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Comparing Dry Needling to Manual Therapy for Patients With Mechanical Low Back Pain

torstai 13. syyskuuta 2018 päivittänyt: Youngstown State University

Randomized Controlled Trial Comparing the Use of Dry Needling to Manual Therapy for Patients With Mechanical Low Back Pain.

This is a comparative study to determine if there is a difference in pain reduction and disability between dry needling and manual therapy for patients with low back pain. Subjects will be seen two times per week for 3 weeks (6 visits) and will receive either dry needling or manual mobilizations along with patient education and a home exercise program.

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

Procedures:

Subjects will sign the informed consent prior to any examination procedures. Eligibility assessment will be performed by the treating physical therapist and will include the subject filling out the demographic / health history questionnaire, outcome measures, and a clinical examination. The treating physical therapist will use 2 components of the examination for eligibility criteria into the study. The treating therapist will press on the subject's joints in their back to try to elicit their chief complaint. The treating physical therapist will also press on the soft tissue of the subject's back to check for any symptomatic points. A symptomatic point would include recreation of their chief complaint, tenderness, hypersensitivity, or referred pain. The treating physical therapist will then draw an X on the patient's back where the most symptomatic tissue exists. This point will be used by the data collecting physical therapist in order to collect pain pressure threshold of the area.

The data collecting physical therapist will have the subject complete an Oswestry Disability Index(ODI), gather a measure of the pain from the patient ,and the pain pressure threshold. Each subject will then be allocated to either the manual therapy group or the dry needling group.

Once a subject is assigned to a group, they will receive either dry needling or manual therapy mobilizations by the treating therapist. Each subject will remain in the assigned group as long as they are continuing in the study up to 3 weeks. In addition to the treatments under investigation, a standardized home exercise program will be assigned to each of the subjects by the treating physical therapist. This program will be given to and reviewed with each subject to ensure they understand the exercises and will perform the exercise program 1x/day for the duration they are under the care of the physical therapist for the study. Subjects will be treated on day 1 of their plan of care and subsequent treatments will occur 2x/week for a total of 3 weeks, unless discharge occurs earlier than the 3 week data point. Early discharge will occur if the subject achieves resolution of symptoms or if they decide they no longer wish to be a research participant.

Subsequent sessions will involve the collection of outcome data by the data-collecting therapist followed by treatment performed by the treating physical therapist. No adjustments will be made to the treatment protocol in any of the sessions. Subjects will only be scheduled with and treated by the same treating physical therapist each session. In the event that a treating physical therapist is unable to see a subject participating in the study, the subject will be rescheduled for a different time to receive care.

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

73

Vaihe

  • Ei sovellettavissa

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

  • Yhdysvallat
    • Ohio
      • Youngstown, Ohio, Yhdysvallat, 44406
        • Youngstown State University

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

18 vuotta - 70 vuotta (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

Inclusion Criteria:

  • There will be 72 subjects participating in this study that present with mechanical low back pain, ranging from 18-70 years old. The 72 subjects includes a 20% attrition rate 12 additional subjects. The total needed for analysis is 60 subjects, 30 per group.

Exclusion Criteria:

  • Subjects will be excluded if the examining therapist cannot provoke either active or latent MTrPs of the subject's low back muscles and/or elicit symptoms with manual passive movement of the spine at the joints of the low back. Exclusion criteria will also consist of the presence of any red flags revealed in the patient history (i.e., tumor, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, prior lumbar surgery, current pregnancy, etc.) or examination (i.e. signs consistent with significant nerve root compression). Subjects will be excluded if they demonstrate signs of Chronic Regional Pain Syndrome (CRPS), are currently seeking litigation, are unable to speak English, and/or have been diagnosed with a condition that can cause prolonged MTrPs such as fibromyalgia, hypothyroidism, or iron deficiency. In addition, no patients who have a transmittable blood disease will be included.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Kaksinkertainen

