NCT05664165|Completed
The Efficiency of Dry Needling and Cold Spray-stretching Treatments
Can the Efficiency of Dry Needling and Cold Spray-stretching Treatments be Documented by Ultrasonography and Electrophysiology?
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Can the Efficiency of Dry Needling and Cold Spray-stretching Treatments be Documented by Ultrasonography and Electrophysiology?
Sponsor study identifier
interventional
60
1 country
1
Study Start
May 25, 2019
Actual (reported)Primary Completion
June 30, 2019
Actual (reported)Study Completion
September 30, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2019
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 25, 2019
Actual (reported)June 30, 2019
Actual (reported)September 30, 2019
Actual (reported)December 7, 2022
Actual (reported)December 23, 2022
Actual (reported)pain intensity1
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
Change from baseline at 3rd week
cervical range of motion angles
measured by goniometer for flexion, extension, left and right lateral flexion of cervical spine
Change from baseline at 3rd week
pain intensity2
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.
Change from baseline at 3rd week
Gray Scale Ultrasonography
Change from baseline at 3rd week
Surface electromyography
Change from baseline at 3rd week
It was performed using a deep dry needling technique using 0.25x25 mm disposable sterile steel acupuncture needles (HuaLong, China) while patient was in prone position. 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 . One session per week, a total of 3 sessions were applied.
The patient was placed on the chair with the head and body upright in the most comfortable position possible and voluntary relaxation was achieved. One end of the muscle was fixed in order to apply passive stretching. 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. One session per week, a total of 3 sessions were applied
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
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.
Haydarpaşa Numune Education and Research Hospital
Istanbul, Turkey (Türkiye)
Duygu Külcü, prof
Haydarpaşa Numune Edutation and Research Hospital
60 participants (actual enrollment reported by the registry).
First Submitted
December 7, 2022
First Posted
December 23, 2022
Study Start
May 25, 2019
Actual (reported)The Effectiveness of Ozone (O2-O3) Injections in the Treatment of Myofascial Pain Syndrome
Disability level
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.
Change from baseline at 3rd week
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Primary Completion
June 30, 2019
Actual (reported)Study Completion
September 30, 2019
Actual (reported)Last Updated
December 23, 2022
Record last verified: 2022-12
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Source: ClinicalTrials.gov.
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