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Functional Exercises for Chronic Low Back Pain

Primary Purpose

Chronic Low Back Pain

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Functional Exercise Protocol
Minimal
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Emilia MoreiraRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Functional exercise

Control Group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Disability associated to low back pain measured with Oswestry Disability Index
Change in Oswestry Disability Index score
Disability associated to low back pain measured with Roland Morris Disability
Change in Roland Morris Disability score
Fear of movement measured with Fear-Avoidance Beliefs Questionnaire
Change in Fear-Avoidance Beliefs Questionnaire score
Quality of life measured with Short form-36 questionnaire
Change in Short form-36 questionnaire score
Function measured with the 6-minute walk test
Change in 6-minute walk test
Function measured with the timed to up and go test
Change in timed to up and go test
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.
Analgesic consumption
Change in analgesic consumption

Full Information

First Posted
December 13, 2017
Last Updated
December 22, 2017
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT03376724
Brief Title
Functional Exercises for Chronic Low Back Pain
Official Title
Effectiveness of the Functional Exercises in Young Adults Chronic Low Back Pain: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 10, 2017 (Actual)
Primary Completion Date
May 10, 2018 (Anticipated)
Study Completion Date
November 10, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Functional exercise
Arm Type
Experimental
Arm Title
Control Group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Functional Exercise Protocol
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Minimal
Intervention Description
Analgesic use when necessary and a single back scholl class
Primary Outcome Measure Information:
Title
Low back of pain intensity measured with Numeric Pain Rating Scale
Description
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.
Time Frame
Baseline, 6, 12 and 24 weeks
Secondary Outcome Measure Information:
Title
Disability associated to low back pain measured with Oswestry Disability Index
Description
Change in Oswestry Disability Index score
Time Frame
Baseline, 6, 12 and 24 weeks
Title
Disability associated to low back pain measured with Roland Morris Disability
Description
Change in Roland Morris Disability score
Time Frame
Baseline, 6, 12 and 24 weeks
Title
Fear of movement measured with Fear-Avoidance Beliefs Questionnaire
Description
Change in Fear-Avoidance Beliefs Questionnaire score
Time Frame
Baseline, 6, 12 and 24 weeks
Title
Quality of life measured with Short form-36 questionnaire
Description
Change in Short form-36 questionnaire score
Time Frame
Baseline, 6, 12 and 24 weeks
Title
Function measured with the 6-minute walk test
Description
Change in 6-minute walk test
Time Frame
Baseline, 6, 12 and 24 weeks
Title
Function measured with the timed to up and go test
Description
Change in timed to up and go test
Time Frame
Baseline, 6, 12 and 24 weeks
Title
Patient's global impression of recovery measured with a likert scale
Description
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.
Time Frame
6, 12 and 24 weeks after baseline
Title
Analgesic consumption
Description
Change in analgesic consumption
Time Frame
6, 12 and 24 weeks after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emilia Moreira, Msc
Phone
5511980879109
Email
emilia.moreira@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jamil Natour
Phone
55764848
Ext
3071
Email
jnatour@unifesp.br
Facility Information:
Facility Name
Emilia Moreira
City
Sao Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emilia PT Moreira
Phone
551125942014
Email
emilia.moreira@hotmail.com
First Name & Middle Initial & Last Name & Degree
Jamil MD Natour, PHD
Phone
551155764239
Email
jnatour@unifesp.br

12. IPD Sharing Statement

Plan to Share IPD
No

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Functional Exercises for Chronic Low Back Pain

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