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: Dry Needling
A total of 30 subjects will be randomized to this experimental arm. If randomized to this arm, subjects will receive dry needling, patient education, and a home exercise program.
Muut: Dry needling
Dry needling involves inserting a dry, mono-filament needle through the skin and into an area of symptomatic soft tissue. The two-inch needles will be placed segmentally and into the lower extremities following peripheral nerve patterning by the treating physical therapist. Following initial penetration into the skin over the tender area, the therapist carefully advances the needle into the tissue below the skin. After the needle has reached the desired depth, the therapist will insert the subsequent needles. Needles will be placed along the segmental levels of the lumbar spine above and below the tender area identified and into the lower extremity in areas that correlate with a peripheral nerve map. Needles will remain in the tissue for up to 5 minutes, removed, and appropriately disposed of.
Muut: Home Exercise Program
A home exercise program will be given to each subject to be completed in the clinic and at home 1x/day. The exercises will consist of active range of motion exercises and core stabilization exercises. The program is standardized for all subjects.
Kokeellinen: Manual Therapy
A total of 30 subjects will be randomized to this experimental arm. If randomized to this arm, subjects will receive manual therapy, patient education, and a home exercise program.
Muut: Home Exercise Program
A home exercise program will be given to each subject to be completed in the clinic and at home 1x/day. The exercises will consist of active range of motion exercises and core stabilization exercises. The program is standardized for all subjects.
Muut: Manual therapy
The therapist will locate the involved segment using passive accessory intervertebral movements. The segment will be localized to the level, which provokes the patient's symptoms most easily, and this segment will be determined to be the involved level. Once this level has been identified, the therapist will compare central glides over the spinous process or a unilateral glide over the facet joint to determine which is more provocative. Whichever is most provocative will be the location of the treatment. The therapist will provide 3 bouts lasting 45 seconds just easing into the patient's symptoms at the most provocative level with approximately 45 seconds rest between each bout.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Oswestry Disability Index (change over time)
Aikaikkuna: The ODI will be recorded at baseline, 1 week, 2 weeks, and discharge/3 weeks.
The ODI is a ten question self report measure that assesses the impact of the patient's pain on their ability to perform everyday activities and is currently considered the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain.
The ODI will be recorded at baseline, 1 week, 2 weeks, and discharge/3 weeks.

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Numerical Pain Rating Scale (change over time)
Aikaikkuna: The NPRS will be recorded at baseline, immediately following treatment, at 1 week, 2 weeks, and discharge/3 weeks.
The patient is asked to rate their level of pain on an 11-point numerical scale 0-10 with 0 being "no pain" and 10 being the "worst possible pain." Pain will be recorded one additional time after the initial treatment session.
The NPRS will be recorded at baseline, immediately following treatment, at 1 week, 2 weeks, and discharge/3 weeks.
Pain pressure threshold (change over time)
Aikaikkuna: The NPRS will be recorded at baseline, immediately following treatment, at 1 week, 2 weeks, and discharge/3 weeks.
PPT will be measured as described above using an algometer to the identified MTrPs. An algometer is an instrument that detects sensitivity to pressure. The force gauge algometer is placed on the area of a patient's identified MTrP. Pressure is gradually increased until the person perceives a noxious sensation. The amount of pressure at the point of pain is recorded then repeated and and PPT will be performed twice each time, and the measures will be averaged together for data analysis. PPT will be collected one additional time post treatment session 1.
The NPRS will be recorded at baseline, immediately following treatment, at 1 week, 2 weeks, and discharge/3 weeks.
Percentage of recovery (one time assessment at the end of the 3 weeks)
Aikaikkuna: 3 weeks or Discharge
A global percentage of improvement is a measure of the patient's perception of the change in their condition. It will be recorded at discharge by asking the subject what percent better they believe their low back problem is compared to when they entered the study.
3 weeks or Discharge
Patient Specific Functional Scale Score
Aikaikkuna: PSFS score collected at baseline, 1 week, 2 weeks, and 3 weeks or discharge
The PSFS is a patient identified self-report questionnaire that measures general activity limitations. The scale ranges from 0 (unable to perform) to 10 (able to perform the activity at the level prior to injury). The patient reports 3 activities and rates each activity from 0 to 10, which are averaged for a composite score.
PSFS score collected at baseline, 1 week, 2 weeks, and 3 weeks or discharge

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Youngstown State University

Tutkijat

  • Päätutkija: Ken Learman, PhD, Faculty
  • Päätutkija: David W Griswold, Doctorate, Faculty

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Yleiset julkaisut

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Maanantai 1. joulukuuta 2014

Ensisijainen valmistuminen (Todellinen)

Keskiviikko 1. elokuuta 2018

Opintojen valmistuminen (Todellinen)

Keskiviikko 1. elokuuta 2018

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Maanantai 24. marraskuuta 2014

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Perjantai 5. joulukuuta 2014

Ensimmäinen Lähetetty (Arvio)

Tiistai 9. joulukuuta 2014

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Maanantai 17. syyskuuta 2018

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Torstai 13. syyskuuta 2018

Viimeksi vahvistettu

Lauantai 1. syyskuuta 2018

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • 159-14

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

PÄÄTTÄMÄTÖN

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