- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07657195
Dry Needling and Quad Strength After Anterior Cruciate Ligament Reconstructon (ACLR)
Effects of Dry Needling on Quadriceps Muscle Strength in Acute Post-Operative Anterior Cruciate Ligament Reconstruction With Quadriceps Autograft in the Pediatric Population.
Dry needling is a skilled intervention provided by trained physical therapists to treat pain, myofascial dysfunction, and a variety of other diagnosis. While there is research demonstrating the benefits of dry needling in reduction of pain and improvement in strength, research in regards the pediatric population is very limited. I recently completed a retrospective chart review regarding dry needling trends and outcomes in the pediatric orthopedic population. We now know the pediatric population is tolerating this treatment and seeing benefits. Physical therapists are already pushing the boundaries and finding additional benefits in the use of dry needling with our current patients. A diagnosis frequently seen in sports medicine is surgical reconstruction of the anterior cruciate ligament (ACL). Over the last couple of years, therapists have seen an increase in the use of quadriceps tendon autograft for reconstruction following ACL tears due to lower incidence rate of retears. These patients have been struggling to regain strength of the quadriceps to meet desired outcomes. The quadricep muscles are one of the major stabilizers of the knee and with a reduction in strength places the patient at a significant increase of retear.
Subjects will be categorized into an experimental group (dry needling intervention + physical therapy) or the control group (physical therapy only) with a N of 20 in each group.
The goal for this research is to determine if dry needling use in the subacute phase of post-operative ACLR following quadriceps autograft can assist with increasing quad strength and improve post-surgical outcomes.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mellony J Mann, DPT
- Phone Number: 913- 717-4750
- Email: mjmann@cmh.edu
Study Contact Backup
- Name: Shannon R Margherio, PT
- Phone Number: 816-816-6927
- Email: srmargherio@cmh.edu
Study Locations
-
-
Kansas
-
Kansas City, Kansas, United States, 66111
- Children's Mercy Sports Medicine Center- Village West
-
Contact:
- Mellony R. Mann, DPT
- Phone Number: (913) 717-4750
- Email: mjmann@cmh.edu
-
Contact:
- Shannon Margherio, PT
- Phone Number: 816-816-6927
- Email: srmargherio@cmh.edu
-
Overland Park, Kansas, United States, 66223
- Children's Mercy - Blue Valley
-
Contact:
- Mellony R. Mann, DPT
- Phone Number: (913) 717-4750
- Email: mjmann@cmh.edu
-
Contact:
- Shannon Margherio, PT
- Phone Number: 816-816-6927
- Email: srmargherio@cmh.edu
-
-
Missouri
-
Kansas City, Missouri, United States, 64108
- Children's Mercy Hospital- Kansas City
-
Contact:
- Mellony R. Mann, DPT
- Phone Number: (913) 717-4750
- Email: mjmann@cmh.edu
-
Contact:
- Shannon Margherio, PT
- Phone Number: 816-816-6927
- Email: srmargherio@cmh.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Status post subacute quadriceps autograft 6 weeks or less
- Ages 10-20 years
- English and/or Spanish speaking
Exclusion Criteria:
- History of surgery on the knee or hip on the testing lower extremity.
- Any surgical intervention to other ligamentous or meniscus structures during time of ACLR
- Any post-surgical complications such as infection
- Current pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Dry Needling Group
For the Intervention Group, dry needling will be completed to the quadriceps muscle.
Strength measurements will be taken using a handheld dynamometer in post-operative weeks 6, 7, and 9.
|
Dry needling is defined as a skilled intervention that utilizes a thin filiform needle to stimulate underlying myofascial trigger points, muscular, and connective tissue in managing pain and movement dysfunction. For the Intervention Group, dry needling will be completed to the quadriceps as stated below. Two sessions of dry needling will be done once per week starting in week 6 and finishing by end of week 7. The patient will be laying in supine. Needles will be placed in the quadriceps muscle. Placement will be at identified trigger points or in mid muscle belly if no trigger point is identified. Electrical stimulation will be applied and increased to an intensity of the patient's tolerance with a visual contraction noted. Electrical stimulation will remain on for 5 minutes. |
|
No Intervention: Control Group (No dry needling)
Participants will not receive dry needling intervention.
Strength measurements will be taken using a handheld dynamometer in post-operative weeks 6, 7, and 9.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Quadriceps Muscle Strength
Time Frame: Muscle strength measurements taken at post-operative week 6, 7, and 9.
|
Muscle strength measurement will be taken with use of the handheld dynamometer and use of stabilizing gait belt.
A max force production will be created over three seconds.
Three trials will be recorded, and average will be used as the final number.
For the intervention group, measurements will be taken immediately prior to dry needling and immediately following dry needling for both sessions of intervention (week 6 and week 7).
Additional post intervention measurements will be taken 2 weeks following dry needling intervention (week 9).
For the Control Group, measurements will be taken during week 6, week 7, and week 9. Measurements will be taken at the start of the physical therapy visit.
|
Muscle strength measurements taken at post-operative week 6, 7, and 9.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Mellony J Mann, DPT, Children's Mercy Hospital Kansas City
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00003889
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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