Low Back PainPhase 1/2NCT00817882
Working Well With Back Pain (Feasibility RCT of Vocational Rehabilitation)
A Phase 1/2 study testing individually targeted vocational rehabilitation and routine back pain rehabilitation in people with Low Back Pain, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
Back pain has a major impact on people's ability to work. Health professionals need to know how they can best use their limited resources to address the occupational needs of people with chronic low back pain. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- individually targeted vocational rehabilitation and routine back pain rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2009to Aug 2010
- Phase
- Phase 1/2
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- low back pain
- offered routine rehabilitation
- employed
- concern about work ability due to low back pain
- referral by GP in South Nottinghamshire
Who cannot join
- not fluent in English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changing Perceptions of Work Ability in People With Low Back Pain: Feasibility Randomised Controlled Trial and Economic Evaluation.
Back pain has a major impact on people's ability to work. Health professionals need to know how they can best use their limited resources to address the occupational needs of people with chronic low back pain. Vocational rehabilitation is the process that helps people with health problems to stay at, return to and remain at work. This study comprises the second phase of a three year study of back pain and vocational rehabilitation. The first phase gathered data from patient interviews and postal surveys of GPs and GP practice managers. These findings have been used to inform this second phase; a feasibility randomised controlled trial. The participants will be thirty employed people with back pain who have been offered an NHS rehabilitation programme, and who are concerned about their ability to work with low back pain. Those who consent will be randomised into two groups. One group will receive routine rehabilitation. The other will receive routine rehabilitation plus an individually tailored vocational intervention carried out by the researcher. Following the trial, individual interviews will be carried out with each of the participants by an independent researcher. An economic study will evaluate the possibility of measuring the cost-effectiveness of the intervention. The hypothesis is that an enhanced vocational intervention plus routine rehabilitation will be more effective in improving patients' work ability than routine rehabilitation alone.
- Conditions
- Low Back Pain
- Being tested
- individually targeted vocational rehabilitation, routine back pain rehabilitation
- Keywords
- vocational, rehabilitation, work, ability, low back pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
individually targeted vocational rehabilitationOther
individually targeted vocational rehabilitation over 4 month period, maximum of 10 sessions, in addition to routine back pain rehabilitation.
Maximum of 25 participants with low back pain
routine back pain rehabilitationOther
routine back pain rehabilitation Maximum of 25 patients with low back pain
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | individually targeted vocational rehabilitation Receives: Other: individually targeted vocational rehabilitation |
| 2 | Active comparator | routine back pain rehabilitation Receives: Other: routine back pain rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
work ability
Measured: prospective
Secondary outcomes (1)
self-efficacy
Measured: prospective
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2009 (estimated)
- Study startMay 2009
- Primary completionJul 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back 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 1/2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Arthritis Research UK
- Investigators
- Carol M Coole, MSc, Principal investigator, University of NottinghamAvril Drummond, PhD, Study director, University of NottinghamPaul J Watson, PhD, Study director, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00817882
- Sponsor's protocol ID
- 17891
- Status last verified
- Nov 2010
- First submitted
- 6 Jan 2009
- Last updated
- 23 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changing Perceptions of Work Ability in People With Low Back Pain: Feasibility Randomised Controlled Trial and Economic Evaluation.
- ClinicalTrials.gov ID
- NCT00817882
- Acronym / sponsor ID
- 17891
- Conditions
- Low Back Pain
- Keywords
- vocational, rehabilitation, work, ability, low back pain
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Arthritis Research UK
- Study start
- May 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 7 Jan 2009 (estimated)
- 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.
Back pain has a major impact on people's ability to work. Health professionals need to know how they can best use their limited resources to address the occupational needs of people with chronic low back pain. Vocational rehabilitation is the process that helps people with health problems to stay at, return to and remain at work. This study comprises the second phase of a three year study of back pain and vocational rehabilitation. The first phase gathered data from patient interviews and postal surveys of GPs and GP practice managers. These findings have been used to inform this second phase; a feasibility randomised controlled trial. The participants will be thirty employed people with back pain who have been offered an NHS rehabilitation programme, and who are concerned about their ability to work with low back pain. Those who consent will be randomised into two groups. One group will receive routine rehabilitation. The other will receive routine rehabilitation plus an individually tailored vocational intervention carried out by the researcher. Following the trial, individual interviews will be carried out with each of the participants by an independent researcher. An economic study will evaluate the possibility of measuring the cost-effectiveness of the intervention. The hypothesis is that an enhanced vocational intervention plus routine rehabilitation will be more effective in improving patients' work ability than routine rehabilitation alone.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: individually targeted vocational rehabilitationindividually targeted vocational rehabilitation |
| 2 | Active comparator | Other: routine back pain rehabilitationroutine back pain rehabilitation |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- low back pain
- offered routine rehabilitation
- employed
- concern about work ability due to low back pain
- referral by GP in South Nottinghamshire
Key exclusion criteria (1 listed)
- not fluent in English
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 |
|---|---|---|
| individually targeted vocational rehabilitationindividually targeted vocational rehabilitation over 4 month period, maximum of 10 sessions, in addition to routine back pain rehabilitation. Maximum of 25 participants with low back pain | Other | 1 |
| routine back pain rehabilitationroutine back pain rehabilitation Maximum of 25 patients with low back pain | Other | 2 |
Primary outcome
work ability
Time frame: prospective
1 secondary outcome
self-efficacy
Time frame: prospective
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 23 Nov 2010.
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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.
Carol M Coole, MSc principal investigator
University of Nottingham
Avril Drummond, PhD study director
University of Nottingham
Paul J Watson, PhD study director
University of Leicester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing individually targeted vocational rehabilitation and routine back pain rehabilitation in people with Low Back Pain, 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 5 inclusion and 1 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 23 Nov 2010. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
work ability (time frame: prospective). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Nov 2010.