Mucopolysaccharidosis type II Nutritional, Metabolic, Endocrine Mucopolysaccharidosis, type II
Conditions
Interventions
Participants are randomised into two groups A and B. While group A initially receives the hydrotherapy treatment, group B receives nothing and completes pain and quality of life questionnaires. Then t
Sponsors
Salford Royal Organisation, Northern Care Alliance NHS Foundation Trust
Eligibility
Sex/Gender
Male
Age
16 Years to 58 Years
Inclusion criteria
Inclusion criteria: 1. Adult MPS II patients (Hunter syndrome; all males aged 18-58 years), who suffer from joint pain and stiffness and/or post-surgical musculoskeletal pain, not responding to analgesic agents 2. Patients with reduced mobility and wheelchair reliance 3. Patients are able to give consent and feedback. In patients with limited capacity, their carers/parents may be asked to help complete the questionnaires. 4. Participants who pass the Trust hydrotherapy risk assessment at baseline
Exclusion criteria
Exclusion criteria: 1. Contraindications to standard hydrotherapy: acute diarrhoea or vomiting, recent acute cerebral vascular accident (CVA)/deep venous thrombosis (DVT)/pulmonary embolism (PE), resting angina, resting shortness of breath, uncontrolled cardiac failure, weight in excess of evacuation equipment, proven chlorine allergy. 2. More severely incapacitated (severe learning needs) and/or immobile patients. 3. The objective Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) score will be used to identify and exclude patients who suffer from predominantly neuropathic pain (rather than musculoskeletal nociceptive-driven pain). This assessment will be performed by a pain specialist.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of life assessed using the Short Form Health Survey 36 scale (performed by nurse) at baseline, 6 weeks and 12 weeks while undergoing hydrotherapy and then separately while in the non-intervention arm | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessed at baseline, at a 6- and 12-week follow-up unless stated otherwise: 1. Risk assessment at baseline 2. Symptom severity assessed using the Brief Pain Inventory and pain-related questionnaires related to anxiety (GAD-7), quality of life (PHQ9) and kinesiophobia (TSK11) (performed by pain specialist/nurse) 3. The objective LANSS score will be used to identify and exclude patients who suffer from predominantly neuropathic pain (rather than musculoskeletal nociceptive-driven pain). This assessment will be performed by a pain specialist. 4. Global impression of change for patients with learning difficulties as assessed by the MDT team (consultant, physiotherapist & nurse) 5. Physiotherapy assessment including joint range of movement, muscle strength, functional mobility using ‘Timed Up and Go’ and either a 6-minute walk test or 10-m walk test as appropriate (performed by a specialist physiotherapist) 6. Medication utilization assessed using questionnaires before and after the intervention (performed by a nurse) 7. Adverse event log from starting hydrotherapy e.g. balance problems after each hydrotherapy session 8. Patient satisfaction assessed using a questionnaire at the end of the study | — |
Countries
England, United Kingdom
Contacts
Public ContactMarie Meehan
Outcome results
None listed