Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03128801
Recruitment Status : Completed
First Posted : April 25, 2017
Last Update Posted : August 18, 2020
Sponsor:
Information provided by (Responsible Party):
Thais Cristina Chaves, University of Sao Paulo

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.


Condition or disease Intervention/treatment Phase
Low Back Pain Procedure: Global Stretching Program Procedure: Stabilization Exercises Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : April 30, 2017
Actual Primary Completion Date : August 30, 2019
Actual Study Completion Date : August 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03128801


Locations
Layout table for location information
Brazil
University of Sao Paulo
Ribeirão Preto, São Paulo, Brazil, 14049-900
Sponsors and Collaborators
University of Sao Paulo
Investigators
Layout table for investigator information
Study Chair: Thais C Chaves, Professor University of São Paulo - Ribeirao Preto School of Medicine
Layout table for additonal information
Responsible Party: Thais Cristina Chaves, 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., University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03128801    
Other Study ID Numbers: 045641
First Posted: April 25, 2017    Key Record Dates
Last Update Posted: August 18, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The results will be available in manuscripts published in peer reviewed journals.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Thais Cristina Chaves, University of Sao Paulo:
Low Back Pain
Back Pain
Muscle Stretching Exercises
Stabilization Exercise
Exercise Therapy
Exercise Movement
Exercise Movement Tecniques
Pain
Disability
Additional relevant MeSH terms:
Layout table for MeSH terms
Back Pain
Low Back Pain
Pain
Neurologic Manifestations