NHS Greater Glasgow and Clyde
Glasgow, United Kingdom
NCT Number: NCT06026579
This cross-sectional study will gather participant data from clinical assessment and questionnaires for individuals with a clinical diagnosis of Greater Trochanteric Pain Syndrome.
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Notify Me18 year and older
All sexes
Observational
Glasgow, United Kingdom
Greater trochanteric pain syndrome (GTPS) is characterised by pain over and around the greater trochanter and is primarily due to gluteal tendinopathy. Pain associated with GTPS can affect an individual's ability to perform daily activities while also having a negative impact on sleep, work and participation in sport. Quality of life is often impaired and comparable to severe hip osteoarthritis. A significant number report chronic pain and disability with 29% and 45% of individuals continuing to experience pain at five and 11-year follow-up respectively.
Exercise programmes which specifically target the gluteal muscles and tendons are normally the first-line treatment for GTPS, however 20-50% of individuals do not fully recover within 12 months with this intervention. The reasons for this poor response remain unclear but may be associated with the presence of certain clinical characteristics. Diabetes, obesity, co-existing musculoskeletal disorders, psychological factors and physical activity level may affect prognosis and treatment outcome in GTPS. Co-existing low back and/or hip joint pain is common in this population and a higher number of pain sites has been associated with poorer outcome in other musculoskeletal conditions. In clinical trials, participants with GTPS are often grouped together regardless of individual clinical characteristics. Current treatment strategies appear inadequate for a proportion of patients with this condition meaning alternative options are required to achieve a positive clinical outcome.
Subgroups of patients within the same condition have been identified in low back pain, osteoarthritis and patellofemoral pain. Thus, it is important to look for subgroups within the clinically diagnosed GTPS population.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline and 12 months
The NPRS is a unidimensional measure of pain intensity.Worst and average lateral hip pain over past week will be measured on an 11-point scale between 0 (no pain) and 10 (worst pain imaginable).
Time frame: Baseline and 12 months
Function will be assessed using the PSFS. Each participant will identify three activities they are unable to perform or have difficulty performing due to their problem. They rate the difficulty on a scale from 0 (unable to perform) to 10 (able to perform at prior level). I
Time frame: Baseline and 12 months
Disability will be measured using the VISA-G questionnaire It is currently the preferred option to capture the disability associated with GTPS and has previously been validated for use in this condition.
Time frame: Baseline and 12 months
The TSK-17 is a 17-item questionnaire used to assess fear of movement and reinjury. Four-point Likert scales are used. Total scores range from 17 to 68 with a score greater than 37 indicating kinesiophobia.
Time frame: Baseline and 12 months
Anxiety and depression will be measured using the DASS-21 questionnaire.The DASS items are scored on a 4-point scale ranging from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). Higher scores indicate more frequent symptomatology.
Time frame: Baseline and 12 months
PSEQ is a 10-item questionnaire which measures a person's beliefs about whether they can engage in activities and enjoy life despite experiencing pain. Participants rate how confidently they can perform each activity on a 7-point Likert scale. The total score ranges from 0 to 60, where higher scores reflect stronger self-efficacy.
Time frame: Baseline and 12 months
The EQ-5D-5L is a five-dimension questionnaire for measuring health-related quality of life. Participants rate their health status on five dimension; mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each of these five dimensions has five statements and each participant will tick one of five boxes for each dimension. An index value (0-1) is calculated from five separate questions. A score of 1 reflects greater quality of life. Each participant also evaluates their current overall health status using a visual analogue scale with a score of 0 indicating the worst imaginable health and a score of 100 the best imaginable health.
Time frame: Baseline and 12 months
The IPAQ-SF is a widely used questionnaire to measure physical activity. The seven questions relate to the amount of time the participant has spent being physically active in the previous 7 days. It covers the domains of leisure time, work-related, transport related and domestic and gardening activities.
NHS Greater Glasgow and Clyde
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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