Acupuncture for Insertional Achilles Tendinopathy Effectiveness

March 17, 2021 updated by: Mike O'Callaghan Military Hospital

Acupuncture for Insertional Achilles Tendinopathy in the Primary Care Setting: A Randomized Comparative Effectiveness Trial

The purpose of this study is to compare acupuncture plus a prescribed home exercise program versus a prescribed home exercise program alone to determine which has better outcomes at improving pain relief and physical function in adult patients with insertional Achilles tendinopathy.

The investigators want to compare a combination of two standard of care treatments (acupuncture plus a prescribed home exercise program) versus a single standard of care treatment (a prescribed home exercise program) to determine which has better outcomes with improving pain relief and physical function in patients with insertional Achilles tendinopathy. The investigators hypothesize that there will be a significant improvement in pain and functional outcomes, both acutely and over time, in the acupuncture plus a prescribed home exercise program group versus the group performing a prescribed home exercise program alone. The investigators will measure Achilles pain relief and physical function immediately prior to treatment (baseline), immediately after the initial treatment at day 1, 2 weeks, 4 weeks, 6 weeks, and 12 weeks using the Victorian Institute of Sports Assessment - Achilles Questionnaire (VISA-A). After 3 months, patients with continuing pain in the non-acupuncture arm will be given the option to crossover to the acupuncture arm of the study for an additional 12 weeks of treatment with the subject's concurrence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Screening Visit (research-related):

  • Obtain and document signed Informed Consent document and HIPAA Authorization.
  • Review past medical history in Armed Forces Health Longitudinal Technology Application (AHLTA) to verify the inclusion/exclusion criteria including previous encounter, vital signs review, co-morbidities, demographics, and problems list.
  • Record: Date of birth, age, gender, race, ethnicity, DoD ID number, name of standard of care medications (over-the-counter and prescription), current email address (to be used for scheduling), height (in inches), weight (in pounds),history of prior injury to the injured leg, and note any prior acupuncture received for Achilles tendinopathy.
  • If the subject is an active duty member, the investigators will ask: Have you or are you currently on a fitness restriction for Achilles tendinopathy.

If so, what are/were the dates of the restriction?

• There are several standard of care treatments for Achilles tendinopathy which include physical therapy as well as a prescribed home exercise program. The investigators will standardize what patients in this study are receiving by having all subjects follow a standard home exercise program defined as the Insertional Achilles Tendinopathy Eccentric Training Protocol and have them discontinue any formal physical therapy or other therapies when entering this study. Regular physical activity such as exercise is allowed.

Randomization: Subjects will be randomized into 1 of 2 research treatment groups using block randomization with repeated measures:

  • Group 1: Acupuncture (needles will be placed at BL 60, BL 61, KI 3, KI 4 with needles directed into the Achilles tendon. Needles inserted until a firm catch of the needle entering the tendon was appreciated. Energy (a small electrical current) is placed from KI 3(-) KI 4(+) and BL 61 (-) BL 60(+) at 30 Hz for 15min) plus the prescribed home exercise program
  • Group 2: The prescribed home exercise program alone.

Visit 1-Day 1 (may be same day as screening visit) (research-related)::

  • Subjects will be given a study diary to document the number of times they performed the Insertional Achilles Tendinopathy Eccentric Training Protocol.
  • Subjects will be advised to complete exercises twice a day for three sets of 15 repetitions for 12 weeks.4
  • Administer the Victorian Institute of Sports Assessment - Achilles Questionnaire (VISA-A)
  • Document Morphine Equivalent Units (MEU) and over-the-counter and prescription medications used in the last 2 weeks.
  • Self-reported pain severity pre-intervention (0 for no pain to 10 being the worst pain)
  • Research treatment intervention according to their randomization group:

Group 1:

Subjects will be asked what their expectations are regarding acupuncture's effectiveness for Achilles tendinopathy.

The prescribed home exercise program will be reviewed. Acupuncture will be performed. Research coordinator will record the name of the investigator performing the acupuncture

Group 2:

The prescribed home exercise program will be reviewed. Self-reported pain severity post-intervention (0 for no pain to 10 being the worst pain)

Visit 2-Week 2 (research-related)::

  • Subjects' study diaries will be reviewed and the number of times the Insertional Achilles Tendinopathy Eccentric Training Protocol was performed will be documented.
  • Subjects will be reminded to complete the exercises twice a day for three sets of 15 repetitions for 12 weeks.
  • Administer the Victorian Institute of Sports Assessment - Achilles Questionnaire (VISA-A)
  • Document Morphine Equivalent Units (MEU) and over-the-counter and prescription medications used since the last visit.
  • Self-reported pain severity pre-intervention (0 for no pain to 10 being the worst pain)
  • Research treatment intervention according to their randomization group:

Group 1:

The prescribed home exercise program will be reviewed. Acupuncture will be performed. Research coordinator will record the name of the investigator performing the acupuncture

Group 2:

The prescribed home exercise program will be reviewed. Self-reported pain severity post-intervention (0 for no pain to 10 being the worst pain)

Visit 3-Week 4 (research-related):

