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Completed

NCT Number: NCT04487327

The Effect of Needle Placement on Muscle Stiffness, Gait, Balance, Pain and Functional Outcomes in Individuals With Injury to the Ankle and/or Hindfoot

The purpose of this randomized controlled trial is to assess the effect of DN at either the site of the identified myofascial trigger point/s (MTrP) of in the same muscle, but away from the MTrP site/s in individuals with ankle and/or hindfoot injury. Assessments will be of self-reported outcomes, self-reported pain, gait, balance, muscle stiffness, and pain pressure threshold. The secondary purpose of this study is to determine the validity of dry needling specific muscles of the lower extremity based upon needle placement, location relative to anatomical structures and accuracy of needle placement in muscle using ultrasound imaging.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Regis University

Denver, Colorado, 80221, United States

About this study

Few studies have assessed the validity of needling muscles of the lower extremity. For muscles such as the tibialis posterior that are not easily accessible or directly palpable secondary to the deep anatomical position and due to the proximity of the tibial nerve and the posterior tibial artery within the deep compartment, examining accurate needle placement is clinically relevant. In addition, DN has been shown to be a beneficial management strategy for individuals with lower extremity condition; however, the investigators may be able to optimize these beneficial effects by performing DN on the MTrP versus other sites within the same muscle.

If needling directly into the MTrP is more effective than needling away from the MTrP but into the same muscle, it is possible that the improved efficiency could help to optimize management of patients with injury to the ankle/hindfoot with less visits and potentially decreasing health care costs.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants with a previous lower extremity injury occurring to the ankle and/or hindfoot within the previous 12 months AND
  • pain greater than 3 out of 10 on the numeric pain rating scale (NPRS) OR
  • limited weightbearing dorsiflexion range of motion of greater than 2.0 cm side-to-side difference as measured by the ankle lunge test (ALT) OR
  • greater than 3.5% side-to-side difference as assessed by the Y-balance test.

Exclusion criteria

  • Operative fixation within the past 3 months to the lower extremity
  • Have received DN of the lower extremity within the past 30 days
  • Current pregnancy
  • Have a history of systemic disorders in which DN would be contraindicated (bleeding disorders or current anticoagulant medication use)
  • Immunocompromised
  • Decline participation

Treatment and study plan

dry needling

Other

The dry-needling treatment will consist of inserting a sterile needle into 2-4 muscles of the participant either at the MTrP or 2 cm away from the MTrP, but within the same muscle. To assist in the reduction of infection risk and protection of the participants, the site will be cleaned with alcohol prior to treatment and investigators performing the needling treatment will wear gloves and handle needles using aseptic technique throughout the procedure. Each needle insertion will last approximately 5 seconds using a "pistoning" (in and out) technique.

Primary outcomes

  1. DN location effect on self-reported and clinical outcomes

    Time frame: 2 year

    Foot and Ankle Ability Measure (FAAM)

  2. DN location effect on clinical outcomes - Muscle Stiffness

    Time frame: 2 year

    Muscle Stiffness Measured with the MyotonPro

  3. DN location effect on clinical outcomes - Gait

    Time frame: 2 year

    Plantar pressure during gait measured by the EMED system and GAITRite

  4. DN location effect on clinical outcomes - Dynamic Balance

    Time frame: 2 year

    Balance measured by the Y-balance test

  5. DN location effect on clinical outcomes - PPT

    Time frame: 2 year

    Pain pressure threshold measured by an algometer

Secondary outcomes

  1. Validation of needle placement in lower extremity muscles

    Time frame: 6 month

    Individuals will receive dry needling with the aseptic technique previously described. With the needle in place, diagnostic ultrasound will be performed. The accuracy of the needle placement will be assessed and the distance from the needle to major arteries, nerve, and veins will be measured in millimeters and documented. Only one visit lasting approximately 30 minutes will be required for this portion of the study.

Sponsors and collaborators

Lead sponsor

Regis University

Other

Registry information

Official study title

The Effect of Needle Placement on Muscle Stiffness, Gait, Balance, Pain and Functional

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 27, 2020
Registry last updated
Oct 10, 2023

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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