Achilles TendinopathyNCT04632979
Backward Running on a Negative Slope as a Treatment for Achilles Tendinopathy in Runners
A study testing Backwards running on a Treadmil with a negative slope in people with Achilles Tendinopathy, run by Meuhedet. Healthcare Organization at 1 site in Israel.
Trial summary
This study will look to evaluate the feasibility of a backwards downhill running program as an option for the treatment of Achilles tendinopathy in runners. It is known that exercise on the Achilles tendon during elongation (eccentric exercise) improves tendon function after injury. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Achilles Tendinopathy
- What is being tested?
- Backwards running on a Treadmil with a negative slope
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteIsrael
- Study dates
- 3 Oct 2019to 1 May 2020
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Distinct tenderness of Achilles tendon with no pain in the neighboring structures.
- Nontraumatic diffuse pain in the posterior calf with local tenderness in the Achilles tendon.
- A history of running for at least one session a week in the past three months.
- Age > 18 and < 70
Who cannot join
- Achilles pain longer than six months.
- Patients with an additional lower extremity injury unable to bear full weight on the limb.
- Patients who are currently receiving physical therapy for Achilles tendinopathy, have received a steroid injection into the tendon in the three months prior, or underwent Achilles tendon surgery.
Trial locations and contacts
1 site in 1 country.
About this study
This study will look to evaluate the feasibility of a backwards downhill running program as an option for the treatment of Achilles tendinopathy in runners. It is known that exercise on the Achilles tendon during elongation (eccentric exercise) improves tendon function after injury. However, during recovery, the patient is required to stop tendon-loading activities such as jumps and sprints. Therefore, during recovery, athletes decline in physical fitness.
Backward running on a negative slope can achieve a biomechanical load similar to eccentric exercise without decreasing physical fitness.
Read the detailed description
The study was a prospective, single-arm feasibility study. Participants were patients who met the entry criteria and were referred to the Meuhedet health service Physical Therapy outpatient clinic, Jerusalem, from September 2019 to February 2020. The sample size was based on previous recommendations for pilot and feasibility studies (Julious 2005; Billingham, Whitehead, and Julious 2013). Inclusion criteria were: AT that was clinically determined by an orthopedic surgeon (E.S) according to nontraumatic pain and tenderness at the Achilles tendon and report of decreased activity levels secondary to Achilles pain; a history of running for at least one session a week in the past three months; age > 18 and < 70. Exclusion criteria were having other lower extremity injuries; prior treatment with eccentric exercise or currently receiving Physical Therapy for AT; received a steroid injection into the tendon in the three months prior, or underwent Achilles tendon surgery.
Participants received a total of nine treatment sessions, twice a week for a total of five weeks. Each treatment consisted of backward walking / running over an 8º negatively inclined treadmill. (Landice L7 Rehabilitation treadmill, New Jersey, USA) with a warmup and a cooldown on a stationary bike. A detailed description of the protocol is presented in Table 1. As backward locomotion on a treadmill was novel for all participants they were advised to hold the treadmill handles during the adjustment period (treatment sessions 1-3). Participants were also instructed to refrain from specific sports which involve continuous jumping and forward running throughout the intervention period. Patients were informed that if they do not feel comfortable with the training protocol, they could terminate their participation at any point.
Assessments took place at baseline, pretreatment four, pretreatment six, and at a separate meeting after treatment nine
- Conditions
- Achilles Tendinopathy
- Being tested
- Backwards running on a Treadmil with a negative slope
- Keywords
- Achilles tendinopathy, backward running, exercise, running overuse injury
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Backwards running on a Treadmil with a negative slopeProcedure or surgery
Running backward on a treadmill with a negative slope
| Study group | Role | What they receive |
|---|---|---|
| Backward runners | Experimental | Training protocol patients Receives: Procedure: Backwards running on a Treadmil with a negative slope |
What is being measured
The primary outcome is the main question the study is designed to answer.
