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
About this trial
This is an interventional treatment trial for Proximal Hamstring Tendinopathy
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
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
NCT ID
NCT04683107
First Posted
December 20, 2020
Last Updated
December 20, 2020
Sponsor
University of Haifa
Collaborators
Tel-Aviv Sourasky Medical Center
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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