Non Specific Chronic Neck PainNCT06891963
Transcutaneous Electrical Nerve Stimulation Versus Dry Needling in Non Specific Chronic Neck Pain
A study testing Acupuncture-like TENS, Dry needling and Conventional treatment in people with Non Specific Chronic Neck Pain, run by Cairo University at 1 site in Egypt.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Non Specific Chronic Neck Pain
- What is being tested?
- Acupuncture-like TENS, Dry needling and Conventional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Mar 2025to 31 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Having at least 1 active trigger point in upper trapezius muscles will use a recommended diagnostic criterion to find active MTrPs which is:
- The presence of a palpable taut band in the skeletal muscle.
- The presence of a hypersensitive spot in the taut band.
- Local twitch response provoked by snapping palpation.
- Production of a typical referred pain pattern in response to the compression of tender spots.
- Spontaneous presence of the typical referred pain pattern.
Show all 9Show fewer
- Duration of symptoms of acute stage (2-4) weeks.
- Age between (20-40) years.
- Having a normal neurological examination result .
Who cannot join
- Existence of cervical disc hernia, advanced cervical osteoarthritis, radiculopathy, or myelopathy.
- Having trigger point injection or physical therapy in the last 6 months.
- Having a rheumatologic disease, such as fibromyalgia, rheumatoid arthritis, or a hormonal disease, such as hypothyroidism, hyperthyroidism or hyperparathyroidism.
- Existence of kyphosis, scoliosis, forward head posture or cervicogenic headache.
- History of spine surgery.
- Having a cardiovascular problem.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rania Reda Mohamed, PhD contact
Egypt1 site
Zagazig general hospital
Zagazig
Sara Galal Mohammed Soliman, B.Sc, +20 12 86741048, Jalalsarah31@gmail.com
About this study
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.
Read the detailed description
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.
- Acupuncture-Like Transcutaneous Electrical Nerve Stimulation (Acupuncture-like TENS): Acupuncture-like TENS
- Acupuncture-like or Low frequency/High intensity TENS parameters include a low frequency (usually 1-4Hz), a high intensity (high enough to produce visible muscle contractions) and a long pulse duration (~200μs). Acupuncture-like TENS primarily stimulates the Group III (Aδ) and IV (C) nociceptive fibres and small motor fibres. As the mechanism of pain relief associated with this TENS mode requires afferent signals from muscle receptors, the electrodes should be positioned to produce visible muscle contractions, e.g. over a myotome related to the painful area. The user will therefore experience par aesthesia and muscle contraction (twitching type) with this mode. As muscle contractions occur, additional sensory information is carried from the muscle spindle via muscle afferents. This mode of TENS is believed to operate primarily through the release of endogenous opioids via the descending pain suppression system; therefore, there is a relatively longer onset to analgesia but the analgesia typically lasts longer with this mode than with Conventional TENS.
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.
- Conditions
- Non Specific Chronic Neck Pain
- Being tested
- Acupuncture-like TENS, Dry needling, Conventional treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture-like TENSOther
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.
Dry needlingOther
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.
Conventional treatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture-like TENS + Conventional treatment | Experimental | This group will receive acupuncture like TENS with conventional treatment for 4 weeks. Receives: Other: Acupuncture-like TENS; Other: Conventional treatment |
| Dry needling + Conventional treatment | Experimental | This group will receive dry needling with conventional treatment for 4 weeks. Receives: Other: Dry needling; Other: Conventional treatment |
| Conventional treatment | Active comparator | This group will receive conventional treatment for 4 weeks. Receives: Other: Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of neck pain intensity
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.
Measured: 4 weeks
Assessment of pressure pain threshold (PPT)
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.
Measured: 4 weeks
Secondary outcomes (7)
Measurement of cervical flexion range of motion (ROM)
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.
Measured: 4 weeks
Measurement of cervical extension ROM
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.
Measured: 4 weeks
Measurement of cervical lateral flexion to the right ROM
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.
Measured: 4 weeks
Measurement of cervical lateral flexion to the left ROM
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.
Measured: 4 weeks
Measurement of cervical rotation to the right ROM
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.
Measured: 4 weeks
Measurement of cervical rotation to the left ROM
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.
