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Efficacy of Activator Trigger Point and Shock Wave Therapy on Pain and Function in Active Upper Trapezius Trigger Points: A Randomized Controlled Study

14. mai 2026 oppdatert av: Mina Magdy Wahba, Cairo University

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

Har ikke rekruttert ennå

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:

  1. The number of participants: 200 (50 per group to ensure 40 completers per arm after attrition).
  2. Important characteristics

    • Adult (27:40 years):
    • Gender: both gender
    • Diagnosis: Active upper trapezius trigger points 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.
      4. 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.

Studietype

Intervensjonell

Registrering (Antatt)

100

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

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

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Samarbeidspartnere

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juli 2026

Primær fullføring (Antatt)

12. november 2026

Studiet fullført (Antatt)

1. desember 2026

Datoer for studieregistrering

Først innsendt

7. mai 2026

Først innsendt som oppfylte QC-kriteriene

14. mai 2026

Først lagt ut (Faktiske)

18. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

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Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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