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Managing Non-acute Low Back Symptoms in Occupational Health: Two Trials

Primary Purpose

Low Back Pain, Recurrent, Low Back Pain

Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Moderate
Mild
Mild vs. NC
Moderate vs. NC
Sponsored by
University of Helsinki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Low Back Pain, Recurrent focused on measuring low back pain, recurrent, subacute, secondary prevention, primary care, occupational health, back book, rehabilitation

Eligibility Criteria

18 Years - 56 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age 18-56 years
  • present employment at the company

  • at least one criteria out the following qualified for the study:

    • nonspecific LBP with the duration of 2 weeks or more
    • radiating, present low back pain
    • recurrent LBP (2 or more episodes per year)
    • work absence because of LBP
  • included subjects also responded having low back pain during preceding week prior to the questionnaire (VAS ≥ 10 mm, Visual Analogue Scale 0-100 mm)

According to pain level, patients were later divided into two separate RCT's, "mild": VAS 10mm - 34mm, "moderate": VAS 35mm or more.

Exclusion Criteria:

  • retirement
  • acute nerve root compression symptoms
  • malignant tumor
  • recent fracture
  • severe osteoporosis
  • other specific disease preventing participation in the follow-up

Sites / Locations

  • University of Helsinki

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

BB

BB+A

DBC

PMU

NC

Arm Description

Subjects received the back book booklet, which is an self-information booklet about managing low back symptoms. Included in the Mild and Mild vs. NC interventions.

Subjects received a back book booklet and also oral advice based on the back book by the occupational health professional (OH Nurse or OH Physician in mild or moderate intervention, respectively). Included in the Mild and Mild vs. NC interventions. Arm was also used as a control at the Moderate and Moderate vs. NC interventions.

A graded activity back school program was carried out in a physiotherapy out-patient clinic that consisted of one-hour session twice or three times per week, lasting for 12 weeks, supervised by a specially trained physiotherapist. Arm is included in the MOderate and Moderate vs. NC interventions.

An intensive, multidisciplinary LBP rehabilitation program was carried out in a physical medicine out-patient unit at the local Central Hospital. The program included a 3-week pre-course of 1,5 hour session at 3 days per week, closely followed by a 3-week intensive rehabilitation course of 6.5 hours per day for 5 days per week. A personal graded activity training program was made for each subject and patients were later called for follow-up visit within 1 year of the initial course. Arm is included in the MOderate and Moderate vs. NC interventions.

Natural course of low back pain

Outcomes

Primary Outcome Measures

Sickness absence days (Low back (LB) specific, other than LB, total)
Low back pain (VAS)
Disability (Roland Morris 18)
Quality of Life (15-D)

Secondary Outcome Measures

Sickness absence periods
Disability (Oswestry's index)

Full Information

First Posted
May 19, 2009
Last Updated
March 17, 2015
Sponsor
University of Helsinki
Collaborators
University of Oulu, Juho Vainio Foundation, Finnish Cultural Foundation, Yrjo Jahnsson Foundation, Finnish Work Environment Fund
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1. Study Identification

Unique Protocol Identification Number
NCT00908102
Brief Title
Managing Non-acute Low Back Symptoms in Occupational Health: Two Trials
Official Title
The Prevalence of Low Back Symptoms in a Finnish Forestry Company - Effectiveness of Primary Care Interventions for Non-acute Low Back Symptoms in Occupational Health. Two Separate Randomised Controlled Trials (RCT) of Various Levels.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2001 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Helsinki
Collaborators
University of Oulu, Juho Vainio Foundation, Finnish Cultural Foundation, Yrjo Jahnsson Foundation, Finnish Work Environment Fund