VISA-A questionnaire
Subjective questionnaire specific for Achilles tendinopathy
Measured: baseline
VISA-A questionnaire
Subjective questionnaire specific for Achilles tendinopathy
Measured: two weeks
VISA-A questionnaire
Subjective questionnaire specific for Achilles tendinopathy
Measured: three weeks
VISA-A questionnaire
Subjective questionnaire specific for Achilles tendinopathy
Measured: five weeks
Number of single legged heel raises from a flat surface before the onset of pain
Heel raise height will be defined by a pretest of one maximum single legged heel raise assessed by a measuring tape in centimeters
Measured: baseline
Number of single legged heel raises from a flat surface before the onset of pain
Heel raise height will be defined by a pretest of one maximum single legged heel raise assessed by a measuring tape in centimeters
Measured: two weeks
Number of single legged heel raises from a flat surface before the onset of pain
Heel raise height will be defined by a pretest of one maximum single legged heel raise assessed by a measuring tape in centimeters
Measured: three weeks
Number of single legged heel raises from a flat surface before the onset of pain
Heel raise height will be defined by a pretest of one maximum single legged heel raise assessed by a measuring tape in centimeters
Measured: five weeks
Onset of relevant Achilles tendon pain (measured in seconds) during Forward running at a self-selected comfortable pace on a treadmill
Forward running on treadmill until the onset of relevant pain
Measured: baseline
Onset of relevant Achilles tendon pain (measured in seconds) during Forward running at a self-selected comfortable pace on a treadmill
Forward running on treadmill until the onset of relevant pain
Measured: three weeks
Onset of relevant Achilles tendon pain (measured in seconds) during Forward running at a self-selected comfortable pace on a treadmill
Forward running on treadmill until the onset of relevant pain
Measured: five weeks
Compliance
Treatment sessions will be calculated upon the patient's completion of the full treatment protocol for that specific session. Inclusion will be terminated upon lack of fulfilling the treatment protocol or failing to complete a total of at least eight sessions.
Measured: five weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start3 Oct 2019
- Primary completion1 Apr 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Achilles TendinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meuhedet. Healthcare Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shmuel Springer, prof, Study director, Ariel University, Physical Therapy Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04632979
- Sponsor's protocol ID
- MeuhedetHCO1
- Status last verified
- Sep 2019
- First submitted
- 9 Nov 2020
- Last updated
- 17 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Braunstein M, Baumbach SF, Herterich V, Bocker W, Polzer H. [Acute achilles tendon rupture : State of the art]. Unfallchirurg. 2017 Dec;120(12):1007-1014. doi: 10.1007/s00113-017-0420-4. German.
PubMed 29038897Bovend'Eerdt TJ, Botell RE, Wade DT. Writing SMART rehabilitation goals and achieving goal attainment scaling: a practical guide. Clin Rehabil. 2009 Apr;23(4):352-61. doi: 10.1177/0269215508101741. Epub 2009 Feb 23.
PubMed 19237435Billingham SA, Whitehead AL, Julious SA. An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network database. BMC Med Res Methodol. 2013 Aug 20;13:104. doi: 10.1186/1471-2288-13-104.
PubMed 23961782
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Backward Running on a Negative Slope as a Treatment for Achilles Tendinopathy in Runners
- ClinicalTrials.gov ID
- NCT04632979
- Acronym / sponsor ID
- MeuhedetHCO1
- Conditions
- Achilles Tendinopathy
- Keywords
- Achilles tendinopathy, backward running, exercise, running overuse injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Meuhedet. Healthcare OrganizationUniversity, hospital or other
- Study start
- 3 Oct 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 17 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will look to evaluate the feasibility of a backwards downhill running program as an option for the treatment of Achilles tendinopathy in runners. It is known that exercise on the Achilles tendon during elongation (eccentric exercise) improves tendon function after injury. However, during recovery, the patient is required to stop tendon-loading activities such as jumps and sprints. Therefore, during recovery, athletes decline in physical fitness.
Backward running on a negative slope can achieve a biomechanical load similar to eccentric exercise without decreasing physical fitness.
Detailed description
The study was a prospective, single-arm feasibility study. Participants were patients who met the entry criteria and were referred to the Meuhedet health service Physical Therapy outpatient clinic, Jerusalem, from September 2019 to February 2020. The sample size was based on previous recommendations for pilot and feasibility studies (Julious 2005; Billingham, Whitehead, and Julious 2013). Inclusion criteria were: AT that was clinically determined by an orthopedic surgeon (E.S) according to nontraumatic pain and tenderness at the Achilles tendon and report of decreased activity levels secondary to Achilles pain; a history of running for at least one session a week in the past three months; age > 18 and < 70. Exclusion criteria were having other lower extremity injuries; prior treatment with eccentric exercise or currently receiving Physical Therapy for AT; received a steroid injection into the tendon in the three months prior, or underwent Achilles tendon surgery.
