NCT05668728

Brief Summary

Myofascial pain syndrome (MAS) is defined as a regional painful syndrome characterized by pain and tenderness in a muscle group or a muscle, a taut band within the muscle, pain reflected by pressing, and the presence of trigger points. It causes localized muscle pain in the shoulder and neck. The frequency of mas is around 12% in the normal population, and its frequency increases in those with chronic diseases. It is more common in the 30-60 age range and in the female population. Mechanical causes such as micro-macro trauma, nociceptive disorders, physical fatigue, psychological stress and genetic factors are blamed in its etiopathogenesis. Painful myofascial trigger points may occur by pressing on all muscles in the body, although it is more common in the trazius muscle, especially in those who work at a desk, who are constantly in a certain position, and who are sedentary. Myofascial trigger points are often detected by examination.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

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

First Submitted

Initial submission to the registry

December 6, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

December 30, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2023

Completed
Last Updated

May 30, 2023

Status Verified

May 1, 2023

Enrollment Period

2 months

First QC Date

December 6, 2022

Last Update Submit

May 26, 2023

Conditions

Keywords

Dry NeedlingNeck PainMyofascial Pain Syndromes

Outcome Measures

Primary Outcomes (1)

  • Visuel Analog Scale

    It is used to convert some values that cannot be measured numerically into numeric. Two end definitions of the parameter to be evaluated are written at the two ends of a 100 mm line, and the patient is asked to indicate where on this line their situation is appropriate by drawing a line or by placing a dot or pointing. For example, for pain, I have no pain at one end and very severe pain at the other end, and the patient marks his/her current state on this line. The length of the distance from the point where there is no pain to the point marked by the patient indicates the patient's pain.

    one month

Secondary Outcomes (2)

  • Neck Disability Index

    one month

  • European Quality of Life 5 Dimensions 3 Level Version

    One month

Study Arms (3)

Group 1

ACTIVE COMPARATOR

Dry needling + standard exercise program with 4 sessions of stick and pull out method at 1 week intervals

Other: Group 1: Peppering

Group 2

ACTIVE COMPARATOR

Dry needling + standard exercise program with 4 sessions of turn-and-wait method at 1-week intervals

Other: group 2: spin and wait

Group 3

ACTIVE COMPARATOR

Dry needling + standard exercise program with 4 sessions of stick and turn and wait method 1-week intervals

Other: group 3: Peppering and spin and wait

Interventions

Before injection we will palpate the muscles of trapezius, m. rhomboideus, m. levator scapula for finding painful trigger points, and we will mark the point. the skin will be cleaned with an appropriate antiseptic. Before the needle is inserted, the area to be applied will be palpated once again to detect the painful trigger point between the thumb and index fingers. The needle will be guided to painful trigger points detected by palpation. Stainless steel 25x25 mm needles will be used for dry needling. The needle will be inserted and removed until the local twitch response disappears, at least 10 times at each point found. Afterwards, the patient will be given a standard exercise program for the neck muscles. With this method, dry needling will be applied to the patient 4 times a week, once a week.

Group 1

Just before the injection, painful trigger points in the bilateral muscles of trapezius, m. rhomboideus, and m. levator scapula will be identified and marked by palpation, and the skin will be cleaned with an appropriate antiseptic. Before the needle is inserted, the area to be applied will be palpated once again to detect the painful trigger point between the thumb and index fingers. The needle will be guided to painful trigger points detected by palpation. Stainless steel 25x25 mm needles will be used for dry needling. After the dry needle is inserted at each point found, it will be spinned counterclockwise and left. Waiting time for each patient will be limited to 15 minutes. Afterwards, the patient will be given a standard exercise program for the neck muscles. With this method, dry needling will be applied to the patient 4 times a week, once a week.

Group 2

Just before the injection, painful trigger points in the bilateral muscles of trapezius, m. rhomboideus, and m. levator scapul will be identified and marked with palpation, and the skin will be cleaned with an appropriate antiseptic. Before the needle is inserted, the area to be applied will be palpated once again to detect the painful trigger point between the thumb and index fingers. The needle will be guided to painful trigger points detected by palpation. Stainless steel 25x25 mm needles will be used for dry needling. After the needle is inserted and removed, it will be spinned counterclockwise for 15 minutes in each patient until the local twitch response disappears, at least 10 times at each point found. Afterwards, the patient will be given a standard exercise program. With this method, dry needling will be applied to the patient 4 times a week, once a week.

Group 3

Eligibility Criteria

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

You may qualify if:

  • Among the patients who applied to Sultan 2. Abdulhamid Han Hospital Physical Medicine and Rehabilitation Department and were diagnosed with myofascial pain syndrome
  • Decided to receive dry needling treatment
  • Between the ages of 18 and 65
  • At least 1 painful myofascial trigger point in the m.trapezius, m.levator scapula muscles
  • Patients with neck pain lasting less than 6 months

You may not qualify if:

  • Those with a history of cervical operation
  • Those who have a history of shoulder operation
  • Patients with radiculopathy as a result of the examination
  • Those who have been injected into the determined area in the last 3 months
  • Those diagnosed with fibromyalgia according to the 2018 fibromyalgia scale
  • Those with cervical disc herniation in the MR imaging taken within the last 1 year
  • Pregnant/pregnant women
  • Those who are allergic to silver
  • Those with a history of malignancy
  • Those with positive red flags
  • Those with known rheumatological disease
  • Those who do not accept dry needling
  • Those with cognitive impairment
  • Those who have local infection in the application area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sultan 2. Abdulhamid Han Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

  • Stieven FF, Ferreira GE, Wiebusch M, de Araujo FX, da Rosa LHT, Silva MF. Dry Needling Combined With Guideline-Based Physical Therapy Provides No Added Benefit in the Management of Chronic Neck Pain: A Randomized Controlled Trial. J Orthop Sports Phys Ther. 2020 Aug;50(8):447-454. doi: 10.2519/jospt.2020.9389. Epub 2020 Apr 9.

  • Gattie E, Cleland JA, Snodgrass S. The Effectiveness of Trigger Point Dry Needling for Musculoskeletal Conditions by Physical Therapists: A Systematic Review and Meta-analysis. J Orthop Sports Phys Ther. 2017 Mar;47(3):133-149. doi: 10.2519/jospt.2017.7096. Epub 2017 Feb 3.

  • Raeissadat SA, Rayegani SM, Sadeghi F, Rahimi-Dehgolan S. Comparison of ozone and lidocaine injection efficacy vs dry needling in myofascial pain syndrome patients. J Pain Res. 2018 Jun 29;11:1273-1279. doi: 10.2147/JPR.S164629. eCollection 2018.

MeSH Terms

Conditions

Myofascial Pain SyndromesNeck Pain

Interventions

spindlin

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Emre Ata, Ass.Prof.

    Sultan II. Abdulhamidhan Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 3 GROUPS DİFFERENT TYPES OF DRY NEEDLİNG
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Proffesor

Study Record Dates

First Submitted

December 6, 2022

First Posted

December 30, 2022

Study Start

January 1, 2023

Primary Completion

February 15, 2023

Study Completion

April 15, 2023

Last Updated

May 30, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations