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Active, Not Recruiting

NCT Number: NCT06248905

Shock Wave Therapy Plus Exercise in GTPS

The aim of this randomized controlled study is to investigate if the sequential administration of focused shock wave therapy and of a rehabilitation program based on the strengthening of gluteal muscles is more effective than a standard shock wave treatment for greater trochanteric pain syndrome

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Greater Trochanteric Pain Syndrome of Both Lower Limbs

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Unilateral hip pain of four weeks or longer duration
  • Pain to palpation in the greater trochanteric area at physical examination
  • Pain in hip end-range abduction/rotation/adduction at physical examination
  • Gluteal tendinopathy, in absence of full thickness tears at a sonographic examination of the gluteal tendons
  • Adult age and written informed consent

Exclusion criteria

  • No hip osteoarthritis, diagnosed according to Altman's criteria
  • No history of knee osteoarthritis
  • No history of rheumatologic diseases
  • No previous fractures or surgery in the affected limb
  • No clinical signs of lumbar radiculopathy at physical examination
  • No corticosteroid injections, since the onset of the current pain episode
  • No general contraindication to shock wave therapy (pregnancy, bleeding disorders or anticoagulant drug usage, cancer in the focal area)

Treatment and study plan

Rehabilitation program based on the strengthening of gluteal muscles

Other

Physiotherapy program (8 weeks)

Extracorporeal Shock Wave Therapy

Other

Focused shock wave therapy (3 weeks)

Primary outcomes

  1. NRS Pain

    Time frame: 6 months

    Change in lateral hip pain measured by the Numeric Rating Scale (NRS)

Secondary outcomes

  1. EQ5D Quality of life

    Time frame: 12 months

    Change in quality of life measured by EQ-5D-3L

  2. VISA-G Disability

    Time frame: 12 months

    Change in disability measured by VISA-G questionnaire

  3. Functional capacity (strength of gluteal muscles)

    Time frame: 12 months

    Change in functional capacity measured by MRC scale

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Official study title

Shock Wave Therapy Combined With Strengthening Exercise of Hip Abductor Muscles in the Greater Trochanteric Pain Syndrome: a Randomized Controlled Trial

Acronym: GTPSSWEX

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Feb 8, 2024
Registry last updated
Feb 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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