Training Therapy for the Prevention of Back Pain
Condition: Back Pain; Lower Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Work place related (lower) back pain in medical personnel is limiting to workability.

      Even though occupational prevention programs are increasingly established, data on the
      effectiveness of training interventions offered at work-sites is largely missing.

      In this randomized, investigator-blind, controlled feasibility study we aim to compare the
      effectiveness of device assisted training therapy in comparison to a general recommendation
      "to stay active" or group gymnastics in terms of pain frequency and intensity (main outcome).
      Additional outcome variables are: quality of life, psychological well-being, work efficiency,
      of sick-leave days.

      Eligible employees (2 x 30) of the General Hospital of Vienna (AKH) over the age of 45 years
      suffering from (lower) back pain (>30 days/last year) of intensity ≥ 3 (numeric scale 0-10)
      will be included in two parallel groups. Group I starts with a device (DAVID) assisted
      training (40 training sessions; 2x / week) of the core trunk musculature. Group II gets
      instructions and an advice on how to "stay active" during the first 6 months. Assessment will
      be conducted before and after these 6 months; then groups are switched, thus, study subjects
      act as their own controls.
    

Detailed description: 
      Work place related pain syndromes of the (lower) back pose a major health problem for medical
      personnel. Beside the discomfort and limitations of the affected patients, a severe
      restriction of their ability to work must be considered.

      For secondary prevention of back pain, health promotion programs are recommended. These
      consist of psychosocial and ergonomic interventions and, above all, a regular strengthening
      of the stabilizing muscle groups. Specific strength and endurance training for the trunk
      musculature with appropriate equipment is considered as a useful preventive measure and thus
      commonly offered at large corporations, even during working hours of the staff. However, data
      clearly demonstrating the effectivity and cost-effectiveness of these interventions is
      largely missing.

      This pilot study serves several purposes:

      On one hand, the feasibility of a randomized, controlled study is to be examined, which is to
      prove the effectiveness of the medical training therapy in comparison to a general
      recommendation "to stay active" or in comparison to group gymnastics. In particular,
      logistical problems in the organization of training therapy and training compliance must be
      clarified.

      On the other hand, this pilot study serves to generate hypotheses. Several variables in
      regard to possible changes due to the training intervention will be investigated. Collected
      pilot data will be used for corresponding case number estimates of a subsequent confirmatory
      study. The outcome variables are: number of back pain days and intensity, quality of life,
      psychological well-being, work efficiency, days of sick-leave.

      Study Design Randomized, investigator-blind, controlled pilot study with parallel group
      comparison of outcomes in employees of the General Hospital of Vienna (AKH) over the age of
      45 years

      Study Subjects 2 x 30 employees over the age of 45, who suffered more than 30 days of back
      and / or lower back pain of moderate to high intensity ≥ 3 (numeric scale 0-10) in the last
      year and suffer from pain in up to 3 body parts (in total) or less. Group I starts with a
      machine assisted training, group II starts after a period of observation half a year later.

      Study Interventions 40 training sessions (2x / week) with DAVID training machines, which aim
      to improve the strength, endurance and performance of the core trunk musculature. The
      training will be initiated after a sufficiently long period of adjustment to the guidelines
      of the American College of Sports Medicine. The training plan is created individually for
      each subject. 4 to 6 people per hour can work out simultaneously. The training should be
      completed in max 6 months or less.

      Group II gets instructions and an advice on how to "stay active" during the first 6 months.
      Assessment will be conducted before and after these 6 months.

      After 6 months the groups are switched (group I with the initial DAVID machine assisted
      training is left with recommendations to "stay active"; subjects from group II are now
      trained for 6 months by means of 40 training sessions (2x / week) with DAVID assistance),
      thus, study subjects act as their own controls.
    

Intervention name(s): DAVID assisted training; training recommendation
Intervention type(s): Other; Other
Intervention description(s): DAVID device assisted training under supervision; training recommendation to "stay active"
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention