Musculoskeletal PainWAVENCT04543097
Work And Vocational advicE Study - Effectiveness of Adding a Brief Vocational Support Intervention to Usual Primary Care
A study testing Vocational Support in people with Musculoskeletal Pain and Mental Health Issue, run by Keele University at 1 site in United Kingdom.
Trial summary
Maintaining the population's fitness for work is a priority for the UK Government. People with poor health often struggle at work and take sick leave. Work brings financial, social and health benefits. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Musculoskeletal Pain, Mental Health Issue, Mental Health Disorder
- What is being tested?
- Vocational Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Dec 2020to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years and over
- currently in paid employment (full or part time)
- current absence from work of at least two consecutive calendar weeks but not more than six continuous months
- received a fit note
- access to a mobile phone that can receive and respond to SMS text messages
- able to read and write English
- able to give full informed consent
- willing to participate.
Who cannot join
- Long-term work absence defined as over six continuous months
- pregnancy or on maternity leave
- patients presenting with signs or symptoms indicative of serious illness requiring urgent medical attention ('red' flags)
- severe mental health problems (e.g. severe depression with risk of self-harm, exacerbation of schizophrenia or bipolar disorder, cognitive impairment or lack of capacity)
- high vulnerability (e.g. palliative stages of illness, recent bereavement, dementia).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Work And Vocational advicE (WAVE) in Primary Care: a Randomised Controlled Trial
Maintaining the population's fitness for work is a priority for the UK Government. People with poor health often struggle at work and take sick leave. Work brings financial, social and health benefits. Few employees receive support to manage their health at work, known as vocational advice, so when their health affects work they visit their general practitioner (GP). The investigators have recently shown the benefits of providing vocational advice for adults consulting in primary care with musculoskeletal pain.
The WAVE study research question is: in patients consulting in general practice who receive a fit note for time off work, does a brief vocational advice intervention lead to fewer days lost from work than usual primary care, and is it cost-effective?
Read more
WAVE includes a feasibility phase to adapt a vocational advice intervention for a broader group of patients and test it in a small sample of patients; followed by a pragmatic, multi-centre, two-arm, parallel-group randomised (1:1) trial with internal pilot phase, mixed methods process evaluation and health economic analysis.
Patients will be randomised to either (i) vocational advice intervention plus usual care, or (ii) usual care alone. The vocational advice intervention is designed as a stepped care model based on the principles of case management and delivered by trained Vocational Support Workers (VSWs).
The investigators will also interview patients, General Practitioners (GPs), VSWs and employers to understand their views about the intervention and return to work.
Participants in the trial will be followed-up over 6 months with fortnightly text messages and postal questionnaires at 6 weeks and 6 months.
- Conditions
- Musculoskeletal Pain, Mental Health Issue, Mental Health Disorder, Other Physical Health Condition, Absence
- Being tested
- Vocational Support
- Keywords
- Work absence, Other health conditions, Return to work, Musculoskeletal pain, Mental health
- Medical subject headings
- Musculoskeletal Pain, Mental Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vocational SupportBehavioural
Participants randomised to receive vocational advice will all be offered:
Step 1, contact by phone to undertake an assessment with a trained Vocational Support Worker (VSW) to identify obstacles to Return to Work (RTW) and support RTW planning.
Step 2, face-to-face (in person or by videoconference) in-depth discussion of obstacles to RTW and further support for RTW planning.
Step 3, contact by the VSW (with participant consent) with the participants' workplace.
The frequency of contact will be individualised to the needs of participants and the offer of support continued until sustained RTW (defined as return to any work for at least 4 weeks) or until 6 months of absence, after which participants will be signposted to other services.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Participants randomised to the usual care arm will continue to receive care as usual for their health and vocational needs. For most patients, this will comprise usual clinical care, without formal vocational advice. |
| Usual care plus vocational support | Experimental | Vocational support following a stepped care model based on the principles of case management in addition to usual primary care. Receives: Behavioral: Vocational Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Days Absent From Work
Self reported work absence calculated as the number of days off work over the previous 6 months (since randomisation).
