- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Mellony J Mann, DPT
- Telefonnummer: 913- 717-4750
- E-post: mjmann@cmh.edu
Studer Kontakt Backup
- Navn: Shannon R Margherio, PT
- Telefonnummer: 816-816-6927
- E-post: srmargherio@cmh.edu
Studiesteder
-
-
Kansas
-
Kansas City, Kansas, Forente stater, 66111
- Children's Mercy Sports Medicine Center- Village West
-
Ta kontakt med:
- Mellony R. Mann, DPT
- Telefonnummer: (913) 717-4750
- E-post: mjmann@cmh.edu
-
Ta kontakt med:
- Shannon Margherio, PT
- Telefonnummer: 816-816-6927
- E-post: srmargherio@cmh.edu
-
Overland Park, Kansas, Forente stater, 66223
- Children's Mercy - Blue Valley
-
Ta kontakt med:
- Mellony R. Mann, DPT
- Telefonnummer: (913) 717-4750
- E-post: mjmann@cmh.edu
-
Ta kontakt med:
- Shannon Margherio, PT
- Telefonnummer: 816-816-6927
- E-post: srmargherio@cmh.edu
-
-
Missouri
-
Kansas City, Missouri, Forente stater, 64108
- Children's Mercy Hospital- Kansas City
-
Ta kontakt med:
- Mellony R. Mann, DPT
- Telefonnummer: (913) 717-4750
- E-post: mjmann@cmh.edu
-
Ta kontakt med:
- Shannon Margherio, PT
- Telefonnummer: 816-816-6927
- E-post: srmargherio@cmh.edu
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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. |
|
Ingen inngripen: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Quadriceps Muscle Strength
Tidsramme: 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.
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Mellony J Mann, DPT, Children's Mercy Hospital Kansas City
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- STUDY00003889
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .