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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02532595
Other study ID # 03261504F
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2015
Est. completion date December 31, 2018

Study information

Verified date January 2020
Source Nova Southeastern University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
manual therapy and exercise
soft tissue mobilization, stretches, concentric and eccentric strengthening
trigger point dry needling
trigger point dry needling to trigger points located in the gastrocnemius, soleus and tibialis posterior

Locations

Country Name City State
United States Breakthrough Physical Therapy Fayetteville North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Nova Southeastern University

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. Review. — View 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. — View Citation

Fernández-Carnero J, La Touche R, Ortega-Santiago R, Galan-del-Rio F, Pesquera J, Ge HY, Fernández-de-Las-Peñas 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. — View 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. — View Citation

González-Iglesias J, Cleland JA, del Rosario Gutierrez-Vega M, Fernández-de-las-Peñas 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. — View 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. — View Citation

Llamas-Ramos R, Pecos-Martín D, Gallego-Izquierdo T, Llamas-Ramos I, Plaza-Manzano G, Ortega-Santiago R, Cleland J, Fernández-de-Las-Peñas 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. — View 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. Review. — View Citation

Tekin L, Akarsu S, Durmus O, Cakar E, Dinçer 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Functional Activity Level from baseline with the Functional Ankle Ability Measure 4 weeks
Primary Change in Functional Activity Level from baseline with the Functional Ankle Ability Measure 3 months
Primary Change in Pain from Baseline with the Numeric Pain Rating Scale 4 weeks
Primary Change in Pain from Baseline with the Numeric Pain Rating Scale 3 months
Primary Change in Fear of Activity from baseline with the Tampa Scale of Kinesiophobia 4 weeks
Primary Change in Fear of Activity from baseline with the Tampa Scale of Kinesiophobia 3 months
Primary Change in Pain from baseline with the Global Rating of Change 4 weeks
Primary Change in Pain from baseline with the Global Rating of Change 3 months
Primary 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. 4 weeks
Primary 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. 3 months
Primary Change in strength from baseline with the Muscle Endurance Test for single leg heel raise 4 weeks
Primary Change in strength from baseline with the Muscle Endurance Test for single leg heel raise 3 months
Secondary Age Demographic information - baseline
Secondary Height Demographic information baseline
Secondary Weight Demographic information baseline
Secondary Gender Demographic information baseline
Secondary Duration of Pain Demographic information baseline
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