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

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

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Musculoskeletal Pain
• Intervention / Treatment: Behavioral: Strength training; Behavioral: Usual care (control)

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia
    • Lliria, Valencia, Spain, 46160
      • Primary care center of Lliria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Strength training; Specific strength training exercises for the lumbar and abdominal muscles for 8 weeks	Behavioral: Strength training; Specific strength training exercises for the lumbar and abdominal muscles for 8 weeks; Behavioral: Usual care (control); Will receive the usual care at the hospital
Active Comparator: Usual care (control); Will receive the usual care at the hospital	Behavioral: Usual care (control); Will receive the usual care at the hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Low back pain intensity	Low back pain intensity (VAS 0-10)	change from baseline to 8-week follow-up
Back pain recurrence	number of episodes with back pain recurrence after termination of the intervention	1 to 100 days, beginning from the last day of termination of the 8-week intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Roland-Morris disability	The Roland-Morris disability questionnaire	change from baseline to 8-week follow-up
Muscle endurance	The Biering-Sørensen test	change from baseline to 8-week follow-up
Use of analgesics	Number of days using analgesic within the last week	change from baseline to 8-week follow-up
Handgrip strength	Maximal force (kg) in handgrip	change from baseline to 8-week follow-up
Pain sites	Number of pain sites	change from baseline to 8-week follow-up

Collaborators and Investigators

• Sponsor: National Research Centre for the Working Environment, Denmark
• Collaborators: University of Valencia

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): November 1, 2018

Study Registration Dates

• First Submitted: May 30, 2017
• First Submitted That Met QC Criteria: May 31, 2017
• First Posted (Actual): June 1, 2017

Study Record Updates

• Last Update Posted (Actual): November 30, 2018
• Last Update Submitted That Met QC Criteria: November 29, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Back Pain; Low Back Pain; Musculoskeletal Pain
• Other Study ID Numbers: IRMA20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No