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Effects of Exercise and Back Counselling for Nurses

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Exercise
Back counselling
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Low Back Pain

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • China Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise and back counselling group

Back counselling group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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

Full Information

First Posted
August 30, 2018
Last Updated
August 9, 2021
Sponsor
China Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03660956
Brief Title
Effects of Exercise and Back Counselling for Nurses
Official Title
Comparative Effects of Exercise and Back Counselling on Improving Low Back Pain for Nurses
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
February 26, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Medical University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A Quasi-Experimental design is used in this study. Participants are randomly assigned to exercise and back counselling group or back counselling only group.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise and back counselling group
Arm Type
Experimental
Arm Title
Back counselling group
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Back counselling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline in Pain on Visual Analogue Scale (VAS) at week 6, week 12, month 3, and month 6
Description
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.
Time Frame
Baseline, week 6, week 12, month 3, month 6.
Secondary Outcome Measure Information:
Title
Change from Baseline Musculoskeletal Symptoms in the Low Back Area at week 6, week 12, month 3 and month 6
Description
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.
Time Frame
Baseline, week 6, week 12, month 3, month 6.
Title
Change from Baseline Functional Status at week 6, week 12, month 3 and month 6
Description
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
Time Frame
Baseline, week 6, week 12, month 3, month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsin-Hsin Shih, PhD
Organizational Affiliation
China Medical University, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
China Medical University
City
Taichung
ZIP/Postal Code
406040
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Exercise and Back Counselling for Nurses

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