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

Ankle and or Hindfoot Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04487327
• Other study ID #: albin2020
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: September 1, 2023

Study information

• Verified date: October 2023
• Source: Regis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: September 1, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankle and or Hindfoot Injury
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	Regis University	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Regis University

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

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