Functional Exercises for Chronic Low Back Pain

Effectiveness of the Functional Exercises in Young Adults Chronic Low Back Pain: a Randomized Controlled Trial

Non-specific low back pain is a common condition. Exercise is effective treatment for chronic low back pain. We hypothesized the functional exercise group will present pain reduction and functional improvement.

The purpose of this study is investigated the effectiveness of an functional exercise program for people with nonspecific chronic low back pain. Patients will be randomly divided into 2 groups: control group (minimal intervention - mini back school and analgesic) and group will receive a functional exercise protocol associated with minimal intervention.

Study Overview

• Status: Unknown
• Conditions: Chronic Low Back Pain
• Intervention / Treatment: Other: Functional Exercise Protocol; Other: Minimal

• Study Type: Interventional
• Enrollment (Anticipated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emilia Moreira, Msc; Phone Number: 5511980879109; Email: emilia.moreira@hotmail.com
• Study Contact Backup: Name: Jamil Natour; Phone Number: 3071 55764848; Email: jnatour@unifesp.br

Study Locations

• Brazil
  • Sao Paulo, Brazil
    • Recruiting
    • Emilia Moreira
    • Contact: Emilia PT Moreira; Phone Number: 551125942014; Email: emilia.moreira@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Aged between 18 and 50 years
• Low back pain for more than 3 months
• Low back pain with numeric pain scale between 3 - 8 cm
• Understand Portuguese well enough to be able to fill in the questionnaires

Exclusion Criteria:

• Inflammatory/rheumatological diseases, tumor, infection or vertebral fracture;
• Main pain as leg pain (eg: nerve root compression or herniated disc with radicular pain / radiculopathy, lateral and central stenosis)
• Less than 6 months after lumbar spine, lower limb or abdomen surgery
• Previous spinal surgery;
• Previous spinal infiltration for pain relief in the last 3 months;
• Several scoliosis;
• Litigation;
• Pregnancy;
• Fibromyalgia;
• People who had changed physical activity or undergone physical therapy in the previous 3 months;
• Presence of any contraindication to exercise;
• Planned travel in the next 12 weeks;
• Geographic inaccessibility.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group	Other: Minimal; Analgesic use when necessary and a single back scholl class
Experimental: Functional exercise	Other: Functional Exercise Protocol; Functional exercise protocol. This protocol started with corporal conscience exercise, breathing, abdominal activation, activities such as sitting, getting up, climbing stairs, reaching with arms, moving forward, bodyweight exercises, bridges and boards. This protocol will be performed during 12 weeks, two sessions per week.; Other: Minimal; Analgesic use when necessary and a single back scholl class

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Low back of pain intensity measured with Numeric Pain Rating Scale	It will be measured by the Brazilian version of the Numeric Pain Rating Scale (NPRS) 11 points. The NPRS goes from 0 to 10, where 0 is "no pain" and 10 is "the worst pain imaginable." Participants will be asked to answer about their pain levels based on the last seven days. Change in pain score or an improvement of 2 levels or more is accepted as clinically relevant.	Baseline, 6, 12 and 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disability associated to low back pain measured with Oswestry Disability Index	Change in Oswestry Disability Index score	Baseline, 6, 12 and 24 weeks
Disability associated to low back pain measured with Roland Morris Disability	Change in Roland Morris Disability score	Baseline, 6, 12 and 24 weeks
Fear of movement measured with Fear-Avoidance Beliefs Questionnaire	Change in Fear-Avoidance Beliefs Questionnaire score	Baseline, 6, 12 and 24 weeks
Quality of life measured with Short form-36 questionnaire	Change in Short form-36 questionnaire score	Baseline, 6, 12 and 24 weeks
Function measured with the 6-minute walk test	Change in 6-minute walk test	Baseline, 6, 12 and 24 weeks
Function measured with the timed to up and go test	Change in timed to up and go test	Baseline, 6, 12 and 24 weeks
Patient's global impression of recovery measured with a likert scale	It will be evaluated based on the global perceived effect by the Likert Scale Score. The Likert scale, used to evaluate the patient's global perceived effect with treatment. The patients answered the question 'After starting the treatment, how do you think your low back is?' with one of the following statements: much worse, a little worse, unchanged, a little better, much better.	6, 12 and 24 weeks after baseline
Analgesic consumption	Change in analgesic consumption	6, 12 and 24 weeks after baseline

Collaborators and Investigators

• Sponsor: Federal University of São Paulo

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2017
• Primary Completion (Anticipated): May 10, 2018
• Study Completion (Anticipated): November 10, 2018

Study Registration Dates

• First Submitted: December 13, 2017
• First Submitted That Met QC Criteria: December 13, 2017
• First Posted (Actual): December 18, 2017

Study Record Updates

• Last Update Posted (Actual): December 26, 2017
• Last Update Submitted That Met QC Criteria: December 22, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: CEP 1.346.703

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No