Back to resultsComparison of Vibration and Dry Needle in Trigger Point Therapy
Primary Purpose
Myofascial Pain Syndrome, Trigger Point Pain, Myofascial
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Dry needle
Localize vibration
Sponsored by
About this trial
This is an interventional treatment trial for Myofascial Pain Syndrome focused on measuring Myofascial Pain Syndrome, Trigger Point, Dry Needling, Vibration
Eligibility Criteria
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
Sites / Locations
- Istanbul Physical Medicine Rehabilitation Training & Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Dry needling treatment group
Localized vibration treatment group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
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).
Full Information
NCT ID
NCT04900857
First Posted
May 20, 2021
Last Updated
May 24, 2021
Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04900857
Brief Title
Comparison of Vibration and Dry Needle in Trigger Point Therapy
Official Title
Comparison of Vibration Applied to the Trigger Point and Dry Needle in Acute Myofascial Pain Syndrome: a Prospective Randomized Controlled Research
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
December 7, 2020 (Actual)
Primary Completion Date
February 25, 2021 (Actual)
Study Completion Date
February 25, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain Syndrome, Trigger Point Pain, Myofascial
Keywords
Myofascial Pain Syndrome, Trigger Point, Dry Needling, Vibration
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomized controlled trial
Masking
ParticipantOutcomes Assessor
Masking Description
Double (Participant, Outcomes Assessor)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dry needling treatment group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Localized vibration treatment group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Dry needle
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Localize vibration
Intervention Description
the vibration was applied with 110 Hz and 5.57 mm amplitude.
Primary Outcome Measure Information:
Title
Pressure pain threshold
Description
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
Time Frame
Change from baseline pressure pain threshold score at immediately after, 1 day after and 1 week after the last session
Secondary Outcome Measure Information:
Title
Visual analog scale
Description
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.
Time Frame
Change from baseline VAS score at immediately after, 1 day after and 1 week after the last session
Title
Pain tolerance
Description
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.
Time Frame
Change from baseline Pain tolerance score at immediately after, 1 day after and 1 week after the last session
Title
Short Form 36 (SF-36)
Description
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).
Time Frame
Change from baseline Short Form 36 score at immediately after the 3rd session and 1 week after the treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nurdan Paker, Prof
Organizational Affiliation
Istanbul Physical Medicine Rehabilitation Training & Research Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Istanbul Physical Medicine Rehabilitation Training & Research Hospital
City
Istanbul
ZIP/Postal Code
34173
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32521284
Citation
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, Avon). 2020 Aug;78:105071. doi: 10.1016/j.clinbiomech.2020.105071. Epub 2020 Jun 3.
Results Reference
background
PubMed Identifier
8043247
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. doi: 10.1097/00002060-199407000-00006.
Results Reference
background
PubMed Identifier
16230984
Citation
Issurin VB. Vibrations and their applications in sport. A review. J Sports Med Phys Fitness. 2005 Sep;45(3):324-36.
Results Reference
background
PubMed Identifier
20823359
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.
Results Reference
background
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Comparison of Vibration and Dry Needle in Trigger Point Therapy
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