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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.
Screening Visit (research-related):
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:
Visit 1-Day 1 (may be same day as screening visit) (research-related)::
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)::
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):
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.
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)::
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture and Home Exercise | Experimental | Acupuncture and home exercise. |
|
| Home Exercise Alone | Active Comparator | The prescribed home exercise program alone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture and Home Exercise | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain over time as measured by the Victorian Institute of Sports Assessment - Achilles Questionnaire (VISA-A) | 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 |
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** THIS STUDY IS BEING CONDUCTED AT A MILITARY INSTALLATION. YOU MUST HAVE MILITARY INSURANCE IN ORDER TO PARTICIPATE IN THIS STUDY **
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Hawks, MD | Mike O'Callaghan Military Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 96th Medical Group | Eglin Air Force Base | Florida | 32542 | United States | ||
| Mike O'Callaghan Military Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27885357 | Background | Li HY, Hua YH. Achilles Tendinopathy: Current Concepts about the Basic Science and Clinical Treatments. Biomed Res Int. 2016;2016:6492597. doi: 10.1155/2016/6492597. Epub 2016 Nov 3. | |
| 11579069 | Background | Robinson JM, Cook JL, Purdam C, Visentini PJ, Ross J, Maffulli N, Taunton JE, Khan KM; Victorian Institute Of Sport Tendon Study Group. The VISA-A questionnaire: a valid and reliable index of the clinical severity of Achilles tendinopathy. Br J Sports Med. 2001 Oct;35(5):335-41. doi: 10.1136/bjsm.35.5.335. |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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|
| Home Exercise Alone | Other | The prescribed home exercise program alone. |
|
| Nellis Air Force Base |
| Nevada |
| 89191 |
| United States |
| 22319681 | Background | Iversen JV, Bartels EM, Langberg H. The victorian institute of sports assessment - achilles questionnaire (visa-a) - a reliable tool for measuring achilles tendinopathy. Int J Sports Phys Ther. 2012 Feb;7(1):76-84. |
| 23547590 | Background | Childress MA, Beutler A. Management of chronic tendon injuries. Am Fam Physician. 2013 Apr 1;87(7):486-90. |
| 23006143 | Background | Rowe V, Hemmings S, Barton C, Malliaras P, Maffulli N, Morrissey D. Conservative management of midportion Achilles tendinopathy: a mixed methods study, integrating systematic review and clinical reasoning. Sports Med. 2012 Nov 1;42(11):941-67. doi: 10.1007/BF03262305. |
| 29671490 | Background | Arnold MJ, Moody AL. Common Running Injuries: Evaluation and Management. Am Fam Physician. 2018 Apr 15;97(8):510-516. |
| 28736593 | Background | Hawks MK. Successful Treatment of Achilles Tendinopathy with Electroacupuncture: Two Cases. Med Acupunct. 2017 Jun 1;29(3):163-165. doi: 10.1089/acu.2017.1232. |
| 10741815 | Background | Breivik EK, Bjornsson GA, Skovlund E. A comparison of pain rating scales by sampling from clinical trial data. Clin J Pain. 2000 Mar;16(1):22-8. doi: 10.1097/00002508-200003000-00005. |
| 9728862 | Background | Ludington E, Dexter F. Statistical analysis of total labor pain using the visual analog scale and application to studies of analgesic effectiveness during childbirth. Anesth Analg. 1998 Sep;87(3):723-7. doi: 10.1097/00000539-199809000-00045. No abstract available. |