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Effects of Association of Trunk Stretching and Segmental Stabilization Exercises in Chronic Unspecific Low Back Pain

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
SSASG
SSPSG
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Physical therapy, Muscle Stretching Exercises, Low Back pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Carina Carvalho Correia Coutinho
  • Carina Carvalho

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

SSASG

SSPSG

Arm Description

Stabilization and stretching group, 12 session, 60 minutes each. This group will perform stretching for back muscles in different positions, associated with stabilization exercises using a protocol developed by Richardson, 2005.

Stabilization Group, 12 session, 60 minutes each. This group will perform placebo stretching for upper limb muscles (the muscle is not stretched in it maximum extent) with stabilization exercises, using a protocol developed by Richardson, 2005.

Outcomes

Primary Outcome Measures

Change in pain through Pain visual analogue scale

Secondary Outcome Measures

Global Perceived Effect Scale

Full Information

First Posted
December 5, 2016
Last Updated
February 21, 2019
Sponsor
University of Sao Paulo General Hospital
Collaborators
Federal University of Paraíba
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1. Study Identification

Unique Protocol Identification Number
NCT02985892
Brief Title
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

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
Federal University of Paraíba

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Physical therapy, Muscle Stretching Exercises, Low Back pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SSASG
Arm Type
Experimental
Arm Description
Stabilization and stretching group, 12 session, 60 minutes each. This group will perform stretching for back muscles in different positions, associated with stabilization exercises using a protocol developed by Richardson, 2005.
Arm Title
SSPSG
Arm Type
Experimental
Arm Description
Stabilization Group, 12 session, 60 minutes each. This group will perform placebo stretching for upper limb muscles (the muscle is not stretched in it maximum extent) with stabilization exercises, using a protocol developed by Richardson, 2005.
Intervention Type
Other
Intervention Name(s)
SSASG
Intervention Description
Both groups will perform segmental stabilization exercises (SS), which emphasis is for the lumbar multifidus muscles (ML) and transversus abdominis (TAR), using protocol proposed by Richardson et al. Four types of exercises will be carried out with four sets of ten exercises. Muscle contractions will be held for ten seconds and followed by ten seconds rest. Between each type of exercise patients will rest for one-minute interval. Patients of segmental stabilization active stretching group (SSASG) will perform stretch exercises in four sets of 30 seconds for each muscle. The active stretching exercises will last 15 minutes. The muscles that will be stretched are pectorals, latissimus dorsi, latissimus dorsi, teres major, rectus abdominis, external and internal oblique.
Intervention Type
Other
Intervention Name(s)
SSPSG
Intervention Description
Both groups will perform segmental stabilization exercises (SS), which emphasis is for the lumbar multifidus muscles (ML) and transversus abdominis (TAR), using protocol proposed by Richardson et al. Four types of exercises will be carried out with four sets of ten exercises. Muscle contractions will be held for ten seconds and followed by ten seconds rest. Between each type of exercise patients will rest for one-minute interval. Patients of segmental stabilization placebo stretching group (SSPSG) will perform exercises that simulate stretching, but the muscles will not suffer effective stretch. The placebo stretching exercises will last 15 minutes. The muscles that will be stretched are wrist flexors and extensors muscles and fingers flexors and extensors muscles.
Primary Outcome Measure Information:
Title
Change in pain through Pain visual analogue scale
Time Frame
Before the treatment and after the treatment (immediately after the treatment, and 3 and 6 months after treatment)
Secondary Outcome Measure Information:
Title
Global Perceived Effect Scale
Time Frame
Before the treatment and after the treatment (immediately after the treatment, and 3 and 6 months after treatment)
Other Pre-specified Outcome Measures:
Title
Beck Depression Inventory
Time Frame
Before the treatment and after the treatment (immediately after the treatment, and 3 and 6 months after treatment)
Title
Visual analogue scale for anxiety
Time Frame
Before the treatment and after the treatment (immediately after the treatment, and 3 and 6 months after treatment)
Title
Symptoms and Adverse events or side effects
Time Frame
Before the treatment and after the treatment (immediately after the treatment, and 3 and 6 months after treatment)
Title
Instrument for Measuring Patient Satisfaction (MedRisk)
Time Frame
Before the treatment and after the treatment (immediately after the treatment, and 3 and 6 months after treatment)
Title
Roland Morris Disability Questionnaire
Time Frame
Before the treatment and after the treatment (immediately after the treatment, and 3 and 6 months after treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raquel Casarotto, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carina Carvalho Correia Coutinho
City
Joao Pessoa
State/Province
Paraiba
ZIP/Postal Code
58030-390
Country
Brazil
Facility Name
Carina Carvalho
City
João Pessoa
State/Province
Paraíba
ZIP/Postal Code
58051900
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Association of Trunk Stretching and Segmental Stabilization Exercises in Chronic Unspecific Low Back Pain

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