NCT04803669

Brief Summary

In the literature, studies reporting that symptoms such as limitation of motion in the neck, reduced functionality, and disability and depression occur in cervical pain are frequently encountered. Treatments such as medical therapy, intramuscular injections, and traditional physical therapy modalities have been used in the treatment of these symptoms. In recent years, the popularity of the instrument-assisted soft tissue mobilization (IASTM) technique in the treatment of soft tissue-related problems has increased and has been widely used in studies. This technique is a low-cost, easy-to-apply, and accessible method that is frequently used in extremity soft tissue problems and trigger point treatment. The investigators did not find any study on the effectiveness of the IASTM technique on pain and functionality in cervical region disorders. For this reason, the primary purpose of the study is; While the effectiveness of the IASTM technique on pain and functionality in patients with neck pain caused by cervical disc herniation, the secondary purpose is to reveal the effect of IASTM on anxiety-depression.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

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 18, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 18, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2021

Completed
Last Updated

April 19, 2022

Status Verified

April 1, 2022

Enrollment Period

8 months

First QC Date

March 14, 2021

Last Update Submit

April 16, 2022

Conditions

Keywords

neck painneck disabilityInstrument-assisted soft tissue mobilization techniqueconventional therapy

Outcome Measures

Primary Outcomes (1)

  • Neck Pain Changing

    Pain will be evaluated with Visual Analog Scale. The scale is scored between 0 and 10. "0" means no pain, "10" means very severe pain.

    Change from Baseline Neck Pain at 6. week

Secondary Outcomes (3)

  • Neck Disability Changing

    Change from Baseline Neck Disability at 6. week

  • Anxiety Changing

    Change from Baseline Anxiety at 6. week

  • Depression Changing

    Change from Baseline Depression at 6. week

Study Arms (2)

Conventional Treatment Group

ACTIVE COMPARATOR

Includes Hotpack, TENS, Ultrasound and Exercise programs.

Procedure: Conventional Treatment

IASTM Group

EXPERIMENTAL

Inludes Hotpack, TENS, Ultrasound, Exercise program and Instrument-assisted Soft Tissue Mobilization Technique

Procedure: Intrument-assisted soft tissue mobilization techniqueProcedure: Conventional Treatment

Interventions

This technique; It is applied with the help of a tool made of stainless steel. The instrument is rubbed on the skin at an angle of about 30 degrees, creating a massage-like effect on the soft tissue (2 sessions per week and 5 minutes per session, 8 sessions in total for 4 weeks).

IASTM Group

Hotpack, TENS, Ultrasound and Exercise will be applied as conventional treatment methods.

Conventional Treatment GroupIASTM Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having bulging or protruding cervical disc herniation,
  • Pain severity\> 2 according to VAS,
  • Having neck pain complaint for at least three months

You may not qualify if:

  • Having any neck-shoulder area injury or surgery,
  • Using cortisone medication,
  • Having extrusion and sequestered disc herniation,
  • Being diagnosed with fibromyalgia,
  • Having malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University

Istanbul, 34083, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Adem Aktürk, Medical Doktor (specialist)

    İstanbul Gelişim University

    PRINCIPAL INVESTIGATOR
  • Mehmet Özkeskin, PhD

    Ege University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Conventional Treatment Conventional Treatment + Instrument-assisted soft tissue mobilization technique
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

March 14, 2021

First Posted

March 18, 2021

Study Start

January 18, 2021

Primary Completion

September 23, 2021

Study Completion

October 25, 2021

Last Updated

April 19, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations