The Effect of Needle Placement on Muscle Stiffness, Gait, Balance, Pain and Functional Outcomes i… (NCT04487327) | Clinical Trial Compass
CompletedNot Applicable
The Effect of Needle Placement on Muscle Stiffness, Gait, Balance, Pain and Functional Outcomes in Individuals With Injury to the Ankle and/or Hindfoot
United States75 participantsStarted 2020-10-01
Plain-language 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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
DN location effect on self-reported and clinical outcomes
Timeframe: 2 year
2
DN location effect on clinical outcomes - Muscle Stiffness
Timeframe: 2 year
3
DN location effect on clinical outcomes - Gait
Timeframe: 2 year
4
DN location effect on clinical outcomes - Dynamic Balance