Effect of High Intensity Interval Exercise on Chronic Low Back Pain Patients
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

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.
    

Intervention name(s): High intensity interval exercise
Intervention type(s): Other
Intervention description(s): 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 intervention name(s): Conventional physiotherapy- Hot packs, TENS
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: It is a single blinded randomised clinical trial
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Chronic low back pain, Heart rate variability