Myofascial Pain SyndromesNCT05664165
The Efficiency of Dry Needling and Cold Spray-stretching Treatments
A study testing dry needling and cold spray and stretching in people with Myofascial Pain Syndromes and Myofascial Trigger Point Pain, run by Haydarpasa Numune Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Myofascial Pain Syndromes, Myofascial Trigger Point Pain
- What is being tested?
- dry needling and cold spray and stretching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 May 2019to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Haydarpaşa Numune Education and Research Hospital
Istanbul
About this study
Official title: 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.
Read the 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.
- Being tested
- dry needling, cold spray and stretching
- Keywords
- cold spray, dry neddling, histogram, trigger point
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dry needlingOther
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 stretchingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: cold spray and stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Change from baseline at 3rd week
Secondary outcomes (2)
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.
Measured: 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.
Measured: Change from baseline at 3rd week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start25 May 2019
- Primary completion30 Jun 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Pain SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haydarpasa Numune Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duygu Geler Külcü, Haydarpasa Numune Training and Research Hospital
- Investigators
- Duygu Külcü, prof, Principal investigator, Haydarpaşa Numune Edutation and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05664165
- Sponsor's protocol ID
- HNEAH-KAEK 2019/38
- Status last verified
- Dec 2022
- First submitted
- 7 Dec 2022
- Last updated
- 23 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can the Efficiency of Dry Needling and Cold Spray-stretching Treatments be Documented by Ultrasonography and Electrophysiology?
- ClinicalTrials.gov ID
- NCT05664165
- Acronym / sponsor ID
- HNEAH-KAEK 2019/38
- Keywords
- cold spray, dry neddling, histogram, trigger point
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Haydarpasa Numune Training and Research HospitalUniversity, hospital or other
- Study start
- 25 May 2019 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 23 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry needling | Experimental | Other: dry needlingIt 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. |
| Cold spray and stretching | Experimental | Other: cold spray and stretchingThe 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dry needlingThe 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 | Other | Dry needling |
| cold spray and stretchingThe 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. | Other | Cold spray and stretching |
Primary outcome
pain intensity1
Time frame: Change from baseline at 3rd week
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
cervical range of motion angles
Time frame: Change from baseline at 3rd week
measured by goniometer for flexion, extension, left and right lateral flexion of cervical spine
pain intensity2
Time frame: Change from baseline at 3rd week
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.
Disability level
Time frame: Change from baseline at 3rd week
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.
2 secondary outcomes
Gray Scale Ultrasonography
Time frame: Change from baseline at 3rd week
Surface electromyography
Time frame: Change from baseline at 3rd week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Duygu Külcü, prof principal investigator
Haydarpaşa Numune Edutation and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dry needling and cold spray and stretching in people with Myofascial Pain Syndromes and Myofascial Trigger Point Pain, run by Haydarpasa Numune Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain intensity1 (time frame: Change from baseline at 3rd week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2022.