  • Subjects' study diaries will be reviewed and the number of times the Insertional Achilles Tendinopathy Eccentric Training Protocol was performed will be documented.
  • Subjects will be reminded to complete the exercises twice a day for three sets of 15 repetitions for 12 weeks.
  • Administer the Victorian Institute of Sports Assessment - Achilles Questionnaire (VISA-A)
  • Document Morphine Equivalent Units (MEU) and over-the-counter and prescription medications used since the last visit.
  • Self-reported pain severity pre-intervention (0 for no pain to 10 being the worst pain)
  • Research treatment intervention according to their randomization group:

Group 1:

The prescribed home exercise program will be reviewed. Acupuncture will be performed. Research coordinator will record the name of the investigator performing the acupuncture

Group 2:

The prescribed home exercise program will be reviewed. Self-reported pain severity post-intervention (0 for no pain to 10 being the worst pain)

Visit 4-Week 6 (research-related)::

Subjects' study diary will be reviewed and the number of times the Insertional Achilles Tendinopathy Eccentric Training Protocol was performed will be documented.

  • Subjects will be reminded to complete the exercises twice a day for three sets of 15 repetitions for 12 weeks.4
  • Administer the Victorian Institute of Sports Assessment - Achilles Questionnaire (VISA-A)
  • Document Morphine Equivalent Units (MEU) and over-the-counter and prescription medications used since the last visit.
  • Self-reported pain severity pre-intervention (0 for no pain to 10 being the worst pain)
  • Research treatment intervention according to their randomization group:

Group 1:

The prescribed home exercise program will be reviewed. Acupuncture will be performed. Research coordinator will record the name of the investigator performing the acupuncture

Group 2:

The prescribed home exercise program will be reviewed. Self-reported pain severity post-intervention (0 for no pain to 10 being the worst pain)

Visit 5-Week 12 (research-related)::

  • Collect subjects' study diaries.
  • Administer the Victorian Institute of Sports Assessment - Achilles Questionnaire (VISA-A)
  • Document Morphine Equivalent Units (MEU) and over-the-counter and prescription medications used since the last visit.
  • Self-reported pain severity (0 for no pain to 10 being the worst pain)
  • Ask if subjects' expectations were met or changed regarding acupuncture's effectiveness for Achilles Tendinopathy. (Group 1 ONLY)

CROSSOVER: At Visit 5 (final visit), patients in the non-acupuncture group with continuing pain will be given the option to crossover into the acupuncture arm of the study where they will complete visit 1 through 5. Visit 1 will be on the same day with corresponding measures as described above for a total study enrollment time of 24 weeks.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Eglin Air Force Base, Florida, United States, 32542
        • 96th Medical Group
    • Nevada
      • Nellis Air Force Base, Nevada, United States, 89191
        • Mike O'Callaghan Military Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

** THIS STUDY IS BEING CONDUCTED AT A MILITARY INSTALLATION. YOU MUST HAVE MILITARY INSURANCE IN ORDER TO PARTICIPATE IN THIS STUDY **

Inclusion Criteria:

  • Male and female DoD beneficiaries, age 18 years or older
  • diagnosed with Achilles tendinopathy OR patients meeting criteria of pain 2cm or less from the insertion to the Achilles tendon on the calcaneus.
  • Patients must have had pain for greater than 8 weeks and a VISA-A score less than 60.

Exclusion Criteria:

  • Pregnant
  • Active cellulitis over the area of needle insertion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acupuncture and Home Exercise
Acupuncture and home exercise.
Other: Acupuncture and Home Exercise
Acupuncture (needles will be placed at BL 60, BL 61, KI 3, KI 4 with needles directed into the Achilles tendon. Needles inserted until a firm catch of the needle entering the tendon was appreciated. Energy (a small electrical current) is placed from KI 3(-) KI 4(+) and BL 61 (-) BL 60(+) at 30 Hz for 15min) plus the prescribed home exercise program
Active Comparator: Home Exercise Alone
The prescribed home exercise program alone.
Other: Home Exercise Alone
The prescribed home exercise program alone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain over time as measured by the Victorian Institute of Sports Assessment - Achilles Questionnaire (VISA-A)
Time Frame: the first visit, 2 weeks, 4 weeks, 6 weeks, and 12 weeks
Change in pain over time as measured by the Victorian Institute of Sports Assessment - Achilles Questionnaire (VISA-A). The VISA-A is measured as a score out of 100, where a lower score indicates a worse outcome.
the first visit, 2 weeks, 4 weeks, 6 weeks, and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mike O'Callaghan Military Hospital

Investigators

  • Principal Investigator: Matthew Hawks, MD, Mike O'Callaghan Military Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2018

Primary Completion (Actual)

January 4, 2021

Study Completion (Actual)

March 16, 2021

Study Registration Dates

First Submitted

November 14, 2018

First Submitted That Met QC Criteria

November 19, 2018

First Posted (Actual)

November 20, 2018

Study Record Updates

Last Update Posted (Actual)

March 18, 2021

Last Update Submitted That Met QC Criteria

March 17, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FWH20180170H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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