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

NCT04487327 | Completed DMC

• 1 other identifier: albin2020
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankle and or Hindfoot Injury

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Validation of needle placement in lower extremity muscles

  6 month

Study Arms (2)

Dry Needling within the Myofascial Trigger Point

EXPERIMENTAL

Randomized to receive DN at the site of the MTrP

Other: Dry Needling

Dry Needling away from Myofascial Trigger Point Site

ACTIVE COMPARATOR

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

Other: Dry Needling

Interventions

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.

Dry Needling away from Myofascial Trigger Point Site; Dry Needling within the Myofascial Trigger Point

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Regis University: lead

Study Sites (1)

Regis University

Denver, Colorado, 80221, United States

Location

Related Publications (2)

• 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.

  PMID: 25582412 BACKGROUND

• 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.

  PMID: 28413118 BACKGROUND

MeSH Terms

Conditions

Ankle Injuries

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Officials

• Stephanie Albin

  Regis University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: July 27, 2020
• Study Start: October 1, 2020
• Primary Completion: August 31, 2023
• Study Completion: September 1, 2023
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)