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Determine if the addition of a specific acupuncture protocol to a standard of care prescribed exercise program is more effective at improving pain and function in adult patients with plantar fasciosis.
This is a randomized, controlled, multi-site trial investigating whether a specific acupuncture protocol can improve pain and function in adults with plantar fasciosis when added to standard of care treatment. The investigators hypothesize that there will be a significant improvement in both pain and functional outcomes, both acutely and over time, in the experimental group compared to the control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention + Standard of care | Experimental | Acupuncture with electrostimulation plus standard of care prescribed home exercise program. |
|
| Standard of care | Active Comparator | Standard of care prescribed home exercise program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention + Standard of care | Device | Acupuncture with electrostimulation plus standard of care prescribed home exercise program for treatment of plantar fasciosis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Defense and Veterans Pain Rating Scale (DVPRS) | The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used | visit 1 (Day 1) |
| Defense and Veterans Pain Rating Scale (DVPRS) | The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used | visit 2 (week 2) |
| Defense and Veterans Pain Rating Scale (DVPRS) | The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used | visit 3 (week 4) |
| Defense and Veterans Pain Rating Scale (DVPRS) | The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used | visit 4 (week 6) |
| Defense and Veterans Pain Rating Scale (DVPRS) |
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**Patients must be able to get care at Nellis Air Force Base, Scott Air Force Base, or Eglin Air Force Base (a military installation) in order to participate in this study**
Inclusion Criteria:
Those with acute and chronic diagnoses will be included.
Exclusion Criteria:
Pregnant
Any of the following in the foot being included into the study:
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| Name | Affiliation | Role |
|---|---|---|
| Paul F Crawford, MD | United States Air Force | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 96th Medical Group | Eglin Air Force Base | Florida | 32542 | United States | ||
| Scott AFB |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20807448 | Background | Cotchett MP, Landorf KB, Munteanu SE. Effectiveness of dry needling and injections of myofascial trigger points associated with plantar heel pain: a systematic review. J Foot Ankle Res. 2010 Sep 1;3:18. doi: 10.1186/1757-1146-3-18. | |
| 24080555 | Background | Covey CJ, Mulder MD. Plantar fasciitis: How best to treat? J Fam Pract. 2013 Sep;62(9):466-71. |
| Label | URL |
|---|---|
| General Hospital and Personal Use Therapeutic Devices | View source |
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We do not plan on sharing data
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Feb 23, 2021 | Jan 13, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D008722 | Methods |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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| Standard of care | Other | Standard of care prescribed home exercise program for treatment of plantar fasciosis. |
|
The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used |
| visit 5 (week 12) |
| Defense and Veterans Pain Rating Scale Supplemental Questions | The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. For clinicians to evaluate the biopsychosocial impact of pain. | visit 1 (Day 1) |
| Defense and Veterans Pain Rating Scale Supplemental Questions | The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. For clinicians to evaluate the biopsychosocial impact of pain. | visit 2 (week 2) |
| Defense and Veterans Pain Rating Scale Supplemental Questions | The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. For clinicians to evaluate the biopsychosocial impact of pain. | visit 3 (week 4) |
