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

Achilles Tendinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04632979
• Other study ID #: MeuhedetHCO1
• Status: Completed
• Phase: N/A
• Start date: October 3, 2019
• Est. completion date: May 1, 2020

Study information

• Verified date: September 2019
• Source: Meuhedet. Healthcare Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: May 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Achilles Tendinopathy
• Tendinopathy

Intervention

Procedure:
• Backwards running on a Treadmil with a negative slope
Running backward on a treadmill with a negative slope

Locations

Country	Name	City	State
Israel	Meuhedet Health Services	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Meuhedet. Healthcare Organization

Country where clinical trial is conducted

Israel, 

References & Publications (3)

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. — View 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VISA-A questionnaire	Subjective questionnaire specific for Achilles tendinopathy	baseline
Primary	VISA-A questionnaire	Subjective questionnaire specific for Achilles tendinopathy	two weeks
Primary	VISA-A questionnaire	Subjective questionnaire specific for Achilles tendinopathy	three weeks
Primary	VISA-A questionnaire	Subjective questionnaire specific for Achilles tendinopathy	five weeks
Primary	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	baseline
Primary	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	two weeks
Primary	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	three weeks
Primary	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	five weeks
Primary	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	baseline
Primary	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	three weeks
Primary	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	five weeks
Primary	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.	five weeks