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

June 28, 2021 updated by: Nova Southeastern University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Fayetteville, North Carolina, United States, 28311
        • Breakthrough Physical Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nova Southeastern University

Investigators

  • Study Chair: Josh Cleland, DPT, PhD, Nova Southeastern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

August 14, 2015

First Submitted That Met QC Criteria

August 21, 2015

First Posted (Estimate)

August 26, 2015

Study Record Updates

Last Update Posted (Actual)

June 30, 2021

Last Update Submitted That Met QC Criteria

June 28, 2021

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03261504F

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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