Contact information
Type
Scientific
Primary contact
Dr Angela Morgan
ORCID ID
Contact details
University of Wolverhampton
School of Health and Wellbeing
Centre for Health and Social Care Improvement
Deanery Row
Off Molineux Street
Wolverhampton
WV1 1DT
United Kingdom
+44 (0)1902 322455
Angela-Morgan@wlv.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Version 4 - 23rd february 2010
Study information
Scientific title
The effect of using copper heelers in alleviating joint and musculoskeletal aches and pains: A double blinded, randomised, placebo controlled trial
Acronym
CH
Study hypothesis
Investigation of the effect of copper heelers (insoles) in a controlled randomised double blind trial in relieving joint and musculoskeletal aches and pains.
Ethics approval
1. South Staffordshire research ethics committee, 04/03/2010
2. Royal Wolverhampton hospital trust research and development, 18/01/2010
Study design
Randomised double-blind placebo-controlled parallel-group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Patient information material can be found at http://home.wlv.ac.uk/~in7458/pi1.pdf
Condition
Rheumatology
Intervention
Randomisation between the copper heeler and placebo heeler will be carried out by the research nurse, by use of a concealed envelope system which will be co-ordinated and recorded by the chief investigator. Patients will be provided with written instructions and training on how to use, care for and dispose of the device. Patients will be required to attend the rheumatology clinic on 6 occasions. Actual usage of the device will be for a period of 12 weeks to collect the study data. Initial assessment will include demographic data, diagnosis, arthritic symptoms and painful sites affected. Details of medication, in particular painkillers, anti-inflammatories and exact dose of these will also be recorded. A baseline visual analogue scale will be used to benchmark their current status along with a simple patient questionnaire to ask patients whether they have had any changes in their symptoms and daily activities, and the device's general usability. Following assessments will consist of a visual analogue scale to assess any change in arthritic symptoms. The frequency and the dose of painkillers and/or the anti-inflammatories will be recorded. At various timepoints another patient questionnaire will be completed to assess any change in symptoms, daily activities and usage.
The total duration of the intervention is 12 weeks.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Beneficial effects will be judged by a minimum of 20% or more improvement in arthritic symptoms and/or 20% or more in reduction of frequency and dose of painkillers and/or anti-inflammatory medication, as judged by visual analogue scale (VAS) score
2. Reduction of pain and stiffness in a joint, as judged by
2.1. Activity score (e.g., comfort of walking)
2.2. Hospital anxiety depression scale (HADS)
2.3. Health assessment questionnaire (HAQ) scores
Outcomes will be assessed at baseline and completion of 100 and 200 participants.
Secondary outcome measures
1. Time taken from 1st usage of the device to it giving some relief of symptoms
2. Dosage of medications taken from 1st use of the device to last study visit
3. Frequency of medications taken from 1st use of the device to last study visit
4. Change in day-to-day activities
Outcomes will be assessed at baseline and completion of 100 and 200 participants.
Overall trial start date
04/03/2010
Overall trial end date
04/03/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Adult males and females, age 16 to 80 years
2. On stable medication (painkillers and anti-inflammatories) without any change for a period of 4 weeks pre-entry (no new drugs have been introduced within that time period and there has been no significant change in pattern of analgesia usage within the current drug regime)
3. Joint and musculoskeletal aches and pains can be present in any part of the body, not just lower limbs
4. Attendees of a rheumatology clinic with confirmed clinical diagnosis of arthritis, inflammatory arthritis i.e. rheumatoid arthritis provided that no steroids in the form of joint injections, oral steroids or intra muscular (IM) depomedrone have been used for three months pre-trial and are unlikely to be required for the period of the trial
5. On stable disease modifying anti-rheumatic drugs without any change or addition for three months pre-trial
6. Osteoarthritis
7. Mental ability to follow instructions as judged by investigator
8. Good understanding of oral and written English
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200
Participant exclusion criteria
1. No known allergy or otherwise intolerance to copper
2. Not pregnant or undergoing pre-conception planning interventions
3. Inability to provide written informed consent
4. Age <16 or >80 years
5. Received steroids in the form of joint injections, oral steroids or IM depomedrone within three months pre-trial
6. Likely to require steroids in the form of joint injections, oral steroids or IM depomedrone during the trial
Recruitment start date
04/03/2010
Recruitment end date
04/03/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Wolverhampton
Wolverhampton
WV1 1DT
United Kingdom
Sponsor information
Organisation
University of Wolverhampton Corporate Services Ltd (UK)
Sponsor details
School of Health and Wellbeing
Deanery Row
Off Molineux Street
Wolverhampton
WV1 1DT
United Kingdom
+44 (0)1902 518614
Angela-Morgan@wlv.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Anthony Andrews Master Shoemaker (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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