Chronic PainPAWNCT05838677
Pain at Work Toolkit in Employees With Chronic Pain
A study testing Pain at Work Toolkit in people with Chronic Pain and Pain, Chronic, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
This project will test the feasibility and acceptability of the Pain at Work (PAW) Toolkit which aims to help employees self-manage chronic or persistent pain at work. Ultimately, the investigators want to discover if it improves employees' health, wellbeing, confidence to self-manage their condition, and reduces… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain, Pain, Chronic
- What is being tested?
- Pain at Work Toolkit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2023to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- organisations in England
- organisations with 10 or more employees.
- working-age adults (employees)
- aged 18 and over
- self-reported chronic pain interfering with their ability to undertake or enjoy productive work
- able to comprehend English language
- able to provide informed consent.
- access to the internet to be able to access the web-based intervention and online surveys for data collection.
Who cannot join
- organisations outside of England
- micro-organisations with fewer than 10 employees
- unemployed at recruitment
- under 18 years of age
- no chronic pain at recruitment
- unable to comprehend English language
- unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicentre Pragmatic Cluster Randomised Controlled Feasibility Trial to Assess Potential Effectiveness and Cost-effectiveness of the Pain at Work Toolkit in Employees With Chronic or Persistent Pain
This project will test the feasibility and acceptability of the Pain at Work (PAW) Toolkit which aims to help employees self-manage chronic or persistent pain at work. Ultimately, the investigators want to discover if it improves employees' health, wellbeing, confidence to self-manage their condition, and reduces impacts on their ability to work and be productive at work. Prior to testing the effectiveness and cost-effectiveness of the PAW Toolkit in a large-scale randomised trial, the investigators are conducting a multicentre pragmatic cluster randomised controlled feasibility trial. This will establish whether the PAW Toolkit, and our research processes, are feasible and acceptable in workplace settings, and will inform the design of a future trial. In this feasibility study, organisations will be randomised at site level to receive the intervention (PAW Toolkit plus occupational therapist (OT) support calls) or control (treatment as usual) for any individual employees who consent to take part. The investigators aim to recruit around 120 participants ("individual employees") from around 8 sites ("clusters"). Data will be collected from employees and organisations at baseline, 3 months and 6 months, using online surveys. At 6 months, up tp 40 people from across different sites and job roles will be interviewed, including employees who have accessed the PAW Toolkit, and other stakeholders (people who have been involved in supporting them at work, such as their line manager).
The data will be used assess whether the intervention and the research processes are acceptable and feasible, and the information collected will be used to plan a large-scale randomised controlled trial.
Read the detailed description
Background:
Chronic or persistent pain affects around 28 million adults in the United Kingdom (UK), reducing quality of life and people's ability to work or be productive at work. Sickness absence and reduced productivity costs the UK economy £73 billion per year.
Access to work advice and support for people living with pain is variable. Most people with chronic pain do not receive work advice through healthcare services, and employers do not routinely provide education or support for people with chronic pain. The Pain at Work (PAW) Toolkit aims to equip people who have pain with the knowledge, skills and confidence to: effectively self-manage a painful condition at work; access help and support; enjoy a better work experience; remain in the workforce.
Aims:
The aim of the trial is to determine the feasibility of conducting a definitive cluster randomised controlled trial (cRCT) of the effectiveness and cost-effectiveness of the PAW Toolkit for working-age adults with chronic or persistent pain. To achieve this, the objectives are:
- To measure feasibility outcomes to assess whether it would be possible to recruit to a definitive trial (recruitment, retention).
- To test the feasibility of reaching different employee groups (e.g., age, gender, ethnicity, job role or type), sectors (e.g., public, private, third) and organisation types (e.g., small-to-medium, or large enterprises).
- To explore whether participants and employers find the intervention and trial design acceptable.
- To obtain an estimate of the intra-cluster correlation coefficient to inform the future sample size calculation for the main trial.
- To collect a range of outcome measures to help identify the most appropriate primary outcome for a definitive trial.
- To collect data to assess the feasibility of capturing health economic data in a future trial.
