NCT03172962

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 1, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

November 30, 2018

Status Verified

November 1, 2018

Enrollment Period

1.3 years

First QC Date

May 30, 2017

Last Update Submit

November 29, 2018

Conditions

Musculoskeletal PainLow Back Pain

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • Roland-Morris disability

    change from baseline to 8-week follow-up

  • Muscle endurance

    change from baseline to 8-week follow-up

  • Use of analgesics

    change from baseline to 8-week follow-up

  • Handgrip strength

    change from baseline to 8-week follow-up

  • Pain sites

    change from baseline to 8-week follow-up

Study Arms (2)

Strength training

EXPERIMENTAL

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

Behavioral: Strength trainingBehavioral: Usual care (control)

Usual care (control)

ACTIVE COMPARATOR

Will receive the usual care at the hospital

Behavioral: Usual care (control)

Interventions

Strength trainingBEHAVIORAL

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

Strength training
Usual care (control)BEHAVIORAL

Will receive the usual care at the hospital

Strength trainingUsual care (control)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Primary care center of Lliria

Llíria, Valencia, 46160, Spain

Location

MeSH Terms

Conditions

Musculoskeletal PainLow Back Pain

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBack Pain

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Joaquin Calatayud, PhD

    University of Valencia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2017

First Posted

June 1, 2017

Study Start

July 1, 2017

Primary Completion

October 1, 2018

Study Completion

November 1, 2018

Last Updated

November 30, 2018

Record last verified: 2018-11

Locations

ES(1)