Insertional Achilles TendinopathyNCT03747549
Acupuncture for Insertional Achilles Tendinopathy Effectiveness
A study testing Acupuncture and Home Exercise and Home Exercise Alone in people with Insertional Achilles Tendinopathy, run by Mike O'Callaghan Military Hospital at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insertional Achilles Tendinopathy
- What is being tested?
- Acupuncture and Home Exercise and Home Exercise Alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Dec 2018to 16 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnant
- Active cellulitis over the area of needle insertion.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
96th Medical Group
Eglin Air Force Base, Florida, 32542
Mike O'Callaghan Military Medical Center
Nellis Air Force Base, Nevada, 89191
About this study
Official title: 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.
Read the 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.
- Conditions
- Insertional Achilles Tendinopathy
- Being tested
- Acupuncture and Home Exercise, Home Exercise Alone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture and Home ExerciseOther
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
Home Exercise AloneOther
The prescribed home exercise program alone.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture and Home Exercise | Experimental | Acupuncture and home exercise. Receives: Other: Acupuncture and Home Exercise |
| Home Exercise Alone | Active comparator | The prescribed home exercise program alone. Receives: Other: Home Exercise Alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: the first visit, 2 weeks, 4 weeks, 6 weeks, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start12 Dec 2018
- Primary completion4 Jan 2021
- Study completion16 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Insertional Achilles TendinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mike O'Callaghan Military Hospital
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Matthew Hawks, MD, Principal investigator, Mike O'Callaghan Military Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03747549
- Sponsor's protocol ID
- FWH20180170H
- Status last verified
- Sep 2024
- First submitted
- 14 Nov 2018
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27885357Robinson 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.
PubMed 11579069Iversen 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.
PubMed 22319681Childress MA, Beutler A. Management of chronic tendon injuries. Am Fam Physician. 2013 Apr 1;87(7):486-90.
PubMed 23547590Rowe 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.
PubMed 23006143Arnold MJ, Moody AL. Common Running Injuries: Evaluation and Management. Am Fam Physician. 2018 Apr 15;97(8):510-516.
PubMed 29671490Hawks 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.
PubMed 28736593Breivik 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.
PubMed 10741815Ludington 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.
PubMed 9728862
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for Insertional Achilles Tendinopathy in the Primary Care Setting: a Randomized Comparative Effectiveness Trial
- ClinicalTrials.gov ID
- NCT03747549
- Acronym / sponsor ID
- FWH20180170H
- Conditions
- Insertional Achilles Tendinopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Mike O'Callaghan Military HospitalUS federal agency
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- 4 Jan 2021 (actual)
- Study completion
- 16 Mar 2021 (actual)
- First posted
- 20 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture and Home Exercise | Experimental | Other: Acupuncture and Home ExerciseAcupuncture and home exercise. |
| Home Exercise Alone | Active comparator | Other: Home Exercise AloneThe prescribed home exercise program alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Pregnant
- Active cellulitis over the area of needle insertion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture and Home ExerciseAcupuncture (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 | Other | Acupuncture and Home Exercise |
| Home Exercise AloneThe prescribed home exercise program alone. | Other | Home Exercise Alone |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 27885357Li 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.
- Background: PubMed 11579069Robinson 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.
- Background: PubMed 22319681Iversen 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.
- Background: PubMed 23547590Childress MA, Beutler A. Management of chronic tendon injuries. Am Fam Physician. 2013 Apr 1;87(7):486-90.
- Background: PubMed 23006143Rowe 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.
- Background: PubMed 29671490Arnold MJ, Moody AL. Common Running Injuries: Evaluation and Management. Am Fam Physician. 2018 Apr 15;97(8):510-516.
- Background: PubMed 28736593Hawks 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.
- Background: PubMed 10741815Breivik 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.
- Background: PubMed 9728862Ludington 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Hawks, MD principal investigator
Mike O'Callaghan Military Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and Home Exercise and Home Exercise Alone in people with Insertional Achilles Tendinopathy, run by Mike O'Callaghan Military Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03747549, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.