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

Study Overview
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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.

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

Conditions
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Achilles Tendon Injury

Intervention / Treatment
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* Procedure: manual therapy and exercise
* Procedure: trigger point dry needling


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1 manual therapy and exercise<br>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. | Procedure: manual therapy and exercise<br>* soft tissue mobilization, stretches, concentric and eccentric strengthening<br>|
| Experimental: Group 2 TDN, manual therapy and exercise<br>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. | Procedure: manual therapy and exercise<br>* soft tissue mobilization, stretches, concentric and eccentric strengthening<br>Procedure: trigger point dry needling<br>* trigger point dry needling to trigger points located in the gastrocnemius, soleus and tibialis posterior<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Functional Activity Level from baseline with the Functional Ankle Ability Measure |  | 4 weeks | 
| Change in Functional Activity Level from baseline with the Functional Ankle Ability Measure |  | 3 months | 
| Change in Pain from Baseline with the Numeric Pain Rating Scale |  | 4 weeks | 
| Change in Pain from Baseline with the Numeric Pain Rating Scale |  | 3 months | 
| Change in Fear of Activity from baseline with the Tampa Scale of Kinesiophobia |  | 4 weeks | 
| Change in Fear of Activity from baseline with the Tampa Scale of Kinesiophobia |  | 3 months | 
| Change in Pain from baseline with the Global Rating of Change |  | 4 weeks | 
| Change in Pain from baseline with the Global Rating of Change |  | 3 months | 
| 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 | 
| 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 | 
| Change in strength from baseline with the Muscle Endurance Test for single leg heel raise |  | 4 weeks | 
| Change in strength from baseline with the Muscle Endurance Test for single leg heel raise |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age | Demographic information - | baseline | 
| Height | Demographic information | baseline | 
| Weight | Demographic information | baseline | 
| Gender | Demographic information | baseline | 
| Duration of Pain | Demographic information | baseline |