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Clinical Trials/NCT02420236
NCT02420236CompletedNot Applicable

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

Norwegian University of Science and Technology1 site in 1 country99 target enrollmentStarted: January 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
99
Locations
1
Primary Endpoint
Low back-related disability as assessed by the oswestry disability index

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Investigator)

Eligibility Criteria

Ages
16 Years to 65 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

High-intensity resistance training

Experimental

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.

Intervention: High-intensity resistance training (Behavioral)

High-intensity resistance training

Experimental

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.

Intervention: Multidisciplinary rehabilitation program (Behavioral)

General physical activity

Active Comparator

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.

Intervention: General physical activity (Behavioral)

General physical activity

Active Comparator

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.

Intervention: Multidisciplinary rehabilitation program (Behavioral)

Outcomes

Primary Outcomes

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

Time Frame: 12 weeks

Oswestry disability index

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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