Plain English Summary
Background and study aims
Chronic (long-term) pain is any pain that has lasted for more than 12 weeks. As we get older, it is particularly common to experience pain in muscles and joints (musculoskeletal pain), especially in the over 65s age group. Studies have shown that when a person is in pain, they are likely to avoid movement and physical activity which could make their pain worse. This has led to many people over the age of 65 becoming very inactive. The benefits of exercise on the body are well documented, and so it is important to encourage older people to be more active. An acceptable form of exercise which does not put too much strain on the body is walking. iPOPP (increasing physical activity in older people) is a new programme which has been developed to encourage older people to walk more. It involves face-to-face appointments with specially trained health care assistants (HCAs) as well as the delivery of motivational messages to encourage people to continue with the programme. The aim of this study is to find out whether the iPOPP programme is an effective way of improving physical activity in older people suffering from chronic pain.
Who can participate?
Adults aged 65 or over who have seen their GP about musculoskeletal pain in the last 12 months.
What does the study involve?
Participants are randomly allocated to one of three groups. Participants in the first group (control group) continue to receive usual care, such as seeing their GP, taking medication and receiving treatment (i.e. physiotherapy) and are also posted a copy of the pain toolkit (a simple booklet which provides tips and skills to help people to manage their chronic pain). Participants in the second group continue to receive their usual care, but are also given two appointments with a trained HCA. At the first appointment, they are given a pedometer and user guide, a walking diary (to record how much they are walking) and a copy of the pain toolkit and at the second appointment (by telephone) they are asked for feedback about how much they are walking. Participants also receive motivational messages every week for 8 weeks in the form of a postcard, email or text, to encourage them to maintain their walking plan. Participants in the third group receive the pedometer, user guide, walking diary and pain toolkit in the post, as well as continuing to receive their usual care.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Arthritis Research UK Primary Care Centre (UK)
When is the study starting and how long is it expected to run for?
December 2015 to May 2016
Who is funding the study?
Arthritis Research UK (UK)
Who is the main contact?
Ms Jacqueline Gray
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
20117
Study information
Scientific title
Increasing Physical activity in Older People with chronic musculoskeletal Pain: A brief and simple intervention to promote walking
Acronym
iPOPP
Study hypothesis
The aim of this study is to find out whether a brief and simple intervention to promote walking can be delivered by Health Care Assistants (HCAs) and is acceptable to patients suffering with chronic musculoskeletal pain.
Ethics approval
15/WM/0329
Study design
Randomised; Interventional; Design type: Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Primary Care, Musculoskeletal disorders, Ageing; Subtopic: Musculoskeletal (all Subtopics), Ageing, Primary care; Disease: Musculoskeletal, All Diseases, All Ageing
Intervention
Participants are randomly allocated to one of threw study arms.
Control arm: Participants will continue to be managed via usual care but will be posted a copy of the pain toolkit, which is a simple information booklet that provides patients with tips and skills to support them to manage their chronic pain. Usual primary care management normally consists of a patient consulting their GP or practice nurse for their pain and may include advice and education, the prescription of medication and referrals to other appropriate services i.e. physiotherapy, podiatry, occupational therapy.
iPOPP arm: Participants will be offered an initial appointment for a face-to-face consultation at their general practice with a trained HCA. At this initial consultation patients will receive a pedometer, the user guide and walking diary (as above) plus a copy of the pain toolkit. Participants will receive a second consultation either face-to-face or via telephone (depending on participant preference) consisting of a review of progress since session one, positive feedback in relation to effort and achievement, and possible revision of goals set. Participants will then receive the 8 weekly motivational prompts which will be in the form of a postcard, email or text. The type of prompt will be based on individual patient preference. Patients allocated to this intervention arm will also continue to be able to access usual care.
Pedometer arm: Participants will receive a pedometer, a pedometer user guide, a walking diary and the pain toolkit in the post. In addition, these patients will continue to be able to access usual care.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Acceptability and feasibility of training the HCAs and delivery of the iPOPP intervention.
Secondary outcome measures
Not provided at time of registration.
Overall trial start date
08/12/2015
Overall trial end date
30/05/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Adults aged 65 years and over
2. Consulted at their general practice for musculoskeletal pain in one or more index sites (foot, knee, hip, back, shoulder or neck) in the last 12 months
3. Registered with one of the participating GP practices during the specified trial period for that practice
4. Chronic Pain Grade score of between 2 to 4, determined through a brief postal chronic pain screening survey
5. Able to provide full, informed, written consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 150; UK Sample Size: 150
Participant exclusion criteria
1. Traumatic injury related pain (recent sports injury, fall or accident) to rule out traumatic fractures
2. Patients with complex medical conditions deemed at risk of exerciserelated complications by their GP (e.g. chest pain on exertion, severe hypertension, congestive heart failure, syncope, uncontrolled epilepsy, recent fracture, active and severe synovitis)
3. Vulnerable patients (i.e. patients with significant cognitive impairment (e.g. dementia), or in palliative stage of care)
4. Patients who reside in a residential or nursing home
Recruitment start date
08/12/2015
Recruitment end date
30/05/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Arthritis Research UK Primary Care Centre
Primary Care Sciences
Keele University
Newcastle-Under-Lyme
ST5 5BG
United Kingdom
Funders
Funder type
Charity
Funder name
Arthritis Research UK
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list