NCT04809038

Brief Summary

the aim of this trial is to compare dry needling and magnesium sulphate iontophoresis in subjects with mechanical neck pain

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable chronic-pain

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable chronic-pain

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

March 18, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 22, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

July 27, 2022

Status Verified

July 1, 2022

Enrollment Period

5 months

First QC Date

March 18, 2021

Last Update Submit

July 24, 2022

Conditions

Keywords

dry needling, iontophoresis, neck pain

Outcome Measures

Primary Outcomes (2)

  • pain intensity

    pain will be measured by visual analogue scale

    up to four weeks

  • muscle activity in the form of normalized root mean square

    muscle activity will be measured by electromyograph

    up to four weeks

Secondary Outcomes (2)

  • function

    up to four weeks

  • pressure pain threshold

    up to four weeks

Study Arms (3)

dry needling

EXPERIMENTAL

dry needling will be received twice a week for four weeks

Other: dry needlingOther: stretching exercise

magnesium sulphate iontophoresis

EXPERIMENTAL

magnesium sulphate iontophoresis will be received twice a week for four weeks

Other: magnesium sulphate iontophoresisOther: stretching exercise

stretching exercise

ACTIVE COMPARATOR

stretching will be received twice a week for four weeks

Other: stretching exercise

Interventions

Patient will be placed in a comfortable prone position and encouraged to maintain complete relaxation. The selected active MTrPs was prepared by wiping the area with alcohol pad, and a gauge needle with its plastic guide tube in place will be palced over the active MTrPs .a tapping motion will be used to advance the needle to a depth of 5 to 10 mm for 30 seconds

dry needling

The subjects in the iontophoresis group received MgSO4 iontophoresis using an iontophoretic drug delivery system (Phoresor\_IIAuto,ModelPM850,IOMED. MTrPs were examined using pincer palpation and marked by pin. MgSO4 was applied to the active positive electrode using a syringe with a concentration of 100 mg/cm2. The active electrode was placed directly over the marked area where the sensitive MTrPs were located. The dispersive electrode was applied to the skin 6 inches distal from the active electrode.

magnesium sulphate iontophoresis

The patient will be placed in a comfortable and relaxed sitting position with his back supported ; one hand was placed on the side of the head applying the stretching force, while the other hand was placed on the patients shoulder applying shoulder stablization . The direction of stretched force was in flexion , side bending to the opposite side and rotation to the same side . The stretched position will be sustained for 30 seconds , then a relaxation period of 30 seconds . This procedure was repeated 3 times .

dry needlingmagnesium sulphate iontophoresisstretching exercise

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • All patients had active trigger myofascial trigger points (MTrPs) in upper trapeziues muscle in the dominant side with mechanical neck pain.
  • The patients age ranged from 18-35years The patients had been choosen from both sexes . patient agrees not to receive additional treatment for their painful condition during the trial (apart from NSAIDs and pain killers The patients body mass index \< 30 kg/m²

You may not qualify if:

  • 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

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

Chronic PainNeck Pain

Interventions

Dry NeedlingMuscle Stretching Exercises

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
opaque sealed envelope
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: this trial has three group; two experimental and one control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
al shaymaa shaaban abd el azeim

Study Record Dates

First Submitted

March 18, 2021

First Posted

March 22, 2021

Study Start

April 1, 2021

Primary Completion

August 30, 2021

Study Completion

August 30, 2021

Last Updated

July 27, 2022

Record last verified: 2022-07

Locations