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

Achilles Tendon Injury Clinical Trial

Official title:

Trigger Point Dry Needling, Manual Therapy and Exercise vs Manual Therapy and Exercise For the Management of Achilles Tendinopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02532595
• Other study ID #: 03261504F
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Achilles Tendon Injury
• Tendinopathy
• Tendon Injuries

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