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?

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.

Study Overview

• Status: Completed
• Conditions: Myofascial Pain Syndromes; Myofascial Trigger Point Pain
• Intervention / Treatment: Other: dry needling; Other: cold spray and stretching

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Haydarpasa Numune Education and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dry needling; 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.	Other: dry needling; 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
Experimental: Cold spray and stretching; 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	Other: cold spray and 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gray Scale Ultrasonography	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.	Change from baseline at 3rd week
Surface electromyography	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.	Change from baseline at 3rd week

Collaborators and Investigators

• Sponsor: Haydarpasa Numune Training and Research Hospital
• Investigators: Principal Investigator: Duygu Külcü, prof, Haydarpaşa Numune Edutation and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2019
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): September 30, 2019

Study Registration Dates

• First Submitted: December 7, 2022
• First Submitted That Met QC Criteria: December 16, 2022
• First Posted (Estimate): December 23, 2022

Study Record Updates

• Last Update Posted (Estimate): December 23, 2022
• Last Update Submitted That Met QC Criteria: December 16, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: trigger point; cold spray; dry neddling; histogram
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: HNEAH-KAEK 2019/38

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No