IONTOPHORESIS Versus Ultrasound in Mechanical Neck Pain
Primary Purpose
Trigger Point Pain, Myofascial
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Magnesium Sulphate Iontophoresis +conventional therapy
High- Power Pain Threshold Ultrasound +conventional therapy
conventional theapy
Sponsored by
About this trial
This is an interventional treatment trial for Trigger Point Pain, Myofascial
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
• 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.
Sites / Locations
- Faculty of Physical Therapy Cairo UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Other
Arm Label
Group (A)
Group (B)
Group (c)
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Pain pressure threshold (PPT)
Pain pressure threshold (PPT) is used to measure deep muscular tissue sensitivity by Algometer.
neck disability
will be measured by Arabic neck disability index
range of motion
will be measured by myrin gravity reference goniometer
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05474898
Brief Title
IONTOPHORESIS Versus Ultrasound in Mechanical Neck Pain
Official Title
Magnesium Sulphate Iontophoresis Versus High- Power Pain Threshold Ultrasound in Mechanical Neck Pain
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 8, 2022 (Actual)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
November 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
Myofascial pain syndrome (MPS) is a musculoskeletal chronic pain disorder that affects the majority of pain population and characterized by the presence of trigger points. MPS is usually associated with tenderness, spasm, movement limitation and referred pain .
Myofascial trigger points (MTrPs) are hyperirritable taut fibers of skeletal muscle. The taut fibers within the muscle create palpable nodules that may cause local pain, and refer pain elsewhere with soft tissue examination .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigger Point Pain, Myofascial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group (A)
Arm Type
Experimental
Arm Title
Group (B)
Arm Type
Experimental
Arm Title
Group (c)
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Magnesium Sulphate Iontophoresis +conventional therapy
Intervention Description
will receive Mgso4 Iontophoresis in addition to conventional therapy twice a week/4 weeks
Intervention Type
Other
Intervention Name(s)
High- Power Pain Threshold Ultrasound +conventional therapy
Intervention Description
will receive HPPT-US on the upper trapezius in addition to conventional therapy twice a week/4 weeks
Intervention Type
Other
Intervention Name(s)
conventional theapy
Intervention Description
will receive postural correction exercise-stretching and strengthening twice a week/4weeks
Primary Outcome Measure Information:
Title
pain intensity
Description
The scale that will be used the VAS ;each subject will instructed to put point on line from no pain to tolerable pain
Time Frame
up to four weeks
Secondary Outcome Measure Information:
Title
Pain pressure threshold (PPT)
Description
Pain pressure threshold (PPT) is used to measure deep muscular tissue sensitivity by Algometer.
Time Frame
up to four weeks
Title
neck disability
Description
will be measured by Arabic neck disability index
Time Frame
up to four weeks
Title
range of motion
Description
will be measured by myrin gravity reference goniometer
Time Frame
up to four weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
23 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
• 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hend Hamdy, PHD
Phone
01024420121
Email
hendhamdy110@yahoo.com
Facility Information:
Facility Name
Faculty of Physical Therapy Cairo University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hend Hamdy, PHD
Phone
01024420121
Email
hendhamdy110@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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IONTOPHORESIS Versus Ultrasound in Mechanical Neck Pain
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