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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Ankle and or Hindfoot Injury

Intervention / Treatment
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* Other: Dry Needling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Specific Aim 1: To evaluate if DN has an effect on muscle stiffness, gait, pain pressure threshold, and balance in individuals with injuries to the ankle and/or hindfoot. The dependent variables for Aim1 are: muscle stiffness, plantar pressure, PPT, and balance. The independent variables for Aim1 are Group (MTrP needling versus away from the MTrP site) and Time. The primary aim will be examined using linear mixed modeling with any baseline differences between groups used as a co-variate. A separate model will be created for each dependent variable. Specific Aim 2: 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 with in vivo ultrasound imaging.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dry Needling within the Myofascial Trigger Point<br>Randomized to receive DN at the site of the MTrP | Other: Dry Needling<br>* 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.<br>|
| Active Comparator: Dry Needling away from Myofascial Trigger Point Site<br>Randomized to receive DN 2 cm away from the site of the MTrP but within the same muscle | Other: Dry Needling<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DN location effect on self-reported and clinical outcomes | Foot and Ankle Ability Measure (FAAM) | 2 year | 
| DN location effect on clinical outcomes - Muscle Stiffness | Muscle Stiffness Measured with the MyotonPro | 2 year | 
| DN location effect on clinical outcomes - Gait | Plantar pressure during gait measured by the EMED system and GAITRite | 2 year | 
| DN location effect on clinical outcomes - Dynamic Balance | Balance measured by the Y-balance test | 2 year | 
| DN location effect on clinical outcomes - PPT | Pain pressure threshold measured by an algometer | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of needle placement in lower extremity muscles | 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. | 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dry needling, muscle stiffness, ankle injury, hindfoot injury, plantar pressure