Dry Needling Versus Magnesium Sulphate Iontophoresis in Subjects With Chronic Mechanical Neck Pain (DN)

• ClinicalTrials.gov Identifier: NCT04809038
• Recruitment Status: Not yet recruiting
• First Posted: March 22, 2021
• Last Update Posted: March 22, 2021
• Sponsor: Cairo University
• Information provided by (Responsible Party): Al Shaymaa Shaaban Abd El Azeim, Cairo University

Study Description

Brief Summary:

the aim of this trial is to compare dry needling and magnesium sulphate iontophoresis in subjects with mechanical neck pain

Condition or disease	Intervention/treatment	Phase
Chronic Pain	Other: dry needling; Other: magnesium sulphate iontophoresis; Other: stretching exercise	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: this trial has three group; two experimental and one control
• Masking: Single (Participant)
• Masking Description: opaque sealed envelope
• Primary Purpose: Treatment
• Official Title: Dry Needling Versus Magnesium Sulphate Iontophoresis in Chronic Mechanical Neck Pain
• Estimated Study Start Date: April 1, 2021
• Estimated Primary Completion Date: June 1, 2021
• Estimated Study Completion Date: June 1, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: dry needling; dry needling will be received twice a week for four weeks	Other: dry needling; 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; Other: stretching exercise; 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 .
Experimental: magnesium sulphate iontophoresis; magnesium sulphate iontophoresis will be received twice a week for four weeks	Other: magnesium sulphate iontophoresis; 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.; Other: stretching exercise; 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 .
Active Comparator: stretching exercise; stretching will be received twice a week for four weeks	Other: stretching exercise; 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 .

Outcome Measures

Primary Outcome Measures :

1. pain intensity [ Time Frame: up to four weeks ]
   pain will be measured by visual analogue scale
2. muscle activity in the form of normalized root mean square [ Time Frame: up to four weeks ]
   muscle activity will be measured by electromyograph

Secondary Outcome Measures :

1. function [ Time Frame: up to four weeks ]
   neck function will be measured by Arabic neck disability index
2. pressure pain threshold [ Time Frame: up to four weeks ]
   pressure pain threshold will be measured by pressure algometer

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 35 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Contacts

Contact: al shaymaa sh abd el azeim, lecturer; 01033771553; alshaymaa.shaaban@pt.cu.edu.eg

Contact: al shaymaa sh abd el azeim, lecturer; 01033771553; alshaymaa.ahaaban@pt.cu.edu.eg

Locations

Egypt

Al Shaymaa Shaaban Abd El Azeim

Giza, Egypt, 12511

Contact: al shaymaa sh abd el azeim, lecturer 01033771553 alshaymaa.shaaban@pt.cu.edu.eg

Sponsors and Collaborators

Cairo University

More Information

• Responsible Party: Al Shaymaa Shaaban Abd El Azeim, al shaymaa shaaban abd el azeim, Cairo University
• ClinicalTrials.gov Identifier: NCT04809038
• Other Study ID Numbers: p.t.REC/012/003108
• First Posted: March 22, 2021
• Last Update Posted: March 22, 2021
• Last Verified: March 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Al Shaymaa Shaaban Abd El Azeim, Cairo University:

dry needling, iontophoresis, neck pain

Additional relevant MeSH terms:

Chronic Pain; Neck Pain; Pain; Neurologic Manifestations; Magnesium Sulfate; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anesthetics; Central Nervous System Depressants; Anti-Arrhythmia Agents; Anticonvulsants; Calcium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Calcium-Regulating Hormones and Agents; Tocolytic Agents; Reproductive Control Agents