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

Not Applicable

Completed

• Conditions: Achilles Tendon Injury
• Interventions: Procedure: manual therapy and exercise; Procedure: trigger point dry needling

• Registration Number: NCT02532595
• Lead Sponsor: Nova Southeastern University

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.

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-08-14
• Study First Submitted QC: 2015-08-21
• Study First Posted: 2015-08-26
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2020-01
• Last Update Submitted: 2021-06-28
• Last Update Posted: 2021-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2 TDN, manual therapy and exercise	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 2 TDN, manual therapy and exercise	trigger point dry needling	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 1 manual therapy and exercise	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.

Primary Outcome Measures

Name	Time	Method
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	3 months
Change in Pain from baseline with the Pain Pressure Threshold Measure	3 months	Primary site of pain on the Achilles tendon. All measurements taken with the Wagner FPK 20 Algometer.
Change in strength from baseline with the Muscle Endurance Test for single leg heel raise	3 months
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	3 months

Secondary Outcome Measures

Name	Time	Method
Age	baseline	Demographic information -
Height	baseline	Demographic information
Weight	baseline	Demographic information
Gender	baseline	Demographic information
Duration of Pain	baseline	Demographic information

Trial Locations

Locations (1)

Breakthrough Physical Therapy; 🇺🇸 Fayetteville, North Carolina, United States