Trials Sponsors Conditions Drugs Pricing

Conditions

Bursitis Hip Gluteal Tendinitis Mobility Limitation Pain Syndrome Trochanteric Syndrome

Keywords

Greater Trochanteric Pain Syndrome,GlutealTendinopathyESWTshockwave

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.

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 applicatorDevice

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 AGroup B

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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.

Sponsors & Collaborators

University of Roma La Sapienza
Otherlead

Study Sites (1)

Sant'Andrea Hospital

Roma, RM, 00144, Italy

MeSH Terms

Conditions

Mobility LimitationSomatoform DisordersTendinopathy

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsMental DisordersMuscular DiseasesMusculoskeletal DiseasesTendon InjuriesWounds and Injuries

Study Officials

Maria Chiara Vulpiani, MD, PHD
Università Sapienza Roma
PRINCIPAL INVESTIGATOR

Enrollment

103 participants (actual enrollment reported by the registry).

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

Extracorporeal Shockwave Treatment for Greater Trochanteric Pain Syndrome

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

Group A

Group B

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

Group A

Group B

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations