The Efficiency of Dry Needling and Cold Spray-stretching Treatments

NCT05664165 | Completed

• 1 other identifier: HNEAH-KAEK 2019/38
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Myofascial Pain Syndromes; Myofascial Trigger Point Pain

Keywords

cold spray; dry neddling; histogram; trigger point

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Gray Scale Ultrasonography

  Change from baseline at 3rd week

• Surface electromyography

  Change from baseline at 3rd week

Study Arms (2)

Dry needling

EXPERIMENTAL

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

Cold spray and stretching

EXPERIMENTAL

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

Interventions

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

Dry needling

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.

Cold spray and stretching

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Haydarpasa Numune Training and Research Hospital: lead

Study Sites (1)

Haydarpaşa Numune Education and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Officials

• Duygu Külcü, prof

  Haydarpaşa Numune Edutation and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 23, 2022
• Study Start: May 25, 2019
• Primary Completion: June 30, 2019
• Study Completion: September 30, 2019
• Last Updated: December 23, 2022

Record last verified: 2022-12

Locations

TU (1)