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Backward Running on a Negative Slope as a Treatment for Achilles Tendinopathy in Runners

Primary Purpose

Achilles Tendinopathy

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Backwards running on a Treadmil with a negative slope
Sponsored by
Meuhedet. Healthcare Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Achilles Tendinopathy focused on measuring Achilles tendinopathy, backward running, exercise, running overuse injury

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Distinct tenderness of Achilles tendon with no pain in the neighboring structures.
  2. Nontraumatic diffuse pain in the posterior calf with local tenderness in the Achilles tendon.
  3. A history of running for at least one session a week in the past three months.
  4. Age > 18 and < 70

Exclusion Criteria:

  1. Achilles pain longer than six months.
  2. Patients with an additional lower extremity injury unable to bear full weight on the limb.
  3. 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.

Sites / Locations

  • Meuhedet Health Services

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Backward runners

Arm Description

Training protocol patients

Outcomes

Primary Outcome Measures

VISA-A questionnaire
Subjective questionnaire specific for Achilles tendinopathy
VISA-A questionnaire
Subjective questionnaire specific for Achilles tendinopathy
VISA-A questionnaire
Subjective questionnaire specific for Achilles tendinopathy
VISA-A questionnaire
Subjective questionnaire specific for Achilles tendinopathy
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
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
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
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
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
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
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
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.

Secondary Outcome Measures

Full Information

First Posted
November 9, 2020
Last Updated
November 16, 2020
Sponsor
Meuhedet. Healthcare Organization
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1. Study Identification

Unique Protocol Identification Number
NCT04632979
Brief Title
Backward Running on a Negative Slope as a Treatment for Achilles Tendinopathy in Runners
Official Title
Backward Running on a Negative Slope as a Treatment for Achilles Tendinopathy in Runners
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
October 3, 2019 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
May 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meuhedet. Healthcare Organization

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achilles Tendinopathy
Keywords
Achilles tendinopathy, backward running, exercise, running overuse injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Backward runners
Arm Type
Experimental
Arm Description
Training protocol patients
Intervention Type
Procedure
Intervention Name(s)
Backwards running on a Treadmil with a negative slope
Intervention Description
Running backward on a treadmill with a negative slope
Primary Outcome Measure Information:
Title
VISA-A questionnaire
Description
Subjective questionnaire specific for Achilles tendinopathy
Time Frame
baseline
Title
VISA-A questionnaire
Description
Subjective questionnaire specific for Achilles tendinopathy
Time Frame
two weeks
Title
VISA-A questionnaire
Description
Subjective questionnaire specific for Achilles tendinopathy
Time Frame
three weeks
Title
VISA-A questionnaire
Description
Subjective questionnaire specific for Achilles tendinopathy
Time Frame
five weeks
Title
Number of single legged heel raises from a flat surface before the onset of pain
Description
Heel raise height will be defined by a pretest of one maximum single legged heel raise assessed by a measuring tape in centimeters
Time Frame
baseline
Title
Number of single legged heel raises from a flat surface before the onset of pain
Description
Heel raise height will be defined by a pretest of one maximum single legged heel raise assessed by a measuring tape in centimeters
Time Frame
two weeks
Title
Number of single legged heel raises from a flat surface before the onset of pain
Description
Heel raise height will be defined by a pretest of one maximum single legged heel raise assessed by a measuring tape in centimeters
Time Frame
three weeks
Title
Number of single legged heel raises from a flat surface before the onset of pain
Description
Heel raise height will be defined by a pretest of one maximum single legged heel raise assessed by a measuring tape in centimeters
Time Frame
five weeks
Title
Onset of relevant Achilles tendon pain (measured in seconds) during Forward running at a self-selected comfortable pace on a treadmill
Description
Forward running on treadmill until the onset of relevant pain
Time Frame
baseline
Title
Onset of relevant Achilles tendon pain (measured in seconds) during Forward running at a self-selected comfortable pace on a treadmill
Description
Forward running on treadmill until the onset of relevant pain
Time Frame
three weeks
Title
Onset of relevant Achilles tendon pain (measured in seconds) during Forward running at a self-selected comfortable pace on a treadmill
Description
Forward running on treadmill until the onset of relevant pain
Time Frame
five weeks
Title
Compliance
Description
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.
Time Frame
five weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shmuel Springer, prof
Organizational Affiliation
Ariel University, Physical Therapy Department
Official's Role
Study Director
Facility Information:
Facility Name
Meuhedet Health Services
City
Jerusalem
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29038897
Citation
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.
Results Reference
background
PubMed Identifier
19237435
Citation
Bovend'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. Erratum In: Clin Rehabil. 2010 Apr;24(4):382.
Results Reference
background
PubMed Identifier
23961782
Citation
Billingham 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.
Results Reference
background

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Backward Running on a Negative Slope as a Treatment for Achilles Tendinopathy in Runners

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