Comparison of Efficiency of Interferential Current Application Methods in Chronic Neck Pain

NCT06562933 | Recruiting

• 1 other identifier: AIBU-FTR-SK-8
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the effects of Interferential Current Therapy on pain, disability, and quality of life in patients with chronic neck pain and to compare the effects of applying Interferential Current Therapy with vacuum electrodes versus carbon-silicon pad electrodes.

Conditions

Chronic Neck Pain

Outcome Measures

Primary Outcomes (8)

• The Numerical Pain Rating Scale

  It is used to measure pain. The numerical scale for perceived pain intensity usually includes 11 numbers. The participant selects the number that best reflects their pain.In our study, participants were informed that '0' indicates no pain and '10' represents pain of unbearable intensity.

  Before treatment

• The Numerical Pain Rating Scale

  It is used to measure pain. The numerical scale for perceived pain intensity usually includes 11 numbers. The participant selects the number that best reflects their pain.In our study, participants were informed that '0' indicates no pain and '10' represents pain of unbearable intensity.

  2 week after treatment

• Pressure Pain Threshold

  A pressure algometer (dolorimeter) is a device used for assessing pain sensitivity and measuring pressure perception.It has been proven useful in evaluating trigger points, arthritis activation, and visceral pain-pressure sensitivity. The pressure algometer consists of a metal piston with a rubber disc at the end, which has a 1 cm² surface, and is connected to a gauge that measures pressure in kilograms of force (kgf). In our study, a manual algometer (BaselineR Dolorimeter, Fabrication Enterprises, Inc, NY, USA) was used. The algometric measurement will be performed three times on the most painful point as reported by the patient and detected by palpation. The average of these three measurements will be included in the evaluation.

  Before treatment

• Pressure Pain Threshold

  A pressure algometer (dolorimeter) is a device used for assessing pain sensitivity and measuring pressure perception.It has been proven useful in evaluating trigger points, arthritis activation, and visceral pain-pressure sensitivity. The pressure algometer consists of a metal piston with a rubber disc at the end, which has a 1 cm² surface, and is connected to a gauge that measures pressure in kilograms of force (kgf). In our study, a manual algometer (BaselineR Dolorimeter, Fabrication Enterprises, Inc, NY, USA) was used. The algometric measurement will be performed three times on the most painful point as reported by the patient and detected by palpation. The average of these three measurements will be included in the evaluation.

  2 week after treatment

• Neck Bournemouth Questionnaire

  Adapted from the Bournemouth Low Back Pain Questionnaire developed by Bolton and Humphreys in 2002, this questionnaire includes variables that must be assessed in individuals with neck pain. The content of the questionnaire covers pain intensity, the impact of pain on daily living activities and social life, anxiety and depression levels, kinesiophobia, and pain coping strategies. Each of the 7 questions is scored from 0 to 10. The highest possible score is 70, with a higher score indicating a higher level of disability.

  Before treatment

• Neck Bournemouth Questionnaire

  Adapted from the Bournemouth Low Back Pain Questionnaire developed by Bolton and Humphreys in 2002, this questionnaire includes variables that must be assessed in individuals with neck pain. The content of the questionnaire covers pain intensity, the impact of pain on daily living activities and social life, anxiety and depression levels, kinesiophobia, and pain coping strategies. Each of the 7 questions is scored from 0 to 10. The highest possible score is 70, with a higher score indicating a higher level of disability.

  2 week after treatment

• Neck Disability Index

  The Neck Disability Index (NDI) Turkish version was used for assessing patients' disability. This index is a scale consisting of 10 questions used to evaluate how and to what extent neck pain affects the patient's daily living activities. The scale includes parameters such as pain intensity, self-care, lifting, reading, headache, concentration, driving, sleep, and social activities. Patients were asked to mark the option that best applies to them from the 6 choices provided for each parameter. Each item is scored from 0 (no disability) to 5 (complete disability). The total score ranges from 0 (no disability) to 50 (total disability). After obtaining the total score, the value calculated according to the formula is expressed as a percentage of impairment. As the score increases, disability increases; as the score decreases, disability decreases.