| Defense and Veterans Pain Rating Scale Supplemental Questions | The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. For clinicians to evaluate the biopsychosocial impact of pain. | visit 4 (week 6) |
| Defense and Veterans Pain Rating Scale Supplemental Questions | For clinicians to evaluate the biopsychosocial impact of pain. | The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. visit 5 (week 12) |
| Foot function index revised short (FFI-R short) | FFI-R short uses a likert questionnaire to document foot pain severity, foot stiffness, difficulty performing activities, activity limitation, and social issues related to affected foot. It consists of 23 self-reported items divided into 3 subcategories on the basis of patient values: pain, disability and activity limitation.The patient has to score each question on a scale from 0 (no pain or difficulty) to 10 (worst pain imaginable or so difficult it requires help), that best describes their foot over the past week. | visit 1 (Day 1) |
| Foot function index revised short (FFI-R short) | FFI-R short uses a likert questionnaire to document foot pain severity, foot stiffness, difficulty performing activities, activity limitation, and social issues related to affected foot. It consists of 23 self-reported items divided into 3 subcategories on the basis of patient values: pain, disability and activity limitation.The patient has to score each question on a scale from 0 (no pain or difficulty) to 10 (worst pain imaginable or so difficult it requires help), that best describes their foot over the past week. | visit 2 (week 2) |
| Foot function index revised short (FFI-R short) | FFI-R short uses a likert questionnaire to document foot pain severity, foot stiffness, difficulty performing activities, activity limitation, and social issues related to affected foot. It consists of 23 self-reported items divided into 3 subcategories on the basis of patient values: pain, disability and activity limitation.The patient has to score each question on a scale from 0 (no pain or difficulty) to 10 (worst pain imaginable or so difficult it requires help), that best describes their foot over the past week. | visit 3 (week 4) |
| Foot function index revised short (FFI-R short) | FFI-R short uses a likert questionnaire to document foot pain severity, foot stiffness, difficulty performing activities, activity limitation, and social issues related to affected foot. It consists of 23 self-reported items divided into 3 subcategories on the basis of patient values: pain, disability and activity limitation.The patient has to score each question on a scale from 0 (no pain or difficulty) to 10 (worst pain imaginable or so difficult it requires help), that best describes their foot over the past week. | visit 4 (week 6) |
| Foot function index revised short (FFI-R short) | FFI-R short uses a likert questionnaire to document foot pain severity, foot stiffness, difficulty performing activities, activity limitation, and social issues related to affected foot. It consists of 23 self-reported items divided into 3 subcategories on the basis of patient values: pain, disability and activity limitation.The patient has to score each question on a scale from 0 (no pain or difficulty) to 10 (worst pain imaginable or so difficult it requires help), that best describes their foot over the past week. | visit 5 (week 12) |
| Belleville |
| Illinois |
| 62225 |
| United States |
| Mike O'Callaghan Military Medical Center | Nellis Air Force Base | Nevada | 89191 | United States |
| 25682385 | Background | Glickman-Simon R, Wallace J. Acupuncture for knee osteoarthritis, chasteberry for premenstrual syndrome, probiotics for irritable bowel syndrome, yoga for hypertension, and trigger point dry needling for plantar fasciitis. Explore (NY). 2015 Mar-Apr;11(2):157-61. doi: 10.1016/j.explore.2014.12.009. Epub 2014 Dec 29. No abstract available. |
| 21916393 | Background | Goff JD, Crawford R. Diagnosis and treatment of plantar fasciitis. Am Fam Physician. 2011 Sep 15;84(6):676-82. |
| 23227789 | Background | Kumnerddee W, Pattapong N. Efficacy of electro-acupuncture in chronic plantar fasciitis: a randomized controlled trial. Am J Chin Med. 2012;40(6):1167-76. doi: 10.1142/S0192415X12500863. |
