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

Influence of Using Different Amplitude Modulated Frequencies on the Effectiveness of Interferential Current in Treating Trapezius Trigger Points: a Randomized Controlled Trial.

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.

Study Overview

• Status: Completed
• Conditions: Trigger Point Pain
• Intervention / Treatment: Other: interferential current

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Hail, Saudi Arabia, 3994
    • University of Hail
  • Hail, Saudi Arabia, 3994
    • Hisham Hussein

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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).	Other: 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.; Other Names: medium frequency current
Experimental: amplitude modulated frequency 4Hz group; 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.; standard physical therapy treatment as in the first group	Other: 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.; Other Names: medium frequency current
Experimental: amplitude modulated frequency (AMF) 130Hz group; 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.; standard physical therapy treatment as in the first group	Other: 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.; Other Names: medium frequency current
Experimental: amplitude modulated frequency (AMF) 80Hz group; 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.; standard physical therapy treatment as in the first group	Other: 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.; Other Names: medium frequency current

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Active Range of motion (AROM) for cervical spine.	Active range of motion (AROM) of neck side flexion (ipsilateral and contralateral) will be measured using a valid and reliable inclinometer application for Android phone. Measurements will be collected while the participant seated on a chair with back support. The phone will be placed horizontally on the back of the head while the participants assume neutral head position. The participant will be instructed to keep the shoulder rested and move the head to one side till the end of the available range. The procedure will be repeated 3 times and the average value will be used for analysis.	at baseline
Active Range of motion (AROM) for cervical spine.	Active range of motion (AROM) of neck side flexion (ipsilateral and contralateral) will be measured using a valid and reliable inclinometer application for Android phone. Measurements will be collected while the participant seated on a chair with back support. The phone will be placed horizontally on the back of the head while the participants assume neutral head position. The participant will be instructed to keep the shoulder rested and move the head to one side till the end of the available range. The procedure will be repeated 3 times and the average value will be used for analysis.	at 4 weeks
Active Range of motion (AROM) for cervical spine.	Active range of motion (AROM) of neck side flexion (ipsilateral and contralateral) will be measured using a valid and reliable inclinometer application for Android phone. Measurements will be collected while the participant seated on a chair with back support. The phone will be placed horizontally on the back of the head while the participants assume neutral head position. The participant will be instructed to keep the shoulder rested and move the head to one side till the end of the available range. The procedure will be repeated 3 times and the average value will be used for analysis.	at 4 weeks after the end of the treatment (follow-up)
Pain pressure threshold by pressure algometer	The assessor will assess the pain pressure threshold in Kg/cm2 using a pressure algometer (FDIX25 Digital Force Gauge, Greenwich, CT, USA). The algometer will be placed with its tip perpendicular over the TrP then gradual pressure will be applied. The participants will be asked to report pain once they feel it. Measurements will be repeated twice with 30-s rest intervals in-between trials. The mean value will be used for analysis. the more improvement the higher value of pain pressure can be tolerated before pain sensation percieved	at baseline
Pain pressure threshold by pressure algometer	The assessor will assess the pain pressure threshold in Kg/cm2 using a pressure algometer (FDIX25 Digital Force Gauge, Greenwich, CT, USA). The algometer will be placed with its tip perpendicular over the TrP then gradual pressure will be applied. The participants will be asked to report pain once they feel it. Measurements will be repeated twice with 30-s rest intervals in-between trials. The mean value will be used for analysis. the more improvement the higher value of pain pressure can be tolerated before pain sensation percieved	at 4 weeks
Pain pressure threshold by pressure algometer	The assessor will assess the pain pressure threshold in Kg/cm2 using a pressure algometer (FDIX25 Digital Force Gauge, Greenwich, CT, USA). The algometer will be placed with its tip perpendicular over the TrP then gradual pressure will be applied. The participants will be asked to report pain once they feel it. Measurements will be repeated twice with 30-s rest intervals in-between trials. The mean value will be used for analysis. the more improvement the higher value of pain pressure can be tolerated before pain sensation percieved	at 4 weeks after the end of the treatment (follow-up)
Function using neck disability index	The participant's functional status will be assessed by a validated Arabic version of the neck disability index (NDI). The NDI is a 10-item questionnaire scored from 0-50 points (0-100%) in which higher scores indicate higher levels of disability. The cutoff points are: score of 5-14 points (10- 28%) indicates mild disability, 15-24 points (30-48%) indicates moderate disability, 25-38 points (50-68%) indicates severe disability, and above 34 points (68%) for complete disability	at baseline
Function using neck disability index	The participant's functional status will be assessed by a validated Arabic version of the neck disability index (NDI). The NDI is a 10-item questionnaire scored from 0-50 points (0-100%) in which higher scores indicate higher levels of disability. The cutoff points are: score of 5-14 points (10- 28%) indicates mild disability, 15-24 points (30-48%) indicates moderate disability, 25-38 points (50-68%) indicates severe disability, and above 34 points (68%) for complete disability	at 4 weeks
Function using neck disability index	The participant's functional status will be assessed by a validated Arabic version of the neck disability index (NDI). The NDI is a 10-item questionnaire scored from 0-50 points (0-100%) in which higher scores indicate higher levels of disability. The cutoff points are: score of 5-14 points (10- 28%) indicates mild disability, 15-24 points (30-48%) indicates moderate disability, 25-38 points (50-68%) indicates severe disability, and above 34 points (68%) for complete disability	at 4 weeks after the end of treatment (follow-up)
number of painful episode in the trapezius muscle	This outcome will be simply assessed by asking the participant try to accurately determine the number of pain attacks in the affected muscle during the last/ previous 4 weeks. the participant will report the number of painful episodes during the last 4 weeks before engaging in the study, then at the 4 months of the treatment program, then at 4 weeks of the end of the treatment program	at baseline
number of painful episode in the trapezius muscle	This outcome will be simply assessed by asking the participant try to accurately determine the number of pain attacks in the affected muscle during the last/ previous 4 weeks. the participant will report the number of painful episodes during the last 4 weeks before engaging in the study, then at the 4 months of the treatment program, then at 4 weeks of the end of the treatment program	at 4 weeks
number of painful episode in the trapezius muscle	This outcome will be simply assessed by asking the participant try to accurately determine the number of pain attacks in the affected muscle during the last/ previous 4 weeks. the participant will report the number of painful episodes during the last 4 weeks before engaging in the study, then at the 4 months of the treatment program, then at 4 weeks of the end of the treatment program	at 4 weeks after the end of treatment (follow-up)

Collaborators and Investigators

• Sponsor: University of Hail

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Actual): July 30, 2024
• Study Completion (Actual): August 1, 2024

Study Registration Dates

• First Submitted: May 28, 2023
• First Submitted That Met QC Criteria: May 28, 2023
• First Posted (Actual): June 7, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 5, 2025
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: H-2023-289

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: all data will be with the principal investigator

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No