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

NCT02420236 | Completed

• 1 other identifier: 2014/1157-B
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

Exercise therapy; Resistance training; Multidisciplinary treatment

Outcome Measures

Primary Outcomes (1)

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

  Oswestry disability index

  12 weeks

Secondary Outcomes (12)

• Pain assessed by the Numerical Pain Rating Scale

  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

• Patients' perceived effect of the treatment assessed by the Patient specific functioning scale

  3 and 12 weeks + 6 and 12 months

• Anxiety and depression assessed by Hopkins symptom checklist

  3 and 12 weeks + 6 and 12 months

• Quality of life assessed by EQ-5D-5L

  3 and 12 weeks + 6 and 12 months

Study Arms (2)

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.

Behavioral: High-intensity resistance training; Behavioral: Multidisciplinary rehabilitation program

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.

Behavioral: General physical activity; Behavioral: Multidisciplinary rehabilitation program

Interventions

High-intensity resistance training BEHAVIORAL

High-intensity resistance training

General physical activity BEHAVIORAL

General physical activity

Multidisciplinary rehabilitation program BEHAVIORAL

General physical activity; High-intensity resistance training

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator
• Norwegian Fund for Postgraduate Training in Physiotherapy: collaborator
• Kommunal Landspensjonskasse: collaborator

Study Sites (1)

St. Olavs University Hospital - Department of Physical Medicine and Rehabilitation

Trondheim, Norway

Location

Related Publications (2)

• 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.

  PMID: 29740641 BACKGROUND

• 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.

  PMID: 29603805 RESULT

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marius S Fimland, PhD

  Norwegian University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2015
• First Posted: April 17, 2015
• Study Start: January 1, 2015
• Primary Completion: January 4, 2017
• Study Completion: March 15, 2017
• Last Updated: June 18, 2018

Record last verified: 2018-06

Locations

NO (1)