Condition or disease | Intervention/treatment | Phase |
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Achilles Tendinopathy | Other: Electric dry needling and conventional PT Other: Conventional PT | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 110 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Electrical Dry Needling as an Adjunct to Eccentric Exercise, Stretching and Manual Therapy for Mid-portion Achilles Tendinopathy: a Multicenter Randomized Clinical Trial |
Actual Study Start Date : | June 10, 2019 |
Estimated Primary Completion Date : | August 1, 2021 |
Estimated Study Completion Date : | August 1, 2021 |
Arm | Intervention/treatment |
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Experimental: Electrical Dry Needling and conventional PT
Electrical Dry Needling, Eccentric Exercise, Stretching and Manual Therapy
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Other: Electric dry needling and conventional PT
Electrical Dry Needling, Eccentric Exercise, Stretching and Manual Therapy
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Active Comparator: Conventional PT
Eccentric Exercise, Stretching and Manual Therapy
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Other: Conventional PT
Eccentric Exercise, Stretching and Manual Therapy
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Diagnosis of noninsertional tendinopathy, defined as the following
Exclusion Criteria:
Two or more positive neurologic signs consistent with nerve root compression, including any two of the following:
Contact: James Dunning, DPT | 18017079056 | jamesdunning@hotmail.com | |
Contact: Raymond Butts, DPT PhD | 8034223954 | fellowship@spinalmanipulation.org |
United States, South Carolina | |
Prisma Health - Research PT Specialists | Recruiting |
Columbia, South Carolina, United States, 29201 | |
Contact: Kris Phillips, DPT 803-296-2273 Kris.Phillips@prismahealth.org |
Principal Investigator: | James Dunning, DPT | American Academy of Manipulative Therapy |
Tracking Information | |||||||||
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First Submitted Date ICMJE | May 28, 2019 | ||||||||
First Posted Date ICMJE | May 30, 2019 | ||||||||
Last Update Posted Date | December 29, 2020 | ||||||||
Actual Study Start Date ICMJE | June 10, 2019 | ||||||||
Estimated Primary Completion Date | August 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Change in VISA-A Questionnaire [ Time Frame: baseline, 2 weeks, 6 weeks, 3 months ] Index of severity of Achilles tendinopathy. Lower score means greater severity of condition.
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Original Primary Outcome Measures ICMJE |
Change in achilles pain (NPRS) (Rating Score) [ Time Frame: baseline, 2 weeks, 6 weeks, 3 months ] Rating Score. Baseline score must exceed 2/10 to be included in the study.
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Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Electrical DN as an Adjunct to Eccentric Exercise, Stretching + MT for Achilles Tendinopathy | ||||||||
Official Title ICMJE | Electrical Dry Needling as an Adjunct to Eccentric Exercise, Stretching and Manual Therapy for Mid-portion Achilles Tendinopathy: a Multicenter Randomized Clinical Trial | ||||||||
Brief Summary | The purpose of this research is to compare two different approaches for treating patients with achilles tendinopathy: eccentric exercise, stretching and manual therapy VS Electric dry needling, eccentric exercise, stretching and manual therapy. Physical therapists commonly use all of these techniques to treat achilles tendinopathy. This study is attempting to find out if one treatment strategy is more effective than the other. | ||||||||
Detailed Description | Patients with achilles tendinopathy will be randomized to receive 8-10 treatments (1-2 treatments per week) over 6 weeks (10 treatments max) of either: (1)Eccentric exercise, stretching, manual therapy and electrical dry needling or 2. eccentric exercise, stretching and manual therapy | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Achilles Tendinopathy | ||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
110 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | August 1, 2021 | ||||||||
Estimated Primary Completion Date | August 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03968614 | ||||||||
Other Study ID Numbers ICMJE | AAMT30 | ||||||||
Has Data Monitoring Committee | Not Provided | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | James Dunning, DPT, MSc, FAAOMPT, Alabama Physical Therapy & Acupuncture | ||||||||
Study Sponsor ICMJE | Alabama Physical Therapy & Acupuncture | ||||||||
Collaborators ICMJE | Universidad Rey Juan Carlos | ||||||||
Investigators ICMJE |
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PRS Account | Alabama Physical Therapy & Acupuncture | ||||||||
Verification Date | December 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |