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Functional Exercises for Chronic Low Back Pain

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ClinicalTrials.gov Identifier: NCT03376724
Recruitment Status : Recruiting
First Posted : December 18, 2017
Last Update Posted : December 25, 2017
Sponsor:
Information provided by (Responsible Party):

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.


Condition or disease Intervention/treatment
Chronic Low Back Pain Other: Functional Exercise Protocol Other: Minimal

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of the Functional Exercises in Young Adults Chronic Low Back Pain: a Randomized Controlled Trial
Actual Study Start Date : November 10, 2017
Estimated Primary Completion Date : May 10, 2018
Estimated Study Completion Date : November 10, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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
Active Comparator: Control Group Other: Minimal
Analgesic use when necessary and a single back scholl class


Outcome Measures

Primary Outcome Measures :
  1. Low back of pain intensity measured with Numeric Pain Rating Scale [ Time Frame: Baseline, 6, 12 and 24 weeks ]
    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 :
  1. Disability associated to low back pain measured with Oswestry Disability Index [ Time Frame: Baseline, 6, 12 and 24 weeks ]
    Change in Oswestry Disability Index score

  2. Disability associated to low back pain measured with Roland Morris Disability [ Time Frame: Baseline, 6, 12 and 24 weeks ]
    Change in Roland Morris Disability score

  3. Fear of movement measured with Fear-Avoidance Beliefs Questionnaire [ Time Frame: Baseline, 6, 12 and 24 weeks ]
    Change in Fear-Avoidance Beliefs Questionnaire score

  4. Quality of life measured with Short form-36 questionnaire [ Time Frame: Baseline, 6, 12 and 24 weeks ]
    Change in Short form-36 questionnaire score

  5. Function measured with the 6-minute walk test [ Time Frame: Baseline, 6, 12 and 24 weeks ]
    Change in 6-minute walk test

  6. Function measured with the timed to up and go test [ Time Frame: Baseline, 6, 12 and 24 weeks ]
    Change in timed to up and go test

  7. Patient's global impression of recovery measured with a likert scale [ Time Frame: 6, 12 and 24 weeks after baseline ]
    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.

  8. Analgesic consumption [ Time Frame: 6, 12 and 24 weeks after baseline ]
    Change in analgesic consumption


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03376724


Contacts
Contact: Emilia Moreira, Msc 5511980879109 emilia.moreira@hotmail.com
Contact: Jamil Natour 55764848 ext 3071 jnatour@unifesp.br

Locations
Brazil
Emilia Moreira Recruiting
Sao Paulo, Brazil
Contact: Emilia PT Moreira    551125942014    emilia.moreira@hotmail.com   
Contact: Jamil MD Natour, PHD    551155764239    jnatour@unifesp.br   
Sponsors and Collaborators
Federal University of São Paulo
More Information

Responsible Party: Emilia Moreira, PT, Pfysiotherapist, MsC, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT03376724     History of Changes
Other Study ID Numbers: CEP 1.346.703
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: December 25, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms