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TDN, Manual Therapy and Exercise For the Management of Achilles Tendinopathy

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ClinicalTrials.gov Identifier: NCT02532595
Recruitment Status : Recruiting
First Posted : August 26, 2015
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
Nova Southeastern University

Brief Summary:
Conflicting evidence exists regarding the recommendations from the Orthopaedic section of the American Physical Therapy Association for treatment of Achilles tendinitis. Trigger point dry needling is effective in reducing pain in several body regions, but no published (TDN) studies are found reporting the effect on Achilles tendinopathy. The purpose of this study is to investigate whether a treatment program performed including TDN, manual therapy and exercise will result in a significant improvement in pain, strength and function compared to a treatment program including manual therapy and exercise for Achilles tendinopathy. Subjects with Achilles tendinopathy that receive treatment including TDN, manual therapy and exercise will demonstrate a significant improvement in pain, strength and functional outcomes compared to the group that receives manual therapy and exercise.

Condition or disease Intervention/treatment Phase
Achilles Tendon Injury Procedure: manual therapy and exercise Procedure: trigger point dry needling Not Applicable

Detailed Description:
This study is a randomized controlled trial, pretest-posttest control group design comparing the effect of TDN, manual therapy and exercise to manual therapy and exercise on human subjects with Achilles tendinopathy following eight treatments in four weeks and a follow up examination at three months.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Trigger Point Dry Needling, Manual Therapy and Exercise vs Manual Therapy and Exercise For the Management of Achilles Tendinopathy
Study Start Date : May 2015
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group 1 manual therapy and exercise
manual therapy with soft tissue mobilization to trigger points in the gastrocnemius, soleus, and tibialis posterior; exercise including stretching, concentric and eccentric exercises to the hip, triceps surae, tibialis posterior and foot intrinsics.
Procedure: manual therapy and exercise
soft tissue mobilization, stretches, concentric and eccentric strengthening

Experimental: Group 2 TDN, manual therapy and exercise
trigger point dry needling (TDN) to trigger points in the gastrocnemius, soleus and tibialis posterior; manual therapy with soft tissue mobilization to trigger points in the gastrocnemius, soleus, and tibialis posterior; exercise including stretching, concentric and eccentric exercises to the hip, triceps surae, tibialis posterior and foot intrinsics.
Procedure: manual therapy and exercise
soft tissue mobilization, stretches, concentric and eccentric strengthening

Procedure: trigger point dry needling
trigger point dry needling to trigger points located in the gastrocnemius, soleus and tibialis posterior




Primary Outcome Measures :
  1. Change in Functional Activity Level from baseline with the Functional Ankle Ability Measure [ Time Frame: 4 weeks ]
  2. Change in Functional Activity Level from baseline with the Functional Ankle Ability Measure [ Time Frame: 3 months ]
  3. Change in Pain from Baseline with the Numeric Pain Rating Scale [ Time Frame: 4 weeks ]
  4. Change in Pain from Baseline with the Numeric Pain Rating Scale [ Time Frame: 3 months ]
  5. Change in Fear of Activity from baseline with the Tampa Scale of Kinesiophobia [ Time Frame: 4 weeks ]
  6. Change in Fear of Activity from baseline with the Tampa Scale of Kinesiophobia [ Time Frame: 3 months ]
  7. Change in Pain from baseline with the Global Rating of Change [ Time Frame: 4 weeks ]
  8. Change in Pain from baseline with the Global Rating of Change [ Time Frame: 3 months ]
  9. Change in Pain from baseline with the Pain Pressure Threshold Measure [ Time Frame: 4 weeks ]
    Primary site of pain on the Achilles tendon. All measurements taken with the Wagner FPK 20 Algometer.

  10. Change in Pain from baseline with the Pain Pressure Threshold Measure [ Time Frame: 3 months ]
    Primary site of pain on the Achilles tendon. All measurements taken with the Wagner FPK 20 Algometer.

  11. Change in strength from baseline with the Muscle Endurance Test for single leg heel raise [ Time Frame: 4 weeks ]
  12. Change in strength from baseline with the Muscle Endurance Test for single leg heel raise [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Age [ Time Frame: baseline ]
    Demographic information -

  2. Height [ Time Frame: baseline ]
    Demographic information

  3. Weight [ Time Frame: baseline ]
    Demographic information

  4. Gender [ Time Frame: baseline ]
    Demographic information

  5. Duration of Pain [ Time Frame: baseline ]
    Demographic information



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. pain onset greater than 4 weeks
  2. primary region of pain 2-6 cm proximal to the insertion on the calcaneus
  3. read and write in english

Exclusion Criteria:

  1. Fear of needles or unwilling to have needling performed due to fear or personal beliefs.
  2. Vascular or sensory disturbances in the lower leg which include but is not limited to injury to the nerve root or peripheral nerve in the affected lower leg, inflammatory diseases, bleeding or clotting disorders, lymphedema, peripheral vascular or peripheral arterial disease. Diabetes is included in this group due to the progressive changes to the sensation and circulation in the lower extremities.
  3. Recent infection.
  4. Previous surgery to the foot/ankle.
  5. Steroid by injection or transdermal delivery to the posterior heel within three months.
  6. Full rupture of the Achilles tendon.
  7. Pregnant or may be pregnant.
  8. Participants with a work related injury insured by the bureau of worker's compensation or involved in litigation related to injury of the lower leg, foot or ankle.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02532595


Contacts
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Contact: Alex M Koszalinski, DPT 330-329-1718 alexkoszalinski@yahoo.com

Locations
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United States, North Carolina
Breakthrough Physical Therapy Recruiting
Fayetteville, North Carolina, United States, 28311
Contact: Adam Autry, DPT    910-920-4903    adama@breakthroughptclinics.com   
Contact: Kristen Wulfing, DPT    (910) 920-4903    kristenw@breakthroughptclinics.com   
Sub-Investigator: Drew Schlabach, DPT         
Sub-Investigator: Matt Ware, DPT         
Sub-Investigator: Aaron Gray, DPT         
Sponsors and Collaborators
Nova Southeastern University
Investigators
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Study Chair: Josh Cleland, DPT, PhD Nova Southeastern University

Publications of Results:

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Responsible Party: Nova Southeastern University
ClinicalTrials.gov Identifier: NCT02532595     History of Changes
Other Study ID Numbers: 03261504F
First Posted: August 26, 2015    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018
Additional relevant MeSH terms:
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Tendinopathy
Tendon Injuries
Muscular Diseases
Musculoskeletal Diseases
Wounds and Injuries