NCT03660956

Brief Summary

Low back pain (LBP) is most common occupational health problem among nurses. Therefore, how to prevent and reduce low back pain have been the important issue for nurses. A Quasi-Experimental design is used in this study to compare the effectiveness of 12-week exercise and counselling program to reduce low back pain in nursing personnel compared with counselling alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Sep 2018

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

August 30, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 7, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

August 11, 2021

Status Verified

August 1, 2021

Enrollment Period

6 months

First QC Date

August 30, 2018

Last Update Submit

August 9, 2021

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in Pain on Visual Analogue Scale (VAS) at week 6, week 12, month 3, and month 6

    Visual Analogue Scale (VAS) is used in this study to assess the intensity of low back pain with numeric rating scale 0-100 mm during the past month.

    Baseline, week 6, week 12, month 3, month 6.

Secondary Outcomes (2)

  • Change from Baseline Musculoskeletal Symptoms in the Low Back Area at week 6, week 12, month 3 and month 6

    Baseline, week 6, week 12, month 3, month 6.

  • Change from Baseline Functional Status at week 6, week 12, month 3 and month 6

    Baseline, week 6, week 12, month 3, month 6

Study Arms (2)

Exercise and back counselling group

EXPERIMENTAL
Behavioral: ExerciseBehavioral: Back counselling

Back counselling group

ACTIVE COMPARATOR
Behavioral: Back counselling

Interventions

ExerciseBEHAVIORAL

Twelves-week exercise training sessions include a variety of strength, flexibility, and coordination exercises. Each exercise session lasts for one hour. Participants are expected to attend exercise session once a week and are encouraged to continue exercising at home.

Exercise and back counselling group
Back counsellingBEHAVIORAL

Procedure of back counselling includes one session back counselling, lasting one hour. The topics of back counselling session are as follows: (1) Anatomy of lumbar; (2) Factors causing low back pain; (3) Problems of physical inactivity for the lumbar; (4) Risk of poor postures for developing persistent/chronic low back pain; (5) Maintaining right posture of the lumbar; (6) Avoiding harmful loading of the back during work and leisure time.

Back counselling groupExercise and back counselling group

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Has worked at current job for at least 12 months;
  • Intensity of low back pain on Visual Analogue Scale (scale 0-10) at least two during the past 3 months.

You may not qualify if:

  • Serious former back injury (fracture, surgery, disc protrusion);
  • Pregnant;
  • Other serious disease or symptoms that limit participation exercise defined by a physician.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University

Taichung, 406040, Taiwan

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Hsin-Hsin Shih, PhD

    China Medical University, China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A Quasi-Experimental design is used in this study. Participants are randomly assigned to exercise and back counselling group or back counselling only group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2018

First Posted

September 7, 2018

Study Start

September 1, 2018

Primary Completion

February 26, 2019

Study Completion

July 31, 2019

Last Updated

August 11, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)