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Efficacy of Eccentric Versus Isometric Exercise in Reducing Pain in Runners With Proximal Hamstring Tendinopathy

Primary Purpose

Proximal Hamstring Tendinopathy, Tendinopathy, Eccentric Exercise

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Eccentric protocol
Isometric protocol
Sponsored by
University of Haifa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Proximal Hamstring Tendinopathy

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Medium and long distance runners and endurance athletes (triathlon, Iron Man)
  • over the age of 40
  • With tendon pain lasting 3 months or more, at the location of hamstring insertion in Ischial tuberosity, that increases during or after running.

Exclusion Criteria:

  • Hamstring tear (posterior thigh muscle) according to MRI
  • Stress fractures of the ischium bone
  • Radiated pain in the posterior thigh originating in the lumbar spine, hip joint or sacroiliac joint
  • Other pathologies or rupture of the hamstring muscle
  • Exclude people who have received therapeutic intervention in the last month
  • Medication use for PHT
  • Pain located medially or laterally to the Ischial tuberosity
  • Pregnant women

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Eccentric protocol

    Isometric protocol

    Arm Description

    Outcomes

    Primary Outcome Measures

    Victorian Institute of Sport Assessment-Proximal Hamstring Tendons (VISA-H) questionnaire
    VISA-H is a patient reported outcome questionnaire with high psychometric properties for measuring pain, function and sporting activity in patients with PHT
    Isometric and eccentric muscle force
    Running performance
    measuring running time for 1.5 km

    Secondary Outcome Measures

    Full Information

    First Posted
    December 20, 2020
    Last Updated
    December 20, 2020
    Sponsor
    University of Haifa
    Collaborators
    Tel-Aviv Sourasky Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04683107
    Brief Title
    Efficacy of Eccentric Versus Isometric Exercise in Reducing Pain in Runners With Proximal Hamstring Tendinopathy
    Official Title
    Efficacy of Eccentric Versus Isometric Exercise in Reducing Pain in Runners With Proximal Hamstring Tendinopathy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2021 (Anticipated)
    Primary Completion Date
    July 2021 (Anticipated)
    Study Completion Date
    September 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Haifa
    Collaborators
    Tel-Aviv Sourasky Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Tendon injuries are the most common injuries in sports. They are difficult to treat and cause prolonged absence and decreased athlete performance. Proximal hamstring tendinopathy (PHT) is one of them. First described by Puranen and Orava in 1988 as hamstring syndrome. This injury is most common in the active population. PHT is a chronic degenerative injury that is produced by mechanical overload and repetitive stretch. Risk factors include overuse, poor lumbopelvic stability and relative weakness of the hamstring muscles. The phenomenon manifests itself with deep pain in the ischial tuberosity area and projection to the posterior thigh, pain during prolonged sitting, pain during hip flexion and knee extension and pain that increases or arises during running, especially during the swing phase. Risk factors are divided into internal (systemic and biomechanical) and external factors. Internal factors associated with systemic characteristics, include advanced age, sex, obesity, genetics, inflammation and autoimmune conditions, diabetes, hyperlipidemia, and drug use. The external factors, which are more modifiable, are those that depend on the patient's external environment and include training errors such as increasing training volume and / or intensity too quickly and insufficient recovery that cause an overload on the tendon. For PHT two conditions are considered provocative - energy storage, an action that is typical in the late swing phase while running and repetitive movements that cause compressive forces of the tendon on ischial tuberosity. Compressive forces increase as the hip or trunk flex which explains why training errors such as an increase in volume or intensity of the training and non-gradual change in training type, such as hurdle or hills training, are considered to be factors involved in PHT. PHT treatment options include physiotherapy, shock waves, Platelet rich plasma (PRP) and surgical treatment. Non-surgical treatments for tendinopathy includes gradual loading of the tendon under the supervision of the level of pain. The load on the tendon causes an increase in collagen synthesis and an increase in the stiffness and capacity of the tendon which ultimately helps return the athlete to function and reduces the level of pain. Although the injury mechanism is common among runners and athletes from various endurance disciplines (medium and long distance runners, triathletes, etc.) the phenomenon and its treatment has not been sufficiently studied within this population.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Proximal Hamstring Tendinopathy, Tendinopathy, Eccentric Exercise, Isometric Exercise, Hamstring Tendon Injury

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    42 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Eccentric protocol
    Arm Type
    Experimental
    Arm Title
    Isometric protocol
    Arm Type
    Experimental
    Intervention Type
    Other
    Intervention Name(s)
    Eccentric protocol
    Intervention Description
    Participants in this arm will perform progressive eccentric exercise protocol
    Intervention Type
    Other
    Intervention Name(s)
    Isometric protocol
    Intervention Description
    Participants in this arm will perform progressive isometric exercise protocol
    Primary Outcome Measure Information:
    Title
    Victorian Institute of Sport Assessment-Proximal Hamstring Tendons (VISA-H) questionnaire
    Description
    VISA-H is a patient reported outcome questionnaire with high psychometric properties for measuring pain, function and sporting activity in patients with PHT
    Time Frame
    6 weeks
    Title
    Isometric and eccentric muscle force
    Time Frame
    6 weeks
    Title
    Running performance
    Description
    measuring running time for 1.5 km
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Medium and long distance runners and endurance athletes (triathlon, Iron Man) over the age of 40 With tendon pain lasting 3 months or more, at the location of hamstring insertion in Ischial tuberosity, that increases during or after running. Exclusion Criteria: Hamstring tear (posterior thigh muscle) according to MRI Stress fractures of the ischium bone Radiated pain in the posterior thigh originating in the lumbar spine, hip joint or sacroiliac joint Other pathologies or rupture of the hamstring muscle Exclude people who have received therapeutic intervention in the last month Medication use for PHT Pain located medially or laterally to the Ischial tuberosity Pregnant women
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Doron Schlissel, BPT
    Phone
    972-545491070
    Email
    schlissel.doron@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Einat Kodesh, PHD
    Phone
    972-523489854
    Email
    ekodesh@gmail.com

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy of Eccentric Versus Isometric Exercise in Reducing Pain in Runners With Proximal Hamstring Tendinopathy

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