NCT02056197

Brief Summary

Motor control exercises have demonstrated a good option for recovery from chronic low back pain. The purpose of this study is investigated the effectiveness of an exercise program for trunk stabilization performed in stable and unstable surfaces for people with nonspecific chronic low back pain (NCLBP). Patients will be randomly divided into 3 groups; control group will receive placebo treatment with shortwave; stable group will receive an exercise protocol to stabilize the trunk on a stable surface and unstable group will receive the same exercise protocol but performed on an unstable surface. We hypothesized the unstable group will present pain reduction and functional improvement.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started May 2013

Typical duration for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 5, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

February 5, 2014

Status Verified

January 1, 2014

Enrollment Period

1.6 years

First QC Date

January 28, 2014

Last Update Submit

February 4, 2014

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

  • Pain Scores on the Visual Analog Scale

    4 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Shortwave 30 minutes.

Other: Placebo

Stable

ACTIVE COMPARATOR

Stable surface exercises

Other: Stable surface exercises

Unstable

EXPERIMENTAL

Unstable surface exercises

Other: Unstable surface exercises

Interventions

PlaceboOTHER

Shortwave

Placebo
Stable surface exercisesOTHER

Stable surface exercises

Stable
Unstable surface exercisesOTHER
Unstable

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non-specific low back pain
  • Sedentary
  • Previous low back pain last 6 months

You may not qualify if:

  • Traumatic, inflammatory, infectious or tumours etiology
  • Positive neurological findings (leg pain)
  • Pregnancy
  • Previous spine or lower limb surgery
  • Contraindicated for short-waves aplication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Nove de Julho

São Paulo, São Paulo, 02117-020, Brazil

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Paulo RG Lucareli, PhD

    University of Nove de Julho

    STUDY CHAIR

Central Study Contacts

André S Bley, MS

CONTACT

+5511995216393

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 28, 2014

First Posted

February 5, 2014

Study Start

May 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

February 5, 2014

Record last verified: 2014-01

Locations

BR(1)