NCT05554887

Brief Summary

The aim of this study is to investigate the effect of one session thoracic manipulation on pressure pain threshold and rhomboid muscle strength in healthy individuals with latent trigger point.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

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

First Submitted

Initial submission to the registry

September 16, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 26, 2022

Completed
15 days until next milestone

Study Start

First participant enrolled

October 11, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2022

Completed
Last Updated

December 28, 2022

Status Verified

December 1, 2022

Enrollment Period

2 months

First QC Date

September 16, 2022

Last Update Submit

December 25, 2022

Conditions

Keywords

latent trigger pointthorasic manipulationmuscle strengthpressure pain threshold

Outcome Measures

Primary Outcomes (2)

  • pressure pain threshold

    assessed with algometer

    up to 3 months

  • rhomboid muscle strength

    assessed with hand held dynamometer

    up to 3 months

Study Arms (2)

Thrust manipulation Group

EXPERIMENTAL

Participants undergoing thrust manipulation

Other: Thrust manipulation

Sham thrust manipulation group

SHAM COMPARATOR

Participants undergoing sham thrust manipulation

Other: Sham thrust manipulation

Interventions

Participants will be positioned prone and the clinician will perform a high-speed, low-amplitude thrust into the most symptomatic segment of the thoracic spine. TM type, thrust direction, and number of thrusts will be at the clinician's discretion and will be based on the individualized assessment of the patient.

Thrust manipulation Group

The same protocol will be applied as the push thoracic manipulation application, but no push will be applied.

Sham thrust manipulation group

Eligibility Criteria

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

You may qualify if:

  • not having any systemic disease
  • not having any neuromuscular deficit
  • To be defined as inactive (less than 30 minutes of moderate physical activity five times a week) according to the minimum activity guidelines published by the American College of Sports Medicine

You may not qualify if:

  • Being actively involved in any sport
  • Participating in a regular exercise program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Şule Şimşek

Denizli, Sarayköy, 09200, Turkey (Türkiye)

Location

Related Publications (2)

  • Hanney WJ, Puentedura EJ, Kolber MJ, Liu X, Pabian PS, Cheatham SW. The immediate effects of manual stretching and cervicothoracic junction manipulation on cervical range of motion and upper trapezius pressure pain thresholds. J Back Musculoskelet Rehabil. 2017 Sep 22;30(5):1005-1013. doi: 10.3233/BMR-169573.

    PMID: 28505955BACKGROUND
  • The effect of lower cervical and upper thoracic spinal manipulative therapy on pressure algometer readings of rhomboid and infraspinatus muscles by influencing the fascial tension of the spiral line: Doctoral dissertation, Johannesburg: University of Johannesburg, 2015.

    BACKGROUND

Study Officials

  • Şule Şimşek, Phd

    Phd faculty member

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
All these evaluations will be carried out by a blind evaluator who does not know which group the participants belong to.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomised sham controlled study involving 2 parallel groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 16, 2022

First Posted

September 26, 2022

Study Start

October 11, 2022

Primary Completion

December 1, 2022

Study Completion

December 12, 2022

Last Updated

December 28, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations