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出境医 / 临床实验 / Electrical DN as an Adjunct to Eccentric Exercise, Stretching + MT for Achilles Tendinopathy

Electrical DN as an Adjunct to Eccentric Exercise, Stretching + MT for Achilles Tendinopathy

Study Description
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.

Condition or disease Intervention/treatment Phase
Achilles Tendinopathy Other: Electric dry needling and conventional PT Other: Conventional PT Not Applicable

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 Design
Layout table for study information
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
Arms and Interventions
Arm Intervention/treatment
Experimental: Electrical Dry Needling and conventional PT
Electrical Dry Needling, Eccentric Exercise, Stretching and Manual Therapy
Other: Electric dry needling and conventional PT
Electrical Dry Needling, Eccentric Exercise, Stretching and Manual Therapy

Active Comparator: Conventional PT
Eccentric Exercise, Stretching and Manual Therapy
Other: Conventional PT
Eccentric Exercise, Stretching and Manual Therapy

Outcome Measures
Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in achilles pain (NPRS) (Rating Score) [ Time Frame: baseline, 2 weeks, 6 weeks, 3 months ]
    Higher scores mean greater pain

  2. Change in Foot and Ankle Ability Measure - ADL [ Time Frame: baseline, 2 weeks, 6 weeks, 3 months ]
    activities of daily living (0-84 points) 21 Item 84-point ADL Subscale

  3. Change in Foot and Ankle Ability Measure - Sports [ Time Frame: baseline, 2 weeks, 6 weeks, 3 months ]
    Sports (0-32 points) 8 Item 32-point sports subscale

  4. GROC (ranges from -7 to +7). Global Rating of Change score. [ Time Frame: 2 weeks, 6 weeks, 3 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult >18 years old that is able to speak English.
  2. Report of at least 3 months of Achilles pain clinically diagnosed as Achilles tendonitis or Achilles tendinopathy
  3. Patient has not had physical therapy, massage therapy, chiropractic treatment or injections for Achilles pain in the last 6 months:
  4. Diagnosis of noninsertional tendinopathy, defined as the following

    • Subjective report of pain located 2-6 cm proximal to the insertion of Achilles tendon to the calcaneus, particularly with running or jumping
    • Tenderness to palpation of the Achilles tendon while the clinician gently squeezes the tendon between the thumb and index finger in a proximal to distal direction
    • Positive Arc Sign - Intratendinous swelling moves relative to the malleoli with the tendon during active dorsi/plantar Flexion
    • Royal London Test - Tenderness to palpation decreases significantly or disappears with max dorsiflexion

Exclusion Criteria:

  1. Report of red flags to manual physical therapy to include: hypertension infection, diabetes, peripheral neuropathy, heart disease, stroke, chronic ischemia, edema, severe vascular disease, malignancy, etc.
  2. History of previous Achilles tendon surgery, ankle arthrodesis, hind foot fracture, or leg length discrepancy of more than one half inch.
  3. History of arthrosis or arthritis of the ankle and/or foot.
  4. History of significant ankle and/or foot instability
  5. Two or more positive neurologic signs consistent with nerve root compression, including any two of the following:

    1. Muscle weakness involving a major lower extremity muscle group
    2. Diminished lower extremity patella or Achilles tendon reflexes
    3. Diminished / absent sensation in any lower extremity dermatome
  6. Involvement in litigation or worker's compensation regarding foot pain
  7. Any condition that might contraindicate the use of electro-needling
  8. The patient is pregnant.
Contacts and Locations

Contacts
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Contact: James Dunning, DPT 18017079056 jamesdunning@hotmail.com
Contact: Raymond Butts, DPT PhD 8034223954 fellowship@spinalmanipulation.org

