Condition category
Cancer
Date applied
26/02/2007
Date assigned
26/02/2007
Last edited
05/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr C H G Beurskens

ORCID ID

Contact details

University Medical Centre Nijmegen (UMCN)
Afd. Fysiotherapie 645
P.O. Box 9101
Nijmegen
6500 HB
Netherlands
+ 31 (0)24 361 3812
c.beurskens@fysiocss.umcn.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Physiotherapy is effective in patients with mastectomy and Axillary Lymph Node Dissection (ALND), for shoulder/arm mobility and pain primarily and quality of life secondarily.

Ethics approval

Added as of 05/09/2007: The regional medical ethics board approved the study.

Study design

Randomised, active controlled, parallel group, single blinded multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Breast cancer

Intervention

Patients assigned to the treatment group started physiotherapy two weeks following surgery in a private practice of their own choice. The research assistant contacted the physiotherapist who had to comply with the treatment regime and supplied him or her with information regarding the project and treatment guidelines. This information consisted of:
1. A guideline containing advice and exercises for arm/shoulder, posture correction, coordination exercises, exercises for muscular strength and improvement of the general physical condition
2. Exercises to prevent lymph oedema
3. Instruction for scar massage if necessary
4. A registration form to report the content of the treatment sessions and a three-point scale to indicate whether the amount of treatment sessions was sufficient

The total number of treatments was nine (nine being usually covered by the healthcare insurance), once or twice weekly for the first three weeks, thereafter once a fortnight or less. Patients were asked to perform home exercises on a daily basis for approximately ten minutes a day.

Patients assigned to the control group received a leaflet flyer with advice and exercises for the arm/shoulder for the first weeks following surgery and had no further personal contact with a physiotherapist.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Shoulder mobility (flexion [0 - 180°], abduction [0 - 180°]), measured by use of a digital inclinometer under standardised conditions
2. Pain in the shoulder/arm, measured using the VAS score (zero to ten, zero = no pain, ten = unbearable pain)

Secondary outcome measures

1. Disabilities in daily life, measured by the DASH (Disabilities of the Arm, Shoulder and Hand) questionnaire (zero to 100, zero = no functional problems, 100 = maximal problems)
2. Oedema (ml), measured in both arms by means of water displacement, grip strength (Kg) of both hands, measured using the hand-held dynamometer and quality of life, as measured by the SIP (Sickness Impact Profile-short version) questionnaire (zero to 68, zero = good health status, 68 = sever physically disabled)

Overall trial start date

11/08/2003

Overall trial end date

04/11/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. 18 years of age and older
2. Breast cancer with an ALND
3. A Visual Analogue Scale (VAS)-pain score (zero to ten) of one minimally
4. Moderate shoulder disabilities in daily life (minimal three points on a five points disability score list)

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

30

Participant exclusion criteria

1. Patients with a previous contra-lateral mastectomy
2. Patients with insufficient knowledge of the Dutch language to fill in the questionnaires

Recruitment start date

11/08/2003

Recruitment end date

04/11/2004

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Centre Nijmegen (UMCN)
Nijmegen
6500 HB
Netherlands

Sponsor information

Organisation

University Medical Centre Nijmegen (UMCN) (The Netherlands)

Sponsor details

Department of Physiotherapy
Nijmegen
6500 HB
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Other

Funder name

Not provided at time of registration

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17760981

Publication citations

  1. Results

    Beurskens CH, van Uden CJ, Strobbe LJ, Oostendorp RA, Wobbes T, The efficacy of physiotherapy upon shoulder function following axillary dissection in breast cancer, a randomized controlled study., BMC Cancer, 2007, 7, 166, doi: 10.1186/1471-2407-7-166.

Additional files

Editorial Notes