Effects of Exercise and Back Counselling for Nurses

August 9, 2021 updated by: China Medical University Hospital

Comparative Effects of Exercise and Back Counselling on Improving Low Back Pain for Nurses

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.

Study Overview

Status

Completed

Conditions

Detailed Description

A Quasi-Experimental design is used in this study. Purposive sampling is used to recruit participants from medical center in Central Taiwan. Participants will be randomly assigned to two groups: (1) exercise and back counselling, and (2) back counselling only. The results of this study will provide a guideline for nurses to prevent and to improve low back pain.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Taichung, Taiwan, 406040
        • China Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise and back counselling group
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.
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.
Active Comparator: Back counselling group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Pain on Visual Analogue Scale (VAS) at week 6, week 12, month 3, and month 6
Time Frame: Baseline, week 6, week 12, month 3, 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Musculoskeletal Symptoms in the Low Back Area at week 6, week 12, month 3 and month 6
Time Frame: Baseline, week 6, week 12, month 3, month 6.
Version of the low back questionnaire in Nordic Musculoskeletal Questionnaire (NMQ) is used in this study to assess the musculoskeletal symptoms in the low back area.
Baseline, week 6, week 12, month 3, month 6.
Change from Baseline Functional Status at week 6, week 12, month 3 and month 6
Time Frame: Baseline, week 6, week 12, month 3, month 6
Chinese version of Oswestry Disability Index (ODI) is used in this study to assess the baseline functional status and its change over time for patients with back pain
Baseline, week 6, week 12, month 3, month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Hsin-Hsin Shih, PhD, China Medical University, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Actual)

February 26, 2019

Study Completion (Actual)

July 31, 2019

Study Registration Dates

First Submitted

August 30, 2018

First Submitted That Met QC Criteria

September 4, 2018

First Posted (Actual)

September 7, 2018

Study Record Updates

Last Update Posted (Actual)

August 11, 2021

Last Update Submitted That Met QC Criteria

August 9, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMUH107-REC2-120

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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