NCT04900857

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 7, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 25, 2021

Completed
Last Updated

May 26, 2021

Status Verified

May 1, 2021

Enrollment Period

3 months

First QC Date

May 20, 2021

Last Update Submit

May 24, 2021

Conditions

Keywords

Myofascial Pain SyndromeTrigger PointDry NeedlingVibration

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Visual analog scale

    Change from baseline VAS score at immediately after, 1 day after and 1 week after the last session

  • Pain tolerance

    Change from baseline Pain tolerance score at immediately after, 1 day after and 1 week after the last session

  • Short Form 36 (SF-36)

    Change from baseline Short Form 36 score at immediately after the 3rd session and 1 week after the treatment

Study Arms (2)

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.

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.

Device: Localize vibration

Interventions

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.

Dry needling treatment group

the vibration was applied with 110 Hz and 5.57 mm amplitude.

Localized vibration treatment group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Physical Medicine Rehabilitation Training & Research Hospital

Istanbul, 34173, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 32521284BACKGROUND
  • 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. doi: 10.1097/00002060-199407000-00006.

    PMID: 8043247BACKGROUND
  • Issurin VB. Vibrations and their applications in sport. A review. J Sports Med Phys Fitness. 2005 Sep;45(3):324-36.

    PMID: 16230984BACKGROUND
  • 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.

    PMID: 20823359BACKGROUND

MeSH Terms

Conditions

Myofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Study Officials

  • Nurdan Paker, Prof

    Istanbul Physical Medicine Rehabilitation Training & Research Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Double (Participant, Outcomes Assessor)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective randomized controlled trial
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2021

First Posted

May 25, 2021

Study Start

December 7, 2020

Primary Completion

February 25, 2021

Study Completion

February 25, 2021

Last Updated

May 26, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations