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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04683107
Other study ID # University of Haifa (UHaifa)
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 2021
Est. completion date September 2021

Study information

Verified date December 2020
Source University of Haifa
Contact Doron Schlissel, BPT
Phone 972-545491070
Email schlissel.doron@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 42
Est. completion date September 2021
Est. primary completion date July 2021
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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

Study Design


Intervention

Other:
Eccentric protocol
Participants in this arm will perform progressive eccentric exercise protocol
Isometric protocol
Participants in this arm will perform progressive isometric exercise protocol

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Haifa Tel-Aviv Sourasky Medical Center

Outcome

Type Measure Description Time frame Safety issue
Primary 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 6 weeks
Primary Isometric and eccentric muscle force 6 weeks
Primary Running performance measuring running time for 1.5 km 6 weeks
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