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

Not Applicable

Completed

• Conditions: Rheumatology; Musculoskeletal Diseases; Other rheumatoid arthritis

• Registration Number: ISRCTN42466047
• Lead Sponsor: niversity of Wolverhampton Corporate Services Ltd (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2010-03-04
• Study Start: 2010-03-18
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 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<br> 2. Reduction of pain and stiffness in a joint, as judged by<br> 2.1. Activity score (e.g., comfort of walking)<br> 2.2. Hospital anxiety depression scale (HADS)<br> 2.3. Health assessment questionnaire (HAQ) scores<br> Outcomes will be assessed at baseline and completion of 100 and 200 participants.<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Time taken from 1st usage of the device to it giving some relief of symptoms<br> 2. Dosage of medications taken from 1st use of the device to last study visit<br> 3. Frequency of medications taken from 1st use of the device to last study visit<br> 4. Change in day-to-day activities<br> Outcomes will be assessed at baseline and completion of 100 and 200 participants.<br>