Participants received a total of nine treatment sessions, twice a week for a total of five weeks. Each treatment consisted of backward walking / running over an 8º negatively inclined treadmill. (Landice L7 Rehabilitation treadmill, New Jersey, USA) with a warmup and a cooldown on a stationary bike. A detailed description of the protocol is presented in Table 1. As backward locomotion on a treadmill was novel for all participants they were advised to hold the treadmill handles during the adjustment period (treatment sessions 1-3). Participants were also instructed to refrain from specific sports which involve continuous jumping and forward running throughout the intervention period. Patients were informed that if they do not feel comfortable with the training protocol, they could terminate their participation at any point.
Assessments took place at baseline, pretreatment four, pretreatment six, and at a separate meeting after treatment nine
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Backward runners | Experimental | Procedure: Backwards running on a Treadmil with a negative slopeTraining protocol patients |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Distinct tenderness of Achilles tendon with no pain in the neighboring structures.
- Nontraumatic diffuse pain in the posterior calf with local tenderness in the Achilles tendon.
- A history of running for at least one session a week in the past three months.
- Age > 18 and < 70
Key exclusion criteria (3 listed)
- Achilles pain longer than six months.
- Patients with an additional lower extremity injury unable to bear full weight on the limb.
- Patients who are currently receiving physical therapy for Achilles tendinopathy, have received a steroid injection into the tendon in the three months prior, or underwent Achilles tendon surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Backwards running on a Treadmil with a negative slopeRunning backward on a treadmill with a negative slope | Procedure or surgery | Backward runners |
Primary outcome
VISA-A questionnaire
Time frame: baseline
Subjective questionnaire specific for Achilles tendinopathy
VISA-A questionnaire
Time frame: two weeks
Subjective questionnaire specific for Achilles tendinopathy
VISA-A questionnaire
Time frame: three weeks
Subjective questionnaire specific for Achilles tendinopathy
VISA-A questionnaire
Time frame: five weeks
Subjective questionnaire specific for Achilles tendinopathy
Number of single legged heel raises from a flat surface before the onset of pain
Time frame: baseline
Heel raise height will be defined by a pretest of one maximum single legged heel raise assessed by a measuring tape in centimeters
Number of single legged heel raises from a flat surface before the onset of pain
Time frame: two weeks
Heel raise height will be defined by a pretest of one maximum single legged heel raise assessed by a measuring tape in centimeters
Number of single legged heel raises from a flat surface before the onset of pain
Time frame: three weeks
Heel raise height will be defined by a pretest of one maximum single legged heel raise assessed by a measuring tape in centimeters
Number of single legged heel raises from a flat surface before the onset of pain
Time frame: five weeks
Heel raise height will be defined by a pretest of one maximum single legged heel raise assessed by a measuring tape in centimeters
Onset of relevant Achilles tendon pain (measured in seconds) during Forward running at a self-selected comfortable pace on a treadmill
Time frame: baseline
Forward running on treadmill until the onset of relevant pain
Onset of relevant Achilles tendon pain (measured in seconds) during Forward running at a self-selected comfortable pace on a treadmill
Time frame: three weeks
Forward running on treadmill until the onset of relevant pain
Onset of relevant Achilles tendon pain (measured in seconds) during Forward running at a self-selected comfortable pace on a treadmill
Time frame: five weeks
Forward running on treadmill until the onset of relevant pain
Compliance
Time frame: five weeks
Treatment sessions will be calculated upon the patient's completion of the full treatment protocol for that specific session. Inclusion will be terminated upon lack of fulfilling the treatment protocol or failing to complete a total of at least eight sessions.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
- Background: PubMed 29038897Braunstein M, Baumbach SF, Herterich V, Bocker W, Polzer H. [Acute achilles tendon rupture : State of the art]. Unfallchirurg. 2017 Dec;120(12):1007-1014. doi: 10.1007/s00113-017-0420-4. German.
- Background: PubMed 19237435Bovend'Eerdt TJ, Botell RE, Wade DT. Writing SMART rehabilitation goals and achieving goal attainment scaling: a practical guide. Clin Rehabil. 2009 Apr;23(4):352-61. doi: 10.1177/0269215508101741. Epub 2009 Feb 23.
- Background: PubMed 23961782Billingham SA, Whitehead AL, Julious SA. An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network database. BMC Med Res Methodol. 2013 Aug 20;13:104. doi: 10.1186/1471-2288-13-104.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shmuel Springer, prof study director
Ariel University, Physical Therapy Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Backwards running on a Treadmil with a negative slope in people with Achilles Tendinopathy, run by Meuhedet. Healthcare Organization at 1 site in Israel.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VISA-A questionnaire (time frame: baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04632979, which also lists 3 linked publications.
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 17 Nov 2020.