Effekter af Perifer Repetitiv Perifer Magnetisk Stimulation på Personer med Kronisk Albue- eller Håndledssmerter (rPMS)
Effekter af perifer repetitiv perifer magnetisk stimulation på personer med kronisk albue- eller håndledssmerte, et pilot randomiseret kontrolleret forsøg
This pilot, randomized, sham-controlled, single-blind study will evaluate the effectiveness of repetitive peripheral magnetic stimulation (rPMS) in reducing pain in adults with tennis/golfer's elbow or carpal tunnel syndrome. Approximately 40 participants will be randomly assigned to active or sham stimulation delivered over two consecutive days. Outcomes, including pressure pain threshold, subjective pain ratings, and local tissue oxygenation (fNIRS), will be assessed at baseline, immediately post-intervention, and during follow-up up to 6 months to evaluate both clinical effects and underlying physiological mechanisms.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
Objectives - The primary objective is to investigate the effect of active repetitive peripheral magnetic stimulation (rPMS) in reducing pain in individuals with either tennis/golfer elbow syndrome (either medial or lateral epicondylitis) or carpal tunnel syndrome in a pilot randomized placebo-controlled clinical trial. The secondary objective is to investigate the duration of the rPMS effects up to 6 months.
Study Population - The study population will consist of two groups of individuals: one group including 10 with tennis/golfer elbow syndrome and second group including 10 with carpal tunnel syndrome. Participants will be recruited from volunteers by advertising and/or doctors' referral.
Research Design and Study Procedure - This study design is a parallel-cohort exploratory single-blind, randomized, sham-controlled study investigating the effect of rPMS in pain reduction in individuals with either elbow or wrist chronic pain. Eligible participants in each group will be stratified by condition (elbow vs carpal tunnel) and randomized within each stratum to active or sham rPMS. The sham group participants will have the option to receive the active treatment after a month of receiving the sham treatment.
The rPMS protocol is two consecutive days of therapy. In each day, the participants will receive 400 pulses at 10 HZ in 1.5 sec trains with 10-second intertrain intervals. All participants will be assessed for their pain levels at baseline, immediately post-intervention, one week after the intervention and then every month up to 6 months follow-up sessions.
The assessments include subjective Visual Analogue Scale (VAS) score for pain on a scale of 0 to 10, the minimum pressure pain threshold (PPT) and near-infrared spectroscopy (NIRS) over the target area.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Mari Garcia, M.Sc.
- Telefonnummer: (204) 478-6352
- E-mail: MARITERE.GARCIACAMPUZANO@umanitoba.ca
Undersøgelse Kontakt Backup
- Navn: Zahra Moussavi, Ph.D.
- Telefonnummer: 204-474-7023
- E-mail: Zahra.Moussavi@umanitoba.ca
Studiesteder
-
-
Manitoba
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Winnipeg, Manitoba, Canada, R3L 2P4
- Rekruttering
- Riverview Health Center
-
Kontakt:
- Cassandra Aldaba, M.Sc.
- Telefonnummer: 204-478-6163
- E-mail: umaldabc@myumanitoba.ca
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Clinical diagnosis or self-reported history consistent with either medial or lateral epicondylitis or carpal tunnel syndromes.
- Presence of chronic pain in the target area (mentioned above) at the time of enrollment.
- Ability to understand the study procedures and provide informed consent.
Exclusion Criteria:
- Contraindications to peripheral magnetic stimulation, including implanted electronic medical devices or metallic implants in locations deemed unsafe for stimulation.
- Open wounds, active skin conditions, or other local conditions at the stimulation site.
- Current neurological, musculoskeletal, or systemic medical conditions that, in the opinion of the investigators, would interfere with safe participation or interpretation of study outcomes.
- Current upper-limb injury or condition other than tennis/golfer elbow or carpal tunnel syndromes that could confound pain or perfusion measurements.
- Pregnancy.
- Inability to tolerate the stimulation or measurement procedures.
- Inability to adequately understand study instructions or provide informed consent.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Two days active rPMS - Tennis/golfer syndrome
Participants of this arm, suffer from chronic pain at elbow either medial or lateral epicondylitis (tennis/golder syndromes) and receive real rPMS pulses as treatment for two days successively, each day 300 pulses at 10 Hz. |
It is a magnetic coil with a device that creates electromagnetic pulses. The Real one gives pulses with 100% intensity. |
|
Sham-komparator: Two days sham rPM - Tennis/golfer syndrome
Participants of this arm, suffer from chronic pain at elbow either medial or lateral epicondylitis (tennis/golder syndromes) and receive SHAM rPMS pulses as treatment for two days successively, each day 300 pulses at 10 Hz. |
Sham coil gives very weak pulses off target that does not penetrate to the skin. |
|
Eksperimentel: Two days Active rPMS - Carpal Tunnel Syndrome
Participants of this arm, suffer from chronic pain at wrist (carpal tunnel syndrome) and receive REAL rPMS pulses as treatment for two days successively, each day 300 pulses at 10 Hz. |
It is a magnetic coil with a device that creates electromagnetic pulses. The Real one gives pulses with 100% intensity. |
|
Sham-komparator: Two days Sham rPMS - Carpal Tunnel syndrome
Participants of this arm, suffer from chronic pain at wrist (carpal tunnel syndrome) and receive SHAM rPMS pulses as treatment for two days successively, each day 300 pulses at 10 Hz. |
Sham coil gives very weak pulses off target that does not penetrate to the skin. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in pain pressure threshold (PPT)
Tidsramme: from baseline to post-treatment assessments on day 3 and week2 up to 6 months follow-up.
|
PPT is measured by a pressure altimeter and identifies the minimum pressure that the subject feels pain. |
from baseline to post-treatment assessments on day 3 and week2 up to 6 months follow-up.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in visual subjective pain scale
Tidsramme: from Pre-intervention to post on day 3, week 1 and other post assessments up to 6 months.
|
the visual subjective pain scale is a score using 0 to 10 on the pain level. |
from Pre-intervention to post on day 3, week 1 and other post assessments up to 6 months.
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Zahra Moussavi, University of Manitoba
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Albueskader
- Smerte
- Neurologiske manifestationer
- Muskuloskeletale sygdomme
- Sygdomme i nervesystemet
- Muskelsygdomme
- Sår og skader
- Neuromuskulære sygdomme
- Sygdomme i det perifere nervesystem
- Seneskader
- Armskader
- Tendinopati
- Median neuropati
- Mononeuropatier
- Nervekompressionssyndromer
- Kumulative traumelidelser
- Forstuvninger og stammer
- Patologiske tilstande, tegn og symptomer
- Tegn og symptomer
- Albuetendinopati
- Kronisk smerte
- Karpaltunnelsyndrom
Andre undersøgelses-id-numre
- Rithim Harmony - 5266
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
This is a small pilot study. Once there is enough data with good quality, the investigators will consider data sharing.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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