Extracorporeal Shockwave Treatment for Greater Trochanteric Pain Syndrome

NCT03338465 | Completed

• 1 other identifier: 4
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

Greater trochanteric pain syndrome (GTPS) is characterized by pain over the greater trochanter, which can refer down the lateral aspect of the hip. Historically, conservative treatments such as rest/activity modification, anti-inflammatory medication, physiotherapy and local corticosteroid injection, are employed as first-line management, with some refractory cases requiring surgical intervention. Acknowledging the unpredictable response and frequent recurrences associated with traditional non operative treatment, the risks and prolonged rehabilitation associated with surgery, and the favorable results from prior studies involving radial pressure waves as a treatment for GTPS, the aim of this study is to investigate the dose-related effect of focalized shockwave treatment at different total energy influx in patients with chronic GTPS.

Conditions

Mobility Limitation; Trochanteric Syndrome; Gluteal Tendinitis; Bursitis Hip; Pain Syndrome

Keywords

Greater Trochanteric Pain Syndrome,; Gluteal; Tendinopathy; ESWT; shockwave

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale (VAS) for the estimation of the intensity of pain

  The VAS provides a continuous scale for magnitude estimation and consists of a straight line, the ends of which are defined in terms of the extreme limits of pain experience such as 'no pain at all' and 'pain as bad as it could be'. Respondents mark the location on the 10-centimeter line corresponding to the amount of pain experienced. This gives the greatest freedom to choose pain's exact intensity. It also gives the maximum opportunity for each respondent to express a personal response style. VAS data of this type is recorded as the number of millimeters from the left of the line with the range 0-100.

  8 weeks after treatment (T2)

Secondary Outcomes (5)

• Harris Hip Score (HHS) to evaluate hip disability

  4 (T1), 8 (T2), 12 (T3) and 24 (T4) weeks after treatment.

• Lower Extremity Functional Scale (LEFS)

  4 (T1), 8 (T2), 12 (T3) and 24 (T4) weeks after treatment.

• Roles and Maudsley scale (RM) to evaluate patients satisfaction

  4 (T1), 8 (T2), 12 (T3) and 24 (T4) weeks after treatment.

• EuroQoL five dimensions questionnaire (EQ-5D) to evaluate quality of life

  4 (T1), 8 (T2), 12 (T3) and 24 (T4) weeks after treatment.

• Visual Analogue Scale (VAS) for the estimation of the intensity of pain

  4 (T1), 12 (T3) and 24 (T4) weeks after treatment.

Study Arms (2)

Group A

ACTIVE COMPARATOR

3 weekly sessions of focused extracorporeal shockwave treatment (2.000 impulses at 0.20 millijoules/mm2 per session)

Device: Duolith SD1, STORZ Medical, Switzerland with F-SW applicator

Group B

ACTIVE COMPARATOR

3 weekly sessions of focused extracorporeal shockwave treatment (2.000 impulses at 0.01 millijoules/mm2 per session)

Device: Duolith SD1, STORZ Medical, Switzerland with F-SW applicator

Interventions

Duolith SD1, STORZ Medical, Switzerland with F-SW applicator DEVICE

The procedure will be performed with the patient in lateral positioning of the decubitus. The treatment area will be prepared with a coupling ultrasound gel to minimize the loss of shockwave energy at the interface between the tip of the applicator and the skin. The inline ultrasonic guide will be used to concentrate the shockwaves on the pain area in the trochanteric region. No local anesthesia will be applied.

Also known as: Focused Extracorporeal Shock Waves, ESWT

Group A; Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of either sex, aged oved 18 years, complaining of pain located anterior, lateral or posterior to the great trochanter for more than 3 months.
• Pain while lying on the affected side.
• Local tenderness on palpation of the area of the great trochanter of patients with this symptom as the reason for the consultation.

You may not qualify if:

• Presence of signs and symptoms of another cause of regional hip pain.
• Presence of hip internal rotation 20° and extension deficit or other range of motion limitation 10º
• Previous hip surgery or use of ESWT for GTPS.
• Acute low back pain
• Vascular, neurologic, rheumatic diseases.
• Tumor in the area or local infection to the hip joint region.
• Pregnancy.
• Severe coagulation disorders.

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Sant'Andrea Hospital

Roma, RM, 00144, Italy

Location

MeSH Terms

Conditions

Mobility Limitation; Somatoform Disorders; Tendinopathy

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries

Study Officials

• Maria Chiara Vulpiani, MD, PHD

  Università Sapienza Roma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participants will be blinded to the type of ESWT treatment and the assessor, data managers, statistician and study monitors will be blinded to the allocation. All participants who receive ESWT treatment will be treated using the same device (Duolith SD1, STORZ Medical, Switzerland) regardless of what group they are included in. The participants will not be able to predict the allocated group based on the appearance of the ESWT treatment. The blinding will be maintained until the data are locked. For blinding evaluation, allocation guessing will be assessed immediately after the final treatment. Practitioners and assessors will be instructed to treat the participants according to predefined standard operating procedures during the trial to maintain blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Physical Medicine and Rehabilitation Unit, Sant'Andrea Hospital of Rome

Study Record Dates

• First Submitted: November 2, 2017
• First Posted: November 9, 2017
• Study Start: June 1, 2018
• Primary Completion: January 21, 2019
• Study Completion: February 18, 2019
• Last Updated: June 1, 2020

Record last verified: 2020-05

Locations

IT (1)