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

Primary Purpose

Ankle and or Hindfoot Injury

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Dry Needling

About this trial

This is an interventional treatment trial for Ankle and or Hindfoot Injury focused on measuring dry needling, muscle stiffness, ankle injury, hindfoot injury, plantar pressure

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Regis University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dry Needling within the Myofascial Trigger Point

Dry Needling away from Myofascial Trigger Point Site

Arm Description

Randomized to receive DN at the site of the MTrP

Randomized to receive DN 2 cm away from the site of the MTrP but within the same muscle

Outcomes

Primary Outcome Measures

DN location effect on self-reported and clinical outcomes

Foot and Ankle Ability Measure (FAAM)

DN location effect on clinical outcomes - Muscle Stiffness

Muscle Stiffness Measured with the MyotonPro

DN location effect on clinical outcomes - Gait

Plantar pressure during gait measured by the EMED system and GAITRite

DN location effect on clinical outcomes - Dynamic Balance

Balance measured by the Y-balance test

DN location effect on clinical outcomes - PPT

Pain pressure threshold measured by an algometer

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04487327

First Posted

July 14, 2020

Last Updated

October 6, 2023

Sponsor

Regis University

1. Study Identification

Unique Protocol Identification Number

NCT04487327

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

October 1, 2020 (Actual)

Primary Completion Date

August 31, 2023 (Actual)

Study Completion Date

September 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Regis University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ankle and or Hindfoot Injury

Keywords

dry needling, muscle stiffness, ankle injury, hindfoot injury, plantar pressure

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

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

ParticipantOutcomes Assessor

Masking Description

Study investigators collecting outcome assessments will be blinded to group allocation. Participants will be asked not to reveal what group they believe they were randomized to.

Allocation

Randomized

Enrollment

75 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dry Needling within the Myofascial Trigger Point

Arm Type

Experimental

Arm Description

Randomized to receive DN at the site of the MTrP

Arm Title

Dry Needling away from Myofascial Trigger Point Site

Arm Type

Active Comparator

Arm Description

Randomized to receive DN 2 cm away from the site of the MTrP but within the same muscle

Intervention Type

Other

Intervention Name(s)

Dry Needling

Intervention Description

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 Outcome Measure Information:

Title

DN location effect on self-reported and clinical outcomes

Description

Foot and Ankle Ability Measure (FAAM)

Time Frame

2 year

Title

DN location effect on clinical outcomes - Muscle Stiffness

Description

Muscle Stiffness Measured with the MyotonPro

Time Frame

2 year

Title

DN location effect on clinical outcomes - Gait

Description

Plantar pressure during gait measured by the EMED system and GAITRite

Time Frame

2 year

Title

DN location effect on clinical outcomes - Dynamic Balance

Description

Balance measured by the Y-balance test

Time Frame

2 year

Title

DN location effect on clinical outcomes - PPT

Description

Pain pressure threshold measured by an algometer

Time Frame

2 year

Secondary Outcome Measure Information:

Title

Validation of needle placement in lower extremity muscles

Description

Time Frame

6 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephanie Albin

Organizational Affiliation

Regis University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Regis University

City

Denver

State/Province

Colorado

ZIP/Postal Code

80221

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

25582412

Citation

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.

Results Reference

background

PubMed Identifier

28413118

Citation

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.

Results Reference

background

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

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