- To design a future trial and implementation plan.
Protocol/ Method:
Trial configuration includes 3 work packages (WP's): feasibility trial (WP1); health economics evaluation (WP2); nested interview study (WP3).
Setting is community, comprised of employment settings in different sectors (public, private, third) in England, varying in size (small:10-49 workers; medium: 50-249 workers; large: >250 workers).
Sample size estimate: The aim is to recruit a minimum of 8 worksites ("clusters"), approximately 4 per arm. Up to 120 participants ("employees") will be recruited from these clusters over 12 months.
A nested interview study will be conducted, in which up to 40 people will be interviewed after 6 months. Participants in the interview study will include employees from the intervention arm, and stakeholders (identified by employees as having been involved in their support at work). Stakeholders may include line managers, company owners, human resources or occupational health specialists, or trade union representatives).
Organisations are randomised to either i) active control group (TAU: treatment as usual), or ii) TAU plus PAW Toolkit. Intervention participants can also opt in to receive up to 3 telephone calls with an occupational therapist. The content of the calls will include orientation to the PAW Toolkit and individually tailored advice on managing pain at work.
The following outcome measures will be collected (for detail, see Outcome Measures section):
- Feasibility and acceptability outcomes:
- Employer-reported outcome measures
- Participant-reported outcome measures (PROMs)
- Conditions
- Chronic Pain, Pain, Chronic
- Being tested
- Pain at Work Toolkit, Active control
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain at Work ToolkitBehavioural
Also called PAW Toolkit
Online toolkit providing advice and signposting to help people self-manage chronic or persistent pain at work. Access to optional phone call support from an occupational therapist providing individually tailored advice.
Active controlOther
Also called Treatment as usual (TAU)
Treatment as usual which will vary depending on the employing organisation but may include, for example, line manager support, occupational health input etc. Access to optional non-specialist phone call support from a study researcher.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group: Pain at Work Toolkit | Experimental | Intervention participants receive the PAW toolkit plus 3 x optional occupational therapy calls (approximately 30 minutes each) involving orientation to the PAW Toolkit and individually tailored advice and behavioural strategies for managing pain at work. This digital web-based toolkit is designed to support people with chronic pain in self-managing their condition at work. PAW offers evidence-based advice about chronic or persistent pain, disability rights, work capacity, pain self-management strategies and signposting to support. Receives: Behavioral: Pain at Work Toolkit |
| Active Control Group: Treatment as Usual | Active comparator | Participants do not receive the PAW Toolkit but instead have treatment as usual (TAU) from their employer. The nature of TAU will be recorded as part of the feasibility study. Depending on the employing organisation, TAU may consist of (but is not limited to) any combination of the following: occupational health, counselling, line manager support, signposting to education about factors that may have positive or negative effects on chronic pain. Participants can access non-specialist telephone calls from a researcher to discuss their participation in the study. Receives: Other: Active control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment to the study
Number recruited to assess whether it would be possible to recruit to a definitive trial. The investigators will record the number recruited, characteristics of those recruited, and the timescale to recruit.
Measured: Baseline
Acceptability of Intervention
Outcome to assess whether participants find the intervention acceptable. This will be self-reported in participant interviews at 6 months.
Measured: 6 months
Fidelity of intervention (PAW Toolkit)
Intervention fidelity will be checked through collection of usage data for the PAW Toolkit, to assess engagement with the intervention. This data will be collected through a feedback form at 3 months.
Measured: 3 months
Fidelity of intervention (OT support calls)
Intervention fidelity will be checked through recording of the uptake of occupational therapy support calls (to assess engagement with the intervention). This data will be collected through forms completed by the therapist at the time of each phone call which will be summed at 3 months.
Measured: 3 months
Retention to the study at 3 months
Number of participants who complete the first follow-up outcome measures survey.
Measured: 3 months
Retention to the study at 6 months
Number of participants who complete the second follow-up outcome measures survey.
Measured: 6 months
Secondary outcomes (12)
Work presenteeism
Using the Work Limitations Questionnaire-25 (WLQ-25). To measure the degree to which pain interferes with specific components of job performance and the productivity impact of these work limitations. Scale range 0-111. Higher scores indicate worse outcome.
