The Efficiency of Dry Needling and Cold Spray-stretching Treatments

Myofascial Trigger Point Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05664165
• Other study ID #: HNEAH-KAEK 2019/38
• Status: Completed
• Phase: N/A
• Start date: May 25, 2019
• Est. completion date: September 30, 2019

Study information

• Verified date: December 2022
• Source: Haydarpasa Numune Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes
• Myofascial Trigger Point Pain

Intervention

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
• 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.

Locations

Country	Name	City	State
Turkey	Haydarpasa Numune Education and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Haydarpasa Numune Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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