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Completed

NCT Number: NCT02532595

TDN, 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.

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Key information

Conditions

Achilles Tendon Injury

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Breakthrough Physical Therapy

Fayetteville, North Carolina, 28311, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

manual therapy and exercise

Procedure

soft tissue mobilization, stretches, concentric and eccentric strengthening

trigger point dry needling

Procedure

trigger point dry needling to trigger points located in the gastrocnemius, soleus and tibialis posterior

Primary outcomes

  1. Change in Functional Activity Level from baseline with the Functional Ankle Ability Measure

    Time frame: 4 weeks

  2. Change in Functional Activity Level from baseline with the Functional Ankle Ability Measure

    Time frame: 3 months

  3. Change in Pain from Baseline with the Numeric Pain Rating Scale

    Time frame: 4 weeks

  4. Change in Pain from Baseline with the Numeric Pain Rating Scale

    Time frame: 3 months

  5. Change in Fear of Activity from baseline with the Tampa Scale of Kinesiophobia

    Time frame: 4 weeks

  6. Change in Fear of Activity from baseline with the Tampa Scale of Kinesiophobia

    Time frame: 3 months

  7. Change in Pain from baseline with the Global Rating of Change

    Time frame: 4 weeks

  8. Change in Pain from baseline with the Global Rating of Change

    Time frame: 3 months

  9. 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.

  10. 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.

  11. Change in strength from baseline with the Muscle Endurance Test for single leg heel raise

    Time frame: 4 weeks

  12. Change in strength from baseline with the Muscle Endurance Test for single leg heel raise

    Time frame: 3 months

Secondary outcomes

  1. Age

    Time frame: baseline

    Demographic information -

  2. Height

    Time frame: baseline

    Demographic information

  3. Weight

    Time frame: baseline

    Demographic information

  4. Gender

    Time frame: baseline

    Demographic information

  5. Duration of Pain

    Time frame: baseline

    Demographic information

Sponsors and collaborators

Lead sponsor

Nova Southeastern University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Aug 26, 2015
Registry last updated
Jun 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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