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

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ClinicalTrials.gov Identifier: NCT02985892
Recruitment Status : Recruiting
First Posted : December 7, 2016
Last Update Posted : January 5, 2018
Sponsor:
Collaborator:
Federal University of Paraíba
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

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.

Condition or disease Intervention/treatment Phase
Low Back Pain Other: SSASG Other: SSPSG Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Association of Trunk Stretching and Segmental Stabilization Exercises in Chronic Unspecific Low Back Pain: a Randomized Clinical Trial
Study Start Date : October 2016
Actual Primary Completion Date : January 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SSASG
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.
Other: SSASG

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.


Experimental: SSPSG
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.
Other: SSPSG

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 Measures :
  1. 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 Measures :
  1. 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 Outcome Measures:
  1. Beck Depression Inventory [ Time Frame: Before the treatment and after the treatment (immediately after the treatment, and 3 and 6 months after treatment) ]
  2. 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) ]
  3. 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) ]
  4. 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) ]
  5. Roland Morris Disability Questionnaire [ Time Frame: Before the treatment and after the treatment (immediately after the treatment, and 3 and 6 months after treatment) ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT02985892


Contacts
Contact: Carina Carvalho, Ms +55(83)986605931 carina.caarvalho@gmail.com

Locations
Brazil
Carina Carvalho Correia Coutinho Recruiting
Joao Pessoa, Paraiba, Brazil, 58030-390
Contact: Mallison Vasconcelos, Master    +5583999129577    mallison@uol.com.br   
Carina Carvalho Recruiting
João Pessoa, Paraíba, Brazil, 58051900
Contact: Carina Carvalho, Ms    +55(83)986605931    carina.caarvalho@gmail.com   
Sponsors and Collaborators
University of Sao Paulo General Hospital
Federal University of Paraíba
Investigators
Principal Investigator: Raquel Casarotto, PhD University of Sao Paulo

Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02985892     History of Changes
Other Study ID Numbers: EATSSSE
First Posted: December 7, 2016    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Sao Paulo General Hospital:
Physical therapy
Muscle Stretching Exercises
Low Back pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms