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

NCT ID: NCT04487327

Last Updated: 2023-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2023-09-01

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.

Conditions

Ankle and or Hindfoot Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Dry Needling within the Myofascial Trigger Point

Randomized to receive DN at the site of the MTrP

Group Type: EXPERIMENTAL

Dry Needling

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Dry Needling

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regis University

OTHER

Sponsor Role: lead

Responsible Party

Stephanie Albin

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephanie Albin

Role: PRINCIPAL_INVESTIGATOR

Regis University

Locations

Regis University

Denver, Colorado, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 25582412 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28413118 (View on PubMed)

Other Identifiers

albin2020

Identifier Type: -

Identifier Source: org_study_id