NCT07770308

Brief Summary

Cervical MPS is a condition of pain, weakness and loss of function caused by trigger points located in the tense bands in the muscles in the neck and upper back. Pharmacological and non-pharmacological treatments are used in the treatment of MPS. Although different treatment methods are used for MPS today, there is no proven treatment method to be superior to others. This study aimed to compare the effectiveness of exercise therapy, kinesiology taping and TENS therapy on pain, muscle strength and functional status in patients with cervical myofascial pain syndrome.

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 Dec 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2024

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 18, 2026

Completed
Last Updated

August 18, 2026

Status Verified

August 1, 2026

Enrollment Period

4 months

First QC Date

August 8, 2026

Last Update Submit

August 13, 2026

Conditions

Keywords

myofascial pain syndromeTENS therapykinesiology tapingexercise

Outcome Measures

Primary Outcomes (2)

  • VAS (Visual Analogue Scale)

    Pain intensity was assessed using the Visual Analog Scale. Participants rated their pain separately at rest and during activity on a 10-cm horizontal line ranging from 0 to 10, where 0 represents "no pain" and 10 represents "the worst imaginable pain." Higher scores indicate greater pain intensity and therefore a worse outcome.

    Baseline, immediately after treatment, and 4 weeks after treatment completion

  • Ultrasound Elastography

    The last step of the high development rate in ultrasonography technology is ultrasound elastography (UE). UE is a technological advance that can directly measure the mechanical properties of tissue, including muscle stiffness. Elasticity; It is the ability of a tissue to be deformed by an external force and to return to its previous shape and size when this force is removed.

    Baseline, immediately after treatment, and 4 weeks after treatment completion

Secondary Outcomes (2)

  • Range of Motion (ROM)

    Baseline, immediately after treatment, and 4 weeks after treatment completion

  • Neck Disability Index (NDI)

    Baseline, immediately after treatment, and 4 weeks after treatment completion

Study Arms (3)

Group One (Group of Exercise)

ACTIVE COMPARATOR

Patients in the first group will be given trunk stabilization training, scapular adductor muscle strengthening, cervical posterior tilt, and stretching exercises for neck rotators, scalene muscles, levator scapula muscle, upper trapezius muscle, posterior cervical and suboccipital muscles. Among these exercises, it will be said that the strengthening exercises should be done in 2 sets of 30 repetitions a day, and the stretching exercises should be done in 2 sets of 10 repetitions. These exercises will be given as a home program and you will be asked to practice them every day for 4 weeks.

Other: home-based exercises

Group Two ( Group of TENS Therapy and Exercise)

ACTIVE COMPARATOR

TENS is an electric current applied with superficial electrodes placed on the skin and used to relieve pain. It is also used in the treatment of cervical MAS. It can be applied together with other treatment methods. It has a pain relieving effect. The total duration of the application will be 20 minutes and 1 session will be applied every day for two weeks, a total of 10 sessions. In addition to this treatment, patients will also be given exercise therapy.

Other: home-based exercisesDevice: TENS

Group Three (Group of Kinesiology Taping and Exercise)

ACTIVE COMPARATOR

Kinesiology taping is one of the treatment methods used in various musculoskeletal system diseases. It does not restrict daily activities. It supports the person's movement and ensures that muscle functions return to normal. Kinesiology tape is made of 100% cotton and has an elastic structure that can extend up to 30-40% of its length. The tape is water resistant and can stay on the skin for about 1 week. In this study, kinesiology taping will be applied twice a week for three weeks. In addition to this treatment, patients will also be given exercise therapy.

Other: home-based exercisesDevice: kinesiology taping

Interventions

Exercise therapy is one of the most commonly used conservative treatment methods in the cervical MAS treatment protocol. Patients in the first group will be given trunk stabilization training, scapular adductor muscle strengthening, cervical posterior tilt, and stretching exercises for neck rotators, scalene muscles, levator scapula muscle, upper trapezius muscle, posterior cervical and suboccipital muscles. Among these exercises, it will be said that the strengthening exercises should be done in 2 sets of 30 repetitions a day, and the stretching exercises should be done in 2 sets of 10 repetitions. These exercises will be given as a home program and you will be asked to practice them every day for 4 weeks.

