NCT05123105

Brief Summary

Ischemic compression is considered the fastest and most common method for providing relief in trigger point therapy, whereas cupping therapy is not a method often used for this purpose. The muscle that has a great impact on tension-type headaches and neck pain is the trapezius, whose upper fibres are where the most common trigger point in the back is located. The aim of this study was to evaluate and compare the effectiveness of single ischemic compression and single dry cupping therapy on the most common trigger point, on the descending part of the trapezius muscle.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

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

January 23, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

November 17, 2021

Completed
Last Updated

November 17, 2021

Status Verified

November 1, 2021

Enrollment Period

2 months

First QC Date

October 23, 2021

Last Update Submit

November 5, 2021

Conditions

Keywords

ischemic compressioncuppingalgometertrapezius muscle

Outcome Measures

Primary Outcomes (2)

  • Pain pressure threshold test (PPT)

    The trigger points of the upper section of the trapezius on the right and left sides were determined by palpation and were also indicated using a marker. A Wagner FDX 50 Force Gage algometer was applied to the trigger point. The pressure force was increased by 1kg/cm2/s until the patient felt pain, which was the pain pressure threshold (PPT) measured in kg/cm2. The test was performed on both sides. The test was performed twice on each side - before and 2 minutes after the session.

    changes from baseline in pain pressure threshold at 2 minutes after the session

  • Cervical spine mobility test

    Each examination began in a sitting position with a cervical spine mobility test. The following bone points were marked on the participants' skin using a marker: spinous process of the 7th cervical vertebra, external occipital protuberance, the top of the chin, the jugular notch of the sternum, the mastoid of the temporal bone, and the acromion process of the scapula. Next, a linear measurement of the range of motion was performed using a tape measure to ascertain the distance between the marked points in the initial position and after the active movement for flexion (forward bending), extension (backward bending), lateral bending and rotation to both sides, respectively. The mobility was determined by the difference of the two measurements. The test for each movement (i.e. flexion (forward flexion), extension (backward flexion), lateral flexion and both sides rotation) was performed twice - before and 2 minutes after the session.

    changes from baseline in cervical spine mobility at 2 minutes after the session

Secondary Outcomes (2)

  • Height

    Measurements were taken before the first session

  • Weight

    Measurements were taken before the first session

Study Arms (1)

Experimental

EXPERIMENTAL

Each person participated in three tests with an interval of approximately one week between them.

Other: 1) cupping therapyOther: 2) control test (no intervention)Other: 3) ischemic compression

Interventions

The participant lay on his front on a couch. The examiner applied a plastic cup on a pre-marked trigger point, suctioned it with a mechanical pump and left it for 2 minutes. This was a stationary application with medium suction force. Therapy was performed on both sides. Measurements were taken before and 2 minutes after the therapy.

Experimental

The participant lay on his front on a couch for 4 minutes without any activity and without anyy intervention. Measurements were taken before and after the session.

Experimental

The participant lay on his front on a couch. The researcher applied pressure to a pre-marked trigger point using the thumb for 2 minutes until tissue resistance was felt. This included 60-second compression and after a break of a few seconds, another 60 seconds of compression. Therapies were performed on each side. Measurements were taken before and 2 minutes after the therapy.

Experimental

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age 18-30
  • student of The Józef Piłsudski University of Physical Education in Warsaw
  • written consent to participate in the study

You may not qualify if:

  • past or current injury to the trapezius.
  • past or current injury of the cervical spine limiting mobility of this segment.
  • broken skin at the examination site.
  • cardiological disease and use of blood pressure medication, histamine medication and analgesics
  • elevated body temperature, illness symptoms and a period of convalescence.
  • a missed anti-Covid procedure before each examination.
  • inability to find trigger points.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Józef Piłsudski University of Physical Education in Warsaw

Warsaw, Masovian Voivodeship, 00-968, Poland

Location

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

Cupping TherapyAcupressure

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsTherapy, Soft TissueMusculoskeletal ManipulationsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Agnieszka Zdrodowska, PH.D

    Józef Piłsudski University of Physical Education in Warsaw

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Each person participated in three tests with an interval of approximately one week between them. The following study protocol was followed; (short version) 1. cupping therapy; \- a minimum interval of 7 days; 2. control test; \- a minimum interval 7 days; 3. ischemic compression.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
academic researcher, doctor of science

Study Record Dates

First Submitted

October 23, 2021

First Posted

November 17, 2021

Study Start

January 23, 2021

Primary Completion

March 30, 2021

Study Completion

March 30, 2021

Last Updated

November 17, 2021

Record last verified: 2021-11

Locations