Effects of Resistance Training on Pain, Function and Work Ability in Patients With Moderate to Severe Low Back Pain

June 14, 2018 updated by: Norwegian University of Science and Technology
The purpose of this study is to investigate if high-intensity resistance training can induce additional beneficial effects, for patients with moderate to severe long term pain in the low back, when added to a multidisciplinary treatment program.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

99

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway
        • St. Olavs University Hospital - Department of Physical Medicine and Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Referred to the multidisciplinary clinic for treatment of pain in low back
  • Long term (≥ 3months) or recurrent (≥ 2 periods of ≥ 4 weeks the past year) non-specific low back pain
  • Pain intensity ≥ 4 on numerical rating scale (0-10)

Exclusion Criteria:

  • Severe somatic condition (unstable injury, malignity, infectious disease, active rheumatic disease, severe osteoporosis)
  • Psychiatric condition/disease that severely impairs group functioning
  • Insufficient comprehension of Norwegian language to participate in group sessions and fill out questionnaires
  • Awaiting surgery of back
  • Alcohol or drug abuse
  • Ongoing compensation case or applying for disability benefits due to pain in the back
  • Engaged in high-intensity resistance training on a regular basis the last 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: General physical activity
12 weeks of general physical activity - 3 weeks with supervised sessions at the clinic, and 9 weeks of individually adjusted home training. This include circle-training, low-intensity resistance exercises, endurance exercises, ball playing, body awareness, stretching, and relaxation techniques, and similar activities. Neither moderate nor high-intensity resistance exercise is included for participants in this group.Three guided sessions will be offered during the home training period.
Behavioral: Multidisciplinary rehabilitation program
Behavioral: General physical activity
Experimental: High-intensity resistance training
Full body, progressive strength training with Theraband® Elastic bands. Three times per week for 12 weeks - 3 weeks with supervised sessions at the clinic, and 9 weeks of home training. Three guided sessions will be offered during the home training period.
Behavioral: Multidisciplinary rehabilitation program
Behavioral: High-intensity resistance training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Low back-related disability as assessed by the oswestry disability index
Time Frame: 12 weeks
Oswestry disability index
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain assessed by the Numerical Pain Rating Scale
Time Frame: 3 and 12 weeks + 6 and 12 months
3 and 12 weeks + 6 and 12 months
Fear avoidance beliefs assessed by Fear Avoidance Beliefs Questionnaire
Time Frame: 3 and 12 weeks + 6 and 12 months
3 and 12 weeks + 6 and 12 months
Anxiety and depression assessed by Hopkins symptom checklist
Time Frame: 3 and 12 weeks + 6 and 12 months
3 and 12 weeks + 6 and 12 months
Quality of life assessed by EQ-5D-5L
Time Frame: 3 and 12 weeks + 6 and 12 months
3 and 12 weeks + 6 and 12 months
Work ability assessed by Work ability index
Time Frame: 3 and 12 weeks + 6 and 12 months
3 and 12 weeks + 6 and 12 months
Use of analgesics assessed by a questionnaire from the HUNT study
Time Frame: 3 and 12 weeks + 6 and 12 months
3 and 12 weeks + 6 and 12 months
Physical activity level assessed by a questionnaire from the HUNT study
Time Frame: 3 and 12 weeks + 6 and 12 months
3 and 12 weeks + 6 and 12 months
Patients' perceived effect of the treatment assessed by the Patient specific functioning scale
Time Frame: 3 and 12 weeks + 6 and 12 months
3 and 12 weeks + 6 and 12 months
Strength in the low back during maximal isometric contractions of the back extensors
Time Frame: 3 and 12 weeks + 6 and 12 months
3 and 12 weeks + 6 and 12 months
Grip strength using a handheld dynamometer
Time Frame: 3 and 12 weeks + 6 and 12 months
3 and 12 weeks + 6 and 12 months
Patients' perceived effect of the treatment assessed by the Global rating of change scale
Time Frame: 3 and 12 weeks + 6 and 12 months
3 and 12 weeks + 6 and 12 months
Low back-related disability as assessed by the oswestry disability index
Time Frame: 3 weeks + 6 and 12 months
3 weeks + 6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

St. Olavs Hospital
Norwegian Fund for Postgraduate Training in Physiotherapy
Kommunal Landspensjonskasse

Investigators

  • Principal Investigator: Marius S Fimland, PhD, Norwegian University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

January 4, 2017

Study Completion (Actual)

March 15, 2017

Study Registration Dates

First Submitted

March 18, 2015

First Submitted That Met QC Criteria

April 14, 2015

First Posted (Estimate)

April 17, 2015

Study Record Updates

Last Update Posted (Actual)

June 18, 2018

Last Update Submitted That Met QC Criteria

June 14, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014/1157-B

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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