Group One (Group of Exercise)Group Three (Group of Kinesiology Taping and Exercise)Group Two ( Group of TENS Therapy and Exercise)
TENSDEVICE

TENS is an electric current applied with superficial electrodes placed on the skin and used to relieve pain. Conventional (Traditional) TENS is the most commonly used type. It affects the transmission of pain on the gate control theory by affecting the thick, myelinated, afferent A alpha and beta fibers. The effect of conventional TENS begins in 30 minutes and disappears within approximately 2 hours after treatment is stopped. TENS will be applied to the patients in the second group with a Bio-Stim brand VH-1000 model TENS device in the form of symmetrical, biphasic quadrilateral pulses for 100 msec. Frequency is 60 Hertz (Hz), intensity will be adjusted according to the patient's perception of paresthesia. The negative electrode will be placed on the active trigger point on the upper trapezius muscle and the positive electrode on the acromial tendon. The total duration of the application will be 20 minutes and 1 session will be applied every day for two weeks, a total of 10 sessions.

Group Two ( Group of TENS Therapy and Exercise)

Kinesiology taping has a wide range of indications, especially in the musculoskeletal system. It is used to protect against tissue damage in the musculoskeletal system and to treat existing injuries, injuries, pain and dysfunctions. Patients who receive kinesiology taping treatment will receive treatment six times in total for three weeks, with 3-day intervals. After the patient is allowed to sit comfortably on the chair, taping will be performed between the acromioclavicular joint and the C7 spinous process using the upper trapezius inhibition technique. In addition, a small kinesiological taping test will be applied to the patient's volar forearm as a rapid allergy screening test to prevent any dermatological allergic reaction.

Group Three (Group of Kinesiology Taping and Exercise)

Eligibility Criteria

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

You may qualify if:

  • Being between the ages of 18-65 and diagnosed with cervical MAS according to the major and minor diagnostic criteria defined by Travel and Simons.

You may not qualify if:

  • Those diagnosed with myofascial syndrome and receiving medical treatment and physical therapy
  • Those diagnosed with myofascial syndrome and taking an exercise program
  • Those diagnosed with fibromyalgia syndrome
  • Skin disease and edema in the area to be applied
  • Kinesiology tape allergy
  • Neurological diseases (Epilepsy, stroke, upper motor neuron lesions)
  • People using pacemakers
  • Hypertension and diabetes that cannot be controlled with medication
  • Any fracture pathology involving the upper extremity and cervical region,
  • Other cervical pathologies that may cause neck pain other than MAS
  • Pregnancy
  • Cognitive dysfunction and poor cooperation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bakırkoy Dr. Sadi Konuk Hospital

Istanbul, Bakırköy, 34147, Turkey (Türkiye)

Location

Related Publications (14)

  • Hong CZ. Treatment of myofascial pain syndrome. Curr Pain Headache Rep. 2006 Oct;10(5):345-9. doi: 10.1007/s11916-006-0058-3.

    PMID: 16945250BACKGROUND
  • De Meulemeester KE, Castelein B, Coppieters I, Barbe T, Cools A, Cagnie B. Comparing Trigger Point Dry Needling and Manual Pressure Technique for the Management of Myofascial Neck/Shoulder Pain: A Randomized Clinical Trial. J Manipulative Physiol Ther. 2017 Jan;40(1):11-20. doi: 10.1016/j.jmpt.2016.10.008.

    PMID: 28017188BACKGROUND
  • Borg-Stein J, Iaccarino MA. Myofascial pain syndrome treatments. Phys Med Rehabil Clin N Am. 2014 May;25(2):357-74. doi: 10.1016/j.pmr.2014.01.012. Epub 2014 Mar 17.

