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11 February 2012
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| [ Print-friendly version ] |
| The effect of using copper heelers in alleviating joint and musculoskeletal aches and pains |
| ISRCTN | ISRCTN42466047 |
| ClinicalTrials.gov identifier | |
| Public title | The effect of using copper heelers in alleviating joint and musculoskeletal aches and pains |
| 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 |
| Serial number at source | Version 4 - 23rd february 2010 |
| 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. |
| Lay summary | |
| Ethics approval |
1. South Staffordshire research ethics committee approved on the 4th of March 2010
2. Royal Wolverhampton hospital trust research and development approved on the 18th of January 2010 |
| Study design | Randomised double blind placebo controlled parallel group trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Rheumatology |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 04/03/2010 |
| Anticipated end date | 04/03/2010 |
| Status of trial | Completed |
| Patient information material | Patient information material can be found at http://home.wlv.ac.uk/~in7458/pi1.pdf |
| Target number of participants | 200 |
| Interventions |
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. |
| 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
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 measure(s) |
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. |
| Sources of funding | Anthony Andrews Master Shoemaker (UK) |
| Trial website | |
| Publications | |
| Contact name | Dr Angela Morgan |
| Address |
University of Wolverhampton
School of Health and Wellbeing Centre for Health and Social Care Improvement Deanery Row Off Molineux Street |
| City/town | Wolverhampton |
| Zip/Postcode | WV1 1DT |
| Country | United Kingdom |
| Tel | +44 (0)1902 322455 |
| Fax | +44 (0)1902 321161 |
| Angela-Morgan@wlv.ac.uk | |
| Sponsor | University of Wolverhampton Corporate Services Ltd (UK) |
| Address |
School of Health and Wellbeing
Deanery Row Off Molineux Street |
| City/town | Wolverhampton |
| Zip/Postcode | WV1 1DT |
| Country | United Kingdom |
| Tel | +44 (0)1902 518614 |
| Fax | +44 (0)1902 321161 |
| Angela-Morgan@wlv.ac.uk | |
| Date applied | 05/03/2010 |
| Last edited | 18/03/2010 |
| Date ISRCTN assigned | 18/03/2010 |
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| © 2012 ISRCTN unless otherwise stated. | |
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