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

NCT03128801 | Completed DMC

• 1 other identifier: 045641
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Low Back Pain; Back Pain; Muscle Stretching Exercises; Stabilization Exercise; Exercise Therapy; Exercise Movement; Exercise Movement Tecniques; Pain; Disability

Outcome Measures

Primary Outcomes (2)

• Pain Intensity

  The pain intensity measurement will be accomplished by application of a numerical pain rating scale - NPRS which consists of a sequence of eleven numbers from 0 to 10, in which 0 represents "no pain" and 10 represents "worst pain imaginable". Volunteers will rate their pain based on these parameters.

  Immediately after

• Low Back Pain related-Disability

  To assess disability related to chronic low back pain, the Oswestry Low Back Disability Index - ODI, adapted to Brazilian Portuguese will be used. The result is converted into a percentage by multiplying the total score by two. This instrument consists of 10 items, each of which has six response options. The total score will be calculated by summing up the points, the largest possible sum being #50. Previous research has found ODI showed responsiveness to change for patients with CLBP.

  Immediately after

Secondary Outcomes (3)

• Fear avoidance beliefs questionnaire (FABQ)

  Immediately after

• Global Perceived Effect of Treatment

  Immediately after

• Fingertip-to-Floor Test

  Immediately after

Study Arms (2)

Global Stretching Program (GSP)

EXPERIMENTAL

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).

Procedure: Global Stretching Program

Stabilization Exercises

ACTIVE COMPARATOR

A exercise protocol will be administered and the criteria to increase exercise progression was previously described by Hicks et al (2005).

Procedure: Stabilization Exercises

Interventions

Global Stretching Program PROCEDURE

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.

Global Stretching Program (GSP)

Stabilization Exercises PROCEDURE

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.

Stabilization Exercises

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• aged between 18 and 60 years;
• medical diagnosis of chronic non-specific low back pain in the last 3 months and/or pain during at least half of the days in the past 6 months (Deyo et al. 2014), that is located between T12 and the gluteal folds;
• pain intensity equal to or greater than three;
• pain caused by certain postures, activities and movements; and
• score greater than 14% on the Oswestry Lumbar Disability Index (Vibe Fersum et al. 2013)

You may not qualify if:

• red flags (neoplastic diseases or tumors in the spine, inflammatory diseases, infections and fractures);
• serious neurological (or central and peripheral neurological) symptoms, psychiatric, rheumatologic and cardiac diseases;
• acute radiculopathy;
• lumbar stenosis;
• spondylolisthesis;
• history of spinal surgeries;
• pregnancy; and
• underwent physical therapy treatments (less than 6 months before the evaluation period).

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

University of Sao Paulo

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

Related Publications (1)

• Turci AM, Nogueira CG, Nogueira Carrer HC, Chaves TC. Self-administered stretching exercises are as effective as motor control exercises for people with chronic non-specific low back pain: a randomised trial. J Physiother. 2023 Apr;69(2):93-99. doi: 10.1016/j.jphys.2023.02.016. Epub 2023 Mar 21.

  PMID: 36958977 DERIVED

MeSH Terms

Conditions

Low Back Pain; Back Pain; Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Thais C Chaves, Professor

  University of São Paulo - Ribeirao Preto School of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Neuroscience and Behavioral Science at the Ribeirão Preto Medical School at the University of Sao Paulo. Coordinator, Laboratory of Interdisciplinary Research on Musculoskeletal Pain.

Study Record Dates

• First Submitted: April 10, 2017
• First Posted: April 25, 2017
• Study Start: April 30, 2017
• Primary Completion: August 30, 2019
• Study Completion: August 30, 2019
• Last Updated: August 18, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)