Condition category
Musculoskeletal Diseases
Date applied
09/12/2016
Date assigned
12/12/2016
Last edited
09/02/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Patients’ expectations may be linked to their characteristics and the outcome of their treatment. However, few studies have investigated if or how physical medicine and rehabilitation (PMR) consultations affect patients’ expectations regarding pain and functional improvement. The aim of this study is to find out what neck, back and shoulder patients expect regarding improvement in pain and function, and the possible influence of the appointment and of patients’ expectations on their pain and function.

Who can participate?
Patients aged over 15 with neck, back or shoulder pain, referred to a physical medicine and rehabilitation (PMR) outpatient clinic

What does the study involve?
Participants complete three questionnaires. The first questionnaire is completed before the PMR appointment, and records patient characteristics. Participants complete a second questionnaire on the appointment day, and receive a follow-up questionnaire by mail after 6 months. The planned PMR appointment is not interfered with in any way.

What are the possible benefits and risks of participating?
There are no benefits or risks for the participants.

Where is the study run from?
Oslo University Hospital (Norway)

When is the study starting and how long is it expected to run for?
August 2011 to December 2020

Who is funding the study?
Oslo University Hospital (Norway)

Who is the main contact?
Sigrid Skatteboe

Trial website

Contact information

Type

Scientific

Primary contact

Miss Sigrid Skatteboe

ORCID ID

http://orcid.org/0000-0002-6667-4468

Contact details

Physical and Medicine Rehabilitation Ward
Kirkeveien 166
Oslo
0450
Norway

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

The study was approved by the Data Protection Office at Oslo University Hospital, 2012/2574.

Study information

Scientific title

An investigation of what patients with musculoskeletal complaints in shoulder, neck and back expect regarding pain reduction and functional improvement, prior to their first appointment with a specialist in physical medicine and rehabilitation in a public university hospital, and how these expectations possibly influence six months pain and functional status

Acronym

Study hypothesis

The aims of this study is to investigate what patients with neck, back and shoulder complaints expect regarding pain and functional improvement, and to investigate the possible influence of patients’ expectations on improvement in pain and functional status six months after an outpatient physical medicine assessment. Variations between patient groups and patient characteristics are also assessed.

Ethics approval

Data Protection Office at Oslo University Hospital, 01/07/2011, ref: 2012/2574

Study design

1. Pilot cross-sectional study
2. Cross-sectional study
3. Prospective cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

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

Condition

Physical medicine and rehabilitation medicine

Intervention

Information was derived from patient questionnaires. Eligible patients completed three questionnaires in addition to the consenting letter. The first questionnaire was completed prior to the PMR appointment, recording patient characteristics. Consenting participants thereafter completed a second questionnaire on the appointment day. The included patients subsequently received a follow-up questionnaire by mail after six months.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Patient expectations, measured using Numeric Rating Scales at baseline

Secondary outcome measures

1. Pain, measured using Numeric Rating Scales at baseline and 6 months
2. Function, measured using Numeric Rating Scales at baseline and 6 months

The pilot study and the second/cross-sectional study did not include 6-month follow-up data

Overall trial start date

01/08/2011

Overall trial end date

31/12/2020

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with neck/back pain and/or functional problems
2. Referred for the first time to a neck/back PMR outpatient clinic
3. Male and female patients
4. Adult patients (aged >15 years)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Approximately 500

Participant exclusion criteria

1. Previous visits to the clinic
2. Non-consenting patients

Recruitment start date

01/01/2012

Recruitment end date

01/02/2013

Locations

Countries of recruitment

Norway

Trial participating centre

Oslo University Hospital
Physical Medicine and Rehabilitation Ward
Oslo
0450
Norway

Sponsor information

Organisation

University of Oslo

Sponsor details

-
Oslo
0313
Norway
+47 (0)22 85 50 50
postmottak@uio.no

Sponsor type

University/education

Website

www.uio.no

Funders

Funder type

Hospital/treatment centre

Funder name

Oslo University Hospital

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a Physical and Rehabilitations peer reviewed journal

IPD sharing plan
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication

Intention to publish date

31/12/2021

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28125978

Publication citations

Additional files

Editorial Notes

09/02/2017: Internal review. 30/01/2017: Publication reference added.