Effects of Self-Stretching Posture and Segmental Stabilization on Pain and Disability in Patients With Chronic Low Back Pain: Randomized Controlled Trial and Blinded
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Sao Paulo
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Pain Intensity
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
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).
Intervention: Global Stretching Program (Procedure)
Stabilization Exercises
A exercise protocol will be administered and the criteria to increase exercise progression was previously described by Hicks et al (2005).
Intervention: Stabilization Exercises (Procedure)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Fear avoidance beliefs questionnaire (FABQ)(Immediately after)
- Global Perceived Effect of Treatment(Immediately after)
- Fingertip-to-Floor Test(Immediately after)
Investigators
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