NCT05474898

Brief Summary

to investigate the effects of Magnesium Sulphate Iontophoresis versus High Power Pain Threshold Ultrasound on pain, function and range of motion on active MTrPs found in the upper trapezius.

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
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 26, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

August 8, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2022

Completed
Last Updated

September 27, 2022

Status Verified

September 1, 2022

Enrollment Period

2 months

First QC Date

July 23, 2022

Last Update Submit

September 23, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • pain intensity

    The scale that will be used the VAS ;each subject will instructed to put point on line from no pain to tolerable pain

    up to four weeks

Secondary Outcomes (3)

  • Pain pressure threshold (PPT)

    up to four weeks

  • neck disability

    up to four weeks

  • range of motion

    up to four weeks

Study Arms (3)

Group (A)

EXPERIMENTAL
Other: Magnesium Sulphate Iontophoresis +conventional therapyOther: conventional theapy

Group (B)

EXPERIMENTAL
Other: High- Power Pain Threshold Ultrasound +conventional therapyOther: conventional theapy

Group (c)

OTHER
Other: conventional theapy

Interventions

will receive Mgso4 Iontophoresis in addition to conventional therapy twice a week/4 weeks

Group (A)

will receive HPPT-US on the upper trapezius in addition to conventional therapy twice a week/4 weeks

Group (B)

will receive postural correction exercise-stretching and strengthening twice a week/4weeks

Group (A)Group (B)Group (c)

Eligibility Criteria

Age19 Years - 23 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects, with age ranged from 19-23 years (Forman et al, 2014) from both genders. The subjects had active MTrPs in the upper fibers of trapezius muscle.

You may not qualify if:

  • History of whiplash injury.
  • History of cervical spine surgery.
  • Cervical radiculopathy or myelopathy.
  • Having undergone physical therapy within the past three months before the study.
  • Non- rheumatologic diseases as multiple sclerosis, thyroid dysfunction and chronic infection.
  • Rheumatologic condition as poly-articular osteoarthritis, rheumatoid arthritis and advanced cervical spine degenerative diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy Cairo University

Cairo, Egypt

RECRUITING

Related Publications (1)

  • Ibrahim NA, Hamdy HA, Elbanna RHM, Mohamed DMA, Ali EA. Transdermal iontophoresis versus high power pain threshold ultrasound in Mechanical Neck Pain: a randomized controlled trial. J Orthop Surg Res. 2024 Oct 15;19(1):658. doi: 10.1186/s13018-024-05078-z.

MeSH Terms

Conditions

Myofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Central Study Contacts

Hend Hamdy, 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
lecturer of pt for basic science department

Study Record Dates

First Submitted

July 23, 2022

First Posted

July 26, 2022

Study Start

August 8, 2022

Primary Completion

October 1, 2022

Study Completion

November 15, 2022

Last Updated

September 27, 2022

Record last verified: 2022-09

Locations