NCT05434039

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 27, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

July 30, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

July 27, 2022

Status Verified

July 1, 2022

Enrollment Period

1 month

First QC Date

June 22, 2022

Last Update Submit

July 24, 2022

Conditions

Keywords

phonophoresishigh power pain threshold ultrasoundneck pain

Outcome Measures

Primary Outcomes (1)

  • 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

    up to four weeks

Secondary Outcomes (3)

  • cervical range of motion

    up to four weeks

  • pressure pain threshold

    up to four weeks

  • neck disability

    up to four weeks

Study Arms (3)

diclofenac phonophoresis

EXPERIMENTAL

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

Other: diclofenac phonophoresisOther: conventional therapy

high power pain threshold ultrasound

EXPERIMENTAL

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

Other: high power pain threshold ultrasoundOther: conventional therapy

conventional therapy

ACTIVE COMPARATOR

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

Other: conventional therapy

Interventions

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.

diclofenac phonophoresis

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

high power pain threshold ultrasound

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

conventional therapydiclofenac phonophoresishigh power pain threshold ultrasound

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

al shaymaa sh abd el azeim, lecturer

CONTACT

al shaymaa abd el azeim, lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
random generator
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: diclofenac phonophoresis and high power pain threshold
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

June 22, 2022

First Posted

June 27, 2022

Study Start

July 30, 2022

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

July 27, 2022

Record last verified: 2022-07