NCT06530329

Brief Summary

The aim of our study was to investigate the short-term effects of ischemic compression applied in addition to classical massage for the treatment of myofascial trigger points on the upper trapezius muscle in women on pain, functionality and quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2024

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

March 15, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 28, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 31, 2024

Completed
Last Updated

July 31, 2024

Status Verified

July 1, 2024

Enrollment Period

2 months

First QC Date

July 28, 2024

Last Update Submit

July 28, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Visual Analog Scale

    Pain assessment was made with Visual Analog Scale (VAS). The subjects were informed that the number '0' on a 10 cm horizontal line indicated 'no pain' and the number '10' indicated 'unbearable pain'. The subjects were asked to mark the pain they felt on the VAS scale for 3 different areas, namely trapezius pain, neck pain and headache, and the points they marked were recorded as the severity of pain in cm. VAS measurements were performed twice in total, before and after treatment.

    at baseline and at week 2.

  • Active Range of Motion

    Active Range of Motion (AROM) measurement was evaluated using a universal goniometer. While the patient was in a sitting position, the pivot point, fixed arm and movable arm of the goniometer were placed in the specified reference areas. The patient was asked to actively perform neck flexion, extension, right-left lateral flexion and right-left rotation movements and the values at the end of the movements were recorded in degrees. AROM measurements were performed twice in total, before and after treatment.

    at baseline and at week 2.

  • Short-Form 36

    The Short Form-36 (SF-36) scale was used to assess quality of life. The lowest score represents the worst health status. SF-36 measurement was performed twice, before and after treatment.

    at baseline and at week 2.

Study Arms (2)

Group 1

EXPERIMENTAL

Classical massage group

Other: Classical massage

Group 2

EXPERIMENTAL

Classical massage + ischemic compression group

Other: Classical massageOther: Ischemic compression

Interventions

Classical massage was started by general stroking 3 times. Then, it was continued by kneading 3 times. After the kneading movement, fibrocytic nodules on the muscle were searched and friction was applied to the found nodules one by one. The massage of the muscle was completed by applying stroking 3 times. The application was carried out 3 times a week for 2 weeks to evaluate the short-term effect.

Group 1Group 2

Ischemic compression was applied to the trigger points in the upper trapezius muscle using an average pressure of 1 kg at a right angle, and after compression, passive stretching was applied to the upper trapezius muscle 3 times in 20-second periods. The application was performed 3 times a week for 2 weeks to evaluate the short-term effect.

Group 2

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly female
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Being between the ages of 20-50
  • Having a myofascial trigger point detected in the upper trapezius muscle for at least two weeks
  • Being a student or staff of Halic University
  • Being literate

You may not qualify if:

  • Having a history of cervical surgery
  • Having a malignant disease
  • Pregnancy
  • Menopause
  • Having cooperation problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Halic University

Istanbul, Turkey (Türkiye)

Location

Related Publications (4)

  • Alvarez DJ, Rockwell PG. Trigger points: diagnosis and management. Am Fam Physician. 2002 Feb 15;65(4):653-60.

  • Bethers AH, Swanson DC, Sponbeck JK, Mitchell UH, Draper DO, Feland JB, Johnson AW. Positional release therapy and therapeutic massage reduce muscle trigger and tender points. J Bodyw Mov Ther. 2021 Oct;28:264-270. doi: 10.1016/j.jbmt.2021.07.005. Epub 2021 Jul 14.

  • Cagnie B, Castelein B, Pollie F, Steelant L, Verhoeyen H, Cools A. Evidence for the Use of Ischemic Compression and Dry Needling in the Management of Trigger Points of the Upper Trapezius in Patients with Neck Pain: A Systematic Review. Am J Phys Med Rehabil. 2015 Jul;94(7):573-83. doi: 10.1097/PHM.0000000000000266.

  • Sahin D, Kaya Mutlu E, Sakar O, Ates G, Inan S, Taskiran H. The effect of the ischaemic compression technique on pain and functionality in temporomandibular disorders: A randomised clinical trial. J Oral Rehabil. 2021 May;48(5):531-541. doi: 10.1111/joor.13145. Epub 2021 Jan 21.

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Duygu Sahin Altac, PT, MSc.

    Halic Üniversity

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT, MSc.

Study Record Dates

First Submitted

July 28, 2024

First Posted

July 31, 2024

Study Start

March 15, 2024

Primary Completion

May 15, 2024

Study Completion

June 15, 2024

Last Updated

July 31, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations