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Completed

NCT Number: NCT04632979

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

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.

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Key information

Conditions

Achilles Tendinopathy Behavior Motor Activity

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Meuhedet Health Services

Jerusalem, Israel

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Backwards running on a Treadmil with a negative slope

Procedure

Running backward on a treadmill with a negative slope

Primary outcomes

  1. VISA-A questionnaire

    Time frame: baseline

    Subjective questionnaire specific for Achilles tendinopathy

  2. VISA-A questionnaire

    Time frame: two weeks

    Subjective questionnaire specific for Achilles tendinopathy

  3. VISA-A questionnaire

    Time frame: three weeks

    Subjective questionnaire specific for Achilles tendinopathy

  4. VISA-A questionnaire

    Time frame: five weeks

    Subjective questionnaire specific for Achilles tendinopathy

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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.

Sponsors and collaborators

Lead sponsor

Meuhedet. Healthcare Organization

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 17, 2020
Registry last updated
Nov 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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