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

University of Helsinki

Status: Unknown

Conditions: Low Back Pain, Recurrent; Low Back Pain

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00908102

A18/01

Details and patient eligibility

About

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).

Full 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.

Enrollment: 505 patients

Sex: All

Ages: 18 to 56 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

505 participants in 5 patient groups, including a placebo group

BB

Active Comparator group

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.

Treatment:

Other: Mild vs. NC

Other: Mild

BB+A

Experimental group

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.

Treatment:

Other: Mild vs. NC

Other: Moderate vs. NC

Other: Mild

Other: Moderate

DBC

Experimental group

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.

Treatment:

Other: Moderate vs. NC

Other: Moderate

PMU

Experimental group

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.

Treatment:

Other: Moderate vs. NC

Other: Moderate

NC

Placebo Comparator group

Description:

Natural course of low back pain

Treatment:

Other: Mild vs. NC

Other: Moderate vs. NC