search
Back to results

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

Primary Purpose

Musculoskeletal Pain, Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Strength training
Usual care (control)
Sponsored by
National Research Centre for the Working Environment, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Musculoskeletal Pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Primary care center of Lliria

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Strength training

Usual care (control)

Arm Description

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

Will receive the usual care at the hospital

Outcomes

Primary Outcome Measures

Low back pain intensity
Low back pain intensity (VAS 0-10)
Back pain recurrence
number of episodes with back pain recurrence after termination of the intervention

Secondary Outcome Measures

Roland-Morris disability
The Roland-Morris disability questionnaire
Muscle endurance
The Biering-Sørensen test
Use of analgesics
Number of days using analgesic within the last week
Handgrip strength
Maximal force (kg) in handgrip
Pain sites
Number of pain sites

Full Information

First Posted
May 30, 2017
Last Updated
November 29, 2018
Sponsor
National Research Centre for the Working Environment, Denmark
Collaborators
University of Valencia
search

1. Study Identification

Unique Protocol Identification Number
NCT03172962
Brief Title
Effect of Strength Training for Chronic Low Back Pain Patients (IRMA20)
Acronym
IRMA20
Official Title
Effect of Strength Training for Chronic Low Back Pain Patients: Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
October 1, 2018 (Actual)
Study Completion Date
November 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Research Centre for the Working Environment, Denmark
Collaborators
University of Valencia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Pain, Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Strength training
Arm Type
Experimental
Arm Description
Specific strength training exercises for the lumbar and abdominal muscles for 8 weeks
Arm Title
Usual care (control)
Arm Type
Active Comparator
Arm Description
Will receive the usual care at the hospital
Intervention Type
Behavioral
Intervention Name(s)
Strength training
Intervention Description
Specific strength training exercises for the lumbar and abdominal muscles for 8 weeks
Intervention Type
Behavioral
Intervention Name(s)
Usual care (control)
Intervention Description
Will receive the usual care at the hospital
Primary Outcome Measure Information:
Title
Low back pain intensity
Description
Low back pain intensity (VAS 0-10)
Time Frame
change from baseline to 8-week follow-up
Title
Back pain recurrence
Description
number of episodes with back pain recurrence after termination of the intervention
Time Frame
1 to 100 days, beginning from the last day of termination of the 8-week intervention
Secondary Outcome Measure Information:
Title
Roland-Morris disability
Description
The Roland-Morris disability questionnaire
Time Frame
change from baseline to 8-week follow-up
Title
Muscle endurance
Description
The Biering-Sørensen test
Time Frame
change from baseline to 8-week follow-up
Title
Use of analgesics
Description
Number of days using analgesic within the last week
Time Frame
change from baseline to 8-week follow-up
Title
Handgrip strength
Description
Maximal force (kg) in handgrip
Time Frame
change from baseline to 8-week follow-up
Title
Pain sites
Description
Number of pain sites
Time Frame
change from baseline to 8-week follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joaquin Calatayud, PhD
Organizational Affiliation
University of Valencia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Primary care center of Lliria
City
Lliria
State/Province
Valencia
ZIP/Postal Code
46160
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs