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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date June 2018
Source Norwegian University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
High-intensity resistance training

General physical activity

Multidisciplinary rehabilitation program


Locations

Country Name City State
Norway St. Olavs University Hospital - Department of Physical Medicine and Rehabilitation Trondheim

Sponsors (4)

Lead Sponsor Collaborator
Norwegian University of Science and Technology Kommunal Landspensjonskasse, Norwegian Fund for Postgraduate Training in Physiotherapy, St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (2)

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

Outcome

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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