Paracetamol for low back pai

Phase 4

Completed

• Conditions: Acute low back pain; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12609000966291
• Lead Sponsor: The George Institute for International Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-11-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1650

Inclusion Criteria

Primary complaint of pain in the area between the 12th rib and buttock crease, with/without leg pain;
New episode of low back pain, preceded by a period of at least one month without low back pain;
Pain of less than 6 weeks duration;
Low back pain severe enough to cause at least ‘moderate pain’ (as measured by an adaptation of item 7 of the Short Form-36).

Exclusion Criteria

Known or suspected serious spinal pathology;
Currently taking recommended regular doses of paracetamol;
Currenlty taking recommended regular doses of another analgesic for a pre-existing condition;
Spinal surgery within the preceding 6 months;
Currently taking psychotropic medication and whose health condition is considered to prevent reliable recording of study information;
Serious co-morbidities preventing prescription of paracetamol;
Pregnancy or planning a pregnancy during the one-month treatment period.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Days to recovery with recovery defined as a pain score of 0 or 1 on a 0-10 pain scale (numerical pain rating scale) that is maintained for seven consecutive days.[Measured daily from baseline until recovered.];Days to recovery with recovery defined as the first day that the participant has a pain score of 0 or 1 on a 0 to 10 numerical pain rating scale.[Measured daily from baseline until recovered.]

Secondary Outcome Measures

Name	Time	Method
Pain score - numerical pain rating scale[Baseline, 1 week, 2 weeks, 4 weeks, 12 weeks];Disability - Roland Morris Disability Questionnaire[Baseline, 1 week, 2 weeks, 4 weeks, 12 weeks];Function - Patient Specific Functional Scale[Baseline, 1 week, 2 weeks, 4 weeks, 12 weeks];Global Perceived Effect Scale[Baseline, 1 week, 2 weeks, 4 weeks, 12 weeks];Subjective Sleep Quality - Item 6 Pittsburgh Sleep Quality Index[Baseline, 1 week, 2 weeks, 4 weeks, 12 weeks];Quality of Life - Short Form 12[Baseline, 4 weeks, 12 weeks]