Back to resultsEffects of Aerobic Exercises in Patients With Low Back Pain
Primary Purpose
Low Back Pain
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Aerobic exercise
Placebo Group
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring Back pain, Low back pain
Eligibility Criteria
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.
Sites / Locations
- Irlei dos Santos
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Aerobic exercise group
Placebo Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT03668574
First Posted
September 4, 2018
Last Updated
September 24, 2019
Sponsor
Universidade Cidade de Sao Paulo
Collaborators
Leonardo Oliveira Pena Costa
1. Study Identification
Unique Protocol Identification Number
NCT03668574
Brief Title
Effects of Aerobic Exercises in Patients With Low Back Pain
Official Title
Aerobic Exercise for Patients With Non-specific Chronic Low Back Pain: a Feasibility Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
November 15, 2019 (Anticipated)
Study Completion Date
December 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Cidade de Sao Paulo
Collaborators
Leonardo Oliveira Pena Costa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Back pain, Low back pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Aerobic exercise group
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Aerobic exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo Group
Intervention Description
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
Primary Outcome Measure Information:
Title
Pain intensity measured by a 0-10 Numerical Pain Rating Scale.
Description
Pain intensity will be measured by a 0-10 Numerical Pain Rating Scale. Higher values represent higher pain intensity.
Time Frame
Six weeks after randomization
Secondary Outcome Measure Information:
Title
Disability measured with the 0-24 Rolland Morris Disability Questionnaire.
Description
Disability will be measured with the 0-24 Rolland Morris Disability Questionnaire. Higher values represent higher disability.
Time Frame
Six weeks after randomization
Title
Kinesiophobia measured with Tampa Scale of Kinesiophobia
Description
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.
Time Frame
Six weeks after randomization
Title
Global Impression of Recovery measured with the 11-point Global Perceived Effect Scale
Description
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.
Time Frame
Six weeks after randomization
Title
Physical activity levels measured with an Accelerometer
Description
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.
Time Frame
Six weeks after randomization
Title
Maximum exercise capacity measured with the modified Shuttle Walk Test
Description
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.
Time Frame
Six weeks after randomization
Other Pre-specified Outcome Measures:
Title
Adherence
Description
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.
Time Frame
Six weeks after randomization
Title
Recruitment measures
Description
The investigators will record the number of patients who will not agree to participate in the study and reasons for declining.
Time Frame
Prior to randomisation
Title
Satisfaction with care measured with the 0-130 Medrisk Patient Satisfaction Questionnaire
Description
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.
Time Frame
Six weeks after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonardo Costa, PhD
Organizational Affiliation
Universidade Cidade de Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Irlei dos Santos
City
São Paulo
State/Province
SP
ZIP/Postal Code
04313-210
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
16550448
Citation
Airaksinen O, Brox JI, Cedraschi C, Hildebrandt J, Klaber-Moffett J, Kovacs F, Mannion AF, Reis S, Staal JB, Ursin H, Zanoli G; COST B13 Working Group on Guidelines for Chronic Low Back Pain. Chapter 4. European guidelines for the management of chronic nonspecific low back pain. Eur Spine J. 2006 Mar;15 Suppl 2(Suppl 2):S192-300. doi: 10.1007/s00586-006-1072-1. No abstract available.
Results Reference
background
PubMed Identifier
11083348
Citation
van der Velde G, Mierau D. The effect of exercise on percentile rank aerobic capacity, pain, and self-rated disability in patients with chronic low-back pain: a retrospective chart review. Arch Phys Med Rehabil. 2000 Nov;81(11):1457-63. doi: 10.1053/apmr.2000.9629.
Results Reference
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PubMed Identifier
28429142
Citation
Stochkendahl MJ, Kjaer P, Hartvigsen J, Kongsted A, Aaboe J, Andersen M, Andersen MO, Fournier G, Hojgaard B, Jensen MB, Jensen LD, Karbo T, Kirkeskov L, Melbye M, Morsel-Carlsen L, Nordsteen J, Palsson TS, Rasti Z, Silbye PF, Steiness MZ, Tarp S, Vaagholt M. National Clinical Guidelines for non-surgical treatment of patients with recent onset low back pain or lumbar radiculopathy. Eur Spine J. 2018 Jan;27(1):60-75. doi: 10.1007/s00586-017-5099-2. Epub 2017 Apr 20.
Results Reference
background
PubMed Identifier
25299528
Citation
Meng XG, Yue SW. Efficacy of aerobic exercise for treatment of chronic low back pain: a meta-analysis. Am J Phys Med Rehabil. 2015 May;94(5):358-65. doi: 10.1097/PHM.0000000000000188.
Results Reference
background
PubMed Identifier
29194127
Citation
Chiarotto A, Boers M, Deyo RA, Buchbinder R, Corbin TP, Costa LOP, Foster NE, Grotle M, Koes BW, Kovacs FM, Lin CC, Maher CG, Pearson AM, Peul WC, Schoene ML, Turk DC, van Tulder MW, Terwee CB, Ostelo RW. Core outcome measurement instruments for clinical trials in nonspecific low back pain. Pain. 2018 Mar;159(3):481-495. doi: 10.1097/j.pain.0000000000001117.
Results Reference
background
PubMed Identifier
25361861
Citation
de Fatima Costa Oliveira N, Oliveira Pena Costa L, Nelson R, Maher CG, Beattie PF, de Bie R, Oliveira W, Camara Azevedo D, da Cunha Menezes Costa L. Measurement properties of the Brazilian Portuguese version of the MedRisk instrument for measuring patient satisfaction with physical therapy care. J Orthop Sports Phys Ther. 2014 Nov;44(11):879-89. doi: 10.2519/jospt.2014.5150.
Results Reference
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PubMed Identifier
27417610
Citation
Gordon R, Bloxham S. A Systematic Review of the Effects of Exercise and Physical Activity on Non-Specific Chronic Low Back Pain. Healthcare (Basel). 2016 Apr 25;4(2):22. doi: 10.3390/healthcare4020022.
Results Reference
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Effects of Aerobic Exercises in Patients With Low Back Pain
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