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

Primary Purpose

Achilles Tendon Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
manual therapy and exercise
trigger point dry needling
Sponsored by
Nova Southeastern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Achilles Tendon Injury

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Breakthrough Physical Therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group 1 manual therapy and exercise

Group 2 TDN, manual therapy and exercise

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Functional Activity Level from baseline with the Functional Ankle Ability Measure
Change in Functional Activity Level from baseline with the Functional Ankle Ability Measure
Change in Pain from Baseline with the Numeric Pain Rating Scale
Change in Pain from Baseline with the Numeric Pain Rating Scale
Change in Fear of Activity from baseline with the Tampa Scale of Kinesiophobia
Change in Fear of Activity from baseline with the Tampa Scale of Kinesiophobia
Change in Pain from baseline with the Global Rating of Change
Change in Pain from baseline with the Global Rating of Change
Change in Pain from baseline with the Pain Pressure Threshold Measure
Primary site of pain on the Achilles tendon. All measurements taken with the Wagner FPK 20 Algometer.
Change in Pain from baseline with the Pain Pressure Threshold Measure
Primary site of pain on the Achilles tendon. All measurements taken with the Wagner FPK 20 Algometer.
Change in strength from baseline with the Muscle Endurance Test for single leg heel raise
Change in strength from baseline with the Muscle Endurance Test for single leg heel raise

Secondary Outcome Measures

Age
Demographic information -
Height
Demographic information
Weight
Demographic information
Gender
Demographic information
Duration of Pain
Demographic information

Full Information

First Posted
August 14, 2015
Last Updated
June 28, 2021
Sponsor
Nova Southeastern University
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1. Study Identification

