Functional Exercises for Chronic Low Back Pain

Chronic Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03376724
• Other study ID #: CEP 1.346.703
• Status: Recruiting
• Phase: N/A
• First received: December 13, 2017
• Last updated: December 22, 2017
• Start date: November 10, 2017
• Est. completion date: November 10, 2018

Study information

• Verified date: December 2017
• Source: Federal University of São Paulo
• Contact: Emilia Moreira, Msc
• Phone: 5511980879109
• Email: emilia.moreira[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: November 10, 2018
• Est. primary completion date: May 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

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.
• Minimal
Analgesic use when necessary and a single back scholl class

Locations

Country	Name	City	State
Brazil	Emilia Moreira	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Disability associated to low back pain measured with Oswestry Disability Index	Change in Oswestry Disability Index score	Baseline, 6, 12 and 24 weeks
Secondary	Disability associated to low back pain measured with Roland Morris Disability	Change in Roland Morris Disability score	Baseline, 6, 12 and 24 weeks
Secondary	Fear of movement measured with Fear-Avoidance Beliefs Questionnaire	Change in Fear-Avoidance Beliefs Questionnaire score	Baseline, 6, 12 and 24 weeks
Secondary	Quality of life measured with Short form-36 questionnaire	Change in Short form-36 questionnaire score	Baseline, 6, 12 and 24 weeks
Secondary	Function measured with the 6-minute walk test	Change in 6-minute walk test	Baseline, 6, 12 and 24 weeks
Secondary	Function measured with the timed to up and go test	Change in timed to up and go test	Baseline, 6, 12 and 24 weeks
Secondary	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
Secondary	Analgesic consumption	Change in analgesic consumption	6, 12 and 24 weeks after baseline