NCT06891963

Brief 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 specific chronic neck pain.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 24, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

March 25, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2025

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

March 24, 2025

Status Verified

March 1, 2025

Enrollment Period

2 months

First QC Date

March 18, 2025

Last Update Submit

March 18, 2025

Conditions

Non Specific Chronic Neck Pain

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    4 weeks

Secondary Outcomes (7)

  • Measurement of cervical flexion range of motion (ROM)

    4 weeks

  • Measurement of cervical extension ROM

    4 weeks

  • Measurement of cervical lateral flexion to the right ROM

    4 weeks

  • Measurement of cervical lateral flexion to the left ROM

    4 weeks

  • Measurement of cervical rotation to the right ROM

    4 weeks

  • +2 more secondary outcomes

Study Arms (3)

Acupuncture-like TENS + Conventional treatment

EXPERIMENTAL

This group will receive acupuncture like TENS with conventional treatment for 4 weeks.

Other: Acupuncture-like TENSOther: Conventional treatment

Dry needling + Conventional treatment

EXPERIMENTAL

This group will receive dry needling with conventional treatment for 4 weeks.

Other: Dry needlingOther: Conventional treatment

Conventional treatment

ACTIVE COMPARATOR

This group will receive conventional treatment for 4 weeks.

Other: Conventional treatment

Interventions

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.

Acupuncture-like TENS + Conventional treatment
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.

Dry needling + Conventional treatment
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.

Acupuncture-like TENS + Conventional treatmentConventional treatmentDry needling + Conventional treatment

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.
  • Duration of symptoms of acute stage (2-4) weeks.
  • Age between (20-40) years.
  • Having a normal neurological examination result .

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zagazig general hospital

Zagazig, Egypt

Location

MeSH Terms

Interventions

Dry Needling

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Officials

  • Neveen Abdel Latif Abdel Raoof, PhD

    Professor, Cairo university

    STUDY CHAIR

Central Study Contacts

Sara Galal Mohammed Soliman, B.Sc

CONTACT

+20 12 86741048Jalalsarah31@gmail.com

Rania Reda Mohamed, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 18, 2025

First Posted

March 24, 2025

Study Start

March 25, 2025

Primary Completion

May 25, 2025

Study Completion

May 31, 2025

Last Updated

March 24, 2025

Record last verified: 2025-03

Locations

EG(1)