NP: Diclofenac Phonophoresis Versus High Power Pain Threshold Ultrasound on Patients With Neck Pain

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05434039
Collaborator
(none)
60
3
1.1

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Other: diclofenac phonophoresis
  • Other: high power pain threshold ultrasound
  • Other: conventional therapy
N/A

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
diclofenac phonophoresis and high power pain thresholddiclofenac phonophoresis and high power pain threshold
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
random generator
Primary Purpose:
Treatment
Official Title:
Diclofenac Phonophoresis Versus High Power Pain Threshold Ultrasound in Patients With Mechanical Non-specific Neck Pain
Anticipated Study Start Date :
Jul 30, 2022
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: diclofenac phonophoresis

the patients will receive diclofenac phonophoresis and traditional therapy three times a week for four weeks

Other: diclofenac phonophoresis
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.

Other: conventional therapy
the patient will receive an active range of motion exercise, stretching and strengthening of all cervical muscles

Experimental: high power pain threshold ultrasound

the patients will receive high power pain threshold ultrasound and traditional therapy three times a week for four weeks

Other: high power pain threshold ultrasound
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

Other: conventional therapy
the patient will receive an active range of motion exercise, stretching and strengthening of all cervical muscles

Active Comparator: conventional therapy

the patients will receive traditional therapy three times a week for four weeks

Other: conventional therapy
the patient will receive an active range of motion exercise, stretching and strengthening of all cervical muscles

Outcome Measures

Primary Outcome Measures

  1. pain intensity [up to four weeks]

    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

  1. cervical range of motion [up to four weeks]

    range of cervical will be measured by CROM device

  2. pressure pain threshold [up to four weeks]

    pressure pain threshold will be measured by commander algometer

  3. neck disability [up to four weeks]

    neck disability will be measured by Arabic neck disability index

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Al Shaymaa Shaaban Abd El Azeim, principle investigator, Cairo University
ClinicalTrials.gov Identifier:
NCT05434039
Other Study ID Numbers:
  • p.t.REC/012/003672
First Posted:
Jun 27, 2022
Last Update Posted:
Jul 27, 2022
Last Verified:
Jul 1, 2022
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, principle investigator, Cairo University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 27, 2022