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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
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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
  2. body mass index from 18 to 25 kg/m2
  3. their ages from 18-30

Exclusion Criteria:

  1. if they had trigger point injections within the past 6 months
  2. history of neck or upper back surgery, trauma or fracture
  3. history of a whiplash injury, skin diseases and lesions, any sensory disturbances, any vascular syndromes, neck and back deformities
  4. 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

    First Posted
    June 22, 2022
    Last Updated
    July 24, 2022
    Sponsor
    Cairo University
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    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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