Measured: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
Work Ability
Using the Work Ability Index Item1 (WAI1). Assesses current work ability compared to highest work ability ever. Scale range is 0-10. Higher scores indicate better outcome.
Measured: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
Work Self-Efficacy
Using the Work Self-Efficacy Scale (WSES). This includes 10 items assessing perceptions regarding specific work domains such as the capability to manage interpersonal relationships (colleagues and direct superiors), to work with colleagues with different characteristics and experiences, to behave efficaciously in the work context, to learn new working methods, to respect schedules and work deadlines, and to achieve assigned goals. Respondent rates capability on each item from 1 (Not well at all) to 5 (Very well). Higher score indicates better outcome.
Measured: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
Job satisfaction
Global single-item measure. Using the item: 'Taking everything into consideration, how do you feel about your job as a whole?' with responses ranging from 1 = extremely dissatisfied through to 5 = extremely satisfied. Higher score indicates better outcome.
Measured: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
Job stressfulness
Global single-item measure. Using the item: 'In general, how stressful do you find your job?' with responses on a 5 point scale ranging from 1 = 'not at all stressful' through to 5 = 'extremely stressful'. Higher score indicates worse outcome.
Measured: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
Turnover intentions
Global single item measure. Using the item: 'Are you considering leaving your job due to your pain?' (yes or no). Negative response is better outcome.
Measured: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
Depression
Using the Patient Health Questionnaire (PHQ-2). Scale is used to screen for depression. Scores ranges from 0-6. Higher scores indicate worse outcome.
Measured: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
Anxiety
Using the General Anxiety Disorder (GAD-7). Used as a screening tool and severity measure for generalised anxiety disorder. The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions. Total score ranges from 0-21. Higher scores indicate worse outcome.
Measured: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
Health-related quality of life
Using the EuroQol Five Dimensions Questionnaire (EQ-5D-5L). Comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Responses are coded as single-digit numbers expressing the severity level selected in each dimension. For instance, 'slight problems' (e.g. 'I have slight problems in walking about') is always coded as '2'. The digits for the five dimensions can be combined in a 5-digit code that describes the respondent's health state. Higher scores indicate worse outcome.
Measured: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
Impairments in work and activities
Using the Work Productivity and Impairments Scale (WPAI-GH). Measures impairments in both paid work and unpaid work. It measures absenteeism, presenteeism as well as the impairments in unpaid activity because of health problem during the past seven days. The WPAI yields four types of scores:
- Absenteeism (work time missed); 2. Presenteeism (impairment at work / reduced on-the-job effectiveness); 3. Work productivity loss (overall work impairment / absenteeism plus presenteeism); 4. Activity Impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity (worse outcomes).
Measured: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
Health resource use questionnaire
Using a health care resource use questionnaire to measure completion rates for items of resource use, such as frequency of use of secondary and primary care, social care, private health care, and medications. Items are adapted from health economics data capture in previous research with pain populations. Minimum score zero, no maximum. Higher scores indicate greater frequency of resource use.
Measured: Cumulative health resource use at time 0 (baseline), time 1 (3 months), time 2 (6 months)
Social support at work
Using the Demand Control Support Questionnaire (DCSQ) - Social Support Sub-Scale consisting of 6 items covering: pleasant atmosphere, spirit of unity, colleagues support, helpful colleagues, relationship with superiors, relationship with colleagues. Respondents are asked to report their levels of agreement or disagreement on a four-point Likert scale. Higher values indicate better outcome (higher social support at work, score range 6-24).
Measured: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start1 Jul 2023
- Primary completion22 Jul 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is an open-label, two-arm, multicentre, pragmatic cluster randomised controlled feasibility trial.
