for HIIE in addition to standard regular physiotherapy, and Control Group (GC: n=40) will be designated as control group with standard regular physiotherapy only. Pre and post intervention assessment includes pain intensity through Numerical Pain Scale, disability through Oswestry Disability Index (ODI) and autonomic balance through heart rate variability (HRV) and baroreflex sensitivity (BRS) at rest and in response to an orthostatic challenge.

Data will be entered in Microsoft excel and comparisons and correlations will be done using either excel or SPSS version 20 Expectations: It is expected that HIIE will improve the autonomic balance of the CLBP patients to a greater extent compared to no-exercise and consequently improve the pain and disability to a higher degree. HIIE could be a useful, efficacious addition to the list of exercise modalities for patients with nonspecific CLBP, and could be recommended for management of appropriate group of CLBP patients.

Eligibility criteria: Inclusion Criteria:

* Age range 18-65 years.
* BMI 18.5 - 34.9 kg/m2.
* Diagnosed patients as non-specific chronic low back pain patients, referred by orthopedic specialist, rheumatologist, rehabilitation specialist to physical therapy.
* Oswestry Disability Index (ODI): mild to moderate .
* The subjects should be able to understand, communicate and perform the examination and can walk without any walking aids.

Exclusion Criteria:

* Walking with using any walking aids.
* Subjects with secondary LBP, Sciatica, Osteoporosis, Osteoarthritis, generalized neuromuscular problem or any deformity.
* Any diagnosed disease likely to interfere with exercise on bicycle ergometer or safety of the subject (especially cardiac or respiratory disease.
* Patients with known diabetic autonomic complications
* Persons taking medicines that are known to interfere with HRV variables, such as beta blockers, calcium antagonists.
* Pregnancy or lactation.

Primary outcomes:
measure: Change in heart rate variability
timeFrame: baseline and 6 weeks
Secondary outcomes:
measure: Heart Rate Recovery
timeFrame: baseline and after 6 weeks
measure: Numerical pain scale
timeFrame: baseline and after 6 weeks
measure: Oswestry Disability Index
timeFrame: baseline and after 6 weeks
measure: Baroreceptor Sensitivity (BRS)
timeFrame: baseline and 6 weeks
Other outcomes:
Locations:
city: Khobar
country: Saudi Arabia
facility: King Fahd Hospital of the University
state: Eastren
Study officials:
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