- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03660956
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
Intervention / Treatment
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:
- 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.
Exclusion Criteria:
- Serious former back injury (fracture, surgery, disc protrusion);
- Pregnant;
- 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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