- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07594223
Efficacy of Activator Trigger Point and Shock Wave Therapy on Pain and Function in Active Upper Trapezius Trigger Points: A Randomized Controlled Study
This study will be conducted as a randomized controlled trial to evaluate the efficacy of trigger point activator and extracorporeal shock wave therapy in patients with active myofascial trigger points in the upper fibers of the trapezius muscle. Participants who meet the inclusion criteria will be recruited and informed consent will be obtained prior to participation. The subjects will then be randomly allocated into two equal groups. Group A: will receive treatment using the trigger point activator applied to the active trigger points of the upper trapezius muscle. Group B: will receive extracorporeal shock wave therapy applied to the same region.
The treatment will be applied according to standardized therapeutic parameters for a predetermined number of sessions over the study period. Outcome measures will be assessed before the beginning of the treatment program and after completion of the intervention period. Pain intensity and pressure pain threshold will be assessed using an algometer. Functional disability related to the neck will be evaluated using the Neck Disability Index (NDI). All collected data will be recorded and statistically analyzed to determine the effectiveness of both treatment modalities in reducing pain and improving functional outcomes.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This study will be conducted as a randomized controlled trial to evaluate the efficacy of trigger point activator and extracorporeal shock wave therapy in patients with active myofascial trigger points in the upper fibers of the trapezius muscle. Participants who meet the inclusion criteria will be recruited and informed consent will be obtained prior to participation. The subjects will then be randomly allocated into two equal groups. Group A: will receive treatment using the trigger point activator applied to the active trigger points of the upper trapezius muscle. Group B: will receive extracorporeal shock wave therapy applied to the same region.
The treatment will be applied according to standardized therapeutic parameters for a predetermined number of sessions over the study period. Outcome measures will be assessed before the beginning of the treatment program and after completion of the intervention period. Pain intensity and pressure pain threshold will be assessed using an algometer. Functional disability related to the neck will be evaluated using the Neck Disability Index (NDI). All collected data will be recorded and statistically analyzed to determine the effectiveness of both treatment modalities in reducing pain and improving functional outcomes. 15. Participants of the study:
- The number of participants: 200 (50 per group to ensure 40 completers per arm after attrition).
Important characteristics
- Adult (27:40 years):
- Gender: both gender
Diagnosis: Active upper trapezius trigger points Inclusion criteria
- Male or female participants aged between 25 and 40 years.
- Body Mass Index (BMI) between 20 and 30 kg/m².
- Presence of active myofascial trigger points in the upper fibers of the trapezius muscle confirmed by clinical examination.
- Complaints of neck pain associated with upper trapezius trigger points.
- Ability and willingness to participate in the treatment sessions and follow the study protocol.
Exclusion criteria:
- History of neck trauma, cervical spine fracture, or cervical spine surgery.
- Presence of neurological disorders affecting the cervical region.
- Presence of cervical disc prolapse or severe cervical spine pathology.
- Diagnosis of fibromyalgia or systemic musculoskeletal disorders.
- Presence of skin diseases, wounds, or infections at the treatment area.
- Patients with malignancy or severe systemic diseases.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Mina Wahba, phD
- Telefonnummer: +062 3707068
- E-post: mina.magdy@the.suezuni.edu.eg
Studiesteder
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-
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Suez, Egypt
- Suez Uni
-
Ta kontakt med:
- Doha Hamed, PhD
- E-post: dohahamed@buc.edu.eg
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
1. Male or female participants aged between 25 and 40 years. 2. Body Mass Index (BMI) between 20 and 30 kg/m². 3.Presence of active myofascial trigger points in the upper fibers of the trapezius muscle confirmed by clinical examination.
- Complaints of neck pain associated with upper trapezius trigger points. 5. Ability and willingness to participate in the treatment sessions and follow the study protocol.
Exclusion Criteria:
- 1. History of neck trauma, cervical spine fracture, or cervical spine surgery. 2. Presence of neurological disorders affecting the cervical region. 3. Presence of cervical disc prolapse or severe cervical spine pathology. 4. Diagnosis of fibromyalgia or systemic musculoskeletal disorders. 5. Presence of skin diseases, wounds, or infections at the treatment area. 6. Patients with malignancy or severe systemic diseases.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: treatment
receive treatment using the trigger point activator applied to the active trigger points of the upper trapezius muscle.
|
will receive treatment using the trigger point activator applied to the active trigger points of the upper trapezius muscle.
|
|
Aktiv komparator: Shockwave
will receive extracorporeal shock wave therapy applied to the same region.
The treatment will be applied according to standardized therapeutic parameters for a predetermined number of sessions over the study period.
|
will receive extracorporeal shock wave therapy applied to the same region.
12.
The treatment will be applied according to standardized therapeutic parameters for a predetermined number of sessions over the study period.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Neck Disability Index (NDI)
Tidsramme: 6 weeks
|
Questionnaire assessing neck function valid and reilable
|
6 weeks
|
|
VAS
Tidsramme: 6 weeks
|
Pain score
|
6 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
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
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SuezU1
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