Effects of Aerobic Exercises in Patients With Low Back Pain

NCT03668574 | Unknown

• 1 other identifier: 2.661.658
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

Back pain; Low back pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Disability measured with the 0-24 Rolland Morris Disability Questionnaire.

  Six weeks after randomization

• Kinesiophobia measured with Tampa Scale of Kinesiophobia

  Six weeks after randomization

• Global Impression of Recovery measured with the 11-point Global Perceived Effect Scale

  Six weeks after randomization

• Physical activity levels measured with an Accelerometer

  Six weeks after randomization

• Maximum exercise capacity measured with the modified Shuttle Walk Test

  Six weeks after randomization

Other Outcomes (3)

• Adherence

  Six weeks after randomization

• Recruitment measures

  Prior to randomisation

• Satisfaction with care measured with the 0-130 Medrisk Patient Satisfaction Questionnaire

  Six weeks after randomization

Study Arms (2)

Aerobic exercise group

EXPERIMENTAL

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

Placebo Group

PLACEBO COMPARATOR

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

Interventions

Aerobic exercise OTHER

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.

Aerobic exercise group

Placebo Group OTHER

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

Placebo Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Cidade de Sao Paulo: lead
• Leonardo Oliveira Pena Costa: collaborator

Study Sites (1)

Irlei dos Santos

São Paulo, São Paulo, 04313-210, Brazil

Location

Related 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(Suppl 2):S192-300. doi: 10.1007/s00586-006-1072-1. No abstract available.

  PMID: 16550448 BACKGROUND

• 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.

  PMID: 11083348 BACKGROUND

• 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.

  PMID: 28429142 BACKGROUND

• 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.

  PMID: 25299528 BACKGROUND

• 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.

  PMID: 29194127 BACKGROUND

• 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.

  PMID: 25361861 BACKGROUND

• 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.

  PMID: 27417610 BACKGROUND

MeSH Terms

Conditions

Low Back Pain; Back Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Leonardo Costa, PhD

  Universidade Cidade de Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 12, 2018
• Study Start: October 1, 2018
• Primary Completion: November 15, 2019
• Study Completion: December 30, 2019
• Last Updated: September 25, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)