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The Effect of Electrotherapy on Young Individuals With Neck Pain

The Effect of Different Electrotherapy Interventions on Pain and Hand Function in Young Individuals With Neck Pain: a Randomized Controlled Double-blind Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06767839
Enrollment
36
Registered
2025-01-10
Start date
2025-01-15
Completion date
2025-12-21
Last updated
2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neck Pain

Keywords

neck pain, electrotherapy, TENS, HVPGS

Brief summary

The aim of this clinical study was to investigate the effects of different electrotherapy interventions on pain and hand function in young individuals with neck pain. The main question that the study aimed to answer is: are two different electrotherapy interventions superior to each other for pain and hand function? Participants will be assigned to either transcutaneous electrical nerve stimulation, high-voltage pulsed galvanic stimulation, or placebo. Participants will receive a total of 20 sessions of electrotherapy intervention, 20 minutes per day, 3 days a week. Participants will be evaluated before the intervention, after 1 session, and 1 week after the completion of the 20-session intervention.

Interventions

OTHERTranscutaneous Electrical Nerve Stimulation

The current parameters for the TENS to be applied in the study were determined as 100 Hz, 100 microsecond pulse duration, and asymmetric biphasic waveform. The current intensity will be increased until the person feels a tingling sensation and will be applied for a total of 20 minutes. Two superficial electrodes will be placed to cover the application area to create an effect in deep tissue.

OTHERHigh Voltage Pulsed Galvanic Stimulation

YVKGS is a monophasic waveform current with double peaks, short pulse duration and a voltage higher than 100 Volts, the frequency of which can be adjusted optionally. In the study, the current parameters of YVKGS were determined as a frequency of 100 Hz, continuous pulse, double peak monophasic waveform. The current intensity will be applied for 20 minutes at the voltage at which the person feels a tingling sensation. Two superficial electrodes will be placed to cover the application area to create an effect in deep tissue.

The current will be applied to the sham TENS group with the same parameters as the TENS group, and will be reduced and turned off after a while. In TENS application, people normally report that they no longer feel tingling after a few minutes of starting the application. Therefore, it will be explained to the sham TENS group that this situation is normal, and that they no longer feel tingling because they have become accustomed to the applied current.

Sponsors

Burdur Mehmet Akif Ersoy University
Lead SponsorOTHER
Pamukkale University
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Intervention model description

The sample of the study is Burdur Health Services Vocational School students with neck pain. Participants will be assigned to 3 intervention groups by stratified randomization. The strata are age and gender.

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
No

Inclusion criteria

* Being between 18-30 years old * Complaining of neck pain * Volunteering to participate in the study

Exclusion criteria

* Having received any anti-inflammatory treatment in the last 3 months * Having received any physical therapy and rehabilitation treatment in the last 3 months * Doing regular exercise * Not attending work sessions

Design outcomes

Primary

MeasureTime frameDescription
Visual Analog ScaleFrom enrollment to the end of treatment at 7 weeksThe Visual Analog Scale is a 10-centimeter (cm) scale, with 0 being defined as "no pain" and 10 as "unbearable pain." It is a valid and reliable method for assessing the severity of musculoskeletal pain and is frequently used in clinical studies. In a study conducted on patients with chronic musculoskeletal pain, a VAS value of less than 3.4 cm was classified as mild pain, a VAS value between 3.5 and 7.4 cm was classified as moderate pain, and a VAS value greater than 7.5 cm was classified as severe pain.
Treshold Faradic TestFrom enrollment to the end of treatment at 7 weeksPain threshold measurement is performed by applying a surge faradic current with a frequency of 50 Hz and a transition time of 0.1-1 msec. The point at which the current is first felt is defined as the pain threshold. In this test, the active electrode is placed at the motor point of the relevant muscle, while the passive electrode can be placed in a more distal or proximal region.
Patient-Specific Functional ScaleFrom enrollment to the end of treatment at 7 weeksPatients are asked to list the three activities that cause the most difficulty with their neck pain. Each activity is then scored from 0 (unable to perform the activity) to 10 (able to perform the activity at the same level as before the onset of symptoms).
Core Outcome Meassure Index-NeckFrom enrollment to the end of treatment at 7 weeksIt is a symptom-specific measurement tool that includes all the parameters that need to be evaluated in patients with low back pain (pain, function, quality of life, disability), and has the advantages of being short and easy to apply. It consists of six questions and each question is scored between 0 and 10. Higher scores indicate worse results.

Secondary

MeasureTime frameDescription
Nine-Hole Peg TestFrom enrollment to the end of treatment at 7 weeksIt is a standardized, valid and reliable test that measures upper extremity functions and motor speed, consisting of nine cylindrical wooden sticks and a board with nine round holes. Individuals are asked to quickly take 9 wooden sticks from the box they are in, place them in the holes randomly without observing the order, quickly take them out of the holes without waiting and place them back in the box. The total time that elapses while the individuals insert and remove the sticks from the holes is recorded with a stopwatch in seconds.
Gross Grip StrengthFrom enrollment to the end of treatment at 7 weeksGross grip strength will be measured with a Jamar® digital hand dynamometer. The gross grip strength measurement will be performed in the standard measurement position recommended by the American Hand Therapists Association, with the patient sitting in a chair without elbow support, the arm in adduction and neutral rotation, the elbow in 90-degree flexion, and the forearm and wrist in a neutral position. The test will be repeated 3 times. The average of the 3 tests will be taken.
Pinch Grip StrengthFrom enrollment to the end of treatment at 7 weeksPinch grip strength will be measured with a Jamar® digital pinchmeter. The pinch grip strength measurement position will be performed with the patient sitting in a chair without elbow support, the arm in adduction and neutral rotation, the elbow in 90 degrees flexion, the forearm in 90 degrees supination, and the wrist in a neutral position. The test will be repeated 3 times. The average of the 3 tests will be taken.
Upper Extremity StrenghtFrom enrollment to the end of treatment at 7 weeksThe strength of individuals' shoulder flexor, extensor, abductor, adductor and rotator muscles, elbow flexor and extensor muscles, wrist flexor and extensor muscles will be evaluated with a sphygmomanometer. The evaluation will be carried out with the protocol of the person being measured applying maximum force against the device while the person measuring holds the sphygmomanometer steady.
Semmes-Weinstein Monofilament TestFrom enrollment to the end of treatment at 7 weeksIt is a test used to evaluate light touch sensation in individuals. Monofilaments contain different values from 1.65 to 6.65. Monofilaments between 1.65 and 2.83 are interpreted as normal sensation, while an increase in the perceived thickness indicates a sensory defect. The test will be applied to the C3-C8 dermatomes on both upper extremities. The evaluation will start with the 2.83 monofilament, which is considered optimal, and 3 strokes, each lasting 3 seconds, will be applied to each point with the monofilament. Individuals will be asked to give the answer "I felt it". If individuals respond, a lower monofilament will be applied, and if no response is received, a higher monofilament will be applied and the test will be continued.
Cervical Endurance TestFrom enrollment to the end of treatment at 7 weeksTo assess the endurance of the cervical flexors, individuals perform cervical flexion while lying on their back in a chin position, and the time they maintain this position is recorded in seconds. To assess the endurance of the cervical extensors, individuals attempt to maintain a neutral neck position while lying on their stomach with their head hanging off the bed, and the time they maintain this position is recorded in seconds. The test is terminated when the head position changes in the direction of flexion or extension, or when individuals want to stop the test.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026