Effects of Self-Stretching Posture and Segmental Stabilization in Patients With Chronic Low Back Pain

NCT03128801 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-08-18

No results posted yet for this study

Summary

Background: Low back pain is a major problem for public health that affects about 60-85% of the population at some point in life. Approximately 10-40% of individuals with low back pain develop the chronic form. International guidelines consider three groups of treatment options for low back pain: medication, invasive and conservative treatments in which conservative approach is the most recommended. The European Guidelines for Management of Chronic Non-specific Low Back Pain recommends that supervised exercise programs should be used as front-line treatment for chronic low back pain, such as stabilization exercises, conventional stretching and other active exercise, but there is no consensus on literature on the most effective form of treatment. However, there is limited evidence about the effects of a global stretching intervention using self-stretching postures for chronic low back pain.

Objectives: The aim of this research is to compare the effects of an active global stretching program (GSP) using self-management of posture versus stabilization exercises on pain intensity and disability for patients with chronic non-specific low back pain.

Methods: This study is a randomized controlled three arm clinical trial with examiner blinding. A sample of 100 patients with chronic non-specific low back pain will be randomly assigned to two treatment groups (GSP or Stabilization Exercises). The eligibility criteria will be 18 and 50 years, pain in the last three months and/or pain in at least half of the days in the past six months, pain located between T12 and the gluteal folds, pain intensity greater than or equal to three, and score greater than 14% on Oswestry Disability Index. Patients will be assessed in baseline, immediately after treatment and after one and three-months follow-up. Sessions will be provided weekly for eight weeks by a single therapist lasting 40 minutes. The primary outcomes will be pain intensity and low back pain related disability and the secondary outcomes will be fear avoidance, global perceived effect of treatment and muscle flexibility. All statistical analysis will be conducted following principles of intention to treat, and the treatment effects will be calculated using linear mixed models.

Conditions

  • Low Back Pain

Interventions

PROCEDURE

Global Stretching Program

Participants will be submitted to a GSP in self-management postures weekly for 40 minutes session conducted by one one physical therapist, certified to use the technique (Stretching Global Active). The GSP will last for a period of 8 weeks. The protocol is based on the study of Lawand et al (2015) who used all postures global therapeutic stretching. The investigators will use six self-management postures in a standardized manner, each of which will last for 10 to 20 minutes.

PROCEDURE

Stabilization Exercises

The exercise protocol and criteria to increase exercise progression was previously described by Hicks et al (2005). It will be directed by a single therapist one to one session based on specific criteria (being able to maintain muscle contraction eight seconds during 30 repetitions in bilateral exercises or during 20 repetitions for unilateral exercises). Each session will be conducted weekly for 40 minutes.

Sponsors & Collaborators

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Thais C Chaves, Professor · University of São Paulo - Ribeirao Preto School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-30
Primary Completion
2019-08-30
Completion
2019-08-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03128801 on ClinicalTrials.gov