Training Therapy for the Prevention of Back Pain

NCT03393429 | Completed

• 1 other identifier: 1118/2012
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Back Pain; Lower Back Pain

Outcome Measures

Primary Outcomes (1)

• Pain Frequency

  Incidence of pain-days and pain-intensity

  6 months

Secondary Outcomes (1)

• Sick-Leave

  6 months

Study Arms (2)

DAVID assisted training

ACTIVE COMPARATOR

Group I: Training assisted by DAVID devices

Other: DAVID assisted training

training recommendation

PLACEBO COMPARATOR

Group II: Training based on "stay active" recommendations

Other: training recommendation

Interventions

DAVID assisted training OTHER

DAVID device assisted training under supervision

DAVID assisted training

training recommendation OTHER

training recommendation to "stay active"

training recommendation

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• subjects must have suffered from (low) back pain for at least 6 days in the last month, without treatment by a doctor or feeling in need of treatment.
• subject reported pain should reach the level of 3 or more on the numeric rating scale of 0-10 (0 equals no pain and 10 represents the strongest imaginable pain) \[Larsen et al, 2008; Blagsted et al., 2008\].
• protocol documenting pain and work disability/limitations daily for a month must be completed
• written consent after completed patient education by a physician must be given

You may not qualify if:

• in order to rule out generalized musculoskeletal disorders, subjects should report discomfort or pain in no more than 3 different body parts
• arterial hypertension and cardiovascular events such as myocardial infarction within the last year and / or cardiomyopathy NYHA III and IV.
• symptomatic, lumbar disc herniation with associated neurological deficits
• specific spinal diseases as potential underlying reason for a back pain syndrome including rheumatoid arthritis, ankylosing spondylitis, manifested osteoporosis with St.p. vertebral fractures, tumors.
• St.p. traumatic damage of spine, pelvis or femur in the last 6 months
• insufficiently healed surgical wounds in any body area
• imminent musculoskeletal, spinal, hip or knee surgery
• chronic infectious diseases
• diagnosed mental illness
• previous severe trauma with permanent Musculoskeletal dysfunction
• pregnancy prior to study entrance examination
• no written consent to the study
• less than 1 year before retirement or planned job change within one year

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

University Department of Physical Medicine, Rehabilitation and Occupational Medicine

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Back Pain; Low Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gerold Ebenbichler, Prof. Dr.

  University Department of Physical Medicine, Rehabilitation and Occupational Medicine

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 3, 2018
• First Posted: January 8, 2018
• Study Start: November 1, 2017
• Primary Completion: November 1, 2018
• Study Completion: February 1, 2019
• Last Updated: October 20, 2020

Record last verified: 2020-10

Locations

AU (1)