Effects of Aerobic Exercises in Patients With Low Back Pain

Study Overview
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Brief Summary
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The aim of this study is to test the feasibility of a clinical trial testing the effectiveness of aerobic exercises program in patients with chronic non-specific low back pain.

Detailed Description
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A total of 30 patients with chronic non-specific low back pain (with a duration of at least 12 weeks) who are seeking for treatment will be recruited. These patients will be randomly allocated into two groups. Patients allocated to the placebo group will be treated twice a week for a total of 12 weeks with detuned ultrasound and shortwave therapy Patients allocated to the exercise group will be trained with aerobic exercises on a treadmill twice a week for a total of 12 weeks. Primary outcomes will be pain and disability. Feasibility outcomes will be adherence, satisfaction and recruitment. Kinesiophobia, perceived global effect and physical capacity will also be analyzed as secondary outcomes. The outcome assessor of this trial will be blinded to the group allocation.

Official Title
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Aerobic Exercise for Patients With Non-specific Chronic Low Back Pain: a Feasibility Randomized Controlled Trial

Conditions
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Low Back Pain

Intervention / Treatment
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* Other: Aerobic exercise
* Other: Placebo Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with chronic non-specific low back pain with a pain intensity of at least 3 points at the baseline assessment measured by the Numerical Pain Scale, between 18 and 80 years of age and able to read Portuguese. Exclusion Criteria: Patients who have some contraindication to exercise, fractures, tumors, inflammatory and infectious diseases, severe cardiovascular and metabolic diseases, and the development of chronic inflammatory diseases (eg, dyspnoea, limiting diseases of the lower limbs, previous spinal surgery and pregnancy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aerobic exercise group<br>Patients will firstly warm up for 5 minutes and begin training on the treadmill. There will be two weekly sessions, lasting 40 minutes, for 6 weeks, reaching a total of 12 sessions. The exercise intensity will vary from 60 to 90% of the maximum heart rate (HRmax) predicted by the percentage formula HR = HR rep + percentage (HRmax - HR rep), where HRmax = 220-age (years) and HR rep = HR obtained for five minutes of rest. Heart rate and level of subjective perception of the effort will be monitored during all sessions. Patients from this group will also be educated about their back pain by receiving a copy of The back Book. | Other: Aerobic exercise<br>* Aerobic exercise that is defined as a form of exercise lasting 15 to 60 minutes continuous and intensity of 60% to 90% of maximal heart rate.<br>|
| Placebo Comparator: Placebo Group<br>Patients will received a detuned pulsed 5-minute ultrasound and pulsed short-wave diathermy for 25 minutes, twice weekly for 6 weeks. The devices will be used with disconnected internal cables to obtain the placebo effect; however, it will be possible to manipulate the devices and adjust the doses and alarms as if they were connected, in order to simulate the pragmatism of clinical practice as well as to increase the credibility of the use of these devices in patients. Patients from this group will also be educated about their back pain by receiving a copy of The back Book. | Other: Placebo Group<br>* Will be treated with pulsed 5-minute ultrasound and pulsed short-wave diathermy for 25 minutes. The devices will be used with disconnected internal cables to obtain the placebo effect<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity measured by a 0-10 Numerical Pain Rating Scale. | Pain intensity will be measured by a 0-10 Numerical Pain Rating Scale. Higher values represent higher pain intensity. | Six weeks after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability measured with the 0-24 Rolland Morris Disability Questionnaire. | Disability will be measured with the 0-24 Rolland Morris Disability Questionnaire. Higher values represent higher disability. | Six weeks after randomization | 
| Kinesiophobia measured with Tampa Scale of Kinesiophobia | Kinesiophobia (i.e. fear of movement) will be measured with the 17-68 point Tampa Scale of kinesiophobia. The higher the score, the higher is the fear of movement. | Six weeks after randomization | 
| Global Impression of Recovery measured with the 11-point Global Perceived Effect Scale | Global impression of recovery will be measured with the 11-point (-5 to + 5) Global Perceived Effect Scale. A negative score means deterioration of symptoms and positive scores mean improvement. A score of +5 means that the patient is considered as fully recovered. | Six weeks after randomization | 
| Physical activity levels measured with an Accelerometer | Physical Activity will be measured with an accelerometer. Patients will wear an accelerometer for seven consecutive days. The higher the values, the higher the physical activity levels. | Six weeks after randomization | 
| Maximum exercise capacity measured with the modified Shuttle Walk Test | Maximum exercise capacity will be measured with the modified Shuttle Walk Test. The purpose of this test is to see how far and fast patients can walk by following a series of time signals. Patients will be asked to walk between two cones spaced 10 metres apart. Participants will begin by walking at a very slow pace; this pace is set by a beep. Patients will walk around the 10 metre course aiming to turn around a cone at the first beep, and around the second cone at the next beep. The beep's will very gradually get faster, which means that patients will begin to walk at a quicker pace, getting faster and faster until he/she cannot keep up with the set pace, or until the participant is too breathless or tired to continue. The test has 12 levels each lasting 1 minute with a minimum walking speed of 1.2 miles per hour, up to a maximum of 5.3 miles per hour. | Six weeks after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Back pain, Low back pain