NCT05540093

Brief Summary

The purpose of this study will investigate the effect of adding high power pain threshold ultrasound to traditional therapy on axioappendicular muscles amplitude and fatigue in neck pain

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

September 12, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

September 20, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

3 months

First QC Date

September 12, 2022

Last Update Submit

January 23, 2023

Conditions

Keywords

high power pain threshold ultrasoundmechanical neck pain

Outcome Measures

Primary Outcomes (2)

  • pain intensity

    pain will be measured by visual analogue scale

    up to four weeks

  • pressure pain threshold

    commander algometer device will be used to measure pressure pain threshold

    up to four weeks

Secondary Outcomes (2)

  • neck disability

    up to four weeks

  • muscle amplitude and fatigue

    up to four weeks

Study Arms (2)

high power pain threshold ultrasound

EXPERIMENTAL

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

Other: high power pain threshold ultrasoundOther: traditional therapy

traditional therapy

ACTIVE COMPARATOR

the patients will receive traditional therapy twice a week for four weeks

Other: traditional therapy

Interventions

After explaining the procedure, and the trigger points will be marked by a physical therapist that . Then, the hand placed next to the prone position with the head in the neutral position, and the hands placed next to the body. The frequency was set to 1 MHz, and the intensity increased from 0.5 to 2 until the patient reported an unpleasant sensation. The probe will be held there for 4 s; then, the intensity was reduced by 50%, and the probe was moved over and around the trigger point. This process is done several times for three minutes.

high power pain threshold ultrasound

the patients will receive traditional therapy in the form of postural correction exercise, active range of motion and stretching exercise for cervical muscles

high power pain threshold ultrasoundtraditional therapy

Eligibility Criteria

Age19 Years - 38 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients with mechanical neck pain from both genders.
  • age between 19 and 38 years
  • patients will be required to have active TrPs in the upper trapezius and levator muscle and neck pain

You may not qualify if:

  • Patients will be excluded if they have 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 and Rheumatologic condition as mild systemic lupus erythematosus, poly-articular osteoarthritis, rheumatoid arthritis and advanced cervical spine degenerative diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al Shaymaa Shaaban Abd El Azeim

Giza, 12511, Egypt

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
permuted block randomization
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: high power pain threshold ultrasound and traditional therapy
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

September 12, 2022

First Posted

September 14, 2022

Study Start

September 20, 2022

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

January 25, 2023

Record last verified: 2023-01

Locations