NCT02815358

Brief Summary

This study aims to verify the effects of a segmental stabilization exercise program on the anticipatory postural adjustment of subjects with chronic lumbar pain. The effects will be assessed by means of superficial electromyography focused on the registry of the onset of multifidius and deltoid (anterior and posterior) activity during a repetitive shoulder flexion/extension.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

June 22, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 28, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

June 13, 2019

Status Verified

June 1, 2019

Enrollment Period

3 months

First QC Date

June 22, 2016

Last Update Submit

June 12, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Anticipatory Postural Adjustment by means of Electromyography

    Assessed by means of superficial electromyography

    change from pre to post-treatment (8 weeks)

Secondary Outcomes (4)

  • Disability level via the Oswestry Low Back Pain Questionnaire

    change from pre to post-treatment (8 weeks)

  • Fear of pain and avoidance of physical activity via the Fear-avoidance beliefs Questionnaire

    change from pre to post-treatment (8 weeks)

  • Prognosis or risk of poor clinical outcome via the STarT Back Screening Tool

    change from pre to post-treatment (8 weeks)

  • Pain level via visual analogue scale

    change from pre to post-treatment (8 weeks)

Study Arms (2)

Segmental Stabilization Group

EXPERIMENTAL

Patients receiving segmental stabilization exercises.

Other: Segmental Stabilization Exercises

Control Group

ACTIVE COMPARATOR

Patients receiving home exercises.

Other: Home Exercises

Interventions

The stabilization program focuses on the reestablishment of motor control and coordination between deep and superficial trunk muscles. The exercise program is based on the following criteria progression: 1) Precise contraction of the transverse abdominal and multifidus muscles, keeping the lumbar spine in a neutral position (as the middle way between maximum flexion and extension, repeated three times); 2) Keep the neutral position for 10 repetitions of 10 seconds; 3) Perform exercises with lower limbs in different postures.

Segmental Stabilization Group

Home exercises include passive stretching and active mobilization of the spine.

Control Group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women aged between 18 and 65 years old
  • chronic lumbar pain (at least 3 months)
  • average pain intensity of ≥3 on a 10-point scale

You may not qualify if:

  • presence of red flags (i.e.,tumor, known fractures, diagnosed inflammatory joint disease, etc);
  • history of back surgery
  • pregnancy
  • less than 3 months of therapeutic treatment (physiotherapy) for low back pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Health Sciences of Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

June 22, 2016

First Posted

June 28, 2016

Study Start

June 1, 2016

Primary Completion

September 1, 2016

Study Completion

November 1, 2016

Last Updated

June 13, 2019

Record last verified: 2019-06

Locations