Clinical trial NCT05664165: The Efficiency of Dry Needling and Cold Spray-stretching Treatments
Official title: Can the Efficiency of Dry Needling and Cold Spray-stretching Treatments be Documented by Ultrasonography and Electrophysiology?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myofascial Pain Syndromes
Myofascial Trigger Point Pain
Keywords: cold spray
dry neddling
histogram
trigger point
Lead sponsor: Haydarpasa Numune Training and Research Hospital
Sponsor class: OTHER
First posted: 2022-12-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: pain intensity1
timeFrame: Change from baseline at 3rd week
measure: cervical range of motion angles
timeFrame: Change from baseline at 3rd week
measure: pain intensity2
timeFrame: Change from baseline at 3rd week
measure: Disability level
timeFrame: Change from baseline at 3rd week
Secondary outcomes:
measure: Gray Scale Ultrasonography
timeFrame: Change from baseline at 3rd week
measure: Surface electromyography
timeFrame: Change from baseline at 3rd week
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Haydarpaşa Numune Education and Research Hospital
Study officials:
affiliation: Haydarpaşa Numune Edutation and Research Hospital
name: Duygu Külcü, prof
role: PRINCIPAL_INVESTIGATOR
References: