LEICeSter Tendon Extracorporeal Shockwave Studies

NCT02546128 | Unknown

• 1 other identifier: UHL - 11401
• Study Type: interventional
• Target: 720
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tendinopathy

Outcome Measures

Primary Outcomes (1)

• improvement in pain as assessed by a 0-10 visual analogue scale (VAS)

  primary outcome 3 months

Secondary Outcomes (2)

• improvement in pain as assessed by a 0-10 visual analogue scale (VAS)

  secondary outcome at 6 months post treatment

• improvement in function as assessed by several validated patient-rated outcome measures

  3 months and 6 months

Study Arms (2)

intervention

EXPERIMENTAL

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

Device: Extra-Corporeal Shockwave Therapy (ESWT); Other: structured rehabilitation programme

control

PLACEBO COMPARATOR

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

Other: structured rehabilitation programme

Interventions

Extra-Corporeal Shockwave Therapy (ESWT) DEVICE

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

intervention

structured rehabilitation programme OTHER

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

control; intervention

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients age \>18
• Symptoms (typically pain / stiffness) of at least 12 weeks of one of the following sites / conditions:
• Plantar fasciitis
• Insertional Achilles tendinopathy
• Mid-substance Achilles tendinopathy
• Patella tendinopathy
• Trochanteric pain syndrome (gluteus medius insertional tendinopathy / trochanteric bursitis)
• Tennis elbow
• Referred for ESWT (shockwave) within the Sports Medicine Department
• Objective imaging of tendon / structure confirming diagnosis and excluding tear or other structural injury (US or MRI acceptable)

You may not qualify if:

• Previous ESWT treatment for the same condition

Sponsors & Collaborators

• University Hospitals, Leicester: lead

Study Sites (1)

University Hospitals of Leicester NHS Trust

Leicester, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 33512943 DERIVED

MeSH Terms

Conditions

Tendinopathy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries

Study Officials

• Patrick Wheeler

  UHL NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick Wheeler

CONTACT

patrick.wheeler@uhl-tr.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2015
• First Posted: September 10, 2015
• Study Start: July 1, 2015
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 1, 2024

Record last verified: 2023-11

Locations

GB (1)