  Before treatment

• Neck Disability Index

  The Neck Disability Index (NDI) Turkish version was used for assessing patients' disability. This index is a scale consisting of 10 questions used to evaluate how and to what extent neck pain affects the patient's daily living activities. The scale includes parameters such as pain intensity, self-care, lifting, reading, headache, concentration, driving, sleep, and social activities. Patients were asked to mark the option that best applies to them from the 6 choices provided for each parameter. Each item is scored from 0 (no disability) to 5 (complete disability). The total score ranges from 0 (no disability) to 50 (total disability). After obtaining the total score, the value calculated according to the formula is expressed as a percentage of impairment. As the score increases, disability increases; as the score decreases, disability decreases.

  2 week after treatment

Study Arms (3)

Sham vacuum

SHAM COMPARATOR

Sham vacuum

Device: Sham vacuum

Interferential Current Therapy Vacuum Electrodes

ACTIVE COMPARATOR

Interferential Current Therapy Vacuum Electrodes

Device: Interferential Current Therapy Vacuum Electrodes

Interferential Current Therapy Carbon-silicon Pad Electrodes

ACTIVE COMPARATOR

Interferential Current Therapy Carbon-silicon Pad Electrodes

Device: Interferential Current Therapy Carbon-silicon Pad Electrodes

Interventions

Sham vacuum DEVICE

Participants will undergo a total of 10 treatment sessions over two weeks, with one session per day, five days a week. Two-channel four vacuum electrodes will be placed on the neck so that the painful area remains in the middle. The vacuum electrodes will apply continuous vacuum mode for only 10 minutes without delivering interferential current. Following the sham vacuum therapy, a hot pack will be applied to the painful neck area for 20 minutes.

Sham vacuum

Interferential Current Therapy Vacuum Electrodes DEVICE

Participants will undergo a total of 10 treatment sessions over two weeks, with one session per day, five days a week. Two-channel four vacuum electrodes will be placed on the neck so that the painful area remains in the middle. Interferential current therapy with a 4000 Hz carrier frequency and 50 Hz amplitude-modulated frequency will be applied for 10 minutes using the vacuum electrodes. After the interferential current therapy, a hot pack will be applied to the painful neck area for 20 minutes.

Interferential Current Therapy Vacuum Electrodes

Interferential Current Therapy Carbon-silicon Pad Electrodes DEVICE

Participants will undergo a total of 10 treatment sessions over two weeks, with one session per day, five days a week. Two-channel four carbon-silicon pad electrodes will be placed on the neck so that the painful area remains in the middle. Interferential current therapy with a 4000 Hz carrier frequency and 50 Hz amplitude-modulated frequency will be applied for 10 minutes using the carbon-silicon pad electrodes. Following the interferential current therapy, a hot pack will be applied to the painful neck area for 20 minutes.

Interferential Current Therapy Carbon-silicon Pad Electrodes

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with chronic neck pain lasting at least 3 months
• Ages between 20 and 50 years

You may not qualify if:

• Patients with inflammatory or infectious diseases and those with radiculopathy or myelopathy symptoms
• Patients for whom electrotherapy is contraindicated (e.g., those with pregnancy, neurological conditions such as epilepsy, inner ear hearing aids, arrhythmias, pacemakers, active infections, skin lesions, etc.)
• Individuals with a history of malignancy, major surgery, or previous trauma
• Individuals who have received physical therapy within the last year
• Patients whose evaluation could not be completed for any reason
• Patients who do not wish to complete their evaluations for any reason

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Abant Izzet Baysal University

Bolu, 14100, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Serdar Kılınç

CONTACT

905055913181; drserdarkilinc@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: August 18, 2024
• First Posted: August 20, 2024
• Study Start: August 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)