| 39682003 | Background | Landorf KB, Twyford GN, Cotchett MP, Whittaker GA. Revised minimal important difference values for the visual analogue scale and Foot Health Status Questionnaire when used for plantar heel pain. J Foot Ankle Res. 2024 Dec;17(4):e70021. doi: 10.1002/jfa2.70021. |
| 25114704 | Background | Li S, Shen T, Liang Y, Zhang Y, Bai B. Miniscalpel-Needle versus Steroid Injection for Plantar Fasciitis: A Randomized Controlled Trial with a 12-Month Follow-Up. Evid Based Complement Alternat Med. 2014;2014:164714. doi: 10.1155/2014/164714. Epub 2014 Jul 8. |
| 25102533 | Background | Schwartz O, Levinson T, Astman N, Haim L. Attrition due to orthopedic reasons during combat training: rates, types of injuries, and comparison between infantry and noninfantry units. Mil Med. 2014 Aug;179(8):897-900. doi: 10.7205/MILMED-D-13-00567. |
| 26535232 | Background | Owens BD, Wolf JM, Seelig AD, Jacobson IG, Boyko EJ, Smith B, Ryan MA, Gackstetter GD, Smith TC; Millennium Cohort Study Team. Risk Factors for Lower Extremity Tendinopathies in Military Personnel. Orthop J Sports Med. 2013 Jun 11;1(1):2325967113492707. doi: 10.1177/2325967113492707. eCollection 2013 Jan-Jun. |
| 21882780 | Background | Roy TC. Diagnoses and mechanisms of musculoskeletal injuries in an infantry brigade combat team deployed to Afghanistan evaluated by the brigade physical therapist. Mil Med. 2011 Aug;176(8):903-8. doi: 10.7205/milmed-d-11-00006. |
| 19952249 | Background | Scher DL, Belmont PJ Jr, Bear R, Mountcastle SB, Orr JD, Owens BD. The incidence of plantar fasciitis in the United States military. J Bone Joint Surg Am. 2009 Dec;91(12):2867-72. doi: 10.2106/JBJS.I.00257. |
| 27526703 | Background | Thiagarajah AG. How effective is acupuncture for reducing pain due to plantar fasciitis? Singapore Med J. 2017 Feb;58(2):92-97. doi: 10.11622/smedj.2016143. Epub 2016 Aug 16. |
| 25892707 | Background | Woitzik E, Jacobs C, Wong JJ, Cote P, Shearer HM, Randhawa K, Sutton D, Southerst D, Varatharajan S, Brison RJ, Yu H, van der Velde G, Stern PJ, Taylor-Vaisey A, Stupar M, Mior S, Carroll LJ. The effectiveness of exercise on recovery and clinical outcomes of soft tissue injuries of the leg, ankle, and foot: A systematic review by the Ontario Protocol for Traffic Injury Management (OPTIMa) Collaboration. Man Ther. 2015 Oct;20(5):633-45. doi: 10.1016/j.math.2015.03.012. Epub 2015 Mar 28. |
| 19933769 | Background | Zhang SP, Yip TP, Li QS. Acupuncture treatment for plantar fasciitis: a randomized controlled trial with six months follow-up. Evid Based Complement Alternat Med. 2011;2011:154108. doi: 10.1093/ecam/nep186. Epub 2011 Feb 15. |
| 27272528 | Background | Polomano RC, Galloway KT, Kent ML, Brandon-Edwards H, Kwon KN, Morales C, Buckenmaier C' 3rd. Psychometric Testing of the Defense and Veterans Pain Rating Scale (DVPRS): A New Pain Scale for Military Population. Pain Med. 2016 Aug;17(8):1505-19. doi: 10.1093/pm/pnw105. Epub 2016 Jun 6. |
| 26257151 | Background | Nassif TH, Hull A, Holliday SB, Sullivan P, Sandbrink F. Concurrent Validity of the Defense and Veterans Pain Rating Scale in VA Outpatients. Pain Med. 2015 Nov;16(11):2152-61. doi: 10.1111/pme.12866. Epub 2015 Aug 8. |
| 17695343 | Background | Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146. |
| 17145489 | Background | Sloman R, Wruble AW, Rosen G, Rom M. Determination of clinically meaningful levels of pain reduction in patients experiencing acute postoperative pain. Pain Manag Nurs. 2006 Dec;7(4):153-8. doi: 10.1016/j.pmn.2006.09.001. |
| Background | Holm, S. 1979. A simple sequential rejective multiple test procedure. Scand. J. Statistics, 6: 65-70. |
| Background | R Core Team. R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. 2016 URL http://www.R-project.org/. |
| 42131440 | Derived | Moss D, Rasmussen B, Williams W, Crawford P. Electroacupuncture for Plantar Fasciopathy: A Multisite Randomized Clinical Trial. Med Acupunct. 2026 Feb 19;38(1):43-53. doi: 10.1089/acu.2024.0107. eCollection 2026 Feb. |
| D017530 | Health Care Quality, Access, and Evaluation |