Effects of Aerobic Exercises in Patients With Low Back Pain

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03668574
• Other study ID #: 2.661.658
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: December 30, 2019

Study information

• Verified date: September 2019
• Source: Universidade Cidade de Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: December 30, 2019
• Est. primary completion date: November 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Aerobic 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.
• Placebo 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

Locations

Country	Name	City	State
Brazil	Irlei dos Santos	São Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Cidade de Sao Paulo	Leonardo Oliveira Pena Costa

Country where clinical trial is conducted

Brazil, 

References & Publications (7)

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:S192-300. — View 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. — View Citation

de Fátima 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. — View 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). pii: E22. doi: 10.3390/healthcare4020022. Review. — View 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. — View Citation

Stochkendahl MJ, Kjaer P, Hartvigsen J, Kongsted A, Aaboe J, Andersen M, Andersen MØ, Fournier G, Højgaard 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adherence	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.	Six weeks after randomization
Other	Recruitment measures	The investigators will record the number of patients who will not agree to participate in the study and reasons for declining.	Prior to randomisation
Other	Satisfaction with care measured with the 0-130 Medrisk Patient Satisfaction Questionnaire	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.	Six weeks after randomization
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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