Low Back Pain Clinical Trial
Official title:
Effects of Resistance Training on Pain, Function and Work Ability in Patients With Moderate to Severe Low Back Pain
| NCT number | NCT02420236 |
| Other study ID # | 2014/1157-B |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | January 2015 |
| Est. completion date | March 15, 2017 |
| Verified date | June 2018 |
| Source | Norwegian University of Science and Technology |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 99 |
| Est. completion date | March 15, 2017 |
| Est. primary completion date | January 4, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 16 Years to 65 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Norway | St. Olavs University Hospital - Department of Physical Medicine and Rehabilitation | Trondheim |
| Lead Sponsor | Collaborator |
|---|---|
| Norwegian University of Science and Technology | Kommunal Landspensjonskasse, Norwegian Fund for Postgraduate Training in Physiotherapy, St. Olavs Hospital |
Norway,
Iversen VM, Vasseljen O, Mork PJ, Berthelsen IR, Børke JB, Berheussen GF, Tveter AT, Salvesen Ø, 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. — View Citation
Iversen VM, Vasseljen O, Mork PJ, Gismervik S, Bertheussen GF, Salvesen Ø, Fimland MS. Resistance band training or general exercise in multidisciplinary rehabilitation of low back pain? A randomized trial. Scand J Med Sci Sports. 2018 Mar 31. doi: 10.1111 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Low back-related disability as assessed by the oswestry disability index | Oswestry disability index | 12 weeks | |
| Secondary | Pain assessed by the Numerical Pain Rating Scale | 3 and 12 weeks + 6 and 12 months | ||
| Secondary | Fear avoidance beliefs assessed by Fear Avoidance Beliefs Questionnaire | 3 and 12 weeks + 6 and 12 months | ||
| Secondary | Patients' perceived effect of the treatment assessed by the Patient specific functioning scale | 3 and 12 weeks + 6 and 12 months | ||
| Secondary | Anxiety and depression assessed by Hopkins symptom checklist | 3 and 12 weeks + 6 and 12 months | ||
| Secondary | Quality of life assessed by EQ-5D-5L | 3 and 12 weeks + 6 and 12 months | ||
| Secondary | Work ability assessed by Work ability index | 3 and 12 weeks + 6 and 12 months | ||
| Secondary | Use of analgesics assessed by a questionnaire from the HUNT study | 3 and 12 weeks + 6 and 12 months | ||
| Secondary | Physical activity level assessed by a questionnaire from the HUNT study | 3 and 12 weeks + 6 and 12 months | ||
| Secondary | Strength in the low back during maximal isometric contractions of the back extensors | 3 and 12 weeks + 6 and 12 months | ||
| Secondary | Grip strength using a handheld dynamometer | 3 and 12 weeks + 6 and 12 months | ||
| Secondary | Patients' perceived effect of the treatment assessed by the Global rating of change scale | 3 and 12 weeks + 6 and 12 months | ||
| Secondary | Low back-related disability as assessed by the oswestry disability index | 3 weeks + 6 and 12 months |
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