NCT05275634

Brief Summary

To investigate the effect of different carrier frequencies of interferential current on pressure pain threshold, neck disability, cervical range of motion and upper trapezius muscle activity when applied on upper trapezius chronic myofascial trigger points: Randomized Controlled Trial

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 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

February 15, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 11, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

May 26, 2023

Status Verified

May 1, 2023

Enrollment Period

8 months

First QC Date

February 15, 2022

Last Update Submit

May 24, 2023

Conditions

Keywords

Interferential currentCarrier frequencyUpper trapeziusTrigger points

Outcome Measures

Primary Outcomes (1)

  • Change in pressure pain threshold

    Pressure pain threshold will be measured by digital pressure algometer

    Immediately after the end of the treatment

Secondary Outcomes (7)

  • Change in Pressure pain threshold

    12 weeks following the end of the treatment

  • Change in neck disability

    Immediately after the end of the treatment

  • Change in neck disability

    12 weeks following the end of the treatment

  • Change in cervical range of motion

    Immediately after the end of the treatment

  • Change in cervical range of motion

    12 weeks following the end of the treatment

  • +2 more secondary outcomes

Study Arms (4)

Standard treatment and interferential current with carrier frequency 2 KHz

EXPERIMENTAL

Standard treatment and interferential current with carrier frequency 2 KHz will be received three times a week for four weeks.

Other: Stander treatmentDevice: Interferential current with carrier frequency 2 KHz

Standard treatment and interferential current with carrier frequency 4 KHz

EXPERIMENTAL

Standard treatment and interferential current with carrier frequency 4 KHz will be received three times a week for four weeks.

Other: Stander treatmentDevice: Interferential current with carrier frequency 4 KHz

Standard treatment and interferential current with carrier frequency 8 KHz

EXPERIMENTAL

Standard treatment and interferential current with carrier frequency 8 KHz will be received three times a week for four weeks.

Other: Stander treatmentDevice: Interferential current with carrier frequency 8 KHz

Standard treatment and placebo interferential current

PLACEBO COMPARATOR

Standard treatment and placebo interferential current will be received three times a week for four weeks.

Other: Stander treatmentDevice: placebo interferential current

Interventions

Standard treatment will be (active cervical range of motion exercises, myofascial release to upper trapezius muscle and postural advices at home).

Standard treatment and interferential current with carrier frequency 2 KHzStandard treatment and interferential current with carrier frequency 4 KHzStandard treatment and interferential current with carrier frequency 8 KHzStandard treatment and placebo interferential current

Interferential current treatment parameters will be as following; carrier frequency 2 KHz and beat frequency 15 Hz performed for 45 minutes per session.The intensity will be raised according to the subject's tolerance, remaining in the sensory level.

Standard treatment and interferential current with carrier frequency 2 KHz

Interferential current treatment parameters will be as following; carrier frequency 4 KHz and beat frequency 15 Hz performed for 45 minutes per session.The intensity will be raised according to the subject's tolerance, remaining in the sensory level.

Standard treatment and interferential current with carrier frequency 4 KHz

Interferential current treatment parameters will be as following; carrier frequency 8 KHz and beat frequency 15 Hz performed for 45 minutes per session.The intensity will be raised according to the subject's tolerance, remaining in the sensory level.

Standard treatment and interferential current with carrier frequency 8 KHz

Interferential current intensity will not be raised.

Standard treatment and placebo interferential current

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Ages from18-29 years old with unilateral chronic myofascial trigger points in upper trapezius muscle will be included in this study.
  • Participants have chronic myofascial trigger points if they have pain with pressure, local twitch response, jump sign, limited range of motion and referred pain lies over the lateral aspect of the upper trapezius fibers and superiorly to the ipsilateral occiput.
  • Normal body mass index (BMI) from 18-24.9 Kg/m (BMI = body mass in kg divided by participant height in meters).

You may not qualify if:

  • Onset of pain less than 3 months
  • History of whiplash injury
  • History of cervical spine surgery
  • Cervical radiculopathy or myelopathy and cervical disc lesion
  • Cervical spondylolisthesis
  • Having multiple sclerosis, thyroid dysfunction and chronic infection
  • Having rheumatologic condition as poly articular osteoarthritis, rheumatoid arthritis and advanced cervical spine degenerative diseases
  • Skin disease and impaired sensation
  • Phobia of using electrical current
  • Pregnancy, tumor, thrombosis and pacemaker
  • Administration of regular analgesic drugs or any medications that affect skin sensation.
  • Receiving physical therapy intervention during the past three months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy Cairo University

Giza, 12511, Egypt

Location

Related Publications (2)

  • Venancio RC, Pelegrini S, Gomes DQ, Nakano EY, Liebano RE. Effects of carrier frequency of interferential current on pressure pain threshold and sensory comfort in humans. Arch Phys Med Rehabil. 2013 Jan;94(1):95-102. doi: 10.1016/j.apmr.2012.08.204. Epub 2012 Aug 23.

    PMID: 22922327BACKGROUND
  • Correa JB, Costa LO, Oliveira NT, Lima WP, Sluka KA, Liebano RE. Effects of the carrier frequency of interferential current on pain modulation and central hypersensitivity in people with chronic nonspecific low back pain: A randomized placebo-controlled trial. Eur J Pain. 2016 Nov;20(10):1653-1666. doi: 10.1002/ejp.889. Epub 2016 May 6.

    PMID: 27150263BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Double (Participant, Outcomes Assessor)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This trial has four groups; three experimental and one group control.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

February 15, 2022

First Posted

March 11, 2022

Study Start

June 1, 2022

Primary Completion

January 31, 2023

Study Completion

January 31, 2023

Last Updated

May 26, 2023

Record last verified: 2023-05

Locations