Myofascial Pain SyndromeNCT04900857
Comparison of Vibration and Dry Needle in Trigger Point Therapy
A study testing Dry needle and Localize vibration in people with Myofascial Pain Syndrome and Trigger Point Pain, Myofascial, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the effects of localized vibration and dry needling applied to the trigger point in the individuals with acute myofascial pain syndrome.Pressure pain threshold (PPT) was used for the primary outcome measure of the study, and pain intensity, pain tolerance and short form (SF-36) were… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Myofascial Pain Syndrome, Trigger Point Pain, Myofascial
- What is being tested?
- Dry needle and Localize vibration
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Dec 2020to 25 Feb 2021
- 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
- At least one active myofascial trigger point in the upper trapezius muscle
- Symptoms lasting 1 day to 2 weeks
- Cases who did not receive any physical therapy or medication to relieve pain
Who cannot join
- Sensory defect in the area to be treated with vibration
- Active inflammatory, rheumatological or infectious disease
- Peripheral nerve lesions such as polyneuropathy, radiculopathy
- Having a cardiac disorder (rhythm / conduction disorder, cardiac pacemaker, ischemic heart disease)
- Diagnosis of fibromyalgia or other common musculoskeletal pain syndromes with an intact skin surface in the area to be vibrated
- Patients with a history of panic attacks
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Physical Medicine Rehabilitation Training & Research Hospital
Istanbul, 34173
About this study
Official title: Comparison of Vibration Applied to the Trigger Point and Dry Needle in Acute Myofascial Pain Syndrome: a Prospective Randomized Controlled Research
The aim of this study is to compare the effects of localized vibration and dry needling applied to the trigger point in the individuals with acute myofascial pain syndrome.Pressure pain threshold (PPT) was used for the primary outcome measure of the study, and pain intensity, pain tolerance and short form (SF-36) were used for secondary outcome measures.
Read the detailed description
The patients were divided into two groups as dry needling and localized vibration using the permuted block randomization method. The study was completed with 20 (17 women, 3 men) in the dry needling group and 20 in localized vibration (15 women, 5 men). In both applications, a total of 3 sessions were made to the patients at 1-day intervals.Patients' age, gender, duration of pain, localization, presence of additional disease, drug use were questioned and recorded. Pressure pain threshold (PPT) was used for the primary outcome measure of the study, and pain intensity, pain tolerance and short form (SF-36) were used for secondary outcome measures. All evaluation criteria except SF-36 were made before, immediately after and 1 day after each session, 1 week after the last session. SF-36 was evaluated before the 1st session treatment, after the 3rd session treatment and 1 week after the 3rd session treatment.
- Being tested
- Dry needle, Localize vibration
- Keywords
- Myofascial Pain Syndrome, Trigger Point, Dry Needling, Vibration
- 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 needleOther
Local twitch responses (LTRs) were obtained by multiple rapid insertions of the needle in and out of the point, similar to Hong's rapid-entry and rapid exit technique. Hong 1994). The needle was not removed from that site for the maximum stimulation time of 1 minute to 3 minutes after a local twitch response was obtained.
Localize vibrationDevice
the vibration was applied with 110 Hz and 5.57 mm amplitude.
| Study group | Role | What they receive |
|---|---|---|
| Dry needling treatment group | Active comparator | Dry needling treatment group will be treated with acupuncture needles (0.25x25 mm Hua Long Brand).In this group, one active trigger point area in the trapezius muscle was precisely determined and marked with a permanent pen, and dry needling treatment was applied to that area with disposable acupuncture needles in a single session. the trigger point was palpated. From the center, the needle tip was inserted perpendicular to the skin quickly into the subcutaneous tissue and inserted into the muscle with the needle tip until it found the trigger point in the muscle band. Local twitch responses (LTRs) were similar to Hong's rapid entry and exit technique. It was obtained by inserting a large number of rapid needles in and out of. The needle was not removed from that area for the maximum stimulation time of 1 minute to 3 minutes after a local twitch response was obtained. Receives: Other: Dry needle |
| Localized vibration treatment group | Experimental | The tight band in the muscle was determined by palpation, and the location of the most painful points (the middle of the most vertical fibers of the upper part of the trapezius muscle) in the muscle tension band was digitally determined. It was determined with a permanent marker. The skin was cleaned with a suitable antiseptic agent. Localized vibration therapy was applied for 20 minutes with a vibration frequency of 110 Hz and an amplitude of 5.57 mm using a vibrator device. Vibration therapy was applied to our patients by attaching an apparatus with a small area of 1 cm2 to the skin on the trigger point in the trapezius muscle and fixed with medium pressure. We applied a total of 3 sessions every other day in hospital conditions by a single practitioner to all patients. Receives: Device: Localize vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure pain threshold
The test determines the amount of pressure over a given area in which a steadily increasing nonpainful pressure stimulus turns into a painful pressure sensation
Measured: Change from baseline pressure pain threshold score at immediately after, 1 day after and 1 week after the last session
Secondary outcomes (3)
Visual analog scale
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.
