Functional Exercises for Chronic Low Back Pain

NCT03376724 | Unknown DMC

• 1 other identifier: CEP 1.346.703
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Disability associated to low back pain measured with Oswestry Disability Index

  Baseline, 6, 12 and 24 weeks

• Disability associated to low back pain measured with Roland Morris Disability

  Baseline, 6, 12 and 24 weeks

• Fear of movement measured with Fear-Avoidance Beliefs Questionnaire

  Baseline, 6, 12 and 24 weeks

• Quality of life measured with Short form-36 questionnaire

  Baseline, 6, 12 and 24 weeks

• Function measured with the 6-minute walk test

  Baseline, 6, 12 and 24 weeks

Study Arms (2)

Functional exercise

EXPERIMENTAL

Other: Functional Exercise Protocol; Other: Minimal

Control Group

ACTIVE COMPARATOR

Other: Minimal

Interventions

Functional Exercise Protocol OTHER

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.

Functional exercise

Minimal OTHER

Analgesic use when necessary and a single back scholl class

Control Group; Functional exercise

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Emilia Moreira

São Paulo, Brazil

RECRUITING

Central Study Contacts

Emilia Moreira, Msc

CONTACT

5511980879109; emilia.moreira@hotmail.com

Jamil Natour

CONTACT

55764848; jnatour@unifesp.br

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: Pfysiotherapist, MsC

Study Record Dates

• First Submitted: December 13, 2017
• First Posted: December 18, 2017
• Study Start: November 10, 2017
• Primary Completion: May 10, 2018
• Study Completion: November 10, 2018
• Last Updated: December 26, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)