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

Low Back Pain Clinical Trial

— IRMA20  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03172962
• Other study ID #: IRMA20
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: November 1, 2018

Study information

• Verified date: November 2018
• Source: National Research Centre for the Working Environment, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: November 1, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Musculoskeletal Pain

Intervention

Behavioral:
• Strength training
Specific strength training exercises for the lumbar and abdominal muscles for 8 weeks
• Usual care (control)
Will receive the usual care at the hospital

Locations

Country	Name	City	State
Spain	Primary care center of Lliria	Lliria	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
National Research Centre for the Working Environment, Denmark	University of Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Low back pain intensity	Low back pain intensity (VAS 0-10)	change from baseline to 8-week follow-up
Primary	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	Roland-Morris disability	The Roland-Morris disability questionnaire	change from baseline to 8-week follow-up
Secondary	Muscle endurance	The Biering-Sørensen test	change from baseline to 8-week follow-up
Secondary	Use of analgesics	Number of days using analgesic within the last week	change from baseline to 8-week follow-up
Secondary	Handgrip strength	Maximal force (kg) in handgrip	change from baseline to 8-week follow-up
Secondary	Pain sites	Number of pain sites	change from baseline to 8-week follow-up