Plantar FascitisNCT04243343
Specific Acupuncture Protocol for the Treatment of Plantar Fasciosis
A study of Plantar Fascitis, run by brett rasmussen at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Plantar Fascitis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jun 2020to 2 Nov 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 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female DoD beneficiaries, aged 18 to 74 years, who have been diagnosed with plantar fasciosis (in one or both of their feet) OR
- Patients meeting criteria of pain in the bottom of the foot/heel with first steps in the morning \& tender to palpation over the medial calcaneal tubercle (where the plantar fascia inserts).
- Those with acute and chronic diagnoses will be included.
Who cannot join
- Pregnant
- Any of the following in the foot being included into the study:
- Active cellulitis of lower extremity
- Prior surgery for plantar fasciosis
- Steroid injections in the last 12 weeks for plantar fasciosis; if received in last 12 weeks subjects will be offered to be involved in the study after they have completed a 12 -week wash out period.
- If they have every had any prior acupuncture for plantar fasciosis using the defined Deep Ankle Local Periosteal points, any regenerative therapy to include proliferation therapy or platelet rich plasma therapy in the last 12 weeks for plantar fasciosis; if received in last 12 weeks subject will be offered to be involved in the study after they have completed a 12-week wash out period.
- Botox injections for plantar fasciosis injections in the last 12 weeks for plantar fasciosis; if received in last 12 weeks subject will be offered to be involved in the study after they have completed.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Scott AFB
Belleville, Illinois, 62225
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: A Randomized, Controlled, Multi-site Trial of a Specific Acupuncture Protocol for the Treatment of Plantar Fasciosis
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.
Read the detailed description
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.
- Conditions
- Plantar Fascitis
- Being tested
- Intervention + Standard of care, Standard of care
- Keywords
- Plantar fasciosis, acupuncture, electrostimulation, primary care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention + Standard of careDevice
Acupuncture with electrostimulation plus standard of care prescribed home exercise program for treatment of plantar fasciosis.
Standard of careOther
Standard of care prescribed home exercise program for treatment of plantar fasciosis.
| Study group | Role | What they receive |
|---|---|---|
| Intervention + Standard of care | Experimental | Acupuncture with electrostimulation plus standard of care prescribed home exercise program. Receives: Device: Intervention + Standard of care |
| Standard of care | Active comparator | Standard of care prescribed home exercise program. Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: visit 4 (week 6)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: visit 4 (week 6)
Defense and Veterans Pain Rating Scale Supplemental Questions
For clinicians to evaluate the biopsychosocial impact of pain.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: visit 5 (week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start1 Jun 2020
- Primary completion2 Nov 2021
- Study completion2 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Plantar FascitisStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- brett rasmussen
- Sponsor type
- US federal agency
- Responsible party
- Sponsor-investigator, brett rasmussen, Mike O'Callaghan Military Hospital
- Investigators
- Paul F Crawford, MD, Study director, United States Air Force
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04243343
- Sponsor's protocol ID
- FWH20200060H
- Status last verified
- Jan 2022
- First submitted
- 22 Jan 2020
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan on sharing data
Publications
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.
PubMed 20807448Covey CJ, Mulder MD. Plantar fasciitis: How best to treat? J Fam Pract. 2013 Sep;62(9):466-71.
PubMed 24080555Glickman-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.
PubMed 25682385Goff JD, Crawford R. Diagnosis and treatment of plantar fasciitis. Am Fam Physician. 2011 Sep 15;84(6):676-82.
PubMed 21916393Kumnerddee 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.
PubMed 23227789Landorf 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.
PubMed 39682003Li 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.
PubMed 25114704Schwartz 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.
PubMed 25102533Owens 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.
PubMed 26535232Roy 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.
PubMed 21882780Scher 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.
PubMed 19952249Thiagarajah 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.
PubMed 27526703Woitzik 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.
PubMed 25892707Zhang 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.
PubMed 19933769Polomano 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.
