NCT05623735

Brief Summary

The aim of this study is to determine whether the effectiveness of instrument-assisted soft tissue mobilization technique is different from passive prone lying when performed with a functional exercise in individuals with chronic nonspecific low back pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

November 20, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 21, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2023

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2023

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

2 months

First QC Date

November 14, 2022

Last Update Submit

February 14, 2023

Conditions

Keywords

IASTMchronic painflexibilitydisabilitymobilitymuscular endurance

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale (VAS)

    Individuals' pain levels will be measured using the Visual Analogue Scale (VAS) both at rest and during activity. It will be requested to mark any point on a horizontal line of 10 cm length such that 0 no pain, 10 unbearably severe pain.

    3 Weeks

Secondary Outcomes (5)

  • Mobility (Modified Schober Test)

    3 Weeks

  • Flexibility (Sit and Reach Test)

    3 Weeks

  • Flexibility (Maximal Hip Flexion Active Knee Extension (MHFAKE))

    3 Weeks

  • Disability (Oswestry Disability İndex)

    3 Weeks

  • Trunk Extensors Muscle Endurance (Biering-Sorenson Test)

    3 Weeks

Study Arms (2)

Instrument Assisted Soft Tissue Mobilization (IASTM) Group While Lying Prone

EXPERIMENTAL

The application will take a total of 6 sessions, with two sessions per week for 3 weeks. While individuals are lying in the prone position, the IASTM protocol will be applied bilaterally on the erector spinae and then on the hamstrings. The application will take approximately 17 minutes.

Other: Instrument Assisted Soft Tissue Mobilization Group While Lying Prone

Instrument Assisted Soft Tissue Mobilization Group Combined with Functional Movement

EXPERIMENTAL

While standing in the "extended child pose (utthita balasana)" stance, the "IASTM" protocol will be applied bilaterally on the lumbar erector spines, with the hands on them and moving back to the old position. Then, the "IASTM" protocol will be applied bilaterally on the hamstrings by making consecutive knee flexion-extension up to 90 degrees while the individuals are lying prone. The application will take approximately 17 minutes.

Other: Instrument Assisted Soft Tissue Mobilization Group Combined with Functional Movement

Interventions

1. Sliding movements in all directions at 30 - 60 degree angles will be made in the form of mobilizations of 45 seconds with instruments. 2. Mobilizations of 45 seconds will be made with instruments along the quarter circle line in all directions at 30 - 60 degree angles. 3. Starting with an angle of 60 degrees on the area to be treated, the movement of shifting towards an angle of 30 degrees will be made in all directions for 30 seconds. 4. The tissue will be mobilized for 30 consecutive seconds, starting from just caudal to your waist and drawing the letter J towards the cranial. 5. Sliding movements in all directions at 30 - 60 degree angles will be made with instruments in the form of mobilizations for 45 seconds. 6. Mobilizations of 45 seconds will be made with instruments along the quarter circle line in all directions at 30 - 60 degree angles. 7. 30 - 60 degree swipe movement shorter brushing style small movements will be done for 30 seconds.

Instrument Assisted Soft Tissue Mobilization (IASTM) Group While Lying Prone

1. Sliding movements in all directions at 30 - 60 degree angles will be made in the form of mobilizations of 45 seconds with instruments. 2. Mobilizations of 45 seconds will be made with instruments along the quarter circle line in all directions at 30 - 60 degree angles. 3. Starting with an angle of 60 degrees on the area to be treated, the movement of shifting towards an angle of 30 degrees will be made in all directions for 30 seconds. 4. The tissue will be mobilized for 30 consecutive seconds, starting from just caudal to your waist and drawing the letter J towards the cranial. 5. Sliding movements in all directions at 30 - 60 degree angles will be made with instruments in the form of mobilizations for 45 seconds. 6. Mobilizations of 45 seconds will be made with instruments along the quarter circle line in all directions at 30 - 60 degree angles. 7. 30 - 60 degree swipe movement shorter brushing style small movements will be done for 30 seconds.

Instrument Assisted Soft Tissue Mobilization Group Combined with Functional Movement

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Being diagnosed with non-specific low back pain by a specialist physician
  • years old
  • Having 3 or more pains on VAS for the last 3 months.
  • Those who do not use analgesic drugs
  • Not taking physiotherapy for the last 6 months.

You may not qualify if:

  • Those with orthopedic, neurological, psychiatric and systemic diseases (such as fracture, osteoporosis, scoliosis, kyphosis, stenosis, cauda equina, myositis ossificans, severe nerve compressions, rheumatoid arthritis, cancer)
  • Those with a history of spinal surgery
  • Pregnant and lactating
  • Open wound, infection, serious kidney disease
  • Those who have limited hip joint movements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Süleyman Güzelşemme

Famagusta, 99628, Cyprus

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Süleyman Güzelşemme, Res. Asst.

    Eastern Mediterranean University

    PRINCIPAL INVESTIGATOR
  • Sevim Öksüz, Asst. Prof.

    Eastern Mediterranean University

    STUDY DIRECTOR

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
SPONSOR

Study Record Dates

First Submitted

November 14, 2022

First Posted

November 21, 2022

Study Start

November 20, 2022

Primary Completion

January 20, 2023

Study Completion

February 2, 2023

Last Updated

February 15, 2023

Record last verified: 2023-02

Locations