- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07657195
Dry Needling and Quad Strength After Anterior Cruciate Ligament Reconstruction (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. 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.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Mellony J Mann, DPT
- Telefoonnummer: 913- 717-4750
- E-mail: mjmann@cmh.edu
Studie Contact Back-up
- Naam: Shannon R Margherio, PT
- Telefoonnummer: 816-816-6927
- E-mail: srmargherio@cmh.edu
Studie Locaties
-
-
Kansas
-
Kansas City, Kansas, Verenigde Staten, 66111
- Children's Mercy Sports Medicine Center- Village West
-
Contact:
- Mellony R. Mann, DPT
- Telefoonnummer: (913) 717-4750
- E-mail: mjmann@cmh.edu
-
Contact:
- Shannon Margherio, PT
- Telefoonnummer: 816-816-6927
- E-mail: srmargherio@cmh.edu
-
Overland Park, Kansas, Verenigde Staten, 66223
- Children's Mercy - Blue Valley
-
Contact:
- Mellony R. Mann, DPT
- Telefoonnummer: (913) 717-4750
- E-mail: mjmann@cmh.edu
-
Contact:
- Shannon Margherio, PT
- Telefoonnummer: 816-816-6927
- E-mail: srmargherio@cmh.edu
-
-
Missouri
-
Kansas City, Missouri, Verenigde Staten, 64108
- Children's Mercy Hospital- Kansas City
-
Contact:
- Mellony R. Mann, DPT
- Telefoonnummer: (913) 717-4750
- E-mail: mjmann@cmh.edu
-
Contact:
- Shannon Margherio, PT
- Telefoonnummer: 816-816-6927
- E-mail: srmargherio@cmh.edu
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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. |
|
Geen tussenkomst: 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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Quadriceps Muscle Strength
Tijdsspanne: 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.
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Mellony J Mann, DPT, Children's Mercy Hospital Kansas City
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- STUDY00003889
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .