Skip to main content
OpenTrials
Completed

NCT Number: NCT03172962

Effect of Strength Training for Chronic Low Back Pain Patients (IRMA20)

Low back pain (LBP) is common in the population and has great socioeconomic consequences for societies across Europe and the United States. About a third of working-age adults have frequent LBP, and for about 10% the pain becomes chronic with consequences for work and leisure activities. A Cochrane review from April 2017 concluded that physical exercise is an intervention with few adverse events and positive outcomes on pain and function in adults with chronic pain. However, when scrutinizing the specific studies of the review there are large differences in adherence to the exercise interventions and consequently in the results obtained. Thus, there is a need for simple exercises that the patients can easily adhere to.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Musculoskeletal Pain Back Pain Low Back Pain Muscular Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Primary care center of Lliria

Llíria, Valencia, 46160, Spain

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Non-specific Chronic low back pain patient (more than 3 months) at the hospital Arnau de Vilanova

Exclusion criteria

  • Spine surgery
  • neurologic or psyquiatric disorders
  • Low back traumastism
  • Recent participation in a similar training program

Treatment and study plan

strength training

Behavioral

Specific strength training exercises for the lumbar and abdominal muscles for 8 weeks

Usual care (control)

Behavioral

Will receive the usual care at the hospital

Primary outcomes

  1. Low back pain intensity

    Time frame: change from baseline to 8-week follow-up

    Low back pain intensity (VAS 0-10)

  2. Back pain recurrence

    Time frame: 1 to 100 days, beginning from the last day of termination of the 8-week intervention

    number of episodes with back pain recurrence after termination of the intervention

Secondary outcomes

  1. Roland-Morris disability

    Time frame: change from baseline to 8-week follow-up

    The Roland-Morris disability questionnaire

  2. Muscle endurance

    Time frame: change from baseline to 8-week follow-up

    The Biering-Sørensen test

  3. Use of analgesics

    Time frame: change from baseline to 8-week follow-up

    Number of days using analgesic within the last week

  4. Handgrip strength

    Time frame: change from baseline to 8-week follow-up

    Maximal force (kg) in handgrip

  5. Pain sites

    Time frame: change from baseline to 8-week follow-up

    Number of pain sites

Sponsors and collaborators

Lead sponsor

National Research Centre for the Working Environment, Denmark

Other Gov

Collaborators

  • University of Valencia

Registry information

Official study title

Effect of Strength Training for Chronic Low Back Pain Patients: Randomized Clinical Trial

Acronym: IRMA20

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 1, 2017
Registry last updated
Nov 30, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.