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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04900857
Other study ID # IstPMRTRH-MP
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 7, 2020
Est. completion date February 25, 2021

Study information

Verified date May 2021
Source Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 used for secondary outcome measures.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date February 25, 2021
Est. primary completion date February 25, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Intervention

Other:
Dry needle
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.
Device:
Localize vibration
the vibration was applied with 110 Hz and 5.57 mm amplitude.

Locations

Country Name City State
Turkey Istanbul Physical Medicine Rehabilitation Training & Research Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Dueñas L, Zamora T, Lluch E, Artacho-Ramírez 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, Avon). 2020 Aug;78:105071. doi: 10.1016/j.clinbiomech.2020.105071. Epub 2020 Jun 3. — View Citation

Hong 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. — View Citation

Issurin VB. Vibrations and their applications in sport. A review. J Sports Med Phys Fitness. 2005 Sep;45(3):324-36. Review. — View Citation

Kalichman 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Change from baseline pressure pain threshold score at immediately after, 1 day after and 1 week after the last session
Secondary 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.
Change from baseline VAS score at immediately after, 1 day after and 1 week after the last session
Secondary 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. Change from baseline Pain tolerance score at immediately after, 1 day after and 1 week after the last session
Secondary 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). Change from baseline Short Form 36 score at immediately after the 3rd session and 1 week after the treatment
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