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

August 15, 2020 updated by: Thais Cristina Chaves, University of Sao Paulo

Effects of Self-Stretching Posture and Segmental Stabilization on Pain and Disability in Patients With Chronic Low Back Pain: Randomized Controlled Trial and Blinded

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Study design

This study will be a randomized controlled with two arm clinical trial and examiner blinding.

The sample will consist of 100 participants (both genders) with nonspecific chronic low back pain.

Randomization and allocation

Patients will be randomly assigned through a randomization process involving opaque envelopes containing cards stipulating one of the three following groups: (1) Global Stretching Program (GSP) and (2) Stabilization Exercises (SE). An assistant researcher not involved in the recruitment of patients will allocate the randomly using data generated by a group allocation software.

Procedures

The proposed study will follow the recommendations described on Consolidated Standards of Reporting Trials (CONSORT) statement to ensure transparency and quality of the findings.

Each participant will be supervised by a single physical therapist, who will not be involved in the assessment of the patients and/or randomization. A second researcher will conduct the following evaluation in baseline assessment: pain intensity, low back pain related disability and psychosocial factors using questionnaires validated to Brazilian Portuguese.

During the treatment and follow-up periods, the use of drugs will be discouraged. Patients who require rescue medication during the study will be encouraged to register the use.

Initial evaluation and follow-up

After eligibility assessment, participants will be asked to complete a questionnaire with personal data. Subsequently, the psychosocial evaluation will be conducted in accordance with the recommendations of the Initiative on Methods, Measurement and Pain Assessment in Clinical Trials (IMMPACT) for chronic pain. The volunteers will be re-assessed immediately after treatment and after one and three-months follow-up. The main outcome measures will be pain intensity and low back pain related disability. Secondary outcomes will be fear avoidance, global perceived treatment effect and muscle flexibility.

The hypothesis of this study is that patients with chronic low back pain submitted to global stretching exercises will show greater effects to pain intensity and disability than patients submitted to interventions separated.

Primary Outcomes

The pain intensity measurement will be accomplished by application of a numerical pain rating scale - PNRS, 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.

To assess disability related to chronic low back pain, the Oswestry Low Back Disability Index, 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, with MCID of #8 points.

Secondary Outcomes

Fingertip-to-Floor Test, Fear avoidance beliefs questionnaire - FABQ and Global Perceived Effect of Treatment will be assessed pre and post treatment.

The FABQ adapted for Brazilian Portuguese consists of 16 self- response items, rated on a seven-point Likert scale from 0 (completely disagree) to 6 (completely agree). The score is obtained for each separate subscale: one that addressed the fears and beliefs of individuals in relation to work and one that addressed their fears and beliefs about physical activities.

Global Perceived Effect of Treatment is recommended for use in clinical trials of chronic pain as a measure of the perception of global improvement/worsening regarding to treatment. Global Perceived Effect of Treatment is an 11-point scale that ranges from -5 ("vastly worse") through 0 ("no change") to +5 ("completely recovered"). A higher score indicates higher recovery from the condition.

The Fingertip-to-floor test showed excellent levels of validity compared to the radiological measurement (r=0.96) and reproducibility (intra and interexaminer - ICC = 0.99). The test is known for full mobility in the tilted forward position when standing, corresponding to flexion of the spine and pelvis. It is a measure of relevance in rehabilitation results probably because patients simultaneously increase the pelvic and lumbar flexion post treatment.

As baseline intervention the investigators will assess pain catastrophising, anxiety and depression scale and pain self efficacy. Hospital Anxiety and Depression Scale will be used to identify anxiety disorders and depression in physically ill patients. The HADS was translated and validated into Portuguese. Then divided into the anxiety subscale (HADS-A) and the depression subscale (HADS-D), both containing seven interspersed items. It is composed of seven items for depression and seven items for anxiety, each item including four response options ranging from 0 to 3. The cutoff scores are 8 points for anxiety, 9 for depression. Change in depressive symptoms significantly predicted change in pain severity and intensity.

