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

Low Back Pain Clinical Trial

Official title:

Effects of Association of Trunk Stretching and Segmental Stabilization Exercises in Chronic Unspecific Low Back Pain: a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02985892
• Other study ID #: EATSSSE
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: December 2018

Study information

• Verified date: February 2019
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Carina Carvalho Correia Coutinho	Joao Pessoa	Paraiba
Brazil	Carina Carvalho	João Pessoa	Paraíba

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Federal University of Paraíba

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Beck Depression Inventory		Before the treatment and after the treatment (immediately after the treatment, and 3 and 6 months after treatment)
Other	Visual analogue scale for anxiety		Before the treatment and after the treatment (immediately after the treatment, and 3 and 6 months after treatment)
Other	Symptoms and Adverse events or side effects		Before the treatment and after the treatment (immediately after the treatment, and 3 and 6 months after treatment)
Other	Instrument for Measuring Patient Satisfaction (MedRisk)		Before the treatment and after the treatment (immediately after the treatment, and 3 and 6 months after treatment)
Other	Roland Morris Disability Questionnaire		Before the treatment and after the treatment (immediately after the treatment, and 3 and 6 months after treatment)
Primary	Change in pain through Pain visual analogue scale		Before the treatment and after the treatment (immediately after the treatment, and 3 and 6 months after treatment)
Secondary	Global Perceived Effect Scale		Before the treatment and after the treatment (immediately after the treatment, and 3 and 6 months after treatment)