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

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.

Study Overview

• Status: Completed
• Conditions: Ankle and or Hindfoot Injury
• Intervention / Treatment: Other: Dry Needling

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 Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80221
      • Regis University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Regis University
• Investigators: Principal Investigator: Stephanie Albin, Regis University

Publications and helpful links

General Publications

• Pecos-Martin D, Montanez-Aguilera FJ, Gallego-Izquierdo T, Urraca-Gesto A, Gomez-Conesa A, Romero-Franco N, Plaza-Manzano G. Effectiveness of dry needling on the lower trapezius in patients with mechanical neck pain: a randomized controlled trial. Arch Phys Med Rehabil. 2015 May;96(5):775-81. doi: 10.1016/j.apmr.2014.12.016. Epub 2015 Jan 9.
• Fernandez-de-Las-Penas C, Mesa-Jimenez JA, Paredes-Mancilla JA, Koppenhaver SL, Fernandez-Carnero S. Cadaveric and Ultrasonographic Validation of Needling Placement in the Cervical Multifidus Muscle. J Manipulative Physiol Ther. 2017 Jun;40(5):365-370. doi: 10.1016/j.jmpt.2017.03.002. Epub 2017 Apr 13.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: July 14, 2020
• First Submitted That Met QC Criteria: July 22, 2020
• First Posted (Actual): July 27, 2020

Study Record Updates

• Last Update Posted (Estimated): October 10, 2023
• Last Update Submitted That Met QC Criteria: October 6, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: dry needling; muscle stiffness; plantar pressure; ankle injury; hindfoot injury
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: albin2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No