Clinical trial NCT06026579: Clinical Characteristics and Subgroups in Greater Trochanteric Pain Syndrome
Official title: Clinical Characteristics and Subgroups in Greater Trochanteric Pain Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Greater Trochanteric Pain Syndrome
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
Collaborators: name: NHS Research Scotland
First posted: 2023-09-07
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with a clinical diagnosis of GTPS will be recruited from NHS physiotherapy waiting lists in Greater Glasgow and Clyde and also from the general public who currently reside in Greater Glasgow and Clyde.

Brief summary: This cross-sectional study will gather participant data from clinical assessment and questionnaires for individuals with a clinical diagnosis of Greater Trochanteric Pain Syndrome.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Adults aged \> 18 years who currently reside within Greater Glasgow and Clyde
* Lateral hip pain of any duration
* Able to give written informed consent
* Pain on direct palpation of the gluteal tendon insertion on the greater trochanter and additionally at least one of the following pain provocation tests must also be positive:

  1. FABER (Flexion, Abduction, External Rotation of the hip)
  2. FADER (Flexion, Adduction, External Rotation of the hip)
  3. FADER and resisted Internal Rotation (IR) (FADER position plus resisted IR of the hip)
  4. Single leg stand for 30 seconds
  5. Resisted hip abduction at end-range adduction

Exclusion Criteria:

* Lateral hip pain secondary to another source e.g. hip joint pathology or lumbar referred pain
* Inflammatory joint conditions
* Neurological conditions
* Pregnancy
* Unable or unwilling to give informed consent
* Unable to write, read or comprehend English

Primary outcomes:
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: Baseline and 12 months
measure: Patient Specific Functional Scale (PSFS)
timeFrame: Baseline and 12 months
measure: Victoria Institute of Sports Assessment-GTPS (VISA-G)
timeFrame: Baseline and 12 months
measure: Tampa Scale for Kinesiophobia (TSK-17)
timeFrame: Baseline and 12 months
measure: Depression and Anxiety Stress Scales-21 (DASS-21)
timeFrame: Baseline and 12 months
measure: Pain Self-Efficacy Questionnaire (PSEQ)
timeFrame: Baseline and 12 months
measure: Euro Qol (EQ-5D-5L)
timeFrame: Baseline and 12 months
measure: International Physical Activity Questionnaire - Short Form (IPAQ-SF)
timeFrame: Baseline and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde
Study officials:
affiliation: NHS Greater Glasgow and Clyde
name: Chris Clifford, PhD
role: PRINCIPAL_INVESTIGATOR
References: