Effect of High Intensity Interval Exercise on Chronic Low Back Pain Patients

Chronic Low Back Pain Clinical Trial

— CLBP  

Official title:

Effect of High Intensity Interval Exercise on Pain,Disability, and Autonomic Nervous System on Chronic Low Back Pain Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03753165
• Other study ID #: IRB-PGS-2018-01-076
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: October 30, 2019

Study information

• Verified date: March 2020
• Source: Imam Abdulrahman Bin Faisal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 30, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Other:
• High intensity interval exercise
High intensity interval exercise at 80% of the maximal heart rate derived from the maximal graded exercise. Each individual will undergo 12 sessions of HIIE over a period of six weeks

Locations

Country	Name	City	State
Saudi Arabia	King Fahd Hospital of the University	Khobar	Eastren

Sponsors (1)

Lead Sponsor	Collaborator
Imam Abdulrahman Bin Faisal University

Country where clinical trial is conducted

Saudi Arabia, 

References & Publications (16)

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Gibala MJ, Little JP, Macdonald MJ, Hawley JA. Physiological adaptations to low-volume, high-intensity interval training in health and disease. J Physiol. 2012 Mar 1;590(5):1077-84. doi: 10.1113/jphysiol.2011.224725. Epub 2012 Jan 30. Review. — View Citation

Hallman DM, Ekman AH, Lyskov E. Changes in physical activity and heart rate variability in chronic neck-shoulder pain: monitoring during work and leisure time. Int Arch Occup Environ Health. 2014;87(7):735-44. doi: 10.1007/s00420-013-0917-2. Epub 2013 Oct 26. — View Citation

Heart rate variability. Standards of measurement, physiological interpretation, and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Eur Heart J. 1996 Mar;17(3):354-81. — View Citation

Iellamo F, Manzi V, Caminiti G, Sposato B, Massaro M, Cerrito A, Rosano G, Volterrani M. Dose-response relationship of baroreflex sensitivity and heart rate variability to individually-tailored exercise training in patients with heart failure. Int J Cardiol. 2013 Jun 20;166(2):334-9. doi: 10.1016/j.ijcard.2011.10.082. Epub 2011 Nov 9. — View Citation

Jung ME, Bourne JE, Beauchamp MR, Robinson E, Little JP. High-intensity interval training as an efficacious alternative to moderate-intensity continuous training for adults with prediabetes. J Diabetes Res. 2015;2015:191595. doi: 10.1155/2015/191595. Epub 2015 Mar 30. — View Citation

La Rovere MT, Pinna GD, Maestri R, Sleight P. Clinical value of baroreflex sensitivity. Neth Heart J. 2013 Feb;21(2):61-3. doi: 10.1007/s12471-012-0349-8. — View Citation

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* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in heart rate variability	heart rate variability parameters including SDNN, RMSSD, LF, HF, LH/HF	baseline and 6 weeks
Secondary	Heart Rate Recovery	Heart rate recovery from the peak rate at 1st, 2nd and 3rd minute after cessation of heavy exercise	baseline and after 6 weeks
Secondary	Numerical pain scale	Measurement of pain intensity	baseline and after 6 weeks
Secondary	Oswestry Disability Index	Questionnaire to assess the disability in patients with chronic low back pain	baseline and after 6 weeks
Secondary	Baroreceptor Sensitivity (BRS)	recording of finger arterial blood pressure and interbeat interval with finometer and calculating the baroreceptor sensitivity with dedicated software PRVBRS	baseline and 6 weeks