NCT06715969

Brief Summary

The aim of this study is to compare the different effects of two different fascial treatments on pain, flexibility and Asian architecture. 2 different groups 8 sessions, two different fascial treatments will be applied in accordance with the intake criteria, the individuals will be re-evaluated before the treatment, after 8 sessions of treatment and 3 months after the end of the study.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Study Start

First participant enrolled

November 15, 2024

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 4, 2024

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2025

Completed
Last Updated

December 4, 2024

Status Verified

October 1, 2024

Enrollment Period

1 month

First QC Date

November 19, 2024

Last Update Submit

November 28, 2024

Conditions

Keywords

low back painultrasoundtoracolumbal fascia

Outcome Measures

Primary Outcomes (1)

  • pain

    We expect a decrease in pain at the end of 4 weeks. We expect a decrease in the value of the visual analog scale (VAS). According to this scale, it shows 10 very severe pains and 0 pains. We look at the VAS values of people both before and after the study.

    From enrollment to the end of treatment at 4 weeks

Study Arms (3)

myofasyal indiction treatment

ACTIVE COMPARATOR

MIT will be applied to the lumbal region by a physiotherapist trained and experienced in fascial treatments to patients in the MIT group. Applications 2 sessions per week, a total of 8 sessions will be applied, with an average of 20-25 minutes. The application principles of this technique will be as follows. * Induction of the lumbal interfacial triangle region (stroke application) (3 min) * Induction of the lumbal interfacial triangle region (deep induction application) (3 min) * Cross-hands myofascial induction (3 min)

Other: Myofascial Induction Techniques

classıcal phsyotherapy

ACTIVE COMPARATOR

15 sessions of mictowave diathermy (MDD), Vacuum Interference, Infraruj and Classic waist exercise program will be applied to patients in this group.

Other: classıcal phsyotherapy

Myofacial ReleaseTechniques

ACTIVE COMPARATOR

Separate techniques will be applied to the parts of the thoracolumbal fascia that surround the erector spina, quadratus lumborum, latissimus dorsi muscles and extend in that direction to patients in the MFR group. Techniques will continue for 180 seconds, tissue shift will be carried further as relaxation is achieved. Applications Total 8 sessions will be applied twice a week by an experienced physiotherapist.

Other: Myofascial Release Techniques

Interventions

Separate techniques will be applied to the parts of the thoracolumbal fascia that surround the erector spina, quadratus lumborum, latissimus dorsi muscles and extend in that direction to patients in the MFR group. Techniques will continue for 180 seconds, tissue shift will be carried further as relaxation is achieved. Applications Total 8 sessions will be applied twice a week by an experienced physiotherapist.

Myofacial ReleaseTechniques

MIT will be applied to the lumbal region by a physiotherapist trained and experienced in fascial treatments to patients in the MIT group. Applications 2 sessions per week, a total of 8 sessions will be applied, with an average of 20-25 minutes. The application principles of this technique will be as follows. * Induction of the lumbal interfacial triangle region (stroke application) (3 min) * Induction of the lumbal interfacial triangle region (deep induction application) (3 min) * Cross-hands myofascial induction (3 min)

myofasyal indiction treatment

15 sessions of mictowave diathermy (MDD), Vacuum Interference, Infraruj and Classic waist exercise program will be applied to patients in this group.

classıcal phsyotherapy

Eligibility Criteria

Age35 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients between 35-60 years old
  • Patients with low back pain for at least 3 months
  • Patients with pain 4 and above according to VAS
  • Having not received FTR and manual therapy for the last 3 months
  • Those who have not received medical treatment for the last 3 months and those who will not

You may not qualify if:

  • Those with a history of back and spine surgery
  • Patients with a history of trauma
  • Those with instable neurological findings
  • Having a pathology such as hernia and root pressure in the lumbal region
  • Regular users of analgesic and anti-inflammatory drugs
  • Communication problem that will prevent the implementation of evaluations and/or treatment program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MMT Amerikan tıp merkezi

Gaziantep, sehitkamil, 27100, Turkey (Türkiye)

Location

Related Publications (1)

  • Chamorro Comesana A, Suarez Vicente MD, Docampo Ferreira T, Perez-La Fuente Varela MD, Porto Quintans MM, Pilat A. Effect of myofascial induction therapy on post-c-section scars, more than one and a half years old. Pilot study. J Bodyw Mov Ther. 2017 Jan;21(1):197-204. doi: 10.1016/j.jbmt.2016.07.003. Epub 2016 Jul 18.

    PMID: 28167179BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • kezban bayramlar, profesör

    Hasan Kalyoncu University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Myofascial release will be applied to one group, miofascial induction treatment will be applied to the other group.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Expert physiotherapist

Study Record Dates

First Submitted

November 19, 2024

First Posted

December 4, 2024

Study Start

November 15, 2024

Primary Completion

December 15, 2024

Study Completion

April 15, 2025

Last Updated

December 4, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations