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Trial on Subacute Low Back Pain

NCT00923429 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2009-06-18

No results posted yet for this study

Summary

A randomized controlled trial over a 10-week period with a two-year follow-up. The objectives were to compare effects of manual therapy in addition to the stay-active concept versus the stay-active concept only in low back pain patients recruited from primary health care. 160 outpatients with acute or subacute low back pain with or without pain radiation into the legs (70 women, 90 men, ages 20-55 years) were recruited from a geographically defined area and randomly allocated to stay-active care with or without muscle stretching, or to manual therapy with or without specific corticosteroid injections in addition to the stay-active concept. Pain, disability rating index, and sickness absence measures were used as outcome at 10-week follow-up and sickness absence was measured at two-year follow-up.

Conditions

  • Subacute Low Back Pain

Interventions

PROCEDURE

Stay-active care

No other treatment than the stay-active care

PROCEDURE

Stay-active care+stretching

Stay-active care and muscle stretching at home and during physiotherapist appointments

PROCEDURE

Stay-active+stretching+manual therapy

Manual therapy in addition to stay-active care and stretching given during GP or physiotherapist appointments and matching home exercises

PROCEDURE

Stay-active+stretching+manual therapy+steroid injections

Manual therapy including steroid injection when indicated in addition to stay-active care and stretching during GP appointments (injections) and during GP or physiotherapist appointments (remaining treatment modalities)

Sponsors & Collaborators

  • Region Stockholm

    collaborator OTHER_GOV

  • National Social Insurance Board, Sweden

    collaborator UNKNOWN

  • Uppsala County Council, Sweden

    collaborator OTHER_GOV

  • Länsförsäkringar Research Foundation

    collaborator UNKNOWN

  • Uppsala University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1994-01-31
Primary Completion
1998-12-31
Completion
2000-12-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00923429 on ClinicalTrials.gov