Effects of Exercise and Back Counselling for Nurses

Study Overview
=================
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.

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

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Behavioral: Exercise
* Behavioral: Back counselling


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise and back counselling group<br> | Behavioral: Exercise<br>* 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.<br>Behavioral: Back counselling<br>* 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.<br>|
| Active Comparator: Back counselling group<br> | Behavioral: Back counselling<br>* 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.<br>|

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 | 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 | 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 | 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 |