Low Back Pain
Conditions
Keywords
Back pain, Low back pain
Brief summary
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
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.
Interventions
OTHERAerobic exercise
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.
OTHERPlacebo Group
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
Sponsors
Leonardo Oliveira Pena Costa
Universidade Cidade de Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity measured by a 0-10 Numerical Pain Rating Scale. | Six weeks after randomization | Pain intensity will be measured by a 0-10 Numerical Pain Rating Scale. Higher values represent higher pain intensity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Kinesiophobia measured with Tampa Scale of Kinesiophobia | Six weeks after randomization | 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. |
| Global Impression of Recovery measured with the 11-point Global Perceived Effect Scale | Six weeks after randomization | 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. |
| Physical activity levels measured with an Accelerometer | Six weeks after randomization | 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. |
| Maximum exercise capacity measured with the modified Shuttle Walk Test | Six weeks after randomization | 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. |
| Disability measured with the 0-24 Rolland Morris Disability Questionnaire. | Six weeks after randomization | Disability will be measured with the 0-24 Rolland Morris Disability Questionnaire. Higher values represent higher disability. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction with care measured with the 0-130 Medrisk Patient Satisfaction Questionnaire | Six weeks after randomization | The investigators will use the 0-130 Medrisk Patient Satisfaction Questionnaire for measuring satisfaction with care. The higher the score, the higher is the satisfaction with care. |
| Recruitment measures | Prior to randomisation | The investigators will record the number of patients who will not agree to participate in the study and reasons for declining. |
| Adherence | Six weeks after randomization | This is the first measure to test if a larger trial will be feasible: the investigators will count the number of treatment sessions that patients attended during the treatment phase of the trial. The higher the number, the higher the adherence. |
Countries
Brazil
Outcome results
None listed