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

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ClinicalTrials.gov Identifier: NCT04683107
Recruitment Status : Not yet recruiting
First Posted : December 24, 2020
Last Update Posted : December 24, 2020
Sponsor:
Collaborator:
Tel-Aviv Sourasky Medical Center
Information provided by (Responsible Party):
University of Haifa

Study Description
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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.


Condition or disease Intervention/treatment Phase
Proximal Hamstring Tendinopathy Tendinopathy Eccentric Exercise Isometric Exercise Hamstring Tendon Injury Other: Eccentric protocol Other: Isometric protocol Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Eccentric Versus Isometric Exercise in Reducing Pain in Runners With Proximal Hamstring Tendinopathy
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tendinitis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Eccentric protocol Other: Eccentric protocol
Participants in this arm will perform progressive eccentric exercise protocol
Experimental: Isometric protocol Other: Isometric protocol
Participants in this arm will perform progressive isometric exercise protocol


Outcome Measures
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Primary Outcome Measures :
  1. Victorian Institute of Sport Assessment-Proximal Hamstring Tendons (VISA-H) questionnaire [ Time Frame: 6 weeks ]
    VISA-H is a patient reported outcome questionnaire with high psychometric properties for measuring pain, function and sporting activity in patients with PHT

  2. Isometric and eccentric muscle force [ Time Frame: 6 weeks ]
  3. Running performance [ Time Frame: 6 weeks ]
    measuring running time for 1.5 km


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04683107


Contacts
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Contact: Doron Schlissel, BPT 972-545491070 schlissel.doron@gmail.com
Contact: Einat Kodesh, PHD 972-523489854 ekodesh@gmail.com

Sponsors and Collaborators
University of Haifa
Tel-Aviv Sourasky Medical Center
More Information
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Responsible Party: University of Haifa
ClinicalTrials.gov Identifier: NCT04683107    
Other Study ID Numbers: University of Haifa (UHaifa)
First Posted: December 24, 2020    Key Record Dates
Last Update Posted: December 24, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tendinopathy
Tendon Injuries
Muscular Diseases
Musculoskeletal Diseases
Wounds and Injuries