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

• ClinicalTrials.gov Identifier: NCT04632979
• Recruitment Status: Completed
• First Posted: November 17, 2020
• Last Update Posted: November 17, 2020
• Sponsor: Meuhedet. Healthcare Organization
• Information provided by (Responsible Party): Meuhedet. Healthcare Organization

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.

Condition or disease	Intervention/treatment	Phase
Achilles Tendinopathy	Procedure: Backwards running on a Treadmil with a negative slope	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 14 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Backward Running on a Negative Slope as a Treatment for Achilles Tendinopathy in Runners
• Actual Study Start Date: October 3, 2019
• Actual Primary Completion Date: April 1, 2020
• Actual Study Completion Date: May 1, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Backward runners; Training protocol patients	Procedure: Backwards running on a Treadmil with a negative slope; Running backward on a treadmill with a negative slope

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

Israel

Meuhedet Health Services

Jerusalem, Israel

Sponsors and Collaborators

Meuhedet. Healthcare Organization

Investigators

• Study Director: Shmuel Springer, prof; Ariel University, Physical Therapy Department

More Information

Publications:

Braunstein M, Baumbach SF, Herterich V, Böcker 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. Review. German.

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.

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.

• Responsible Party: Meuhedet. Healthcare Organization
• ClinicalTrials.gov Identifier: NCT04632979
• Other Study ID Numbers: MeuhedetHCO1
• First Posted: November 17, 2020
• Last Update Posted: November 17, 2020
• Last Verified: September 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Meuhedet. Healthcare Organization:

Achilles tendinopathy; backward running; exercise; running overuse injury

Additional relevant MeSH terms:

Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries