NCT01259167

Brief Summary

The purpose of this study was to assess whether a training program based on Joba® Core Trainer is effective in reducing pain and improving physical function and quality of life of subjects suffering from Chronic Low Back Pain.

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
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2011

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

December 13, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 14, 2010

Completed
18 days until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

December 14, 2010

Status Verified

November 1, 2010

Enrollment Period

5 months

First QC Date

December 13, 2010

Last Update Submit

December 13, 2010

Conditions

Keywords

JOBA, Low Back Pain, Physical Exercise

Study Arms (3)

BACK group

training with a traditional protocol of Therapeutic Physical Exercise

Group "C".

Control group with sedentary people undergoing usual care.

JOBA group

training with JOBA® Core Trainer

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subject attending the Physiatrist and Geriatric Outpatient Clinics of the Department of Gerontology, Geriatric and Physiatrist Sciences of the University Hospital "Agostino Gemelli" (Rome, Italy) with non-specific Low Back Pain, with or without sciatic irradiation, from at least 3 months.

You may qualify if:

  • Diagnosis of low back pain (back pain, felt between the bottom edge of the costal arch and the inferior gluteus fold)
  • Chronic (with symptoms that persist for more than 12 weeks)
  • Not specific (i.e. not caused by specific pathophysiological mechanisms, such as infections, fractures, tumors, spinal canal stenosis)
  • With or without irradiation of the sciatic nerve

You may not qualify if:

  • Spondylolisthesis \> First Instance
  • Osteoporosis with vertebral collapse
  • Herniated discs expelled for less than 6 months
  • Herniated discs with an indication for surgical treatment
  • Facet joint syndrome, high grade
  • Previous surgery to stabilize the spine in any section
  • Conditions that contraindicate the practice of physical exercise
  • Neuro-sensory limitations (blindness, deafness) that hinder the practice of physical exercise or communication (speech disorder)
  • Cognitive impairment
  • Diagnosis terminal
  • Change of residence over the next four months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Fitness del Policlinico Agostino Gemelli di Roma

Roma, Italy

Location

MeSH Terms

Conditions

Low Back PainMotor Activity

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 13, 2010

First Posted

December 14, 2010

Study Start

January 1, 2011

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

December 14, 2010

Record last verified: 2010-11

Locations