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NCT Number: NCT05664165

The Efficiency of Dry Needling and Cold Spray-stretching Treatments

A prospective randomized single-blind study included 60 patients aged 18-65 years who have MPS with active triger points in the upper trapezius muscle. Patients were randomized into two treatment groups as dry needling (DN) and cold spray-stretching. Both treatment groups received 1 treatment per week and totally 3 sessions. Evaluation parameters were pain level assessed by visual analog scale (VAS) and algometer, neck range of motion angles, functional level assessed by neck disability index (NDI). The effects of the treatments on active trigger points were evaluated by sEMG and US histogram. All parameters were evaluated at the beginning of the treatment and after 3 sessions of treatment. Algometer and sEMG were performed also before and after the 1st and 3rd sessions.

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Key information

Conditions

Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases Myofascial Trigger Point Pain

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haydarpaşa Numune Education and Research Hospital

Istanbul, Turkey (Türkiye)

About this study

OBJECTIVE: To compare the efficacy of dry needling and cold spray stretching treatments using surface electromyography (sEMG) and ultrasound (US) in the treatment of patients with myofascial pain syndrome (MPS) with active trigger point (TrP) in the upper trapezius muscle.

MATERIAL AND METHODS: A prospective randomized single-blind study included 60 patients aged 18-65 years who have MPS with ATP in the upper trapezius muscle. Patients were randomized into two treatment groups as dry needling (DN) and cold spray-stretching. Both treatment groups received 1 treatment per week and totally 3 sessions. Evaluation parameters were pain level assessed by visual analog scale (VAS) and algometer, neck range of motion angles, functional level assessed by neck disability index (NDI). The effects of the treatments on aTP were evaluated by sEMG and US histogram. All parameters were evaluated at the beginning of the treatment and after 3 sessions of treatment. Algometer and sEMG were performed also before and after the 1st and 3rd sessions.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • neck and / or back pain for at least 3 months,
  • pain level> 3 in VAS measurement
  • presence of active trigger point in upper trapezius muscle

Exclusion criteria

  • cervical radiculopathy
  • history of neck and / or shoulder surgery
  • dry needling treatment in the neck and / or shoulder area in the last 1 month
  • coagulation disorder and / or use of anticoagulant therapy
  • migraine or dementia
  • pacemaker
  • needle phobia
  • allergies to the substances in the coolant spray to be used

Treatment and study plan

dry needling

Other

The needle inserted in the trigger point and stimulation was performed by manipulating it up and down several times. The needle was kept in the trigger point for 1-3 minutes and removed after the muscle spasm regressed

cold spray and stretching

Other

The cooler spray (in its content; 0.06% menthol, 2.06% isopropyl alcohol, 2% isopropyl alcohol) was sprayed to the surface at an angle of 30° from a distance of approximately 30-50 cm, while passive stretching was applied.

Primary outcomes

  1. pain intensity1

    Time frame: Change from baseline at 3rd week

    Visual Analog Scale: The Visual Analog Scale (VAS) (0-10 cm) was used to record each patient's current level of neck pain, with 0 indicating no pain and 10 indicating the worst pain that the patient had experienced.Higher scores mean worse outcome

  2. cervical range of motion angles

    Time frame: Change from baseline at 3rd week

    measured by goniometer for flexion, extension, left and right lateral flexion of cervical spine

  3. pain intensity2

    Time frame: Change from baseline at 3rd week

    Algometer: The pain threshold was measured before and after the the first and third sessions with a pressure algometer (Electronic Algometer Commander-USA) in kg / cm². The applied pressure was increased until the point the patient first felt the pain. Measurements were repeated 3 times and the mean average score was recorded.

  4. Disability level

    Time frame: Change from baseline at 3rd week

    Neck Pain Disability Scale: The questionnaire consists of 20 items and measures neck movements, pain intensity, effect of neck pain on emotion factors, and interference with daily life activities. Each section is scored on a 0-5 rating scale and total score ranges from 0 to 100. Higher scores mean worse outcome.

Secondary outcomes

  1. Gray Scale Ultrasonography

    Time frame: Change from baseline at 3rd week

    The upper trapezius muscle, where the trigger point was located, is visualized with US, and the images containing the focal, hypoechoic area (trigger point) in the middle of the muscle are recorded. The echogenicity values of these images is analyzed with ImageJ software.

  2. Surface electromyography

    Time frame: Change from baseline at 3rd week

    While the patient was sitting on a chair, EMG electrodes were placed in the middle of the upper trapezius muscle between the seventh cervical vertebra (C7) and the acromion, covering the trigger point area. The patient was asked to keep the trapezius muscle in the resting position for six seconds, the average of the recordings repeated 3 times with 1 minute intervals was evaluated as resting EMG activity. Then he was asked to raise both shoulders and hold this position in isometric contraction for six seconds. The maximum and average amplitude values obtained from the recordings that were repeated 3 times with 1 minute intervals were also averaged.

Sponsors and collaborators

Lead sponsor

Haydarpasa Numune Training and Research Hospital

Other

Registry information

Official study title

Can the Efficiency of Dry Needling and Cold Spray-stretching Treatments be Documented by Ultrasonography and Electrophysiology?

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 23, 2022
Registry last updated
Dec 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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