Condition category
Signs and Symptoms
Date applied
24/09/2019
Date assigned
24/09/2019
Last edited
24/09/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
More than half of all adults have experienced neck pain during the last six months and neck pain is now the second most common musculoskeletal disorder and is more prevalent in women than men. People who spend the majority of their work time in a static body position with repetitive movements of the arm and shoulder (e.g. computer work) have an increased risk of pain in the neck and shoulder region. Studies have demonstrated reduced pain in the neck and shoulder region after specific strength training of the affected muscles, and some studies have reported greater reductions in pain than general aerobic training. However, common aerobic activities such as cycling and walking do not involve the neck and shoulder muscles to a great extent. Specific resistance training of the neck and shoulder muscles have demonstrated promising results and proven to be more effective than aerobic exercises. Specific resistance training has proven effective in the reduction of muscle tension and pain as well as improvements in isometric strength. Even though previous studies have examined different training volumes using different lengths of sessions or training adherence, it is not clear whether different training volume caused by a greater training frequency per day could relieve the pain to a greater extent than lower training frequency.

Who can participate?
People who perform low intensity, but continuous, isometric contraction in the neck and shoulder region (e.g. computer work, hairdresser or dentist) experiencing mild to moderate pain in the neck and/or shoulder region lasting at least three months

What does the study involve?
The study takes place over a 16-week period with an 8-week control period and an 8-week training period. The treatment was identical in both groups with the exception that one of the groups performed training once per day and the other group performed identical training twice per day. The training consists of four exercises and each session lasts 10 minutes. The treatment lasts 8 weeks. The participants are tested before the control period (pre-test), between the control and training period (mid-test) and after the training period (post-test). The testing includes pain, isometric strength and health-related quality of life.

What are the possible benefits and risks of participating?
The possible benefits may be increased strength in the neck and shoulder region in addition to reduced pain and improved health-related quality of life. However, there is an inherent risk that the participants might experience some muscle soreness at the beginning of the treatment period.

Where is the study run from?
Western Norway University of Applied Sciences (Norway)

When is the study starting and how long is it expected to run for?
August 2016 to January 2017

Who is funding the study?
Western Norway University of Applied Sciences (Norway)

Who is the main contact?
Dr Atle Saeterbakken
atle.saeterbakken@hvl.no

Trial website

Contact information

Type

Scientific

Primary contact

Dr Atle Saeterbakken

ORCID ID

Contact details

Røyrgata 6
Sogndal
N-6856
Norway
+47 (0)57676044
atle.saeterbakken@hvl.no

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Workplace resistance training as treatment for neck and shoulder pain

Acronym

RENS

Study hypothesis

The aim of the present study was to examine the dose-response relationship between resistance training frequency and pain relief among office workers with neck and shoulder pain.

Ethics approval

Approved 14/06/2016, local regional ethics committee (regional komiteer for medisinsk og helsefaglig forskningsetikk, Gullhaugvegen 1-3, 0484 Oslo, Norway; Tel: +47 (0)22 84 55 11; Email: post@helseforskning.etikkom.no), ref: 2016/1280 Sør-øst B

Study design

Randomised parallel trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

Condition

Non-specific mild to moderate pain in the neck and/or shoulder region

Intervention

The study took place over a 16-week period starting with an 8-week control period and an 8-week training period

The treatment or intervention was identical in both arms/groups with the exception that one of the group performed training once per day and the other group performed the identical training twice per day. The training consisted of four exercises and each session lasted 10 minutes. The treatment lasted 8 weeks. The randomization was done by drawing (lottery).

The participants were tested before the control period (pre-test), between the control and training period (mid-test) and after the training period (post-test). The testing included the 0-100mm visual analog scale (VAS) for pain, isometric strength (shrugs and seated row) and health-related quality of life (EQ-5D-5L).

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

General pain and worst pain assessed using 100 mm visual analog scale (VAS) at baseline (pre-test), after the control period/start of treatment period (mid-test) and post-treatment (post-test)

Secondary outcome measures

Measured at baseline (pre-test), after the control period /start of treatment period (mid-test) and post-treatment (post-test):
1. Health-related quality of life on 0–100 scale
2. Isometric strength in the neck and shoulder region (shrugs and seated row)

Overall trial start date

01/08/2016

Overall trial end date

31/01/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Mild to moderate pain (10 – 60mm VAS) in the neck and/or shoulder region lasting at least three months
2. Computer work or low-intensity isometric contraction during work (i.e. dentist, hairdresser)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. People with considerable pain (> 60mm VAS)
2. Receiving treatment from health care professionals in the last six months

Recruitment start date

01/08/2016

Recruitment end date

15/09/2016

Locations

Countries of recruitment

Norway

Trial participating centre

Atle Saeterbakken
Røyrgata 6
Sogndal
N-6856
Norway

Sponsor information

Organisation

Western Norway University of Applied Sciences

Sponsor details

PB 133
Sogndal
6851
Norway
+47 (0)57676044
atle.saeterbakken@hvl.no

Sponsor type

University/education

Website

www.hvl.no

Funders

Funder type

University/education

Funder name

Western Norway University of Applied Sciences

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

One scientific paper in a peer review journal

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Atle Saeterbakken (atle.saeterbakken@hvl.no).

Intention to publish date

15/12/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

24/09/2019: Trial's existence confirmed by ethics committee.