Expectations among musculoskeletal patients
| ISRCTN | ISRCTN40963362 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40963362 |
| Protocol serial number | The study was approved by the Data Protection Office at Oslo University Hospital, 2012/2574. |
| Sponsor | University of Oslo |
| Funder | Oslo University Hospital |
- 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
Plain English summary of protocol
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
Scientific
Physical and Medicine Rehabilitation Ward
Kirkeveien 166
Oslo
0450
Norway
 ORCID ID |
0000-0002-6667-4468 |
|---|
Study information
| Primary study design | Observational |
|---|---|
| Study design | 1. Pilot cross-sectional study 2. Cross-sectional study 3. Prospective cohort study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| 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 |
| Study objectives | 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(s) | Data Protection Office at Oslo University Hospital, 01/07/2011, ref: 2012/2574 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) | Patient expectations, measured using Numeric Rating Scales at baseline |
| Key secondary outcome measure(s) | 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 |
| Completion date | 31/12/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 500 |
| Key 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) |
| Key exclusion criteria | 1. Previous visits to the clinic 2. Non-consenting patients |
| Date of first enrolment | 01/01/2012 |
| Date of final enrolment | 01/02/2013 |
Locations
Countries of recruitment
- Norway
Study participating centre
Oslo
0450
Norway
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
18/12/2020: Contact details updated.
09/02/2017: Internal review.
30/01/2017: Publication reference added.