Measured: 6 months
Secondary outcomes (3)
Work Interference
Work Productivity Activity Impairment (WPAI) Questionnaire to measure impairments to work and activities in the past seven days. The WPAI provides four sets of scores; absenteeism, presenteeism, work productivity loss and activity impairment. It calculates four main scores calculated and expressed as percentages ranging from 0% to 100%. A higher percentage means a greater reduction in productivity and a higher level of impairment due to a health problem:
- Absenteeism ([hours missed due to health, divided by total hours should have worked] multiplied by 100)
- Presenteeism (how much health affected productivity 0 to 10, multiplied by 10)
- Overall Work Impairment (total hours missed, plus [remaining hours worked multiplied by the presenteeism score])
- Activity Impairment (score for how much health affected regular activities 0 to 10, multiplied by 10).
Measured: 6 months
Work Performance
Single Item Productivity Questionnaire (SIPQ) measured using a Visual Analogue Scale with scores ranging from 0 (health has not impacted on work performance at all) to 10 (health is so bad participant has been unable to do their job) a higher score indicates a worse outcome.
Measured: 6 months
Return to Work Self-efficacy (RTW-SE)
Return to work self-efficacy evaluates an employee's confidence in their ability to successfully resume their job while managing a health condition. This is indicated with scores ranging from 1 (not at all confident) to 10 (totally confident), a lower score indicates poorer confidence.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start23 Dec 2020
- Primary completion20 Apr 2023
- Study completion31 Jan 2025
Why it stopped: Challenges experienced in recruiting participants. Multiple options discussed to improve response rates but these remained very low and there were significant concerns about the generalisability of results even if the full sample size was recruited.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keele University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southampton, Guy's and St Thomas' NHS Foundation Trust, University of Birmingham, Aston University
- Responsible party
- Sponsor
- Investigators
- Gwenllian Wynne-Jones, PhD, Principal investigator, Keele University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04543097
- Sponsor's protocol ID
- RG-0283-19
- Other IDs
- HTA 17/94/49
- Acronym
- WAVE
- Status last verified
- Jul 2026
- First submitted
- 12 Aug 2020
- Last updated
- 30 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Any requests for access to the data from anyone outside of the research team (e.g. collaboration, joint publication, data sharing requests from publishers) will follow the Keele University's data sharing procedure.
Publications
Wynne-Jones G, Sowden G, Madan I, Walker-Bone K, Chew-Graham C, Saunders B, Lewis M, Bromley K, Jowett S, Parsons V, Mansell G, Cooke K, Lawton SA, Linaker C, Pemberton J, Cooper C, Foster NE. Can vocational advice be delivered in primary care? The Work And Vocational advicE (WAVE) mixed method single arm feasibility study. BMJ Open. 2025 Dec 29;15(12):e098768. doi: 10.1136/bmjopen-2025-098768.
PubMed 41469060
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Work And Vocational advicE (WAVE) in Primary Care: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04543097
- Acronym / sponsor ID
- WAVE / RG-0283-19
- Conditions
- Musculoskeletal Pain, Mental Health Issue, Mental Health Disorder, Other Physical Health Condition, Absence
- Keywords
- Work absence, Other health conditions, Return to work, Musculoskeletal pain, Mental health
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Challenges experienced in recruiting participants. Multiple options discussed to improve response rates but these remained very low and there were significant concerns about the generalisability of results even if the full sample size was recruited.
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Keele UniversityUniversity, hospital or other
- Collaborators
- University of Southampton, Guy's and St Thomas' NHS Foundation Trust, University of Birmingham, Aston University
- Study start
- 23 Dec 2020 (actual)
- Primary completion
- 20 Apr 2023 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 9 Sep 2020 (actual)
- Results
- Posted 8 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Maintaining the population's fitness for work is a priority for the UK Government. People with poor health often struggle at work and take sick leave. Work brings financial, social and health benefits. Few employees receive support to manage their health at work, known as vocational advice, so when their health affects work they visit their general practitioner (GP). The investigators have recently shown the benefits of providing vocational advice for adults consulting in primary care with musculoskeletal pain.
