Systemic Sclerosis / Scleroderma Skin and Connective Tissue Diseases
Conditions
Interventions
The study will involve 36 people with scleroderma and some associated hand function limitation being recruited from the Rheumatology Department at Salford Royal Hospital. Participation will be over an
Sponsors
Salford Royal NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with scleroderma (systemic sclerosis) all diagnosed by a consultant rheumatologist with an interest in scleroderma, and attending Salford Royal NHS Foundation Trust 2. No previous treatment with hand wax treatment 3. Able to perform wax treatment 4. No known or suspected allergy to the wax used in the treatment 5. Some degree of hand involvement from their scleroderma (modified Rodnan skin score of the fingers >1) 6. No contra-indication to the use of the intervention, primarily digital ulcers, but also including neurological or sensory deficits 7. Willing and able to give informed consent 8. Male and female, aged 18 or over
Exclusion criteria
Exclusion criteria: 1. Unlikely or unable to complete outcome assessments 2. Does not meet the inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure in this study is the Hand Mobility in Scleroderma (HAMIS) (Sanqvist & Eklund 2000). It consists of 9 items that measure mobility of the fingers and the wrist; its primary purpose is to estimate the mobility of the hand precisely enough to detect limitations in range of movement, and at the same time, provide an indication of the patient's ability to use the hand in daily activities (Sanqvist et al. 2004, p.981). It requires some specific equipment which is used to score these nine items between 0 and 3. It takes about 3 minutes to complete. Measured at baseline (week 0), and week 9 (+/-14days) and at week 18 (+/-14days). | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome measures are: 1. SHAQ, Scleroderma Health Assessment Questionnaire (Johnson & Lee 2004) is used to measure disability. It assesses difficulty with daily activities (20 items) and interference of scleroderma symptoms with activities (visual analogue scale [VAS] 0-10 cm for Raynaud phenomenon, finger ulcers, lung problems, pain, gastrointestinal problems and general disease related problems). 2. Pinch / Grip strength: Assessed using a Jamar grip meter and a Jamar pinch meter along standard three repetition maximum score protocols (Roberts et al. 2011). 3. Durouz / Cochin hand scale: A participant completed questionnaire (Brower & Poole 2004). It contains 18 items regarding hand ability in the kitchen, during dressing, while performing personal hygiene, while performing office tasks, and other general items. Persons rate their ability from 0 (no difficulty) to 5 (impossible to do). The questionnaire yields a score from 0 to 90 and takes about 3 minutes to complete 4. Modified Rodnan skin score (mRss): A physician completed assessment of skin thickness and elasticity (Furst et al 1998). 5. Visual Analogue Scale for pain in the hands: To give a score out of ten for the participants? perceived pain levels experiences in their hands over the past week 6. Pain relief medications use (journal / diary): To be reviewed in relation to the participant's VAS pain score 7. Patient completed exercise journal / diary: To assess for compliance and indicate tolerability Measured at baseline (week 0), and week 9 (+/-14days) and at week 18 (+/-14days). | — |
Countries
United Kingdom
Outcome results
None listed