Locations
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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   
Sponsors and Collaborators
Alabama Physical Therapy & Acupuncture
Universidad Rey Juan Carlos
Investigators
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Principal Investigator: James Dunning, DPT American Academy of Manipulative Therapy
Tracking Information
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
 (submitted: June 16, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 28, 2019)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2019)
  • Change in achilles pain (NPRS) (Rating Score) [ Time Frame: baseline, 2 weeks, 6 weeks, 3 months ]
    Higher scores mean greater pain
  • Change in Foot and Ankle Ability Measure - ADL [ Time Frame: baseline, 2 weeks, 6 weeks, 3 months ]
    activities of daily living (0-84 points) 21 Item 84-point ADL Subscale
  • Change in Foot and Ankle Ability Measure - Sports [ Time Frame: baseline, 2 weeks, 6 weeks, 3 months ]
    Sports (0-32 points) 8 Item 32-point sports subscale
  • GROC (ranges from -7 to +7). Global Rating of Change score. [ Time Frame: 2 weeks, 6 weeks, 3 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2019)
  • 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.
  • Foot and Ankle Ability Measure - ADL [ Time Frame: baseline, 2 weeks, 6 weeks, 3 months ]
    activities of daily living (0-84 points) 21 Item 84-point ADL Subscale
  • Foot and Ankle Ability Measure - Sports [ Time Frame: baseline, 2 weeks, 6 weeks, 3 months ]
    Sports (0-32 points) 8 Item 32-point sports subscale
  • GROC (ranges from -7 to +7). Global Rating of Change score. [ Time Frame: 2 weeks, 6 weeks, 3 months ]
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
Condition  ICMJE Achilles Tendinopathy
Intervention  ICMJE
  • Other: Electric dry needling and conventional PT
    Electrical Dry Needling, Eccentric Exercise, Stretching and Manual Therapy
  • Other: Conventional PT
    Eccentric Exercise, Stretching and Manual Therapy
Study Arms  ICMJE
  • Experimental: Electrical Dry Needling and conventional PT
    Electrical Dry Needling, Eccentric Exercise, Stretching and Manual Therapy
    Intervention: Other: Electric dry needling and conventional PT
  • Active Comparator: Conventional PT
    Eccentric Exercise, Stretching and Manual Therapy
    Intervention: Other: Conventional PT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 28, 2019)
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:

  1. Adult >18 years old that is able to speak English.
  2. Report of at least 3 months of Achilles pain clinically diagnosed as Achilles tendonitis or Achilles tendinopathy
  3. Patient has not had physical therapy, massage therapy, chiropractic treatment or injections for Achilles pain in the last 6 months:
  4. Diagnosis of noninsertional tendinopathy, defined as the following

    • Subjective report of pain located 2-6 cm proximal to the insertion of Achilles tendon to the calcaneus, particularly with running or jumping
    • Tenderness to palpation of the Achilles tendon while the clinician gently squeezes the tendon between the thumb and index finger in a proximal to distal direction
    • Positive Arc Sign - Intratendinous swelling moves relative to the malleoli with the tendon during active dorsi/plantar Flexion
    • Royal London Test - Tenderness to palpation decreases significantly or disappears with max dorsiflexion

Exclusion Criteria:

  1. Report of red flags to manual physical therapy to include: hypertension infection, diabetes, peripheral neuropathy, heart disease, stroke, chronic ischemia, edema, severe vascular disease, malignancy, etc.
  2. History of previous Achilles tendon surgery, ankle arthrodesis, hind foot fracture, or leg length discrepancy of more than one half inch.
  3. History of arthrosis or arthritis of the ankle and/or foot.
  4. History of significant ankle and/or foot instability
  5. Two or more positive neurologic signs consistent with nerve root compression, including any two of the following:

    1. Muscle weakness involving a major lower extremity muscle group
    2. Diminished lower extremity patella or Achilles tendon reflexes
    3. Diminished / absent sensation in any lower extremity dermatome
  6. Involvement in litigation or worker's compensation regarding foot pain
  7. Any condition that might contraindicate the use of electro-needling
  8. The patient is pregnant.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: James Dunning, DPT 18017079056 jamesdunning@hotmail.com
Contact: Raymond Butts, DPT PhD 8034223954 fellowship@spinalmanipulation.org
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
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
Principal Investigator: James Dunning, DPT American Academy of Manipulative Therapy
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