ISRCTN ISRCTN40963362
DOI https://doi.org/10.1186/ISRCTN40963362
Secondary identifying numbers The study was approved by the Data Protection Office at Oslo University Hospital, 2012/2574.
Submission date
09/12/2016
Registration date
12/12/2016
Last edited
18/12/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Contact information

Miss Sigrid Skatteboe
Scientific

Physical and Medicine Rehabilitation Ward
Kirkeveien 166
Oslo
0450
Norway

ORCiD logoORCID ID 0000-0002-6667-4468

Study information

Study design1. Pilot cross-sectional study 2. Cross-sectional study 3. Prospective cohort study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeOther
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleAn 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
Study hypothesisThe 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(s)Data Protection Office at Oslo University Hospital, 01/07/2011, ref: 2012/2574
ConditionPhysical medicine and rehabilitation medicine
InterventionInformation 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 typeOther
Primary outcome measurePatient expectations, measured using Numeric Rating Scales at baseline
Secondary outcome measures1. 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 study start date01/08/2011
Overall study end date31/12/2020

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsApproximately 500
Participant inclusion criteria1. 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 exclusion criteria1. Previous visits to the clinic
2. Non-consenting patients
Recruitment start date01/01/2012
Recruitment end date01/02/2013

Locations

Countries of recruitment

  • Norway

Study participating centre

Oslo University Hospital
Physical Medicine and Rehabilitation Ward
Oslo
0450
Norway

Sponsor information

University of Oslo
University/education

-
Oslo
0313
Norway

Phone +47 (0)22 85 50 50
Email postmottak@uio.no
Website www.uio.no
ROR logo "ROR" https://ror.org/01xtthb56

Funders

Funder type

Hospital/treatment centre

Oslo University Hospital

No information available

Results and Publications

Intention to publish date31/12/2021
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planPlanned publication in a Physical and Rehabilitations peer reviewed journal
IPD sharing planThe datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 26/01/2017 Yes No

Editorial Notes

18/12/2020: Contact details updated.
09/02/2017: Internal review.
30/01/2017: Publication reference added.