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

NCT ID: NCT02532595

Last Updated: 2021-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Achilles Tendon Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

manual therapy and exercise

Intervention Type PROCEDURE

soft tissue mobilization, stretches, concentric and eccentric strengthening

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.

Group Type EXPERIMENTAL

manual therapy and exercise

Intervention Type PROCEDURE

soft tissue mobilization, stretches, concentric and eccentric strengthening

trigger point dry needling

Intervention Type PROCEDURE

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

Interventions

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manual therapy and exercise

soft tissue mobilization, stretches, concentric and eccentric strengthening

Intervention Type PROCEDURE

trigger point dry needling

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nova Southeastern University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Josh Cleland, DPT, PhD

Role: STUDY_CHAIR

Nova Southeastern University

Locations

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Breakthrough Physical Therapy

Fayetteville, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 20805627 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17718644 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20213036 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22018577 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23138883 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24700136 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25269764 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20351377 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24261928 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32048918 (View on PubMed)

Other Identifiers

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03261504F

Identifier Type: -

Identifier Source: org_study_id

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