Condition category
Signs and Symptoms
Date applied
20/01/2016
Date assigned
20/01/2016
Last edited
20/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

https://www.keele.ac.uk/pchs/keelectu/studies/ipopp/

Contact information

Type

Public

Primary contact

Ms Jacqueline Gray

ORCID ID

Contact details

Arthritis Research UK Primary Care Centre
Primary Care Sciences
Keele University
Newcastle-Under-Lyme
ST5 5BG
United Kingdom

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 measures

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

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

Sponsor information

Organisation

University of Keele

Sponsor details

Keele
Newcastle
ST5 5BG
United Kingdom

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes