NCT07657195

Brief Summary

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. A recent retrospective chart review regarding dry needling trends and outcomes in the pediatric orthopedic population showed 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 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. 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
11mo left

Started Aug 2026

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 18, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

August 14, 2026

Expected
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

July 22, 2026

Status Verified

July 1, 2026

Enrollment Period

11 months

First QC Date

June 15, 2026

Last Update Submit

July 20, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Quadriceps Muscle Strength

    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.

Study Arms (2)

Dry Needling Group

EXPERIMENTAL

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.

Procedure: Dry Needling

Control Group (No dry needling)

NO INTERVENTION

Participants will not receive dry needling intervention. Strength measurements will be taken using a handheld dynamometer in post-operative weeks 6, 7, and 9.

Interventions

Dry NeedlingPROCEDURE

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.

Dry Needling Group

Eligibility Criteria

Age10 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Status post subacute quadriceps autograft 6 weeks or less
  • Ages 10-20 years
  • English and/or Spanish speaking

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Children's Mercy Sports Medicine Center- Village West

Kansas City, Kansas, 66111, United States

Location

Children's Mercy - Blue Valley

Overland Park, Kansas, 66223, United States

Location

Children's Mercy Hospital- Kansas City

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Interventions

Dry Needling

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Officials

  • Mellony J Mann, DPT

    Children's Mercy Hospital Kansas City

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mellony J Mann, DPT

CONTACT

Shannon R Margherio, PT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical Therapist

Study Record Dates

First Submitted

June 15, 2026

First Posted

June 18, 2026

Study Start (Estimated)

August 14, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

July 22, 2026

Record last verified: 2026-07

Locations