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Completed

NCT Number: NCT02420236

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

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.

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Key information

Conditions

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

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Trondheim, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-intensity resistance training

Behavioral

General physical activity

Behavioral

Multidisciplinary rehabilitation program

Behavioral

Primary outcomes

  1. Low back-related disability as assessed by the oswestry disability index

    Time frame: 12 weeks

    Oswestry disability index

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Kommunal Landspensjonskasse
  • Norwegian Fund for Postgraduate Training in Physiotherapy
  • St. Olavs Hospital

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 17, 2015
Registry last updated
Jun 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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