- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04809038
Dry Needling Versus Magnesium Sulphate Iontophoresis in Subjects With Chronic Mechanical Neck Pain (DN)
Dry Needling Versus Magnesium Sulphate Iontophoresis in Chronic Mechanical Neck Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Mechanical neck pain is a prevalent condition in various populations. Neck pain occurrence is affected by several factors, involving environmental, psychological, and social aspects. Neck pain represents the fourth major disorder responsible for a person's year lived with disability and ranked eleventh as disability-adjusted life years of a person. The neck pain incidence ranges from 10.4 to 23.3% in 1-year time, while the range of prevalence was 0.4 to 86.8%. It has a high prevalence among computer users, office workers, and females, especially females aged 35 to 49 years old. Myofascial trigger point (MTrP) might play an important role in the formation of mechanical neck pain and is known as a hyperirritable spot in skeletal muscle that is accompanied with a hypersensitive palpable nodule in a taut band.
dry needling and iontophoresis play a major role in the treatment of mechanical neck pain so this trial was conducted to determine which one has superiority. this trial has three groups. two experimental and one control group.pain, function, pressure pain threshold and emg will be measured
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Giza, Egypt, 12511
- Al Shaymaa Shaaban Abd El Azeim
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
All patients had active trigger myofascial trigger points (MTrPs) in upper trapeziues muscle in the dominant side with mechanical neck pain.
The patients age ranged from 18-35years The patients had been choosen from both sexes . patient agrees not to receive additional treatment for their painful condition during the trial (apart from NSAIDs and pain killers The patients body mass index < 30 kg/m²
Exclusion Criteria:
History of whiplash injury History of cervical spine surgery Cervical radiculopathy or myelopathy Having undergone physical therapy within the past 3 months before the study. Non -rheumatologic diseases as multiple sclerosis , thyroid dysfunction and chronic infection
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: dry needling
dry needling will be received twice a week for four weeks
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Patient will be placed in a comfortable prone position and encouraged to maintain complete relaxation.
The selected active MTrPs was prepared by wiping the area with alcohol pad, and a gauge needle with its plastic guide tube in place will be palced over the active MTrPs .a
tapping motion will be used to advance the needle to a depth of 5 to 10 mm for 30 seconds
The patient will be placed in a comfortable and relaxed sitting position with his back supported ; one hand was placed on the side of the head applying the stretching force, while the other hand was placed on the patients shoulder applying shoulder stablization .
The direction of stretched force was in flexion , side bending to the opposite side and rotation to the same side .
The stretched position will be sustained for 30 seconds , then a relaxation period of 30 seconds .
This procedure was repeated 3 times .
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|
Experimental: magnesium sulphate iontophoresis
magnesium sulphate iontophoresis will be received twice a week for four weeks
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The patient will be placed in a comfortable and relaxed sitting position with his back supported ; one hand was placed on the side of the head applying the stretching force, while the other hand was placed on the patients shoulder applying shoulder stablization .
The direction of stretched force was in flexion , side bending to the opposite side and rotation to the same side .
The stretched position will be sustained for 30 seconds , then a relaxation period of 30 seconds .
This procedure was repeated 3 times .
The subjects in the iontophoresis group received MgSO4 iontophoresis using an iontophoretic drug delivery system (Phoresor_IIAuto,ModelPM850,IOMED.
MTrPs were examined using pincer palpation and marked by pin.
MgSO4 was applied to the active positive electrode using a syringe with a concentration of 100 mg/cm2.
The active electrode was placed directly over the marked area where the sensitive MTrPs were located.
The dispersive electrode was applied to the skin 6 inches distal from the active electrode.
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Active Comparator: stretching exercise
stretching will be received twice a week for four weeks
|
The patient will be placed in a comfortable and relaxed sitting position with his back supported ; one hand was placed on the side of the head applying the stretching force, while the other hand was placed on the patients shoulder applying shoulder stablization .
The direction of stretched force was in flexion , side bending to the opposite side and rotation to the same side .
The stretched position will be sustained for 30 seconds , then a relaxation period of 30 seconds .
This procedure was repeated 3 times .
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pain intensity
Time Frame: up to four weeks
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pain will be measured by visual analogue scale
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up to four weeks
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muscle activity in the form of normalized root mean square
Time Frame: up to four weeks
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muscle activity will be measured by electromyograph
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up to four weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
function
Time Frame: up to four weeks
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neck function will be measured by Arabic neck disability index
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up to four weeks
|
|
pressure pain threshold
Time Frame: up to four weeks
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pressure pain threshold will be measured by pressure algometer
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up to four weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Chronic Pain
- Neck Pain
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Reproductive Control Agents
- Calcium Channel Blockers
- Tocolytic Agents
- Magnesium Sulfate
Other Study ID Numbers
- p.t.REC/012/003108
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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