The effect of using copper heelers in alleviating joint and musculoskeletal aches and pains
| ISRCTN | ISRCTN42466047 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42466047 |
| Protocol serial number | Version 4 - 23rd february 2010 |
| Sponsor | University of Wolverhampton Corporate Services Ltd (UK) |
| Funder | Anthony Andrews Master Shoemaker (UK) |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
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 |
|---|---|
| Angela-Morgan@wlv.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blind placebo-controlled parallel-group trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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(s) |
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 |
| Key secondary outcome measure(s) |
1. Time taken from 1st usage of the device to it giving some relief of symptoms |
| Completion date | 04/03/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
WV1 1DT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