The patients were asked to score between 0 and 10 for the severity of their pain. It was said that 0 on the scale means no pain, 10 means unbearable pain.
Measured: Change from baseline VAS score at immediately after, 1 day after and 1 week after the last session
Pain tolerance
Using an algometer (WAGNER-FPK20), a pressure of 2.5 kg /cm2 will be applied to the trigger point and patients will be asked to measure their pain with VAS after pressure application. The severity of the pain felt by the patients after the application of pressure will be measured by VAS. The patients were asked to score between 0 and 10 for the severity of their pain. It was said that 0 on the scale means no pain, 10 means unbearable pain.
Measured: Change from baseline Pain tolerance score at immediately after, 1 day after and 1 week after the last session
Short Form 36 (SF-36)
The scale consists of 36 items and these provide the measurement of 8 dimensions; physical function (10 items), social function (2 items), role limitations due to physical functions (4 items), role limitations due to emotional problems (3 items), mental health (5 items), energy / vitality (4 items), pain (2 items) and general perception of health (5 items).
Measured: Change from baseline Short Form 36 score at immediately after the 3rd session and 1 week after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start7 Dec 2020
- Primary completion25 Feb 2021
- Study completion25 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Myofascial Pain SyndromeStudies 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
- Model description
- Prospective randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Nurdan Paker, Prof, Study chair, Istanbul Physical Medicine Rehabilitation Training & Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04900857
- Sponsor's protocol ID
- IstPMRTRH-MP
- Status last verified
- May 2021
- First submitted
- 20 May 2021
- Last updated
- 26 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Duenas L, Zamora T, Lluch E, Artacho-Ramirez MA, Mayoral O, Balasch S, Balasch-Bernat M. The effect of vibration therapy on neck myofascial trigger points: A randomized controlled pilot study. Clin Biomech (Bristol). 2020 Aug;78:105071. doi: 10.1016/j.clinbiomech.2020.105071. Epub 2020 Jun 3.
PubMed 32521284Hong CZ. Lidocaine injection versus dry needling to myofascial trigger point. The importance of the local twitch response. Am J Phys Med Rehabil. 1994 Jul-Aug;73(4):256-63. doi: 10.1097/00002060-199407000-00006.
PubMed 8043247Issurin VB. Vibrations and their applications in sport. A review. J Sports Med Phys Fitness. 2005 Sep;45(3):324-36.
PubMed 16230984Kalichman L, Vulfsons S. Dry needling in the management of musculoskeletal pain. J Am Board Fam Med. 2010 Sep-Oct;23(5):640-6. doi: 10.3122/jabfm.2010.05.090296.
PubMed 20823359
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Vibration Applied to the Trigger Point and Dry Needle in Acute Myofascial Pain Syndrome: a Prospective Randomized Controlled Research
- ClinicalTrials.gov ID
- NCT04900857
- Acronym / sponsor ID
- IstPMRTRH-MP
- Keywords
- Myofascial Pain Syndrome, Trigger Point, Dry Needling, Vibration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 7 Dec 2020 (actual)
- Primary completion
- 25 Feb 2021 (actual)
- Study completion
- 25 Feb 2021 (actual)
- First posted
- 25 May 2021 (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.
The aim of this study is to compare the effects of localized vibration and dry needling applied to the trigger point in the individuals with acute myofascial pain syndrome.Pressure pain threshold (PPT) was used for the primary outcome measure of the study, and pain intensity, pain tolerance and short form (SF-36) were used for secondary outcome measures.