- Masking
- None (open label)
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Nuffield Trust, University of Aberdeen, University of Exeter, Monash University, Versus Arthritis
- Responsible party
- Sponsor
- Investigators
- Holly Blake, PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05838677
- Sponsor's protocol ID
- Blake_PAWFeasibilityTrial_2023
- Other IDs
- DERR1-10.2196/51474, OBF/FR-000023820
- Acronym
- PAW
- Status last verified
- Nov 2023
- First submitted
- 27 Mar 2023
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Protocol - details shared via clinical trials.gov and protocol manuscript (with informed consent form) to be submitted to an open access peer-reviewed journal within 6 months. Data Management Plan will be publicly available on https://dmponline.dcc.ac.uk prior to study start.
Publications
Blake H, Somerset S, Greaves S. The Pain at Work Toolkit for Employees with Chronic or Persistent Pain: A Collaborative-Participatory Study. Healthcare (Basel). 2021 Dec 29;10(1):56. doi: 10.3390/healthcare10010056.
PubMed 35052220Blake H, Chaplin WJ, Wainwright E, Taylor G, McNamee P, McWilliams D, Abbott-Fleming V, Holmes J, Fecowycz A, Walsh DA, Walker-Bone K. The Web-Based Pain-at-Work Toolkit With Telephone Support for Employees With Chronic or Persistent Pain: Protocol for a Cluster Randomized Feasibility Trial. JMIR Res Protoc. 2023 Oct 30;12:e51474. doi: 10.2196/51474.
PubMed 37902814Blake H, Abbott-Fleming V, Greaves S, Somerset S, Chaplin WJ, Wainwright E, Walker-Bone K. Five years of patient and public involvement and engagement (PPIE) in the development and evaluation of the Pain-at-Work toolkit to support employees' self-management of chronic pain at work. Res Involv Engagem. 2025 Jul 15;11(1):81. doi: 10.1186/s40900-025-00757-5.
PubMed 40665420
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Pragmatic Cluster Randomised Controlled Feasibility Trial to Assess Potential Effectiveness and Cost-effectiveness of the Pain at Work Toolkit in Employees With Chronic or Persistent Pain
- ClinicalTrials.gov ID
- NCT05838677
- Acronym / sponsor ID
- PAW / Blake_PAWFeasibilityTrial_2023
- Conditions
- Chronic Pain, Pain, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Nuffield Trust, University of Aberdeen, University of Exeter, Monash University, Versus Arthritis
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 22 Jul 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 1 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project will test the feasibility and acceptability of the Pain at Work (PAW) Toolkit which aims to help employees self-manage chronic or persistent pain at work. Ultimately, the investigators want to discover if it improves employees' health, wellbeing, confidence to self-manage their condition, and reduces impacts on their ability to work and be productive at work. Prior to testing the effectiveness and cost-effectiveness of the PAW Toolkit in a large-scale randomised trial, the investigators are conducting a multicentre pragmatic cluster randomised controlled feasibility trial. This will establish whether the PAW Toolkit, and our research processes, are feasible and acceptable in workplace settings, and will inform the design of a future trial. In this feasibility study, organisations will be randomised at site level to receive the intervention (PAW Toolkit plus occupational therapist (OT) support calls) or control (treatment as usual) for any individual employees who consent to take part. The investigators aim to recruit around 120 participants ("individual employees") from around 8 sites ("clusters"). Data will be collected from employees and organisations at baseline, 3 months and 6 months, using online surveys. At 6 months, up tp 40 people from across different sites and job roles will be interviewed, including employees who have accessed the PAW Toolkit, and other stakeholders (people who have been involved in supporting them at work, such as their line manager).
The data will be used assess whether the intervention and the research processes are acceptable and feasible, and the information collected will be used to plan a large-scale randomised controlled trial.
Detailed description
Background:
Chronic or persistent pain affects around 28 million adults in the United Kingdom (UK), reducing quality of life and people's ability to work or be productive at work. Sickness absence and reduced productivity costs the UK economy £73 billion per year.
Access to work advice and support for people living with pain is variable. Most people with chronic pain do not receive work advice through healthcare services, and employers do not routinely provide education or support for people with chronic pain. The Pain at Work (PAW) Toolkit aims to equip people who have pain with the knowledge, skills and confidence to: effectively self-manage a painful condition at work; access help and support; enjoy a better work experience; remain in the workforce.
