AzTrials
AzTrials

Trigger Point PainNCT05892991

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

A study testing interferential current in people with Trigger Point Pain, run by University of Hail at 2 sites in Saudi Arabia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 17 to 50 years
Conditions the study is for
Trigger Point Pain
What is being tested?
interferential current
Could I receive a placebo?
No, everyone receives an active treatment
How many people
132 participants
Where
2 sitesSaudi Arabia
Study dates
1 Oct 2023to 1 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 17 to 50 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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).
Show all 10Show fewer
  • osteoporosis.
  • complex regional pain syndrome.
  • thoracic outlet syndrome
  • regular analgesic drugs.

Trial locations and contacts

2 sites in 1 country.

Saudi Arabia2 sites
  • Hisham Hussein

    Ha'il, Ha'il Region, 3994

  • University of Hail

    Ha'il, Ha'il Region, 3994

Other trials in Saudi Arabia

About this study

Official title: 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.

Read the 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).

Being tested
interferential current

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • interferential currentOther

    Also called medium frequency 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.

Study groups in NCT05892991
Study groupRoleWhat they receive
standard physical therapy groupActive comparatorthis 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).
Receives: Other: interferential current
amplitude modulated frequency (AMF) 130Hz groupExperimental1. 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
Receives: Other: interferential current
amplitude modulated frequency (AMF) 80Hz groupExperimental1. 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
Receives: Other: interferential current
amplitude modulated frequency 4Hz groupExperimental1. 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
Receives: Other: interferential current

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: at baseline

  2. 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.

    Measured: at 4 weeks

  3. 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.

    Measured: at 4 weeks after the end of the treatment (follow-up)

  4. 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

    Measured: at baseline

  5. 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

    Measured: at 4 weeks

  6. 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

    Measured: at 4 weeks after the end of the treatment (follow-up)

  7. 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

    Measured: at baseline

  8. 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

    Measured: at 4 weeks

  9. 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

    Measured: at 4 weeks after the end of treatment (follow-up)

  10. 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

    Measured: at baseline

  11. 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

    Measured: at 4 weeks

  12. 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

    Measured: at 4 weeks after the end of treatment (follow-up)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2023
  2. Study start1 Oct 2023
  3. Primary completion30 Jul 2024
  4. Study completion1 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
4 arms will receive treatment for 4 weeks
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
132 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05892991
Sponsor's protocol ID
H-2023-289
Status last verified
May 2024
First submitted
28 May 2023
Last updated
7 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: all data will be with the principal investigator

Questions about this trial

What is this clinical trial studying?

A study testing interferential current in people with Trigger Point Pain, run by University of Hail at 2 sites in Saudi Arabia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Active Range of motion (AROM) for cervical spine. (time frame: at baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in