Zagazig general hospital
Zagazig, Egypt
NCT Number: NCT06891963
This study aims to compare between the effectiveness of Acupuncture-Like Transcutaneous Electrical Nerve Stimulation (Acupuncture-like TENS) and dry needling on pain intensity, Pressure pain threshold (PPT) of upper trapezius myofascial trigger points, neck range of motion, and neck function in patients with non specific chronic neck pain.
Trial opening soon.
Get Notified20 year–40 year
All sexes
Interventional
Not applicable
Zagazig, Egypt
The incidence of myofascial trigger points (MTrPs) has been found to vary from 30% to 95% of people who have presented to pain treatment clinics. MPS is common and causes much disability and inability to work so that affect the economy and productivity of workers and employees. According to a previous study, physiotherapy is the most common method used to apply non-invasive techniques and may include the use of modalities for pain relief such as manual therapy, bracing, exercise, Electrical stimulation, kinesio tape, and ultrasound therapy and activity modification. Physiotherapy treatment is recommended to reduce pain, to restore range of motion, function and to strength and stabilize the spine .Trigger points may be relived through many non-pharmacological techniques such as spray and stretch transcutaneous electrical stimulation, massage and dry needing.
Electrotherapy has been widely used as a hypoalgesic agent, which typically involves transcutaneous nerve stimulation. Another well-known hypoalgesic technique is dry needling.
Dry needling (DN) uses a fine, solid needle and is also known as intramuscular stimulation clinical and scientific interest in DN has grown exponentially and various treatment effects are being credited to DN, such as: decreased pain and muscle tension, improved range of motion, muscle strength and coordination.
Although there are many previous studies on the effect of transcutaneous electrical nerve stimulation and dry needling on upper trapezius trigger points, there is no study comparing the therapeutic efficacy between them. However, till now no study compared the therapeutic potential of both modalities. So, this study will be conducted to compare between the effect of transcutaneous electrical nerve stimulation and dry needling in upper trapezius myofascial trigger point.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Having at least 1 active trigger point in upper trapezius muscles will use a recommended diagnostic criterion to find active MTrPs which is:
Exclusion criteria
The first experimental group will receive 20-minute sessions of TENS, where participants adjust the amplitude to achieve strong muscle twitching beneath the electrodes at an intensity below the pain threshold. Acupuncture-like TENS uses high-frequency pulsed currents at two trains per second with an internal pulse frequency of 100 pps. The pulse pattern is set to "burst," with an asymmetrical biphasic waveform and a pulse duration of 200 µs. Minor fluctuations in pulse rate between 100 and 104 pps were noted using a cathode ray oscilloscope before the experiment.
The second experimental group will receive 20-minute sessions of dry needling. Patients will be positioned in a prone, relaxed position, and the overlying skin will be cleaned with alcohol. The muscle will be palpated to locate the trigger point (MTrP), with the muscle grasped between the thumb, index, and middle fingers. A solid filiform needle within a guide tube will be inserted into the MTrP using a tapping motion at an oblique angle. The upper trapezius muscle will be palpated for trigger points, with needle insertion depths ranging from 10-15mm. After obtaining a local twitch response, the needle will be moved vertically 3-5mm until no more twitch responses occur. This group will also receive 20 minutes of conventional physical therapy.
All participants in the three groups will receive conventional treatment in the form of hot pack treatment followed by active range of movement (AROM) exercises. A hot pack will be placed on the patients cervical, paraspinal, and upper thoracic areas (including the upper trapezius muscle with aMTrP) for 20 minutes. This will be followed by AROM exercise for cervical spine joints. Participants were asked to actively flex the neck so that the head dropped toward the contralateral trapezius muscles. Patients then rotated the head toward ipsilateral side. This exercise will be repeated five times.
Time frame: 4 weeks
The Visual Analogue Scale (VAS) will be used to evaluate pain intensity. It is a horizontal line whose length is 10 cm; its left end (zero) indicates no pain, while its right end (ten) reveals the worst imaginable pain. Each subject will be in relaxed position and will be asked to mark the point on the line that exactly corresponded to his/her pain.
Time frame: 4 weeks
The pressure pain threshold (PPT) will be assessed by positioning the tip of the algometer on the trigger point and increasing the pressure by 1 kg per second. When the patient indicates discomfort, the pressure value will be recorded in kg/cm. The procedure will be repeated three times at 60 s intervals, and the mean pressure value will be recorded as the PPT.
Time frame: 4 weeks
It will be measured for all participants in the three groups pre- and post-treatment, using the CROM device. Each participant will asked to perform cervical flexion three times and the mean value will be recorded.
Time frame: 4 weeks
It will be measured for all participants in the three groups pre- and post-treatment, using the CROM device. Each participant will asked to perform cervical extension three times and the mean value will be recorded.
Time frame: 4 weeks
It will be measured for all participants in the three groups pre- and post-treatment, using the CROM device. Each participant will asked to perform cervical lateral flexion to the right three times and the mean value will be recorded.
Time frame: 4 weeks
It will be measured for all participants in the three groups pre- and post-treatment, using the CROM device. Each participant will asked to perform cervical lateral flexion to the left three times and the mean value will be recorded.
Time frame: 4 weeks
It will be measured for all participants in the three groups pre- and post-treatment, using the CROM device. Each participant will asked to perform cervical rotation to the right three times and the mean value will be recorded.
Time frame: 4 weeks
It will be measured for all participants in the three groups pre- and post-treatment, using the CROM device. Each participant will asked to perform cervical rotation to the left three times and the mean value will be recorded.
Time frame: 4 weeks
The Neck Disability Index (NDI) will be used to assess functional status for all participants in the three groups before and after treatment. The NDI is a 10-item questionnaire assessing personal care, pain, reading, lifting, concentration, headaches, work, driving, sleeping, and recreation. Each item is scored from 0 (no disability) to 5 (total disability), with a maximum possible score of 50. Participants will select the answer that best describes their neck function. Total scores are categorized as follows: 0-4 (no disability), 5-14 (mild disability), 15-24 (moderate disability), 25-34 (severe disability), and 35+ (complete disability).
Contact information is provided by the study sponsor or research team.
Rania Reda Mohamed, PhD
CONTACT
Sara Galal Mohammed Soliman, B.Sc
CONTACT
Cairo University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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