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

Sponsor
Nova Southeastern University (Other)
Overall Status
Completed
CT.gov ID
NCT02532595
Collaborator
(none)
18
1
2
44
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: manual therapy and exercise
  • Procedure: trigger point dry needling
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Trigger Point Dry Needling, Manual Therapy and Exercise vs Manual Therapy and Exercise For the Management of Achilles Tendinopathy
Study Start Date :
May 1, 2015
Actual Primary Completion Date :
Dec 31, 2018
Actual Study Completion Date :
Dec 31, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in Functional Activity Level from baseline with the Functional Ankle Ability Measure [4 weeks]

  2. Change in Functional Activity Level from baseline with the Functional Ankle Ability Measure [3 months]

  3. Change in Pain from Baseline with the Numeric Pain Rating Scale [4 weeks]

  4. Change in Pain from Baseline with the Numeric Pain Rating Scale [3 months]

  5. Change in Fear of Activity from baseline with the Tampa Scale of Kinesiophobia [4 weeks]

  6. Change in Fear of Activity from baseline with the Tampa Scale of Kinesiophobia [3 months]

  7. Change in Pain from baseline with the Global Rating of Change [4 weeks]

  8. Change in Pain from baseline with the Global Rating of Change [3 months]

  9. Change in Pain from baseline with the Pain Pressure Threshold Measure [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 [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 [4 weeks]

  12. Change in strength from baseline with the Muscle Endurance Test for single leg heel raise [3 months]

Secondary Outcome Measures

  1. Age [baseline]

    Demographic information -

  2. Height [baseline]

    Demographic information

  3. Weight [baseline]

    Demographic information

  4. Gender [baseline]

    Demographic information

  5. Duration of Pain [baseline]

    Demographic information

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Breakthrough Physical Therapy Fayetteville North Carolina United States 28311

Sponsors and Collaborators

  • Nova Southeastern University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Nova Southeastern University
ClinicalTrials.gov Identifier:
NCT02532595
Other Study ID Numbers:
  • 03261504F
First Posted:
Aug 26, 2015
Last Update Posted:
Jun 30, 2021
Last Verified:
Jan 1, 2020
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 30, 2021