Low Back PainNCT03128801
Effects of Self-Stretching Posture and Segmental Stabilization in Patients With Chronic Low Back Pain
A study testing Global Stretching Program and Stabilization Exercises in people with Low Back Pain, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Global Stretching Program and Stabilization Exercises
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Apr 2017to 30 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- Global Stretching Program, Stabilization Exercises
- Keywords
- Low Back Pain, Back Pain, Muscle Stretching Exercises, Stabilization Exercise, Exercise Therapy, Exercise Movement, Exercise Movement Tecniques, Pain, Disability
- Medical subject headings
- Low Back Pain, Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Global Stretching ProgramProcedure or surgery
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.
Stabilization ExercisesProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Procedure: Stabilization Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Immediately after
Secondary outcomes (3)
Fear avoidance beliefs questionnaire (FABQ)
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.
Measured: Immediately after
Global Perceived Effect of Treatment
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.
Measured: Immediately after
Fingertip-to-Floor Test
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.
Measured: Immediately after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start30 Apr 2017
- Primary completion30 Aug 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thais Cristina Chaves, University of Sao Paulo
- Investigators
- Thais C Chaves, Professor, Study chair, University of São Paulo - Ribeirao Preto School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03128801
- Sponsor's protocol ID
- 045641
- Status last verified
- Aug 2020
- First submitted
- 10 Apr 2017
- Last updated
- 18 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The results will be available in manuscripts published in peer reviewed journals.
Publications
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.
PubMed 36958977
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Self-Stretching Posture and Segmental Stabilization on Pain and Disability in Patients With Chronic Low Back Pain: Randomized Controlled Trial and Blinded
- ClinicalTrials.gov ID
- NCT03128801
- Acronym / sponsor ID
- 045641
- Conditions
- Low Back Pain
- Keywords
- Low Back Pain, Back Pain, Muscle Stretching Exercises, Stabilization Exercise, Exercise Therapy, Exercise Movement, Exercise Movement Tecniques, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 30 Apr 2017 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 25 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Global Stretching Program (GSP) | Experimental | Procedure: Global Stretching ProgramParticipants 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). |
| Stabilization Exercises | Active comparator | Procedure: Stabilization ExercisesA exercise protocol will be administered and the criteria to increase exercise progression was previously described by Hicks et al (2005). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Global Stretching ProgramParticipants 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 or surgery | Global Stretching Program (GSP) |
| Stabilization ExercisesThe 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. | Procedure or surgery | Stabilization Exercises |
Primary outcome
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.
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.
3 secondary outcomes
Fear avoidance beliefs questionnaire (FABQ)
Time frame: Immediately after
Global Perceived Effect of Treatment
Time frame: Immediately after
Fingertip-to-Floor Test
Time frame: Immediately after
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
- Derived from this study: PubMed 36958977Turci 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.
- Individual participant dataSharing planned: Yes. The results will be available in manuscripts published in peer reviewed journals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thais C Chaves, Professor study chair
University of São Paulo - Ribeirao Preto School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Global Stretching Program and Stabilization Exercises in people with Low Back Pain, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: Immediately after). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03128801, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2020; AzTrials last refreshed its copy on 2 Nov 2026.