The effect of using copper heelers in alleviating joint and musculoskeletal aches and pains

ISRCTN	ISRCTN42466047
DOI	https://doi.org/10.1186/ISRCTN42466047
Secondary identifying numbers	Version 4 - 23rd february 2010

Submission date: 05/03/2010
Registration date: 18/03/2010
Last edited: 01/11/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Angela Morgan
Scientific

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

Phone	+44 (0)1902 322455
Email	Angela-Morgan@wlv.ac.uk

Study information

Study design	Randomised double-blind placebo-controlled parallel-group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Patient information material can be found at http://home.wlv.ac.uk/~in7458/pi1.pdf
Scientific title	The effect of using copper heelers in alleviating joint and musculoskeletal aches and pains: A double blinded, randomised, placebo controlled trial
Study acronym	CH
Study objectives	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(s)	1. South Staffordshire research ethics committee, 04/03/2010 2. Royal Wolverhampton hospital trust research and development, 18/01/2010
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	04/03/2010
Completion date	04/03/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	200
Key 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
Key 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
Date of first enrolment	04/03/2010
Date of final enrolment	04/03/2010

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Wolverhampton

Wolverhampton
WV1 1DT
United Kingdom

Sponsor information

University of Wolverhampton Corporate Services Ltd (UK)
University/education

School of Health and Wellbeing
Deanery Row
Off Molineux Street
Wolverhampton
WV1 1DT
England
United Kingdom

Phone	+44 (0)1902 518614
Email	Angela-Morgan@wlv.ac.uk
"ROR"	https://ror.org/01k2y1055

Funders

Funder type

Industry

Anthony Andrews Master Shoemaker (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

01/11/2019: No publications found, all search options exhausted, study status unverified.
31/10/2019: No publications found, verifying study status with principal investigator.
13/06/2016: No publications found, verifying study status with principal investigator.