NCT06267755

Brief Summary

this study will be conducted to investigate the effect of Extracorporeal Shockwave Therapy on Ultrasonography Changes of Upper Trapezius Myofascial Trigger Points in Patients With Non Specific Neck Pain

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

February 20, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

6 months

First QC Date

February 12, 2024

Last Update Submit

February 12, 2024

Conditions

Keywords

Extracorporeal Shockwave TherapyUltrasonography ChangesNon Specific Neck Pain

Outcome Measures

Primary Outcomes (2)

  • muscle thickness

    Ultrasonography device will be used to assess muscle thickness

    up to six weeks

  • hypoechoic area intensity

    An ultrasonography device will be used to assess the hypoechoic area intensity

    up to six weeks

Secondary Outcomes (4)

  • neck disability

    up to six weeks

  • pressure pain threshold

    up to six weeks

  • cervical range of motion

    up to six weeks

  • pain intensity

    up to six weeks

Study Arms (2)

Extracorporeal Shockwave therapy

EXPERIMENTAL

Thirty patients will receive Extracorporeal Shockwave therapy and Traditional physical therapy three times per week for six consecutive weeks.

Other: Extracorporeal Shockwave therapyOther: Traditional physical therapy

Traditional physical therapy

ACTIVE COMPARATOR

Thirty patients will receive Traditional physical therapy three times per week for six consecutive weeks.

Other: Traditional physical therapy

Interventions

the patients will receive Extracorporeal Shockwave therapy sessions by 600 impulses with 1.6 bar pressure at a frequency of 8 Hz on site of the upper trapezius

Extracorporeal Shockwave therapy

the patients will receive Traditional physical therapy in the form of Integrated neuro-muscular inhibition technique + posture correction and scapular stabilization exercises.

Extracorporeal Shockwave therapyTraditional physical therapy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sixty patients receiving a diagnosis of non-specific neck pain with upper trapezius myofascial trigger points by an orthopaedist physician.
  • Body mass index of participants was normal less than (30 kg/m2)(Al-asadi, 2018).
  • Age over 18 years.
  • Presence of taught band.
  • Presence of hyper irritable spot in a taught band, and reproduction of the typical referred pain pattern of the myofascial trigger point in response to compression

You may not qualify if:

  • Having signs and symptoms of neurological disorders that cause nerve root compression.
  • Headache as a consequence of specific headache diagnosis.
  • Having a history of specific signs of malignancy, or infection.
  • Having a history of trauma with or without proven structural disorders in the region of the neck, shoulder, and head (e.g. whiplash).
  • Having signs and symptoms of cerebrovascular insufficiency.
  • Having a severe chronic disease of the locomotor system (e.g. polyarthritis, muscular disease
  • Any participant with contraindications to shock wave therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neck Pain

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic TherapyDiathermyHyperthermia, InducedTherapeuticsPhysical Therapy ModalitiesRehabilitation

Central Study Contacts

Mahmoud Fouad, master

CONTACT

Maher El keblawy, professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
opaque sealed envelope
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: extracorporeal shockwave and traditional therapy
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator nabil mahmoud ismail abdel-aal

Study Record Dates

First Submitted

February 12, 2024

First Posted

February 20, 2024

Study Start

February 20, 2024

Primary Completion

August 30, 2024

Study Completion

August 30, 2024

Last Updated

February 20, 2024

Record last verified: 2024-02