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

Study Overview
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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).

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

Conditions
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Trigger Point Pain

Intervention / Treatment
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* Other: interferential current


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 4 arms will receive treatment for 4 weeks
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: standard physical therapy group<br>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<br>* 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.<br>* Other names: medium frequency current;|
| Experimental: amplitude modulated frequency (AMF) 130Hz group<br>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<br>* 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.<br>* Other names: medium frequency current;|
| Experimental: amplitude modulated frequency (AMF) 80Hz group<br>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<br>* 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.<br>* Other names: medium frequency current;|
| Experimental: amplitude modulated frequency 4Hz group<br>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<br>* 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.<br>* Other names: medium frequency current;|

What is the study measuring?
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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) |