Clinical trial NCT02532595: 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
Overall status: COMPLETED
Phase: NA
Conditions: Achilles Tendon Injury
Lead sponsor: Nova Southeastern University
Sponsor class: OTHER
First posted: 2015-08-26
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Change in Functional Activity Level from baseline with the Functional Ankle Ability Measure
timeFrame: 4 weeks
measure: Change in Functional Activity Level from baseline with the Functional Ankle Ability Measure
timeFrame: 3 months
measure: Change in Pain from Baseline with the Numeric Pain Rating Scale
timeFrame: 4 weeks
measure: Change in Pain from Baseline with the Numeric Pain Rating Scale
timeFrame: 3 months
measure: Change in Fear of Activity from baseline with the Tampa Scale of Kinesiophobia
timeFrame: 4 weeks
measure: Change in Fear of Activity from baseline with the Tampa Scale of Kinesiophobia
timeFrame: 3 months
measure: Change in Pain from baseline with the Global Rating of Change
timeFrame: 4 weeks
measure: Change in Pain from baseline with the Global Rating of Change
timeFrame: 3 months
measure: Change in Pain from baseline with the Pain Pressure Threshold Measure
timeFrame: 4 weeks
measure: Change in Pain from baseline with the Pain Pressure Threshold Measure
timeFrame: 3 months
measure: Change in strength from baseline with the Muscle Endurance Test for single leg heel raise
timeFrame: 4 weeks
measure: Change in strength from baseline with the Muscle Endurance Test for single leg heel raise
timeFrame: 3 months
Secondary outcomes:
measure: Age
timeFrame: baseline
measure: Height
timeFrame: baseline
measure: Weight
timeFrame: baseline
measure: Gender
timeFrame: baseline
measure: Duration of Pain
timeFrame: baseline
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: Breakthrough Physical Therapy
state: North Carolina
Study officials:
affiliation: Nova Southeastern University
name: Josh Cleland, DPT, PhD
role: STUDY_CHAIR
References:
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.
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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.
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.
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.
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.
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.
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.