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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03660956
Other study ID # CMUH107-REC2-120
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2018
Est. completion date July 31, 2019

Study information

Verified date August 2021
Source China Medical University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 4
Est. completion date July 31, 2019
Est. primary completion date February 26, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Exercise
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.
Back counselling
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.

Locations

Country Name City State
Taiwan China Medical University Taichung

Sponsors (1)

Lead Sponsor Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Change from Baseline Musculoskeletal Symptoms in the Low Back Area at week 6, week 12, month 3 and 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.
Secondary Change from Baseline Functional Status at week 6, week 12, month 3 and 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
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