The WAVE study research question is: in patients consulting in general practice who receive a fit note for time off work, does a brief vocational advice intervention lead to fewer days lost from work than usual primary care, and is it cost-effective?
WAVE includes a feasibility phase to adapt a vocational advice intervention for a broader group of patients and test it in a small sample of patients; followed by a pragmatic, multi-centre, two-arm, parallel-group randomised (1:1) trial with internal pilot phase, mixed methods process evaluation and health economic analysis.
Patients will be randomised to either (i) vocational advice intervention plus usual care, or (ii) usual care alone. The vocational advice intervention is designed as a stepped care model based on the principles of case management and delivered by trained Vocational Support Workers (VSWs).
The investigators will also interview patients, General Practitioners (GPs), VSWs and employers to understand their views about the intervention and return to work.
Participants in the trial will be followed-up over 6 months with fortnightly text messages and postal questionnaires at 6 weeks and 6 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Participants randomised to the usual care arm will continue to receive care as usual for their health and vocational needs. For most patients, this will comprise usual clinical care, without formal vocational advice. |
| Usual care plus vocational support | Experimental | Behavioral: Vocational SupportVocational support following a stepped care model based on the principles of case management in addition to usual primary care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults aged 18 years and over
- currently in paid employment (full or part time)
- current absence from work of at least two consecutive calendar weeks but not more than six continuous months
- received a fit note
- access to a mobile phone that can receive and respond to SMS text messages
Key exclusion criteria (5 listed)
- Long-term work absence defined as over six continuous months
- pregnancy or on maternity leave
- patients presenting with signs or symptoms indicative of serious illness requiring urgent medical attention ('red' flags)
- severe mental health problems (e.g. severe depression with risk of self-harm, exacerbation of schizophrenia or bipolar disorder, cognitive impairment or lack of capacity)
- high vulnerability (e.g. palliative stages of illness, recent bereavement, dementia).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vocational SupportParticipants randomised to receive vocational advice will all be offered: Step 1, contact by phone to undertake an assessment with a trained Vocational Support Worker (VSW) to identify obstacles to Return to Work (RTW) and support RTW planning. Step 2, face-to-face (in person or by videoconference) in-depth discussion of obstacles to RTW and further support for RTW planning. Step 3, contact by the VSW (with participant consent) with the participants' workplace. The frequency of contact will be individualised to the needs of participants and the offer of support continued until sustained RTW (defined as return to any work for at least 4 weeks) or until 6 months of absence, after which participants will be signposted to other services. | Behavioural | Usual care plus vocational support |
Primary outcome
Number of Days Absent From Work
Time frame: 6 months
Self reported work absence calculated as the number of days off work over the previous 6 months (since randomisation).
3 secondary outcomes
Work Interference
Time frame: 6 months
Work Performance
Time frame: 6 months
Return to Work Self-efficacy (RTW-SE)
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41469060Wynne-Jones G, Sowden G, Madan I, Walker-Bone K, Chew-Graham C, Saunders B, Lewis M, Bromley K, Jowett S, Parsons V, Mansell G, Cooke K, Lawton SA, Linaker C, Pemberton J, Cooper C, Foster NE. Can vocational advice be delivered in primary care? The Work And Vocational advicE (WAVE) mixed method single arm feasibility study. BMJ Open. 2025 Dec 29;15(12):e098768. doi: 10.1136/bmjopen-2025-098768.
- Individual participant dataSharing planned: Yes. Any requests for access to the data from anyone outside of the research team (e.g. collaboration, joint publication, data sharing requests from publishers) will follow the Keele University's data sharing procedure.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gwenllian Wynne-Jones, PhD principal investigator
Keele University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vocational Support in people with Musculoskeletal Pain and Mental Health Issue, run by Keele University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Days Absent From Work (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04543097, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.