NCT06845475

Brief Summary

The purpose of the study is to determine the effect of extracorporeal shockwave therapy on pain, neck range of motion, and functional activity in adolescent athletes.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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 20, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 25, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

February 25, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2025

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2025

Completed
Last Updated

February 25, 2025

Status Verified

February 1, 2025

Enrollment Period

2 months

First QC Date

February 20, 2025

Last Update Submit

February 20, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Assessment of pain level

    By Pain Quality Assessment Scale (PQAS), which help to measure different aspects of pain. For one patient, a pain might feel extremely hot and burning, but not at all dull, while another patient may not experience any burning pain, but feel like their pain is very dull and achy. High test-retest reliability has been observed in both literate and illiterate patients with neuropathic pain, for construct validity, was high in patients with chronic pain conditions. The scale creates a 20- item measures that would be even more useful for assessing neuropathic pain and also would be used to assess pain qualities associated with non-neuropathic pain. PQAS can be scored as individual ratings (20 items), or the PQAS items can be combined into composite scores.

    4 weeks

Secondary Outcomes (7)

  • Assessment cervical flexion range of motion (ROM)

    4 weeks

  • Assessment cervical extension range of motion (ROM)

    4 weeks

  • Assessment cervical lateral flexion ROM to the right

    4 weeks

  • Assessment cervical lateral flexion ROM to the left

    4 weeks

  • Assessment cervical rotation ROM to the right

    4 weeks

  • +2 more secondary outcomes

Study Arms (2)

Designed physical therapy program

ACTIVE COMPARATOR

It will consist of 20 adolescents, who will receive a designed physical therapy program for the treatment of Myofascial pain syndrome.

Other: Designed physical therapy program

Designed physical therapy program + Extracorporeal shock wave therapy (ESWT)

EXPERIMENTAL

It will consist of 20 adolescents, who will receive the same designed physical therapy program in addition to extracorporeal shock wave therapy (ESWT).

Other: Designed physical therapy programOther: Extracorporeal shock wave therapy (ESWT)

Interventions

Both groups will receive a designed physical therapy program, in the form of myofascial trigger points pressure release, stretching of the upper trapezius muscle, strengthening exercises, and infrared radiation for 4 weeks.

Designed physical therapy programDesigned physical therapy program + Extracorporeal shock wave therapy (ESWT)

Adolescents of the experimental group will receive Extracorporeal shock wave therapy with the following parameters; low-level energy radial extracorporeal shock wave by (STORZ MEDICAL Master Pulse MP200), each subject received 3 sessions per week for 4 weeks with 700 impulse/session 400 impulse was applied to tight band and 300 impulses will be applied surrounding the tight band, with frequency \[10HZ\], resulting in positive energy flux density \[EFD\] 0.056mJ/mm.

Designed physical therapy program + Extracorporeal shock wave therapy (ESWT)

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age ranges from 14 to 18 years.
  • All adolescents have regional pain complaint.
  • Tenderness in cervical trigger points in the midpoint of the upper border of the trapezius muscle, from grade 2 to grade 4 according to the tenderness grading scheme (Hubbard, 1993) (Appendix II).
  • Palpation of a trigger point elicits a stereotypic zone of referred pain specific to that muscle.
  • Identification of a palpable taut band, as well as a palpable, and exquisitely tender spot along the length of that taut band.
  • All adolescents are allowed to practice their regular sports activities.

You may not qualify if:

  • Dermatological disorders.
  • Having myofascial trigger points injection.
  • Chronic pain in both sides of the body.
  • History of findings of cervical injury whether orthopedic or soft tissue injury.
  • Analgesic drugs or NSAIDs during the treatment period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ismailia Medical Complex

Ismailia, Egypt

Location

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic TherapyDiathermyHyperthermia, InducedTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Nanees Essam Mohamed Salem, PhD

    Professor, Cairo university

    STUDY CHAIR

Central Study Contacts

Mohamed Hafez Mohamed, M.Sc

CONTACT

Walaa Abd El Hakeem Abd El Nabi, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 20, 2025

First Posted

February 25, 2025

Study Start

February 25, 2025

Primary Completion

April 25, 2025

Study Completion

May 5, 2025

Last Updated

February 25, 2025

Record last verified: 2025-02

Locations