    PMID: 24787338BACKGROUND
  • Ziaeifar M, Arab AM, Mosallanezhad Z, Nourbakhsh MR. Dry needling versus trigger point compression of the upper trapezius: a randomized clinical trial with two-week and three-month follow-up. J Man Manip Ther. 2019 Jul;27(3):152-161. doi: 10.1080/10669817.2018.1530421. Epub 2018 Oct 15.

    PMID: 30935341BACKGROUND
  • Saxena A, Chansoria M, Tomar G, Kumar A. Myofascial pain syndrome: an overview. J Pain Palliat Care Pharmacother. 2015 Mar;29(1):16-21. doi: 10.3109/15360288.2014.997853. Epub 2015 Jan 5.

    PMID: 25558924BACKGROUND
  • Borg-Stein J, Simons DG. Focused review: myofascial pain. Arch Phys Med Rehabil. 2002 Mar;83(3 Suppl 1):S40-7, S48-9. doi: 10.1053/apmr.2002.32155.

    PMID: 11973695BACKGROUND
  • Ardic F, Sarhus M, Topuz O. Comparison of two different techniques of electrotherapy on myofascial pain. J Back Musculoskelet Rehabil. 2002 Jan 1;16(1):11-6. doi: 10.3233/bmr-2002-16103.

    PMID: 22387359BACKGROUND
  • Graff-Radford SB, Reeves JL, Baker RL, Chiu D. Effects of transcutaneous electrical nerve stimulation on myofascial pain and trigger point sensitivity. Pain. 1989 Apr;37(1):1-5. doi: 10.1016/0304-3959(89)90146-2.

    PMID: 2786179BACKGROUND
  • Kalron A, Bar-Sela S. A systematic review of the effectiveness of Kinesio Taping--fact or fashion? Eur J Phys Rehabil Med. 2013 Oct;49(5):699-709. Epub 2013 Apr 5.

    PMID: 23558699BACKGROUND
  • Paoloni M, Bernetti A, Fratocchi G, Mangone M, Parrinello L, Del Pilar Cooper M, Sesto L, Di Sante L, Santilli V. Kinesio Taping applied to lumbar muscles influences clinical and electromyographic characteristics in chronic low back pain patients. Eur J Phys Rehabil Med. 2011 Jun;47(2):237-44. Epub 2011 Mar 24.

    PMID: 21430611BACKGROUND
  • Kaya E, Zinnuroglu M, Tugcu I. Kinesio taping compared to physical therapy modalities for the treatment of shoulder impingement syndrome. Clin Rheumatol. 2011 Feb;30(2):201-7. doi: 10.1007/s10067-010-1475-6. Epub 2010 Apr 30.

    PMID: 20443039BACKGROUND
  • Gennisson JL, Deffieux T, Fink M, Tanter M. Ultrasound elastography: principles and techniques. Diagn Interv Imaging. 2013 May;94(5):487-95. doi: 10.1016/j.diii.2013.01.022. Epub 2013 Apr 22.

    PMID: 23619292BACKGROUND
  • Domenichini R, Pialat JB, Podda A, Aubry S. Ultrasound elastography in tendon pathology: state of the art. Skeletal Radiol. 2017 Dec;46(12):1643-1655. doi: 10.1007/s00256-017-2726-2. Epub 2017 Aug 1.

    PMID: 28765991BACKGROUND
  • Vernon H. The Neck Disability Index: state-of-the-art, 1991-2008. J Manipulative Physiol Ther. 2008 Sep;31(7):491-502. doi: 10.1016/j.jmpt.2008.08.006.

    PMID: 18803999BACKGROUND

MeSH Terms

Conditions

Myofascial Pain SyndromesMotor Activity

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesBehavior

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Officials

  • Sibel Çağlar

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 8, 2026

First Posted

August 18, 2026

Study Start

December 1, 2023

Primary Completion

March 15, 2024

Study Completion

April 15, 2024

Last Updated

August 18, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Results of the study will be written as a manuscript. In Turkey, we do not have a system sharing data to other researchers.

Locations