- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03638388
Dry Needling vs Dry Needling With ES in Patients With Neck/Shoulder Pain
Rate and Maintenance of Improvement in Myofascial Pain: Dry Needling Alone vs Dry Needling With Intramuscular Electrical Stimulation
First, we aim to determine if there is a difference in the rate of improvement, as measured by the Neck Disability Index (NDI) and Numerical Pain Rating Scale (NPRS), across a 6 week treatment period between those treated with DN only and those treated with DN and intramuscular electrical stimulation (IES) in subjects with upper trapezius active trigger points (aTrPs). Secondly, we want to determine if improvements in clinical outcomes (NDI and NPRS) of patients with upper trapezius active trigger points (aTrPs) treated with dry needling (DN) alone or dry needling with intramuscular electrical stimulation (DN/IES) are maintained 6 weeks post treatment without further intervention.
Research Questions:
- Is there a difference in the rate of improvement in NDI and NPRS across a 6 week treatment period in subjects with upper trapezius active trigger points (aTrPs) between those treated with DN only and those treated with DN and intramuscular electrical stimulation (IES)?
- Are improvements in clinical outcomes (NDI and NPRS) of patients with upper trapezius active trigger points (aTrPs) treated with dry needling (DN) maintained 6 weeks post treatment without further intervention? Tertiary exploration: If improvement is maintained, is there a difference in outcome maintenance between groups? Did improvement increase between 6 and 12 weeks?
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Texas
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Belton, Texas, Stati Uniti, 76513
- University of Mary Hardin-Baylor
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
18-59 years old have an active email account have at least one palpable active trigger point (TrP) (located in one or both upper trapezius) English speaking
Exclusion Criteria:
current or previous history of cancer active infection neurologic deficit cognitive deficit pregnancy connective tissue disease and/or autoimmune disorder smoke tobacco received previous DN treatments within 6 weeks of the study, experienced unilateral or bilateral neck/shoulder pain continuously for 3 months or longer
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Comparatore attivo: Dry Needling (DN)
Subjects will receive dry needling treatment, once a week, for 6 weeks. Outcomes will be measured at baseline (week 0), 3 weeks after initiation of study (week 3), 6 weeks after initiation of study (week 6), and 6 weeks after last treatment (week 12). |
One to three filament needles (similar to an acupuncture needle) with no medication will be inserted into the tender area of my muscle.
The needles will be repositioned a few times to make the muscle twitch.
After several twitches occur, the researcher will leave the needles as they are, and the subject will sit in a chair without moving my arms or head, for 10 minutes.
After 10 minutes the needles are removed and discarded.
|
Comparatore attivo: Dry Needling with Intramuscular electrical stimulation (DNES)
Subjects will receive dry needling treatment with electrical stimulation, once a week, for 6 weeks. Outcomes will be measured at baseline (week 0), 3 weeks after initiation of study (week 3), 6 weeks after initiation of study (week 6), and 6 weeks after last treatment (week 12). |
One to three filament needles (similar to an acupuncture needle) with no medication will be inserted into the tender area of the muscle.
The needles will be repositioned a few times to make the muscle twitch.
After several twitches occur, the researcher will leave the needles as they are, and attach alligator clips to the needles to provide electrical stimulus for 10 minutes while the subject sits in a chair without moving arms or head.
After 10 minutes, the electrical stimulus will be turned off and detached, and the needles removed and discarded.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Rate of improvement in numerical pain rating scale between groups
Lasso di tempo: 6 weeks
|
Between group difference in within group pain changes
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6 weeks
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Rate of improvement in Neck Disability Index between groups
Lasso di tempo: 6 weeks
|
Between group difference of within group disability changes
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6 weeks
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Maintenance of pain improvement in both groups
Lasso di tempo: week 6 compared to week 12 data
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Difference between pain scores in both groups between the 6th week of weekly treatment and those 6 weeks after cessation of treatment.
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week 6 compared to week 12 data
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Maintenance of disability improvement in both groups
Lasso di tempo: week 6 compared to week 12 data
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Difference between neck disability scores in both groups between the 6th week of weekly treatment and those 6 weeks after cessation of treatment.
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week 6 compared to week 12 data
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Kindyle L. Brennan, PHD,PT, University of Mary Hardin-Baylor
Pubblicazioni e link utili
Pubblicazioni generali
- Liu L, Huang QM, Liu QG, Ye G, Bo CZ, Chen MJ, Li P. Effectiveness of dry needling for myofascial trigger points associated with neck and shoulder pain: a systematic review and meta-analysis. Arch Phys Med Rehabil. 2015 May;96(5):944-55. doi: 10.1016/j.apmr.2014.12.015. Epub 2015 Jan 7.
- Cerezo-Tellez E, Torres-Lacomba M, Mayoral-Del Moral O, Sanchez-Sanchez B, Dommerholt J, Gutierrez-Ortega C. Prevalence of Myofascial Pain Syndrome in Chronic Non-Specific Neck Pain: A Population-Based Cross-Sectional Descriptive Study. Pain Med. 2016 Dec;17(12):2369-2377. doi: 10.1093/pm/pnw114. Epub 2016 Jun 20.
- Pilgrim J, Engelke Z. Patient Education: Teaching the patient about myofascial pain syndrome. CINAHL Nursing Guide. December 8, 2017;Available from: Nursing Reference Center Plus, Ipswich, MA. Accessed April 13, 2018.
- Rock JM, Rainey CE. Treatment of nonspecific thoracic spine pain with trigger point dry needling and intramuscular electrical stimulation: a case series. Int J Sports Phys Ther. 2014 Oct;9(5):699-711.
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Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- DNvDN-ES
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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