Detailed description
The patients were divided into two groups as dry needling and localized vibration using the permuted block randomization method. The study was completed with 20 (17 women, 3 men) in the dry needling group and 20 in localized vibration (15 women, 5 men). In both applications, a total of 3 sessions were made to the patients at 1-day intervals.Patients' age, gender, duration of pain, localization, presence of additional disease, drug use were questioned and recorded. Pressure pain threshold (PPT) was used for the primary outcome measure of the study, and pain intensity, pain tolerance and short form (SF-36) were used for secondary outcome measures. All evaluation criteria except SF-36 were made before, immediately after and 1 day after each session, 1 week after the last session. SF-36 was evaluated before the 1st session treatment, after the 3rd session treatment and 1 week after the 3rd session treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Dry needling treatment group | Active comparator | Other: Dry needleDry needling treatment group will be treated with acupuncture needles (0.25x25 mm Hua Long Brand).In this group, one active trigger point area in the trapezius muscle was precisely determined and marked with a permanent pen, and dry needling treatment was applied to that area with disposable acupuncture needles in a single session. the trigger point was palpated. From the center, the needle tip was inserted perpendicular to the skin quickly into the subcutaneous tissue and inserted into the muscle with the needle tip until it found the trigger point in the muscle band. Local twitch responses (LTRs) were similar to Hong's rapid entry and exit technique. It was obtained by inserting a large number of rapid needles in and out of. The needle was not removed from that area for the maximum stimulation time of 1 minute to 3 minutes after a local twitch response was obtained. |
| Localized vibration treatment group | Experimental | Device: Localize vibrationThe tight band in the muscle was determined by palpation, and the location of the most painful points (the middle of the most vertical fibers of the upper part of the trapezius muscle) in the muscle tension band was digitally determined. It was determined with a permanent marker. The skin was cleaned with a suitable antiseptic agent. Localized vibration therapy was applied for 20 minutes with a vibration frequency of 110 Hz and an amplitude of 5.57 mm using a vibrator device. Vibration therapy was applied to our patients by attaching an apparatus with a small area of 1 cm2 to the skin on the trigger point in the trapezius muscle and fixed with medium pressure. We applied a total of 3 sessions every other day in hospital conditions by a single practitioner to all patients. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least one active myofascial trigger point in the upper trapezius muscle
- Symptoms lasting 1 day to 2 weeks
- Cases who did not receive any physical therapy or medication to relieve pain
Key exclusion criteria (6 listed)
- Sensory defect in the area to be treated with vibration
- Active inflammatory, rheumatological or infectious disease
- Peripheral nerve lesions such as polyneuropathy, radiculopathy
- Having a cardiac disorder (rhythm / conduction disorder, cardiac pacemaker, ischemic heart disease)
- Diagnosis of fibromyalgia or other common musculoskeletal pain syndromes with an intact skin surface in the area to be vibrated
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 needleLocal twitch responses (LTRs) were obtained by multiple rapid insertions of the needle in and out of the point, similar to Hong's rapid-entry and rapid exit technique. Hong 1994). The needle was not removed from that site for the maximum stimulation time of 1 minute to 3 minutes after a local twitch response was obtained. | Other | Dry needling treatment group |
| Localize vibrationthe vibration was applied with 110 Hz and 5.57 mm amplitude. | Device | Localized vibration treatment group |
Primary outcome
Pressure pain threshold
Time frame: Change from baseline pressure pain threshold score at immediately after, 1 day after and 1 week after the last session
The test determines the amount of pressure over a given area in which a steadily increasing nonpainful pressure stimulus turns into a painful pressure sensation
3 secondary outcomes
Visual analog scale
Time frame: Change from baseline VAS score at immediately after, 1 day after and 1 week after the last session
Pain tolerance
Time frame: Change from baseline Pain tolerance score at immediately after, 1 day after and 1 week after the last session
Short Form 36 (SF-36)
Time frame: Change from baseline Short Form 36 score at immediately after the 3rd session and 1 week after the treatment
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 26 May 2021.
- Background: PubMed 32521284Duenas L, Zamora T, Lluch E, Artacho-Ramirez MA, Mayoral O, Balasch S, Balasch-Bernat M. The effect of vibration therapy on neck myofascial trigger points: A randomized controlled pilot study. Clin Biomech (Bristol). 2020 Aug;78:105071. doi: 10.1016/j.clinbiomech.2020.105071. Epub 2020 Jun 3.
- Background: PubMed 8043247Hong CZ. Lidocaine injection versus dry needling to myofascial trigger point. The importance of the local twitch response. Am J Phys Med Rehabil. 1994 Jul-Aug;73(4):256-63. doi: 10.1097/00002060-199407000-00006.
- Background: PubMed 16230984Issurin VB. Vibrations and their applications in sport. A review. J Sports Med Phys Fitness. 2005 Sep;45(3):324-36.
- Background: PubMed 20823359Kalichman L, Vulfsons S. Dry needling in the management of musculoskeletal pain. J Am Board Fam Med. 2010 Sep-Oct;23(5):640-6. doi: 10.3122/jabfm.2010.05.090296.
- Individual participant dataSharing planned: No
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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.
Nurdan Paker, Prof study chair
Istanbul Physical Medicine Rehabilitation Training & 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 needle and Localize vibration in people with Myofascial Pain Syndrome and Trigger Point Pain, Myofascial, run by Istanbul Physical Medicine Rehabilitation 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 6 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 26 May 2021. 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?
Pressure pain threshold (time frame: Change from baseline pressure pain threshold score at immediately after, 1 day after and 1 week after the last session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04900857, which also lists 4 linked publications.
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 26 May 2021.