Effects of Association of Trunk Stretching and Segmental Stabilization Exercises in Chronic Unspecific Low Back Pain

NCT02985892 | Completed

• 1 other identifier: EATSSSE
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 2

Brief Summary

The incidence of chronic nonspecific low back pain is the highest in the world population and can lead to disability. One of the standards treatments for this condition is the segmental stabilization exercises, as well as trunk stretching. However, there is no study that associates these two treatments for nonspecific low back pain. This study will be a controlled clinical trial, randomized, prospective, single-blind with a quantitative approach that compares the efficacy of the association between segmental stabilization + trunk stretching with segmental stabilization + placebo stretching in patients with chronic nonspecific low back pain.

Conditions

Low Back Pain

Keywords

Physical therapy; Muscle Stretching Exercises; Low Back pain

Outcome Measures

Primary Outcomes (1)

• Change in pain through Pain visual analogue scale

  Before the treatment and after the treatment (immediately after the treatment, and 3 and 6 months after treatment)

Secondary Outcomes (1)

• Global Perceived Effect Scale

  Before the treatment and after the treatment (immediately after the treatment, and 3 and 6 months after treatment)

Other Outcomes (5)

• Beck Depression Inventory

  Before the treatment and after the treatment (immediately after the treatment, and 3 and 6 months after treatment)

• Visual analogue scale for anxiety

  Before the treatment and after the treatment (immediately after the treatment, and 3 and 6 months after treatment)

• Symptoms and Adverse events or side effects

  Before the treatment and after the treatment (immediately after the treatment, and 3 and 6 months after treatment)

Study Arms (2)

SSASG

EXPERIMENTAL

Stabilization and stretching group, 12 session, 60 minutes each. This group will perform stretching for back muscles in different positions, associated with stabilization exercises using a protocol developed by Richardson, 2005.

Other: SSASG

SSPSG

EXPERIMENTAL

Stabilization Group, 12 session, 60 minutes each. This group will perform placebo stretching for upper limb muscles (the muscle is not stretched in it maximum extent) with stabilization exercises, using a protocol developed by Richardson, 2005.

Other: SSPSG

Interventions

SSASG OTHER

Both groups will perform segmental stabilization exercises (SS), which emphasis is for the lumbar multifidus muscles (ML) and transversus abdominis (TAR), using protocol proposed by Richardson et al. Four types of exercises will be carried out with four sets of ten exercises. Muscle contractions will be held for ten seconds and followed by ten seconds rest. Between each type of exercise patients will rest for one-minute interval. Patients of segmental stabilization active stretching group (SSASG) will perform stretch exercises in four sets of 30 seconds for each muscle. The active stretching exercises will last 15 minutes. The muscles that will be stretched are pectorals, latissimus dorsi, latissimus dorsi, teres major, rectus abdominis, external and internal oblique.

SSASG

SSPSG OTHER

Both groups will perform segmental stabilization exercises (SS), which emphasis is for the lumbar multifidus muscles (ML) and transversus abdominis (TAR), using protocol proposed by Richardson et al. Four types of exercises will be carried out with four sets of ten exercises. Muscle contractions will be held for ten seconds and followed by ten seconds rest. Between each type of exercise patients will rest for one-minute interval. Patients of segmental stabilization placebo stretching group (SSPSG) will perform exercises that simulate stretching, but the muscles will not suffer effective stretch. The placebo stretching exercises will last 15 minutes. The muscles that will be stretched are wrist flexors and extensors muscles and fingers flexors and extensors muscles.

SSPSG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• individuals diagnosed with nonspecific chronic low back pain without radicular symptoms for a period exceeding 12 months,
• pain intensity greater than 3/10 points in Numerical Pain Scale

You may not qualify if:

• patients who have some contraindication to perform exercises according to the American College of Sports Medicine guidelines, such as severe spinal disease (nonunion or malunion, tumors and inflammatory diseases);
• spine surgeries;
• degenerative or inflammatory disorders of the shoulder;
• patients who are in labor dispute; or are doing other types of physical therapy or drug treatment.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Federal University of Paraíba: collaborator

Study Sites (2)

Carina Carvalho Correia Coutinho

João Pessoa, Paraíba, 58030-390, Brazil

Location

Carina Carvalho

João Pessoa, Paraíba, 58051900, Brazil

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Raquel Casarotto, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: December 7, 2016
• Study Start: October 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: December 1, 2018
• Last Updated: February 25, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)