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

NCT05892991 | Completed DMC

• 1 other identifier: H-2023-289
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Trigger Point Pain

Outcome Measures

Primary Outcomes (12)

• 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)

Study Arms (4)

standard physical therapy group

ACTIVE COMPARATOR

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

amplitude modulated frequency (AMF) 130Hz group

EXPERIMENTAL

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

Other: interferential current

amplitude modulated frequency (AMF) 80Hz group

EXPERIMENTAL

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

Other: interferential current

amplitude modulated frequency 4Hz group

EXPERIMENTAL

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

Other: interferential current

Interventions

interferential current 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.

Also known as: medium frequency current

amplitude modulated frequency (AMF) 130Hz group; amplitude modulated frequency (AMF) 80Hz group; amplitude modulated frequency 4Hz group; standard physical therapy group

Eligibility Criteria

• Age: 17 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• males or females,
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Hail: lead

Study Sites (2)

Hisham Hussein

Hail, Ha'il Region, 3994, Saudi Arabia

Location

University of Hail

Hail, Ha'il Region, 3994, Saudi Arabia

Location

MeSH Terms

Interventions

Electric Stimulation Therapy

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: 4 arms will receive treatment for 4 weeks

Study Record Dates

• First Submitted: May 28, 2023
• First Posted: June 7, 2023
• Study Start: October 1, 2023
• Primary Completion: July 30, 2024
• Study Completion: August 1, 2024
• Last Updated: January 7, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

SA (2)