Acupuncture for Insertional Achilles Tendinopathy Effectiveness

NCT03747549 | Completed

• 1 other identifier: FWH20180170H
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Insertional Achilles Tendinopathy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Acupuncture and Home Exercise

EXPERIMENTAL

Acupuncture and home exercise.

Other: Acupuncture and Home Exercise

Home Exercise Alone

ACTIVE COMPARATOR

The prescribed home exercise program alone.

Other: Home Exercise Alone

Interventions

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

Acupuncture and Home Exercise

Home Exercise Alone OTHER

The prescribed home exercise program alone.

Home Exercise Alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Mike O'Callaghan Military Hospital: lead

Study Sites (2)

96th Medical Group

Eglin Air Force Base, Florida, 32542, United States

Location

Mike O'Callaghan Military Medical Center

Nellis Air Force Base, Nevada, 89191, United States

Location

Related Publications (9)

• 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.

  PMID: 27885357 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.

  PMID: 11579069 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.

  PMID: 22319681 BACKGROUND

• Childress MA, Beutler A. Management of chronic tendon injuries. Am Fam Physician. 2013 Apr 1;87(7):486-90.

  PMID: 23547590 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.

  PMID: 23006143 BACKGROUND

• Arnold MJ, Moody AL. Common Running Injuries: Evaluation and Management. Am Fam Physician. 2018 Apr 15;97(8):510-516.

  PMID: 29671490 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.

  PMID: 28736593 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.

  PMID: 10741815 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.

  PMID: 9728862 BACKGROUND

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Matthew Hawks, MD

  Mike O'Callaghan Military Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: November 20, 2018
• Study Start: December 12, 2018
• Primary Completion: January 4, 2021
• Study Completion: March 16, 2021
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)