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

Not Applicable

Completed

• Conditions: Ankle and or Hindfoot Injury
• Interventions: Other: Dry Needling

• Registration Number: NCT04487327
• Lead Sponsor: Regis University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-07-14
• Study First Submitted QC: 2020-07-22
• Study First Posted: 2020-07-27
• Study Start: 2020-10-01
• Primary Completion: 2023-08-31
• Study Completion: 2023-09-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-06
• Last Update Posted: 2023-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Dry Needling within the Myofascial Trigger Point	Dry Needling	Randomized to receive DN at the site of the MTrP
Dry Needling away from Myofascial Trigger Point Site	Dry Needling	Randomized to receive DN 2 cm away from the site of the MTrP but within the same muscle

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Validation of needle placement in lower extremity muscles	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.

Trial Locations

Locations (1)

Regis University; 🇺🇸 Denver, Colorado, United States