Diclofenac Phonophoresis Versus High Power Pain Threshold Ultrasound on Patients With Neck Pain (NP)
Primary Purpose
Neck Pain
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
diclofenac phonophoresis
high power pain threshold ultrasound
conventional therapy
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain focused on measuring phonophoresis, high power pain threshold ultrasound, neck pain
Eligibility Criteria
Inclusion Criteria:
- diagnosed as non-specific neck pain with upper trapezius and suboccipital muscles active myofascial trigger points less than 3 months of duration and have these criteria: taut band on palpation, hyper sensible tender spot in the taut band, local twitch response referred pain pattern
- body mass index from 18 to 25 kg/m2
- their ages from 18-30
Exclusion Criteria:
- if they had trigger point injections within the past 6 months
- history of neck or upper back surgery, trauma or fracture
- history of a whiplash injury, skin diseases and lesions, any sensory disturbances, any vascular syndromes, neck and back deformities
- cervical radiculopathy, and diagnosis of fibromyalgia syndrome, skin diseases
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
diclofenac phonophoresis
high power pain threshold ultrasound
conventional therapy
Arm Description
the patients will receive diclofenac phonophoresis and traditional therapy three times a week for four weeks
the patients will receive high power pain threshold ultrasound and traditional therapy three times a week for four weeks
the patients will receive traditional therapy three times a week for four weeks
Outcomes
Primary Outcome Measures
pain intensity
The scale that will be used is visual analogue scale ;each subject will be instructed to put point on line from no pain to tolerable pain
Secondary Outcome Measures
cervical range of motion
range of cervical will be measured by CROM device
pressure pain threshold
pressure pain threshold will be measured by commander algometer
neck disability
neck disability will be measured by Arabic neck disability index
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05434039
Brief Title
Diclofenac Phonophoresis Versus High Power Pain Threshold Ultrasound on Patients With Neck Pain
Acronym
NP
Official Title
Diclofenac Phonophoresis Versus High Power Pain Threshold Ultrasound in Patients With Mechanical Non-specific Neck Pain
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 30, 2022 (Anticipated)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
September 1, 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
the aim of this study is to investigate the effect of diclofenac phonophoresis versus high power pain threshold ultrasound in patients with mechanical non-specific neck pain
Detailed Description
Neck pain can be a long-lasting condition, Between half and three quarters of patients with neck pain will experience recurrence within 1-5 years. Costs for the society due to neck pain are consequently high. Neck pain (NP) is one of the common musculoskeletal problems. NP can be caused by the stress over the musculoskeletal system due to postural disorders and may also be associated with other causes such as intervertebral disc herniation, nerve compression, or fracture. Musculoskeletal pain due to trigger points is one of the most prevalent reasons for patients to seek treatment. The aim of physical therapy treatment in patient with myofascial pain syndrome is to reduce the pain and restore normal function. Most physical therapy treatments for MPS are targeted to the deactivation of MTrPs. Physical therapy techniques include manual therapies; such as ischemic compression, spray and stretch, strain and counter strain, muscle energy techniques, trigger point pressure release, transverse friction massage; needling therapies, and other techniques such as thermotherapy, ultrasound therapy , phonophoresis and laser therapy.Due to the semi-solid properties, a special method is needed for transdermal permeation of lidocaine. Therefore, many studies have focused on enhancing the level of transdermal permeation by either changing the physiochemical properties of lidocaine or using physical modalities In particular, there has been considerable interest in transdermal permeation using various methods based on the idea that the amount and depth of transdermal permeation can be increased using various physical modalities. patients with mechanical neck pain will be allocated randomly into three equal groups; group A will receive phonophoresis and traditional therapy, group B will receive high power pain thresholdand traditional therapy and group C will receive traditional therapy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
phonophoresis, high power pain threshold ultrasound, neck pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
diclofenac phonophoresis and high power pain threshold
Masking
ParticipantOutcomes Assessor
Masking Description
random generator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
diclofenac phonophoresis
Arm Type
Experimental
Arm Description
the patients will receive diclofenac phonophoresis and traditional therapy three times a week for four weeks
Arm Title
high power pain threshold ultrasound
Arm Type
Experimental
Arm Description
the patients will receive high power pain threshold ultrasound and traditional therapy three times a week for four weeks
Arm Title
conventional therapy
Arm Type
Active Comparator
Arm Description
the patients will receive traditional therapy three times a week for four weeks
Intervention Type
Other
Intervention Name(s)
diclofenac phonophoresis
Intervention Description
the patients will be in comfortable position and apply diclofenac phonophoresis on upper trapezius and suboccipital muscle by ultrasound device. diclofenac gel was applied circularly with a thickness of 2-3 mm. Then ultrasound with was applied with 1 MHz frequency and 1.5 Wt/cm2 power over the trigger points on the trapezius and suboccipital muscle, for 10 min.
Intervention Type
Other
Intervention Name(s)
high power pain threshold ultrasound
Intervention Description
the patients will be in comfortable position and The frequency was set to 1 MHz, and the intensity will be increased from 0.5 to 2 until the patient reported an unpleasant sensation. The probe was held there for 4 s; then, the intensity was reduced by 50%, and the probe will be moved over and around the trigger point. This process is done several times for three minutes
Intervention Type
Other
Intervention Name(s)
conventional therapy
Intervention Description
the patient will receive an active range of motion exercise, stretching and strengthening of all cervical muscles
Primary Outcome Measure Information:
Title
pain intensity
Description
The scale that will be used is visual analogue scale ;each subject will be instructed to put point on line from no pain to tolerable pain
Time Frame
up to four weeks
Secondary Outcome Measure Information:
Title
cervical range of motion
Description
range of cervical will be measured by CROM device
Time Frame
up to four weeks
Title
pressure pain threshold
Description
pressure pain threshold will be measured by commander algometer
Time Frame
up to four weeks
Title
neck disability
Description
neck disability will be measured by Arabic neck disability index
Time Frame
up to four weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosed as non-specific neck pain with upper trapezius and suboccipital muscles active myofascial trigger points less than 3 months of duration and have these criteria: taut band on palpation, hyper sensible tender spot in the taut band, local twitch response referred pain pattern
body mass index from 18 to 25 kg/m2
their ages from 18-30
Exclusion Criteria:
if they had trigger point injections within the past 6 months
history of neck or upper back surgery, trauma or fracture
history of a whiplash injury, skin diseases and lesions, any sensory disturbances, any vascular syndromes, neck and back deformities
cervical radiculopathy, and diagnosis of fibromyalgia syndrome, skin diseases
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
al shaymaa sh abd el azeim, lecturer
Phone
01033771553
Email
shimaashaaban30@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
al shaymaa abd el azeim, lecturer
Phone
01033771553
Email
shimaashaaban30@yahoo.com
12. IPD Sharing Statement
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Diclofenac Phonophoresis Versus High Power Pain Threshold Ultrasound on Patients With Neck Pain
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