Measured: 4 weeks
Assessment of neck function
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).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start25 Mar 2025 (estimated)
- Primary completion25 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Specific Chronic Neck PainStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Galal Mohamed Soliman, Cairo University
- Investigators
- Neveen Abdel Latif Abdel Raoof, PhD, Study chair, Professor, Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06891963
- Sponsor's protocol ID
- P.T.REC/012/003910
- Status last verified
- Mar 2025
- First submitted
- 18 Mar 2025
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Electrical Nerve Stimulation Versus Dry Needling in Non Specific Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT06891963
- Acronym / sponsor ID
- P.T.REC/012/003910
- Conditions
- Non Specific Chronic Neck Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Mar 2025 (estimated)
- Primary completion
- 25 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 24 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
- Acupuncture-Like Transcutaneous Electrical Nerve Stimulation (Acupuncture-like TENS): Acupuncture-like TENS
- Acupuncture-like or Low frequency/High intensity TENS parameters include a low frequency (usually 1-4Hz), a high intensity (high enough to produce visible muscle contractions) and a long pulse duration (~200μs). Acupuncture-like TENS primarily stimulates the Group III (Aδ) and IV (C) nociceptive fibres and small motor fibres. As the mechanism of pain relief associated with this TENS mode requires afferent signals from muscle receptors, the electrodes should be positioned to produce visible muscle contractions, e.g. over a myotome related to the painful area. The user will therefore experience par aesthesia and muscle contraction (twitching type) with this mode. As muscle contractions occur, additional sensory information is carried from the muscle spindle via muscle afferents. This mode of TENS is believed to operate primarily through the release of endogenous opioids via the descending pain suppression system; therefore, there is a relatively longer onset to analgesia but the analgesia typically lasts longer with this mode than with Conventional TENS.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acupuncture-like TENS + Conventional treatment | Experimental | Other: Acupuncture-like TENS, Other: Conventional treatmentThis group will receive acupuncture like TENS with conventional treatment for 4 weeks. |
| Dry needling + Conventional treatment | Experimental | Other: Dry needling, Other: Conventional treatmentThis group will receive dry needling with conventional treatment for 4 weeks. |
| Conventional treatment | Active comparator | Other: Conventional treatmentThis group will receive conventional treatment for 4 weeks. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Having at least 1 active trigger point in upper trapezius muscles will use a recommended diagnostic criterion to find active MTrPs which is:
- The presence of a palpable taut band in the skeletal muscle.
- The presence of a hypersensitive spot in the taut band.
- Local twitch response provoked by snapping palpation.
- Production of a typical referred pain pattern in response to the compression of tender spots.
Key exclusion criteria (6 listed)
- Existence of cervical disc hernia, advanced cervical osteoarthritis, radiculopathy, or myelopathy.
- Having trigger point injection or physical therapy in the last 6 months.
- Having a rheumatologic disease, such as fibromyalgia, rheumatoid arthritis, or a hormonal disease, such as hypothyroidism, hyperthyroidism or hyperparathyroidism.
- Existence of kyphosis, scoliosis, forward head posture or cervicogenic headache.
- History of spine surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture-like TENSThe 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. | Other | Acupuncture-like TENS + Conventional treatment |
| Dry needlingThe 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. | Other | Dry needling + Conventional treatment |
| Conventional treatmentAll 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. | Other | Acupuncture-like TENS + Conventional treatment, Conventional treatment, Dry needling + Conventional treatment |
Primary outcome
Assessment of neck pain intensity
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.
Assessment of pressure pain threshold (PPT)
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.
7 secondary outcomes
Measurement of cervical flexion range of motion (ROM)
Time frame: 4 weeks
Measurement of cervical extension ROM
Time frame: 4 weeks
Measurement of cervical lateral flexion to the right ROM
Time frame: 4 weeks
Measurement of cervical lateral flexion to the left ROM
Time frame: 4 weeks
Measurement of cervical rotation to the right ROM
Time frame: 4 weeks
Measurement of cervical rotation to the left ROM
Time frame: 4 weeks
Assessment of neck function
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rania Reda Mohamed, PhD contact
Neveen Abdel Latif Abdel Raoof, PhD study chair
Professor, Cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture-like TENS, Dry needling and Conventional treatment in people with Non Specific Chronic Neck Pain, run by Cairo University at 1 site in Egypt.
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 9 inclusion and 6 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: opening soon, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Galal Mohammed Soliman, B.Sc (+20 12 86741048, Jalalsarah31@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of neck pain intensity (time frame: 4 weeks). The study lists 2 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 24 Mar 2025.