Carpal tunnel syndrome (CTS) is a common condition of the hands in which the median nerve is squeezed where it passes through the wrist. Typical symptoms of CTS include pain, aching, tingling and numbness in the thumb and fingers and waking at night. It frequently affects both hands and can result in difficulties with everyday activities, work and leisure.
Treatment options include splints and steroid injections for mild to moderate symptoms of CTS and surgical decompression for moderate to severe CTS. It is thought that a number of factors affect how well patients respond to different treatments. At present, however, there is insufficient research evidence to be able to predict what treatment is likely to work in which patients.
This large-scale observational study will follow-up over 700 patients newly diagnosed with CTS over 18 to 24 months. Information on clinical symptoms, general physical and emotional health, treatments received and treatment outcomes will be used to identify what factors predict a good response to treatment and to establish the costs of CTS to the individual, NHS and society.
The PalmS study is addressing the following research questions:
- What is the course and progression of CTS in treated and untreated patients over 18-24 months from diagnosis?
- What are the baseline clinical, psychological and sociodemographic predictors for response to treatment by steroid injection and surgical decompression?
- What are the costs of CTS to the individual, the NHS and society over a period of 18-24 months?
- What are the predictors of costs of CTS?
The PalmS prospective longitudinal cohort study collected data on putative predictive factors for response to treatment by means of a study-specific questionnaire, utilising standardised and non-standardised measures. Patients enrolled on the study were followed-up for 18-24 months and completed questionnaires at six-monthly intervals either online or on paper.
Recruitment took place at four neurophysiology departments and one hand surgery centre across five NHS Trusts in England between July 2013 and December 2015. Patients with CTS diagnosed by clinical examination and nerve conduction studies (NCS) were eligible to take part. A total of 1918 patients, aged 18 and over, with CTS in at least one hand, were identified and invited to participate, of which a total of 754 patients met all eligibility criteria and returned full baseline questionnaires.
Data was collected on symptom severity, hand function, psychological status, health-related quality of life, co-morbidities, treatments received, health care resource use and, in the follow-up questionnaires, a patient-reported outcome measure. Clinical and demographic variables collected at baseline were age, sex, duration of symptoms, height and weight, work status and type, smoking status, alcohol units consumed per week, ethnicity and household income. The NCS reports of enrolled patients were used to grade the compression of the median nerve.
Analysis of the PalmS dataset will provide information on the baseline factors that may predict a favourable response to treatment. It is an important first step towards the development of a set of clinical prediction rules that have the potential to influence future care pathways and to give both service users and service providers a clearer indication of the expected outcome from treatment.
Principal investigator: Professor Christina Jerosch-Herold (School of Health Sciences, UEA)
Co-investigators: Professor Lee Shepstone (Norwich Medical School, UEA), Julian Blake (Department of Physiology, Norfolk & Norwich University Hospital), Dr Ed Wilson (Cambridge Centre for Health Services Research)
Senior Research Assistant: Ms Julie Houghton (School of Health Sciences, UEA)
Database Manager: Antony Colles (Norwich Clinical Trials Unit, UEA)
NHS collaborating sites: Julian Blake and Adrian Tearle (Norfolk and Norwich University Hospitals NHS Trust), Ann Harvey (Ipswich Hospital), Stephen Scott (James Paget Hospital, Gt Yarmouth), Jeremy Bland (Kings College Hospital), Lionel Christopher Bainbridge (Derby Royal Hospital)
Patient and Public Involvement in Research members: Jenny Griffiths and Sue Spooner
The study is funded by a National Institute for Health Research (NIHR) Senior Research Fellowship.