Acupuncture for Insertional Achilles Tendinopathy Effectiveness
| Status: | Recruiting |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/22/2018 |
| Start Date: | December 12, 2018 |
| End Date: | November 2022 |
| Contact: | Amanda J Crawford, BA |
| Email: | amanda.j.crawford.ctr@mail.mil |
| Phone: | 702-653-2113 |
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.
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.
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.
- 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.
** 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.
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