Condition category
Musculoskeletal Diseases
Date applied
25/11/2015
Date assigned
27/11/2015
Last edited
27/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Work-related musculoskeletal pain (pain caused by an injury to the bones, joints and/or muscles) is a serious problem among hospital staff. Nurses have been found to be particularly vulnerable to neck (cervical) and lower back (lumbar) pain, due to daily moving and handling of patients. In many cases, the pain experienced can lead to people avoiding physical activity, which can actually make the problem worse. It has been found that simple exercises designed to gradually increase the range of motion (ROM) of joints could help to reduce pain and stiffness, as well as strengthening muscles. The aim of this study is to investigate the effects of a home-based exercise programme can help to reduce pain and ROM in intensive care nurses.

Who can participate?
Intensive care nurses who have suffered from mild to moderate MSP during the past 6 months.

What does the study involve?
At the start of the study, participants are interviewed in order to assess the intensity of back and neck pain they currently experience. Those who are experiencing the most pain undergo an 8 week programme of exercise therapy (experimental group). The participants taught exercises specially designed to improve the range of motion in their neck and back, and are asked to practice the exercises once a day, six days a week. The other participants are asked to continue with their lives as normal for the 8 week study. At the end of the 8 weeks, participants are interviewed in order to find out if their pain levels have changed. Additionally, at the start of the study and after 8 weeks, participants have the range of motion in the cervical spine (neck) and lumbar region (lower back) using a digital goniometer (device used to make precise measurements of angles).

What are the possible benefits and risks of participating?
Participants may benefit from increased awareness of the importance of physical activity to maintaining their range of motion, which could help to reduce MSP in the neck and lower back. There is a risk related to over-training, which could lead to pain and discomfort.

Where is the study run from?
Tartu University Hospital (Estonia)

When is the study starting and how long is it expected to run for?
September 2010 to September 2011

Who is funding the study?
Archimedes Foundation (Estonia)

Who is the main contact?
Mrs Tiina Freimann

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Tiina Freimann

ORCID ID

http://orcid.org/0000-0002-5611-2998

Contact details

Tartu University Hospital
L.Puusepa 8
Tartu
51014
Estonia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Changes of functional characteristics of cervical and lumbar spine of intensive care unit nurses after 8-week home-exercise therapy

Acronym

HETPN

Study hypothesis

The specially designed home-exercise therapy programme could improve cervical and lumbar range of motion to reduce neck and lower back pain among ICU nurses.

Ethics approval

Research Ethics Committee of the University of Tartu, 14/03/2011, ref: 202T-19

Study design

Single-centre non-randomised interventional study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Cervical and lumbar range of motion

Intervention

The prevalence and intensity of musculo-skeletal pain (MSP) was assessed to select potential participants for the experimental group.

Experimental group: Participants underwent 8-weeks of exercise therapy, with the frequency and intensity of the exercises increasing every two weeks. The participants were asked to perform exercises as one to three sets of 8–10 repetitions.The goal for subjects was to perform exercises once a day, six days a week, for 8 weeks.
Control group: Participants were asked to continue their normal life, and not asked to do any additional exercises.

Cervical and lumbar range of motion of participants in both groups is measured with a digital goniometer at the end of the 8 week intervention period.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

1. Cervical range of motion (CROM) is measured using a digital goniometer (AcumarTM Digital Inclinometer, Version 5.0) at baseline and 8 weeks
2. Lumbar range of motion (LROM) is measured using a digital goniometer (AcumarTM Digital Inclinometer, Version 5.0) at baseline and 8 weeks

Secondary outcome measures

Pain is measured using the 11-point Visual Analogue Scale (VAS) at baseline and 8 weeks.

Overall trial start date

09/09/2010

Overall trial end date

23/09/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Experimental group:
1. Having worked full time for at least a year in the ICU
2. Being under 40 years of age
3. Having a body mass index <32
4. Having experienced mild to moderate pain in the cervical and or lumbar regions during the previous six months
Control group:
1. Being under 40 years of age
2. Having a body mass index <32
3. Experiencing no musculo-skeletal pain (MSP) during the previous six months

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

Total recruitment of participants (n=40); experimental group (n=13); control group (n=11).

Participant exclusion criteria

1. Acute orthopaedic and or neurological diseases
2. Pregnancy

Recruitment start date

06/04/2011

Recruitment end date

25/04/2011

Locations

Countries of recruitment

Estonia

Trial participating centre

Tartu University Hospital
L.Puusepa 1a
Tartu
50406
Estonia

Sponsor information

Organisation

University of Tartu

Sponsor details

Ülikooli 18
Tartu
50090
Estonia

Sponsor type

University/education

Website

http://www.ut.ee

Funders

Funder type

Government

Funder name

Archimedes Foundation (Sihtasutus Archimedes)

Alternative name(s)

Archimedes Foundation

Funding Body Type

government organisation

Funding Body Subtype

federal/national government

Location

Estonia

Results and Publications

Publication and dissemination plan

Planned publication in the BMC Sports Science, Medicine and Rehabilitation journal.

Intention to publish date

30/11/2015

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes