Pain in Paget’s (PiP)
Research type
Research Study
Full title
Deciphering the mechanisms of pain in Paget’s disease
IRAS ID
232314
Contact name
Stuart Ralston
Contact email
Duration of Study in the UK
2 years, 11 months, 30 days
Research summary
Summary of Research
The aim of this project is to investigate the mechanisms of bone pain in patients with established Paget’s disease of the bone (PDB). Bone pain is the most common symptom of PDB and around 73% of patients that come to clinical attention experience bone pain. The mechanisms of bone pain in PDB are incompletely understood, however. We will carefully evaluate a cohort of up to 250 Paget’s patients, some of whom have bone pain and others who do not. Participants will be evaluated clinically by a member of the local care team who will be asked to decide what they think is the most likely cause of the pain. Participants will complete the BPI questionnaire to document the site of pain and its severity and will complete questionnaires to document quality of life. Evidence of neuropathic pain will be sought using the Leeds Assessment of Neuropathic Pain Symptoms and Signs (LANSS) tool and quantitative sensory testing (QST) will be carried out to assess changes in somatosensory processing. Blood samples will be taken for analysis of biochemical markers of bone turnover; for genetic profiling and patients will provide saliva and stool samples for analysis of the microbiome. These measurements will be compared in PDB patients who have pain compared with those that do not to try and gain an insight into the pathophysiology of bone pain in PDB. The study is expected to provide more information on the mechanisms of pain in PDB which in turn should allow a personalised treatment plan to be developed for patients with the disease.Summary of Results
Paget's disease of bone (PDB) is characterised by increased and disorganised bone remodelling. Bone remodelling is a normal process whereby bone tissue is removed from the skeleton and replaced. In PDB, this disorganised bone remodelling can lead to complications such as bone deformity, fracture, and deafness. The most common symptom reported by patients with PDB is pain, but it has until now been unclear what the root cause of this pain was, or why it sometimes does not respond to PDB treatment. The Pain in Paget's (PiP) study found that 72.6% of individuals reported pain. This pain was most commonly due to osteoarthritis unrelated to PDB (44.3%), followed by active PDB (13.1%), bone deformity (11.5%), osteoarthritis at a site of PDB (8.2%), neuropathic pain (8.2%) and other causes (14.8%). Pain was more common in women, and in older individuals. The study illustrates the importance of fully evaluating people with PDB to determine the underlying cause of pain so that management can be tailored appropriately.REC name
West of Scotland REC 3
REC reference
18/WS/0236
Date of REC Opinion
5 Feb 2019
REC opinion
Further Information Favourable Opinion