- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Mina Wahba, phD
- Telefonnummer: +062 3707068
- E-post: mina.magdy@the.suezuni.edu.eg
Studieorter
-
-
-
Suez, Egypten
- Suez Uni
-
Kontakt:
- Doha Hamed, PhD
- E-post: dohahamed@buc.edu.eg
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Neck Disability Index (NDI)
Tidsram: 6 weeks
|
Questionnaire assessing neck function valid and reilable
|
6 weeks
|
|
VAS
Tidsram: 6 weeks
|
Pain score
|
6 weeks
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- SuezU1
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