Clinical trial NCT02985892: Effects of Association of Trunk Stretching and Segmental Stabilization Exercises in Chronic Unspecific Low Back Pain
Official title: Effects of Association of Trunk Stretching and Segmental Stabilization Exercises in Chronic Unspecific Low Back Pain: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Physical therapy
Muscle Stretching Exercises
Low Back pain
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Federal University of Paraíba
First posted: 2016-12-07
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The incidence of chronic nonspecific low back pain is the highest in the world population and can lead to disability. One of the standards treatments for this condition is the segmental stabilization exercises, as well as trunk stretching. However, there is no study that associates these two treatments for nonspecific low back pain. This study will be a controlled clinical trial, randomized, prospective, single-blind with a quantitative approach that compares the efficacy of the association between segmental stabilization + trunk stretching with segmental stabilization + placebo stretching in patients with chronic nonspecific low back pain.

Detailed description: BACKGROUND: Chronic nonspecific low back pain (LCI) has a high incidence in the world population and can lead to disability. Several therapeutic approaches have been studied to treat this pathology, but most investigate only the efficacy of one form of treatment per group. Studies show the effect of Segmental Stabilization in patients with LCI, but there is a gap on the effects of the association of trunk stretches with segmental stabilization exercises on pain and disability with LCI. Therefore, the objective of this study is to investigate the effects of the association of trunk stretching and segmental stabilization exercises on chronic non-specific low back pain in the short and medium term.

Method / Design: It will be a controlled, randomized, prospective, blinded clinical trial with quantitative approach, performed at the Clinical School of Physiotherapy of the UFPB. Participants in the study were 34 subjects of both sexes, aged 18 to 80 years, with pain equal to or greater than 3 by the Numerical Pain Scale (0/10) randomized into two groups: Placebo Stretching Group + Segmental Stabilization (n = 17) who will only do exercises of placebo stretching and segmental stabilization; And Segmental Stretching-Stabilization Group (n = 17), submitted to segmental stabilization exercises associated with trunk stretches; Both groups with 12 sessions. The results on pain intensity, functional capacity, overall effect perception, and clinical-psycho-functional assessment, as per the IMMPACT recommendations for clinical trials of effectiveness and efficacy of treatment for chronic pain, will be made by a blind After the intervention, three and six months after randomization.

Discussion: Because of its design, it will be possible to blind the evaluator, the randomizer, and the patient. At the end of the research we hope to contribute to the clinical decision-making process in the choice of therapies that improve pain and disability in patients with non-specific chronic low back pain.

Eligibility criteria: Inclusion Criteria:

* individuals diagnosed with nonspecific chronic low back pain without radicular symptoms for a period exceeding 12 months,
* pain intensity greater than 3/10 points in Numerical Pain Scale

Exclusion Criteria:

* patients who have some contraindication to perform exercises according to the American College of Sports Medicine guidelines, such as severe spinal disease (nonunion or malunion, tumors and inflammatory diseases);
* spine surgeries;
* degenerative or inflammatory disorders of the shoulder;
* patients who are in labor dispute; or are doing other types of physical therapy or drug treatment.

Primary outcomes:
measure: Change in pain through Pain visual analogue scale
timeFrame: Before the treatment and after the treatment (immediately after the treatment, and 3 and 6 months after treatment)
Secondary outcomes:
measure: Global Perceived Effect Scale
timeFrame: Before the treatment and after the treatment (immediately after the treatment, and 3 and 6 months after treatment)
Other outcomes:
measure: Beck Depression Inventory
timeFrame: Before the treatment and after the treatment (immediately after the treatment, and 3 and 6 months after treatment)
measure: Visual analogue scale for anxiety
timeFrame: Before the treatment and after the treatment (immediately after the treatment, and 3 and 6 months after treatment)
measure: Symptoms and Adverse events or side effects
timeFrame: Before the treatment and after the treatment (immediately after the treatment, and 3 and 6 months after treatment)
measure: Instrument for Measuring Patient Satisfaction (MedRisk)
timeFrame: Before the treatment and after the treatment (immediately after the treatment, and 3 and 6 months after treatment)
measure: Roland Morris Disability Questionnaire
timeFrame: Before the treatment and after the treatment (immediately after the treatment, and 3 and 6 months after treatment)
Locations:
city: Joao Pessoa
country: Brazil
facility: Carina Carvalho Correia Coutinho
state: Paraiba
city: João Pessoa
country: Brazil
facility: Carina Carvalho
state: Paraíba
Study officials:
affiliation: University of Sao Paulo
name: Raquel Casarotto, PhD
role: PRINCIPAL_INVESTIGATOR
References: