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

NCT00908102 | Unknown

• 1 other identifier: A18/01
• Study Type: interventional
• Target: 505
• Locations: 1 country
• Sites: 1

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).

Conditions

Low Back Pain, Recurrent; Low Back Pain

Keywords

low back pain; recurrent; subacute; secondary prevention; primary care; occupational health; back book; rehabilitation

Outcome Measures

Primary Outcomes (4)

• Sickness absence days (Low back (LB) specific, other than LB, total)

  6, 12, 24, 36, 48 months

• Low back pain (VAS)

  0, 3, 6, 12, 24 months

• Disability (Roland Morris 18)

  0, 3, 6, 12, 24 months

• Quality of Life (15-D)

  0, 3, 6, 12, 24 months

Secondary Outcomes (2)

• Sickness absence periods

  6, 12, 24, 36, 48 months

• Disability (Oswestry's index)

  3, 6, 12, 24 months

Study Arms (5)

BB

ACTIVE COMPARATOR

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.

Other: Mild; Other: Mild vs. NC

BB+A

EXPERIMENTAL

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.

Other: Moderate; Other: Mild; Other: Mild vs. NC; Other: Moderate vs. NC

DBC

EXPERIMENTAL

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.

Other: Moderate; Other: Moderate vs. NC

PMU

EXPERIMENTAL

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.

Other: Moderate; Other: Moderate vs. NC

NC

PLACEBO COMPARATOR

Natural course of low back pain

Other: Mild vs. NC; Other: Moderate vs. NC

Interventions

Moderate OTHER

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.

BB+A; DBC; PMU

Mild OTHER

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.

BB; BB+A

Mild vs. NC OTHER

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.

BB; BB+A; NC

Moderate vs. NC OTHER

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.

BB+A; DBC; NC; PMU

Eligibility Criteria

• Age: 18 Years - 56 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Helsinki: lead
• University of Oulu: collaborator
• Juho Vainio Foundation: collaborator
• Finnish Cultural Foundation: collaborator
• Yrjo Jahnsson Foundation: collaborator
• Finnish Work Environment Fund: collaborator

Study Sites (1)

University of Helsinki

Helsinki, 00100, Finland

Location

Related Publications (4)

• 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.

  PMID: 29739371 DERIVED

• 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.

  PMID: 27068751 DERIVED

• 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.

  PMID: 24185642 DERIVED

• 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.

  PMID: 21602539 DERIVED

MeSH Terms

Conditions

Low Back Pain; Recurrence

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• Simo Taimela, MD, docent

  Evalua Finland Co.

  STUDY DIRECTOR

• Jaro Karppinen, MD,professor

  University of Oulu

  STUDY DIRECTOR

• Markku Hupli, MD, PhD

  South Karelian Central Hospital

  STUDY DIRECTOR

• Jarmo O Rantonen, MD

  University of Helsinki

  PRINCIPAL INVESTIGATOR

• Antti Malmivaara, MD, PhD

  Finnish Institute for Health and Welfare

  STUDY DIRECTOR

• Satu Luoto, MD

  South Karelian Central Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 19, 2009
• First Posted: May 25, 2009
• Study Start: September 1, 2001
• Primary Completion: September 1, 2008
• Study Completion: December 1, 2016
• Last Updated: March 18, 2015

Record last verified: 2015-03

Locations

FI (1)