Using Different Amplitude-modulated Frequencies of IFC for the Treatment of Trigger Points

NCT ID: NCT05892991

Last Updated: 2025-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-08-01

Brief Summary

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the authors of this work will conduct a randomized controlled trial intended to examine different amplitude-modulated frequencies of interferential current on different measures related to chronic trigger points located in the upper trapezius muscle.

Detailed Description

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this randomized controlled trial was designed to fill a gap in the literature regarding the most effective amplitude-modulated frequency of interferential current on pain pressure threshold, cervical ROM, and function of the neck region.

this study will be consisted of 4 groups, all groups will receive standard manual treatment commonly used for the treatment of chronic trigger points. this treatment will be conducted 3 times per week for 4 weeks. The standard treatment will consist of an intermittent neuromuscular inhibition technique.

the 3 experimental groups will receive interferential current sessions (3/week) for 4 weeks with the same parameters except for the amplitude-modulated frequency.

outcome measurements will be assessed at baseline, at 4 weeks, and at 4 weeks of the end of the treatment (follow-up).

Conditions

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Trigger Point Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

4 arms will receive treatment for 4 weeks
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Participants will be allocated to groups by a researcher not involved in assessment or treatment (AAI). Permuted blocks generated using http://www.randomization.com/ were used for the allocation to assure equal and random allocation. Randomization codes were kept confidential in sealed opaque envelopes and sequentially numbered to ensure concealed allocation.

Study Groups

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standard physical therapy group

this group will receive 4 physical therapy sessions per week for 4 weeks. The session will consist of intermittent neuromuscular inhibition which is composed of 3 manual approaches (positional release, muscle energy technique, and progressive pressure release).

Group Type ACTIVE_COMPARATOR

interferential current

Intervention Type OTHER

this intervention is a type of therapeutic electrical currents of medium frequency used commonly in physical therapy to relieve acute and chronic pain as well as stimulate muscle contraction.

amplitude modulated frequency (AMF) 130Hz group

1. Chattanooga (Intellect© Advanced, USA) multi-current device will be used to apply the IFC sessions. Carrier frequency 4000Hz, 2 pole placement (pre-modulated), the intensity will be raised till the patient feels a strong but comfortable tingling sensation, AMFs 130. Two vacuum electrodes of medium size will be placed at both sides of the trigger point. The duration of the session will be 30 minutes and will be repeated 3 times per week for 4 weeks.
2. standard physical therapy treatment as in the first group

Group Type EXPERIMENTAL

interferential current

Intervention Type OTHER

this intervention is a type of therapeutic electrical currents of medium frequency used commonly in physical therapy to relieve acute and chronic pain as well as stimulate muscle contraction.

amplitude modulated frequency (AMF) 80Hz group

1. Chattanooga (Intellect© Advanced, USA) multi-current device will be used to apply the IFC sessions. Carrier frequency 4000Hz, 2 pole placement (pre-modulated), the intensity will be raised till the patient feels a strong but comfortable tingling sensation, AMFs 80Hz. Two vacuum electrodes of medium size will be placed at both sides of the trigger point. The duration of the session will be 30 minutes and will be repeated 3 times per week for 4 weeks.
2. standard physical therapy treatment as in the first group

Group Type EXPERIMENTAL

interferential current

Intervention Type OTHER

this intervention is a type of therapeutic electrical currents of medium frequency used commonly in physical therapy to relieve acute and chronic pain as well as stimulate muscle contraction.

amplitude modulated frequency 4Hz group

1. Chattanooga (Intellect© Advanced, USA) multi-current device will be used to apply the IFC sessions. Carrier frequency 4000Hz, 2 pole placement (premodulated), the intensity will be raised till muscle twitching is visible under electrodes, AMFs 4 Hz. Two vacuum electrodes of medium size will be placed at both sides of the trigger point. The duration of the session will be 30 minutes and will be repeated 3 times per week for 4 weeks.
2. standard physical therapy treatment as in the first group

Group Type EXPERIMENTAL

interferential current

Intervention Type OTHER

this intervention is a type of therapeutic electrical currents of medium frequency used commonly in physical therapy to relieve acute and chronic pain as well as stimulate muscle contraction.

Interventions

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interferential current

this intervention is a type of therapeutic electrical currents of medium frequency used commonly in physical therapy to relieve acute and chronic pain as well as stimulate muscle contraction.

Intervention Type OTHER

Other Intervention Names

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medium frequency current

Eligibility Criteria

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Inclusion Criteria

* males or females,
* 17 - 50 years of age,
* unilateral pain in the cervical, neck, and upper shoulder, pain persists for 3 months or more,
* pain should be not less than 2 on the visual analog scale (VAS),
* having positive signs of chronic (latent) trigger point(s) in the upper trapezius muscle

Exclusion Criteria

* cervical and or shoulder pathologies such as disc lesions, arthritis, or compression problems.
* neurological symptoms in the upper limb such as radiculopathy.
* previous cervical, thoracic, or shoulder surgery.
* regular sports practice.
* heavy work-related activities.
* trauma to the cervical spine (whiplash injury).
* osteoporosis.
* complex regional pain syndrome.
* thoracic outlet syndrome
* regular analgesic drugs.
Minimum Eligible Age

17 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Hail

OTHER

Sponsor Role lead

Responsible Party

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Hisham Mohamed Hussein

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hisham Hussein

Hail, Ha'il Region, Saudi Arabia

Site Status

University of Hail

Hail, Ha'il Region, Saudi Arabia

Site Status

Countries

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Saudi Arabia

Other Identifiers

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H-2023-289

Identifier Type: -

Identifier Source: org_study_id

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