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is: Epidemiological part: characteristics of low back pain patients from a forestry company in Finland. Data is collected from occupational health databases and self administered questionnaires. Intervention: To determine the effectiveness and cost-effectiveness of several different interventions in subacute low back pain (LBP) patients in occupational health (OH).
Detailed Description
Eligible subjects were divided into two randomised controlled trials with the name of "mild" or "moderate" low back pain trials (interventions) and also mild vs natural course (NC) and moderate vs. NC interventions. Pain, disability and quality of life were collected up to 2 years by self-administered questionnaires and sickness absences were gathered from electronical records for at least 4 year's follow up time.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Recurrent, Low Back Pain
Keywords
low back pain, recurrent, subacute, secondary prevention, primary care, occupational health, back book, rehabilitation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
505 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BB
Arm Type
Active Comparator
Arm Description
Subjects received the back book booklet, which is an self-information booklet about managing low back symptoms. Included in the Mild and Mild vs. NC interventions.
Arm Title
BB+A
Arm Type
Experimental
Arm Description
Subjects received a back book booklet and also oral advice based on the back book by the occupational health professional (OH Nurse or OH Physician in mild or moderate intervention, respectively). Included in the Mild and Mild vs. NC interventions. Arm was also used as a control at the Moderate and Moderate vs. NC interventions.
Arm Title
DBC
Arm Type
Experimental
Arm Description
A graded activity back school program was carried out in a physiotherapy out-patient clinic that consisted of one-hour session twice or three times per week, lasting for 12 weeks, supervised by a specially trained physiotherapist. Arm is included in the MOderate and Moderate vs. NC interventions.
Arm Title
PMU
Arm Type
Experimental
Arm Description
An intensive, multidisciplinary LBP rehabilitation program was carried out in a physical medicine out-patient unit at the local Central Hospital. The program included a 3-week pre-course of 1,5 hour session at 3 days per week, closely followed by a 3-week intensive rehabilitation course of 6.5 hours per day for 5 days per week. A personal graded activity training program was made for each subject and patients were later called for follow-up visit within 1 year of the initial course. Arm is included in the MOderate and Moderate vs. NC interventions.
Arm Title
NC
Arm Type
Placebo Comparator
Arm Description
Natural course of low back pain
Intervention Type
Other
Intervention Name(s)
Moderate
Intervention Description
A two level active intervention with a control group was executed for patients suffering from non-acute, moderate LBP in occupational health. Patients were selected by using a self-administered postal questionnaire.
Intervention Type
Other
Intervention Name(s)
Mild
Intervention Description
A one level intervention with long-term effectiveness and cost-effectiveness was executed for patients suffering from non-acute mild level LBP in occupational health. Patients were selected by using a self-administered postal questionnaire.
Intervention Type
Other
Intervention Name(s)
Mild vs. NC
Intervention Description
A two level intervention with long-term effectiveness and cost-effectiveness was executed for patients suffering from non-acute mild level LBP in occupational health. Intervention arms were compared to NC - no intervention group.
Intervention Type
Other
Intervention Name(s)
Moderate vs. NC
Intervention Description
A three level intervention with two control groups was executed for patients suffering from non-acute, moderate LBP in occupational health. RCT intervention groups were compared to NC group - i.e. no intervention.
Primary Outcome Measure Information:
Title
Sickness absence days (Low back (LB) specific, other than LB, total)
Time Frame
6, 12, 24, 36, 48 months
Title
Low back pain (VAS)
Time Frame
0, 3, 6, 12, 24 months
Title
Disability (Roland Morris 18)
Time Frame
0, 3, 6, 12, 24 months
Title
Quality of Life (15-D)
Time Frame
0, 3, 6, 12, 24 months
Secondary Outcome Measure Information:
Title
Sickness absence periods
Time Frame
6, 12, 24, 36, 48 months
Title
Disability (Oswestry's index)
Time Frame
3, 6, 12, 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
56 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age 18-56 years present employment at the company at least one criteria out the following qualified for the study: nonspecific LBP with the duration of 2 weeks or more radiating, present low back pain recurrent LBP (2 or more episodes per year) work absence because of LBP included subjects also responded having low back pain during preceding week prior to the questionnaire (VAS ≥ 10 mm, Visual Analogue Scale 0-100 mm) According to pain level, patients were later divided into two separate RCT's, "mild": VAS 10mm - 34mm, "moderate": VAS 35mm or more. Exclusion Criteria: retirement acute nerve root compression symptoms malignant tumor recent fracture severe osteoporosis other specific disease preventing participation in the follow-up
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simo Taimela, MD, docent
Organizational Affiliation
Evalua Finland Co.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jaro Karppinen, MD,professor
Organizational Affiliation
University of Oulu
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Markku Hupli, MD, PhD
Organizational Affiliation
South Karelian Central Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jarmo O Rantonen, MD
Organizational Affiliation
University of Helsinki
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antti Malmivaara, MD, PhD
Organizational Affiliation
Finnish Institute for Health and Welfare
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Satu Luoto, MD
Organizational Affiliation
South Karelian Central Hospital
Official's Role
Study Director
Facility Information:
Facility Name
University of Helsinki
City
Helsinki
ZIP/Postal Code
00100
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
29739371
Citation
Rantonen J, Karppinen J, Vehtari A, Luoto S, Viikari-Juntura E, Hupli M, Malmivaara A, Taimela S. Effectiveness of three interventions for secondary prevention of low back pain in the occupational health setting - a randomised controlled trial with a natural course control. BMC Public Health. 2018 May 8;18(1):598. doi: 10.1186/s12889-018-5476-8.
Results Reference
derived
PubMed Identifier
27068751
Citation
Rantonen J, Karppinen J, Vehtari A, Luoto S, Viikari-Juntura E, Hupli M, Malmivaara A, Taimela S. Cost-effectiveness of providing patients with information on managing mild low-back symptoms in an occupational health setting. BMC Public Health. 2016 Apr 12;16:316. doi: 10.1186/s12889-016-2974-4.
Results Reference
derived
PubMed Identifier
24185642
Citation
Rantonen J, Vehtari A, Karppinen J, Luoto S, Viikari-Juntura E, Hupli M, Malmivaara A, Taimela S. Face-to-face information combined with a booklet versus a booklet alone for treatment of mild low-back pain: a randomized controlled trial. Scand J Work Environ Health. 2014 Mar;40(2):156-66. doi: 10.5271/sjweh.3398. Epub 2013 Nov 1.
Results Reference
derived
PubMed Identifier
21602539
Citation
Rantonen J, Luoto S, Vehtari A, Hupli M, Karppinen J, Malmivaara A, Taimela S. The effectiveness of two active interventions compared to self-care advice in employees with non-acute low back symptoms: a randomised, controlled trial with a 4-year follow-up in the occupational health setting. Occup Environ Med. 2012 Jan;69(1):12-20. doi: 10.1136/oem.2009.054312. Epub 2011 May 20.
Results Reference
derived

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Managing Non-acute Low Back Symptoms in Occupational Health: Two Trials

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