CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 90 enrolled
Drug / intervention
NSAID (Nonsteroidal anti-inflammatory drugs) +1 moredrug
Likely dose
NSAID (Nonsteroidal anti-inflammatory drugs) 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01374269
NCT01374269Phase 4Completed

Improvement in Pain, Function and Quality of Life With a Protocolized Exercise Program Compared With Non-steroidal Anti-inflammatory Analgesics in Patients With Subacute Low Back Pain in Medellín, Colombia, 2009-2010

Grupo Rehabilitacion en Salud·interventional·Posted Jun 15, 2011·Updated Apr 29, 2014

In Brief

A Phase 4 clinical trial evaluating Exercise program and NSAID (Nonsteroidal anti-inflammatory drugs) for Back Pain Lower Back. Completed, enrolled 90 participants across 2 sites.

Detailed Summary

Our clinical trial has the purpose to evaluate the effectiveness in reducing pain and improving function and quality of life during a 6-months follow-up of a therapeutic exercise program compared to pharmacological treatment with NSAIDs in patients with subacute low back pain attending the physiatrist consultation of several ambulatory health centers in Medellín during the years 2009-2010.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesColombia

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 15, 2011
Enrollment StartJun 1, 2009
Primary CompletionOct 1, 2011
Study CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 15.0 years ago

Interventions

Exercise programother

Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.

NSAID (Nonsteroidal anti-inflammatory drugs)drug

The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.