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Proximal Hamstring TendinopathyNCT04683107

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

A study testing Eccentric protocol and Isometric protocol in people with Proximal Hamstring Tendinopathy and Tendinopathy, run by University of Haifa.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
Eccentric protocol and Isometric protocol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
No sites listed yet
Study dates
Jan 2021to Sep 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet.

Doron Schlissel, BPT contact

972-545491070

schlissel.doron@gmail.com

Einat Kodesh, PHD contact

972-523489854

ekodesh@gmail.com

About this study

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.

Read more

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.

Being tested
Eccentric protocol, Isometric protocol
Medical subject headings
Tendinopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Eccentric protocolOther

    Participants in this arm will perform progressive eccentric exercise protocol

  • Isometric protocolOther

    Participants in this arm will perform progressive isometric exercise protocol

Study groups in NCT04683107
Study groupRoleWhat they receive
Eccentric protocolExperimentalNot described
Receives: Other: Eccentric protocol
Isometric protocolExperimentalNot described
Receives: Other: Isometric protocol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 6 weeks

  2. Isometric and eccentric muscle force

    Measured: 6 weeks

  3. Running performance

    measuring running time for 1.5 km

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2020
  2. Study startJan 2021 (estimated)
  3. Primary completionJul 2021 (estimated)
  4. Study completionSep 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04683107
Sponsor's protocol ID
University of Haifa (UHaifa)
Status last verified
Dec 2020
First submitted
20 Dec 2020
Last updated
24 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Eccentric protocol and Isometric protocol in people with Proximal Hamstring Tendinopathy and Tendinopathy, run by University of Haifa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Doron Schlissel, BPT (972-545491070, schlissel.doron@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Victorian Institute of Sport Assessment-Proximal Hamstring Tendons (VISA-H) questionnaire (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2020.

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