Back to results

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

Primary Purpose

Low Back Pain

Status

Completed

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

High-intensity resistance training

General physical activity

Multidisciplinary rehabilitation program

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Exercise therapy, Resistance training, Multidisciplinary treatment

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

St. Olavs University Hospital - Department of Physical Medicine and Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High-intensity resistance training

General physical activity

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Low back-related disability as assessed by the oswestry disability index

Oswestry disability index

Secondary Outcome Measures

Pain assessed by the Numerical Pain Rating Scale

Fear avoidance beliefs assessed by Fear Avoidance Beliefs Questionnaire

Patients' perceived effect of the treatment assessed by the Patient specific functioning scale

Anxiety and depression assessed by Hopkins symptom checklist

Quality of life assessed by EQ-5D-5L

Work ability assessed by Work ability index

Use of analgesics assessed by a questionnaire from the HUNT study

Physical activity level assessed by a questionnaire from the HUNT study

Strength in the low back during maximal isometric contractions of the back extensors

Grip strength using a handheld dynamometer

Patients' perceived effect of the treatment assessed by the Global rating of change scale

Low back-related disability as assessed by the oswestry disability index

Full Information

NCT ID

NCT02420236

First Posted

March 18, 2015

Last Updated

June 14, 2018

Sponsor

Norwegian University of Science and Technology

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT02420236

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Completed

Study Start Date

January 2015 (Actual)

Primary Completion Date

January 4, 2017 (Actual)

Study Completion Date

March 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Norwegian University of Science and Technology

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Back Pain

Keywords

Exercise therapy, Resistance training, Multidisciplinary treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

99 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High-intensity resistance training

Arm Type

Experimental

Arm Description

Arm Title

General physical activity

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

High-intensity resistance training

Intervention Type

Behavioral

Intervention Name(s)

General physical activity

Intervention Type

Behavioral

Intervention Name(s)

Multidisciplinary rehabilitation program

Primary Outcome Measure Information:

Title

Low back-related disability as assessed by the oswestry disability index

Description

Oswestry disability index

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Pain assessed by the Numerical Pain Rating Scale

Time Frame