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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02056197
Other study ID # PL002
Secondary ID
Status Recruiting
Phase N/A
First received January 28, 2014
Last updated February 4, 2014
Start date May 2013
Est. completion date December 2014

Study information

Verified date January 2014
Source University of Nove de Julho
Contact André S Bley, MS
Phone +5511995216393
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 80 Years
Eligibility Inclusion Criteria:

- Non-specific low back pain

- Sedentary

- Previous low back pain last 6 months

Exclusion Criteria:

- Traumatic, inflammatory, infectious or tumours etiology

- Positive neurological findings (leg pain)

- Pregnancy

- Previous spine or lower limb surgery

- Contraindicated for short-waves aplication

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Placebo
Shortwave
Stable surface exercises
Stable surface exercises
Unstable surface exercises


Locations

Country Name City State
Brazil Universidade Nove de Julho São Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Nove de Julho

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain Scores on the Visual Analog Scale 4 weeks Yes
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