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

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ClinicalTrials.gov Identifier: NCT03753165
Recruitment Status : Enrolling by invitation
First Posted : November 26, 2018
Last Update Posted : November 27, 2018
Sponsor:
Information provided by (Responsible Party):
Haya Mohammad ALMaawi, Imam Abdulrahman Bin Faisal University

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.


Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Other: High intensity interval exercise Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: It is a single blinded randomised clinical trial
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of High Intensity Interval Exercise on Pain,Disability, and Autonomic Nervous System on Chronic Low Back Pain Patients
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : March 3, 2021
Estimated Study Completion Date : March 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High Intensity Interval Exercise group
Patients suffering from chronic low back pain perform 12 sessions of high intensity interval exercise (HIIE) over a period of 6 weeks at an intensity of 80% of their maximal Heart rate. In addition they also receive conventional physiotherapy in the form of hot pack or TENS
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
Other Name: Conventional physiotherapy- Hot packs, TENS

No Intervention: Conventional physiotherapy
Patients suffering from chronic low back pain will receive conventional physiotherapy such as TENS and hot packs applied over appropriate areas over a period of 6 weeks



Primary Outcome Measures :
  1. Change in heart rate variability [ Time Frame: baseline and 6 weeks ]
    heart rate variability parameters including SDNN, RMSSD, LF, HF, LH/HF


Secondary Outcome Measures :
  1. Heart Rate Recovery [ Time Frame: baseline and after 6 weeks ]
    Heart rate recovery from the peak rate at 1st, 2nd and 3rd minute after cessation of heavy exercise

  2. Numerical pain scale [ Time Frame: baseline and after 6 weeks ]
    Measurement of pain intensity

  3. Oswestry Disability Index [ Time Frame: baseline and after 6 weeks ]
    Questionnaire to assess the disability in patients with chronic low back pain

  4. Baroreceptor Sensitivity (BRS) [ Time Frame: baseline and 6 weeks ]
    recording of finger arterial blood pressure and interbeat interval with finometer and calculating the baroreceptor sensitivity with dedicated software PRVBRS



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03753165


Locations
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Saudi Arabia
King Fahd Hospital of the University
Khobar, Eastren, Saudi Arabia
Sponsors and Collaborators
Imam Abdulrahman Bin Faisal University

Publications:

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Responsible Party: Haya Mohammad ALMaawi, Principal Investigator, Imam Abdulrahman Bin Faisal University
ClinicalTrials.gov Identifier: NCT03753165     History of Changes
Other Study ID Numbers: IRB-PGS-2018-01-076
First Posted: November 26, 2018    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No there is no plan to make the IPD available

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Haya Mohammad ALMaawi, Imam Abdulrahman Bin Faisal University:
Chronic low back pain, Heart rate variability

Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms