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

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ClinicalTrials.gov Identifier: NCT02420236
Recruitment Status : Completed
First Posted : April 17, 2015
Last Update Posted : June 18, 2018
Sponsor:
Collaborators:
St. Olavs Hospital
Norwegian Fund for Postgraduate Training in Physiotherapy
Kommunal Landspensjonskasse
Information provided by (Responsible Party):
Norwegian University of Science and Technology

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.

Condition or disease Intervention/treatment Phase
Low Back Pain Behavioral: High-intensity resistance training Behavioral: General physical activity Behavioral: Multidisciplinary rehabilitation program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Effects of Resistance Training on Pain, Function and Work Ability in Patients With Moderate to Severe Low Back Pain
Actual Study Start Date : January 2015
Actual Primary Completion Date : January 4, 2017
Actual Study Completion Date : March 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
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: High-intensity resistance training
Behavioral: Multidisciplinary rehabilitation program
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: General physical activity
Behavioral: Multidisciplinary rehabilitation program



Primary Outcome Measures :
  1. Low back-related disability as assessed by the oswestry disability index [ Time Frame: 12 weeks ]
    Oswestry disability index


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


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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02420236


Locations
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Norway
St. Olavs University Hospital - Department of Physical Medicine and Rehabilitation
Trondheim, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Norwegian Fund for Postgraduate Training in Physiotherapy
Kommunal Landspensjonskasse
Investigators
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Principal Investigator: Marius S Fimland, PhD Norwegian University of Science and Technology

Publications of Results:
Other Publications:
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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT02420236     History of Changes
Other Study ID Numbers: 2014/1157-B
First Posted: April 17, 2015    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Norwegian University of Science and Technology:
Exercise therapy
Resistance training
Multidisciplinary treatment

Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms