Clinical trial NCT04487327: 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
Overall status: COMPLETED
Phase: NA
Conditions: Ankle and or Hindfoot Injury
Keywords: dry needling
muscle stiffness
ankle injury
hindfoot injury
plantar pressure
Lead sponsor: Regis University
Sponsor class: OTHER
First posted: 2020-07-27
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: DN location effect on self-reported and clinical outcomes
timeFrame: 2 year
measure: DN location effect on clinical outcomes - Muscle Stiffness
timeFrame: 2 year
measure: DN location effect on clinical outcomes - Gait
timeFrame: 2 year
measure: DN location effect on clinical outcomes - Dynamic Balance
timeFrame: 2 year
measure: DN location effect on clinical outcomes - PPT
timeFrame: 2 year
Secondary outcomes:
measure: Validation of needle placement in lower extremity muscles
timeFrame: 6 month
Other outcomes:
Locations:
city: Denver
country: United States
facility: Regis University
state: Colorado
Study officials:
affiliation: Regis University
name: Stephanie Albin
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.