PubMed 27272528
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Multi-site Trial of a Specific Acupuncture Protocol for the Treatment of Plantar Fasciosis
- ClinicalTrials.gov ID
- NCT04243343
- Acronym / sponsor ID
- FWH20200060H
- Conditions
- Plantar Fascitis
- Keywords
- Plantar fasciosis, acupuncture, electrostimulation, primary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- brett rasmussenUS federal agency
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 2 Nov 2021 (actual)
- Study completion
- 2 Nov 2021 (actual)
- First posted
- 28 Jan 2020 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention + Standard of care | Experimental | Device: Intervention + Standard of careAcupuncture with electrostimulation plus standard of care prescribed home exercise program. |
| Standard of care | Active comparator | Other: Standard of careStandard of care prescribed home exercise program. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female DoD beneficiaries, aged 18 to 74 years, who have been diagnosed with plantar fasciosis (in one or both of their feet) OR
- Patients meeting criteria of pain in the bottom of the foot/heel with first steps in the morning \& tender to palpation over the medial calcaneal tubercle (where the plantar fascia inserts).
- Those with acute and chronic diagnoses will be included.
Key exclusion criteria (7 listed)
- Pregnant
- Any of the following in the foot being included into the study:
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 |
|---|---|---|
| Intervention + Standard of careAcupuncture with electrostimulation plus standard of care prescribed home exercise program for treatment of plantar fasciosis. | Device | Intervention + Standard of care |
| Standard of careStandard of care prescribed home exercise program for treatment of plantar fasciosis. | Other | Standard of care |
Primary outcome
Defense and Veterans Pain Rating Scale (DVPRS)
Time frame: visit 1 (Day 1)
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
Defense and Veterans Pain Rating Scale (DVPRS)
Time frame: visit 2 (week 2)
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
Defense and Veterans Pain Rating Scale (DVPRS)
Time frame: visit 3 (week 4)
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
Defense and Veterans Pain Rating Scale (DVPRS)
Time frame: visit 4 (week 6)
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
Defense and Veterans Pain Rating Scale (DVPRS)
Time frame: visit 5 (week 12)
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
Defense and Veterans Pain Rating Scale Supplemental Questions
Time frame: visit 1 (Day 1)
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.
Defense and Veterans Pain Rating Scale Supplemental Questions
Time frame: visit 2 (week 2)
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.
Defense and Veterans Pain Rating Scale Supplemental Questions
Time frame: visit 3 (week 4)
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.
Defense and Veterans Pain Rating Scale Supplemental Questions
Time frame: visit 4 (week 6)
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.
Defense and Veterans Pain Rating Scale Supplemental Questions
Time frame: The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. visit 5 (week 12)
For clinicians to evaluate the biopsychosocial impact of pain.
Foot function index revised short (FFI-R short)
Time frame: visit 1 (Day 1)
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.
Foot function index revised short (FFI-R short)
Time frame: visit 2 (week 2)
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.
Foot function index revised short (FFI-R short)
Time frame: visit 3 (week 4)
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.
Foot function index revised short (FFI-R short)
Time frame: visit 4 (week 6)
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.
Foot function index revised short (FFI-R short)
Time frame: visit 5 (week 12)
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.
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 28 Jan 2022.
- Background: PubMed 20807448Cotchett 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.
- Background: PubMed 24080555Covey CJ, Mulder MD. Plantar fasciitis: How best to treat? J Fam Pract. 2013 Sep;62(9):466-71.
- Background: PubMed 25682385Glickman-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.
- Background: PubMed 21916393Goff JD, Crawford R. Diagnosis and treatment of plantar fasciitis. Am Fam Physician. 2011 Sep 15;84(6):676-82.
- Background: PubMed 23227789Kumnerddee 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.
- Background: PubMed 39682003Landorf 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.
- Background: PubMed 25114704Li 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.
- Background: PubMed 25102533Schwartz 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.
- Background: PubMed 26535232Owens 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.
- Background: PubMed 21882780Roy 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.
- Background: PubMed 19952249Scher 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.
- Background: PubMed 27526703Thiagarajah 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.
- General Hospital and Personal Use Therapeutic DevicesLink provided by the sponsor.
- Individual participant dataSharing planned: No. We do not plan on sharing data
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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.
Paul F Crawford, MD study director
United States Air Force
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Plantar Fascitis, run by brett rasmussen at 3 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 7 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 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Defense and Veterans Pain Rating Scale (DVPRS) (time frame: visit 1 (Day 1)). The study lists 15 primary outcomes in all. 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 NCT04243343, which also lists 21 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 28 Jan 2022.