Aims:
The aim of the trial is to determine the feasibility of conducting a definitive cluster randomised controlled trial (cRCT) of the effectiveness and cost-effectiveness of the PAW Toolkit for working-age adults with chronic or persistent pain. To achieve this, the objectives are:
- To measure feasibility outcomes to assess whether it would be possible to recruit to a definitive trial (recruitment, retention).
- To test the feasibility of reaching different employee groups (e.g., age, gender, ethnicity, job role or type), sectors (e.g., public, private, third) and organisation types (e.g., small-to-medium, or large enterprises).
- To explore whether participants and employers find the intervention and trial design acceptable.
- To obtain an estimate of the intra-cluster correlation coefficient to inform the future sample size calculation for the main trial.
- To collect a range of outcome measures to help identify the most appropriate primary outcome for a definitive trial.
- To collect data to assess the feasibility of capturing health economic data in a future trial.
- To design a future trial and implementation plan.
Protocol/ Method:
Trial configuration includes 3 work packages (WP's): feasibility trial (WP1); health economics evaluation (WP2); nested interview study (WP3).
Setting is community, comprised of employment settings in different sectors (public, private, third) in England, varying in size (small:10-49 workers; medium: 50-249 workers; large: >250 workers).
Sample size estimate: The aim is to recruit a minimum of 8 worksites ("clusters"), approximately 4 per arm. Up to 120 participants ("employees") will be recruited from these clusters over 12 months.
A nested interview study will be conducted, in which up to 40 people will be interviewed after 6 months. Participants in the interview study will include employees from the intervention arm, and stakeholders (identified by employees as having been involved in their support at work). Stakeholders may include line managers, company owners, human resources or occupational health specialists, or trade union representatives).
Organisations are randomised to either i) active control group (TAU: treatment as usual), or ii) TAU plus PAW Toolkit. Intervention participants can also opt in to receive up to 3 telephone calls with an occupational therapist. The content of the calls will include orientation to the PAW Toolkit and individually tailored advice on managing pain at work.
The following outcome measures will be collected (for detail, see Outcome Measures section):
- Feasibility and acceptability outcomes:
- Employer-reported outcome measures
- Participant-reported outcome measures (PROMs)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is an open-label, two-arm, multicentre, pragmatic cluster randomised controlled feasibility trial.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group: Pain at Work Toolkit | Experimental | Behavioral: Pain at Work ToolkitIntervention participants receive the PAW toolkit plus 3 x optional occupational therapy calls (approximately 30 minutes each) involving orientation to the PAW Toolkit and individually tailored advice and behavioural strategies for managing pain at work. This digital web-based toolkit is designed to support people with chronic pain in self-managing their condition at work. PAW offers evidence-based advice about chronic or persistent pain, disability rights, work capacity, pain self-management strategies and signposting to support. |
| Active Control Group: Treatment as Usual | Active comparator | Other: Active controlParticipants do not receive the PAW Toolkit but instead have treatment as usual (TAU) from their employer. The nature of TAU will be recorded as part of the feasibility study. Depending on the employing organisation, TAU may consist of (but is not limited to) any combination of the following: occupational health, counselling, line manager support, signposting to education about factors that may have positive or negative effects on chronic pain. Participants can access non-specialist telephone calls from a researcher to discuss their participation in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- organisations in England
- organisations with 10 or more employees.
- working-age adults (employees)
- aged 18 and over
- self-reported chronic pain interfering with their ability to undertake or enjoy productive work
Key exclusion criteria (7 listed)
- organisations outside of England
- micro-organisations with fewer than 10 employees
- unemployed at recruitment
- under 18 years of age
- no chronic pain at recruitment
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 |
|---|---|---|
| Pain at Work ToolkitAlso: PAW ToolkitOnline toolkit providing advice and signposting to help people self-manage chronic or persistent pain at work. Access to optional phone call support from an occupational therapist providing individually tailored advice. | Behavioural | Intervention Group: Pain at Work Toolkit |
| Active controlAlso: Treatment as usual (TAU)Treatment as usual which will vary depending on the employing organisation but may include, for example, line manager support, occupational health input etc. Access to optional non-specialist phone call support from a study researcher. | Other | Active Control Group: Treatment as Usual |
Primary outcome
Recruitment to the study
Time frame: Baseline
Number recruited to assess whether it would be possible to recruit to a definitive trial. The investigators will record the number recruited, characteristics of those recruited, and the timescale to recruit.
