LEICeSter Tendon Extracorporeal Shockwave Studies

NCT ID: NCT02546128

Last Updated: 2024-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

720 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To assess whether the addition of Extra-corporeal Shockwave Therapy (ESWT) to a structured home-exercise programme has any additional benefit to patients with tendinopathies

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This involves patients with one of 6 different defined chronic tendinopathies. These individual sites are run as discrete sub-studies, with randomisation n occurring within sub-study grouping

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tendinopathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

intervention

rehabilitation + "active-dose" ESWT (extra-corporeal shockwave therapy)

Group Type EXPERIMENTAL

Extra-Corporeal Shockwave Therapy (ESWT)

Intervention Type DEVICE

The use of ESWT from a commercially available machine at approved settings already in routine clinical use

structured rehabilitation programme

Intervention Type OTHER

a structured and standardised rehabilitation programme specific to the tendon in question - already in routine clinical use

control

rehabilitation + "placebo-dose" ESWT (extra-corporeal shockwave therapy)

Group Type PLACEBO_COMPARATOR

structured rehabilitation programme

Intervention Type OTHER

a structured and standardised rehabilitation programme specific to the tendon in question - already in routine clinical use

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Extra-Corporeal Shockwave Therapy (ESWT)

The use of ESWT from a commercially available machine at approved settings already in routine clinical use

Intervention Type DEVICE

structured rehabilitation programme

a structured and standardised rehabilitation programme specific to the tendon in question - already in routine clinical use

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Patients age \>18
2. Symptoms (typically pain / stiffness) of at least 12 weeks of one of the following sites / conditions:

1. Plantar fasciitis
2. Insertional Achilles tendinopathy
3. Mid-substance Achilles tendinopathy
4. Patella tendinopathy
5. Trochanteric pain syndrome (gluteus medius insertional tendinopathy / trochanteric bursitis)
6. Tennis elbow
3. Referred for ESWT (shockwave) within the Sports Medicine Department
4. Objective imaging of tendon / structure confirming diagnosis and excluding tear or other structural injury (US or MRI acceptable)

Exclusion Criteria

1. Patients with the normal exclusions for ESWT - including pre-existing skin injury over tendon site, recent steroid injection (within 6 weeks of ESWT starting), patients on anticoagulation, patients with haemophilia or other bleeding tendency, patients with current febrile illness
2. Previous ESWT treatment for the same condition
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospitals, Leicester

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Patrick Wheeler

Role: PRINCIPAL_INVESTIGATOR

UHL NHS Trust

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospitals of Leicester NHS Trust

Leicester, , United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Patrick Wheeler

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Sports Medicine Department

Role: primary

0116 2584365

References

Explore related publications, articles, or registry entries linked to this study.

Wheeler PC, Dudson C, Calver R, Goodall D, Gregory KM, Singh H, Boyd KT. Three Sessions of Radial Extracorporeal Shockwave Therapy Gives No Additional Benefit Over "Minimal-Dose" Radial Extracorporeal Shockwave Therapy for Patients With Chronic Greater Trochanteric Pain Syndrome: A Double-Blinded, Randomized, Controlled Trial. Clin J Sport Med. 2022 Jan 1;32(1):e7-e18. doi: 10.1097/JSM.0000000000000880.

Reference Type DERIVED
PMID: 33512943 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UHL - 11401

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.