Clinical trial NCT02420236: 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
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Exercise therapy
Resistance training
Multidisciplinary treatment
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Norwegian Fund for Postgraduate Training in Physiotherapy
name: Kommunal Landspensjonskasse
First posted: 2015-04-17
Enrollment: 99
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Low back-related disability as assessed by the oswestry disability index
timeFrame: 12 weeks
Secondary outcomes:
measure: Pain assessed by the Numerical Pain Rating Scale
timeFrame: 3 and 12 weeks + 6 and 12 months
measure: Fear avoidance beliefs assessed by Fear Avoidance Beliefs Questionnaire
timeFrame: 3 and 12 weeks + 6 and 12 months
measure: Patients' perceived effect of the treatment assessed by the Patient specific functioning scale
timeFrame: 3 and 12 weeks + 6 and 12 months
measure: Anxiety and depression assessed by Hopkins symptom checklist
timeFrame: 3 and 12 weeks + 6 and 12 months
measure: Quality of life assessed by EQ-5D-5L
timeFrame: 3 and 12 weeks + 6 and 12 months
measure: Work ability assessed by Work ability index
timeFrame: 3 and 12 weeks + 6 and 12 months
measure: Use of analgesics assessed by a questionnaire from the HUNT study
timeFrame: 3 and 12 weeks + 6 and 12 months
measure: Physical activity level assessed by a questionnaire from the HUNT study
timeFrame: 3 and 12 weeks + 6 and 12 months
measure: Strength in the low back during maximal isometric contractions of the back extensors
timeFrame: 3 and 12 weeks + 6 and 12 months
measure: Grip strength using a handheld dynamometer
timeFrame: 3 and 12 weeks + 6 and 12 months
measure: Patients' perceived effect of the treatment assessed by the Global rating of change scale
timeFrame: 3 and 12 weeks + 6 and 12 months
measure: Low back-related disability as assessed by the oswestry disability index
timeFrame: 3 weeks + 6 and 12 months
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St. Olavs University Hospital - Department of Physical Medicine and Rehabilitation
Study officials:
affiliation: Norwegian University of Science and Technology
name: Marius S Fimland, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Iversen VM, Vasseljen O, Mork PJ, Berthelsen IR, Borke JB, Berheussen GF, Tveter AT, Salvesen O, Fimland MS. Resistance training in addition to multidisciplinary rehabilitation for patients with chronic pain in the low back: Study protocol. Contemp Clin Trials Commun. 2017 Apr 12;6:115-121. doi: 10.1016/j.conctc.2017.04.001. eCollection 2017 Jun.
citation: Iversen VM, Vasseljen O, Mork PJ, Gismervik S, Bertheussen GF, Salvesen O, Fimland MS. Resistance band training or general exercise in multidisciplinary rehabilitation of low back pain? A randomized trial. Scand J Med Sci Sports. 2018 Sep;28(9):2074-2083. doi: 10.1111/sms.13091. Epub 2018 Apr 24.