Acceptability of Intervention
Time frame: 6 months
Outcome to assess whether participants find the intervention acceptable. This will be self-reported in participant interviews at 6 months.
Fidelity of intervention (PAW Toolkit)
Time frame: 3 months
Intervention fidelity will be checked through collection of usage data for the PAW Toolkit, to assess engagement with the intervention. This data will be collected through a feedback form at 3 months.
Fidelity of intervention (OT support calls)
Time frame: 3 months
Intervention fidelity will be checked through recording of the uptake of occupational therapy support calls (to assess engagement with the intervention). This data will be collected through forms completed by the therapist at the time of each phone call which will be summed at 3 months.
Retention to the study at 3 months
Time frame: 3 months
Number of participants who complete the first follow-up outcome measures survey.
Retention to the study at 6 months
Time frame: 6 months
Number of participants who complete the second follow-up outcome measures survey.
12 secondary outcomes
Work presenteeism
Time frame: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
Work Ability
Time frame: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
Work Self-Efficacy
Time frame: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
Job satisfaction
Time frame: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
Job stressfulness
Time frame: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
Turnover intentions
Time frame: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
Depression
Time frame: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
Anxiety
Time frame: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
Health-related quality of life
Time frame: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
Impairments in work and activities
Time frame: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
Health resource use questionnaire
Time frame: Cumulative health resource use at time 0 (baseline), time 1 (3 months), time 2 (6 months)
Social support at work
Time frame: To assess change between time 0 (baseline), time 1 (3 months) and time 2 (6 months).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Background: PubMed 35052220Blake H, Somerset S, Greaves S. The Pain at Work Toolkit for Employees with Chronic or Persistent Pain: A Collaborative-Participatory Study. Healthcare (Basel). 2021 Dec 29;10(1):56. doi: 10.3390/healthcare10010056.
- Background: PubMed 37902814Blake H, Chaplin WJ, Wainwright E, Taylor G, McNamee P, McWilliams D, Abbott-Fleming V, Holmes J, Fecowycz A, Walsh DA, Walker-Bone K. The Web-Based Pain-at-Work Toolkit With Telephone Support for Employees With Chronic or Persistent Pain: Protocol for a Cluster Randomized Feasibility Trial. JMIR Res Protoc. 2023 Oct 30;12:e51474. doi: 10.2196/51474.
- Derived from this study: PubMed 40665420Blake H, Abbott-Fleming V, Greaves S, Somerset S, Chaplin WJ, Wainwright E, Walker-Bone K. Five years of patient and public involvement and engagement (PPIE) in the development and evaluation of the Pain-at-Work toolkit to support employees' self-management of chronic pain at work. Res Involv Engagem. 2025 Jul 15;11(1):81. doi: 10.1186/s40900-025-00757-5.
- Nuffield Foundation and Arthritis UK Research Funding (Award Ref: OBF/FR-000023820)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Protocol - details shared via clinical trials.gov and protocol manuscript (with informed consent form) to be submitted to an open access peer-reviewed journal within 6 months. Data Management Plan will be publicly available on https://dmponline.dcc.ac.uk prior to study start.
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Breast Cancer, Postoperative Pain
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.
Holly Blake, PhD principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain at Work Toolkit in people with Chronic Pain and Pain, Chronic, run by University of Nottingham 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 7 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: finished, as of the sponsor's last update on 18 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Recruitment to the study (time frame: Baseline). The study lists 6 primary outcomes in all. 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 NCT05838677, which also lists 3 linked publications.
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 18 Dec 2025; AzTrials last refreshed its copy on 6 Nov 2026.