Unique Protocol Identification Number
NCT02532595
Brief Title
TDN, Manual Therapy and Exercise For the Management of Achilles Tendinopathy
Official Title
Trigger Point Dry Needling, Manual Therapy and Exercise vs Manual Therapy and Exercise For the Management of Achilles Tendinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nova Southeastern University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achilles Tendon Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 manual therapy and exercise
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group 2 TDN, manual therapy and exercise
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
manual therapy and exercise
Intervention Description
soft tissue mobilization, stretches, concentric and eccentric strengthening
Intervention Type
Procedure
Intervention Name(s)
trigger point dry needling
Intervention Description
trigger point dry needling to trigger points located in the gastrocnemius, soleus and tibialis posterior
Primary Outcome Measure Information:
Title
Change in Functional Activity Level from baseline with the Functional Ankle Ability Measure
Time Frame
4 weeks
Title
Change in Functional Activity Level from baseline with the Functional Ankle Ability Measure
Time Frame
3 months
Title
Change in Pain from Baseline with the Numeric Pain Rating Scale
Time Frame
4 weeks
Title
Change in Pain from Baseline with the Numeric Pain Rating Scale
Time Frame
3 months
Title
Change in Fear of Activity from baseline with the Tampa Scale of Kinesiophobia
Time Frame
4 weeks
Title
Change in Fear of Activity from baseline with the Tampa Scale of Kinesiophobia
Time Frame
3 months
Title
Change in Pain from baseline with the Global Rating of Change
Time Frame
4 weeks
Title
Change in Pain from baseline with the Global Rating of Change
Time Frame
3 months
Title
Change in Pain from baseline with the Pain Pressure Threshold Measure
Description
Primary site of pain on the Achilles tendon. All measurements taken with the Wagner FPK 20 Algometer.
Time Frame
4 weeks
Title
Change in Pain from baseline with the Pain Pressure Threshold Measure
Description
Primary site of pain on the Achilles tendon. All measurements taken with the Wagner FPK 20 Algometer.
Time Frame
3 months
Title
Change in strength from baseline with the Muscle Endurance Test for single leg heel raise
Time Frame
4 weeks
Title
Change in strength from baseline with the Muscle Endurance Test for single leg heel raise
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Age
Description
Demographic information -
Time Frame
baseline
Title
Height
Description
Demographic information
Time Frame
baseline
Title
Weight
Description
Demographic information
Time Frame
baseline
Title
Gender
Description
Demographic information
Time Frame
baseline
Title
Duration of Pain
Description
Demographic information
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: pain onset greater than 4 weeks primary region of pain 2-6 cm proximal to the insertion on the calcaneus read and write in english Exclusion Criteria: Fear of needles or unwilling to have needling performed due to fear or personal beliefs. 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. Recent infection. Previous surgery to the foot/ankle. Steroid by injection or transdermal delivery to the posterior heel within three months. Full rupture of the Achilles tendon. Pregnant or may be pregnant. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josh Cleland, DPT, PhD
Organizational Affiliation
Nova Southeastern University
Official's Role
Study Chair
Facility Information:
Facility Name
Breakthrough Physical Therapy
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28311
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20805627
Citation
Carcia CR, Martin RL, Houck J, Wukich DK; Orthopaedic Section of the American Physical Therapy Association. Achilles pain, stiffness, and muscle power deficits: achilles tendinitis. J Orthop Sports Phys Ther. 2010 Sep;40(9):A1-26. doi: 10.2519/jospt.2010.0305. No abstract available.
Results Reference
background
PubMed Identifier
17718644
Citation
Ga H, Choi JH, Park CH, Yoon HJ. Dry needling of trigger points with and without paraspinal needling in myofascial pain syndromes in elderly patients. J Altern Complement Med. 2007 Jul-Aug;13(6):617-24. doi: 10.1089/acm.2006.6371.
Results Reference
background
PubMed Identifier
20213036
Citation
Fernandez-Carnero J, La Touche R, Ortega-Santiago R, Galan-del-Rio F, Pesquera J, Ge HY, Fernandez-de-Las-Penas C. Short-term effects of dry needling of active myofascial trigger points in the masseter muscle in patients with temporomandibular disorders. J Orofac Pain. 2010 Winter;24(1):106-12.
Results Reference
background
PubMed Identifier
22018577
Citation
Gonzalez-Iglesias J, Cleland JA, del Rosario Gutierrez-Vega M, Fernandez-de-las-Penas C. Multimodal management of lateral epicondylalgia in rock climbers: a prospective case series. J Manipulative Physiol Ther. 2011 Nov;34(9):635-42. doi: 10.1016/j.jmpt.2011.09.003. Epub 2011 Oct 21.
Results Reference
background
PubMed Identifier
23138883
Citation
Tekin L, Akarsu S, Durmus O, Cakar E, Dincer U, Kiralp MZ. The effect of dry needling in the treatment of myofascial pain syndrome: a randomized double-blinded placebo-controlled trial. Clin Rheumatol. 2013 Mar;32(3):309-15. doi: 10.1007/s10067-012-2112-3. Epub 2012 Nov 9.
Results Reference
background
PubMed Identifier
24700136
Citation
Cotchett MP, Munteanu SE, Landorf KB. Effectiveness of trigger point dry needling for plantar heel pain: a randomized controlled trial. Phys Ther. 2014 Aug;94(8):1083-94. doi: 10.2522/ptj.20130255. Epub 2014 Apr 3.
Results Reference
background
PubMed Identifier
25269764
Citation
Llamas-Ramos R, Pecos-Martin D, Gallego-Izquierdo T, Llamas-Ramos I, Plaza-Manzano G, Ortega-Santiago R, Cleland J, Fernandez-de-Las-Penas C. Comparison of the short-term outcomes between trigger point dry needling and trigger point manual therapy for the management of chronic mechanical neck pain: a randomized clinical trial. J Orthop Sports Phys Ther. 2014 Nov;44(11):852-61. doi: 10.2519/jospt.2014.5229. Epub 2014 Sep 30. Erratum In: J Orthop Sports Phys Ther. 2015 Feb;45(2):147.
Results Reference
background
PubMed Identifier
20351377
Citation
Osborne NJ, Gatt IT. Management of shoulder injuries using dry needling in elite volleyball players. Acupunct Med. 2010 Mar;28(1):42-5. doi: 10.1136/aim.2009.001560.
Results Reference
background
PubMed Identifier
24261928
Citation
Jayaseelan DJ, Moats N, Ricardo CR. Rehabilitation of proximal hamstring tendinopathy utilizing eccentric training, lumbopelvic stabilization, and trigger point dry needling: 2 case reports. J Orthop Sports Phys Ther. 2014 Mar;44(3):198-205. doi: 10.2519/jospt.2014.4905. Epub 2013 Nov 21.
Results Reference
background
PubMed Identifier
32048918
Citation
Koszalinski A, Flynn T, Hellman M, Cleland JA. Trigger point dry needling, manual therapy and exercise versus manual therapy and exercise for the management of Achilles tendinopathy: a feasibility study. J Man Manip Ther. 2020 Sep;28(4):212-221. doi: 10.1080/10669817.2020.1719299. Epub 2020 Feb 12.
Results Reference
derived

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

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