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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

R

Regis University

Status

Completed

Conditions

Ankle and or Hindfoot Injury

Treatments

Other: Dry Needling

Study type

Interventional

Funder types

Other

Identifiers

NCT04487327
albin2020

Details and patient eligibility

About

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.

Full 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.

Enrollment

75 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Double Blind

75 participants in 2 patient groups

Dry Needling within the Myofascial Trigger Point
Experimental group
Description:
Randomized to receive DN at the site of the MTrP
Treatment:
Other: Dry Needling
Dry Needling away from Myofascial Trigger Point Site
Active Comparator group
Description:
Randomized to receive DN 2 cm away from the site of the MTrP but within the same muscle
Treatment:
Other: Dry Needling

Trial contacts and locations

1

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Central trial contact

Larisa Hoffman; Stephanie Albin

Data sourced from clinicaltrials.gov

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