Pain catastrophising scale (PCS) will be used to assess catastrophising thoughts. The scale is composed of 13 items staggered on a Likert scale, ranging from 0 to 5 points. The total score is the sum of the items divided by the number of items answered, with the minimum score being 0 and the maximum being 5 for each item. Higher scores indicated a greater presence of catastrophic thoughts. The total score of the scale could vary between 0 and 52 points. A recent systematic review found that found catastrophising to be associated with pain and disability at follow-up in CLBP patients.

The Chronic Pain Self-Efficacy Scale (CPSS) will be used to assess self-efficacy perception related to chronic pain, which can be defined as an individual's personal conviction that they can successfully execute an action to produce desirable results related to living with chronic pain. The scale has 22 items and was adapted and validated to Brazilian Portuguese. Previous research suggested that rehabilitation programs for CLBP should target pain self-efficacy which mediates the relationship between depressive symptoms and pain severity.

Interventions

Participants will be randomly assigned to two possible interventions: GPS and Stabilization Exercises intervention group. Treatment protocol will be conducted by eight weeks, one time per week. The session will last for 40 minutes.

Data Analysis

The pain intensity outcome was considered for sample size calculation. A change of at least 2 units on NPRS was considered for analysis. The sample size obtained was 78 (39 subjects each). The following specifications were considered: α = 5%, statistical power of 90% and 0.61 effect size for F-test. The GPower software was used to calculate the sample size (GPower 3.0.10 of the University of Kiel, Germany). Thus, to ensure a power suitable and assuming sample losses, 100 (50 subjects per group) participants will be considered (GPower 3.0.10, University of Kiel, Germany).

The statistician will be given grouped data, but data will be coded so that the statistician will remain blinded to patients' group allocation and to protect patient confidentiality. The mean effects of the interventions and the group differences for all outcomes (primary and secondary) will be calculated using linear mixed models that incorporated terms for the treatment groups, time (post-intervention and follow-up), and interaction terms (treatment subgroups and time) as well as psychosocial variables, sex and age as covariates. Secondary analysis will be conducted using regression models to determine whether baseline scores of psychosocial variables (HADS, PCS, CPSS) will moderate the effect of treatments. The analyzes will follow the intention-to-treat principles. For all of these analyzes, IBM SPSS software package will be used, version 22 (IBM Corp, New York).

The Statistical Package for the Social Sciences (SPSS) software version 22 (Chicago, IL, USA) will be used for analysis, and the significance level was established at 0.05.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Ribeirão Preto, São Paulo, Brazil, 14049-900
        • University of Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Global Stretching Program (GSP)
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
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.
ACTIVE_COMPARATOR: Stabilization Exercises
A exercise protocol will be administered and the criteria to increase exercise progression was previously described by Hicks et al (2005).
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain Intensity
Time Frame: Immediately after
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
Time Frame: Immediately after
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fear avoidance beliefs questionnaire (FABQ)
Time Frame: Immediately after
The FABQ adapted for Brazilian Portuguese, consists of 16 self- response items, rated on a seven-point Likert scale from 0 (completely disagree) to 6 (completely agree). The score is obtained for each separate subscale: one that addressed the fears and beliefs of individuals in relation to work and one that addressed their fears and beliefs about physical activities.
Immediately after
Global Perceived Effect of Treatment
Time Frame: Immediately after
Global Perceived Effect of Treatment is recommended for use in clinical trials of chronic pain as a measure of the perception of global improvement/worsening regarding to treatment. Global Perceived Effect of Treatment is an 11-point scale that ranges from -5 ("vastly worse") through 0 ("no change") to +5 ("completely recovered"). A higher score indicates higher recovery from the condition.
Immediately after
Fingertip-to-Floor Test
Time Frame: Immediately after
The Fingertip-to-floor test showed excellent levels of validity compared to the radiological measurement (r=0.96) and reproducibility (intra and interexaminer - ICC = 0.99). The test is known for full mobility in the tilted forward position when standing, corresponding to flexion of the spine and pelvis. It is a measure of relevance in rehabilitation results probably because patients simultaneously increase the pelvic and lumbar flexion post treatment.
Immediately after

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Sao Paulo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Thais C Chaves, Professor, University of São Paulo - Ribeirao Preto School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 30, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 25, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 18, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 045641

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The results will be available in manuscripts published in peer reviewed journals.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Low Back Pain

Clinical Trials on Global Stretching Program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings