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The Effect of Instrument-assisted Soft Tissue Mobilization Technique on Neck Pain (IASTM)

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Intrument-assisted soft tissue mobilization technique
Conventional Treatment
Sponsored by
Emresenocak
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring neck pain, neck disability, Instrument-assisted soft tissue mobilization technique, conventional therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Marmara University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional Treatment Group

IASTM Group

Arm Description

Includes Hotpack, TENS, Ultrasound and Exercise programs.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Neck Disability Changing
Disability will be assessed by the Copenhagen Neck Functional Disability Scale. The scale is scored between 0-30. "0" means no disability, "30" means maximum neck pain and disability.
Anxiety Changing
Anxiety will be evaluated with the Hospital Anxiety and Depression Scale. High score means high anxiety.
Depression Changing
Depression will be evaluated with the Hospital Anxiety and Depression Scale. High score means high depression.

Full Information

First Posted
March 14, 2021
Last Updated
April 16, 2022
Sponsor
Emresenocak
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1. Study Identification

Unique Protocol Identification Number
NCT04803669
Brief Title
The Effect of Instrument-assisted Soft Tissue Mobilization Technique on Neck Pain
Acronym
IASTM
Official Title
The Investigation of Instrument-assisted Soft Tissue Mobilization Technique on Pain and Disability in Patients With Cervical Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 18, 2021 (Actual)
Primary Completion Date
September 23, 2021 (Actual)
Study Completion Date
October 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Emresenocak

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Ethics Approval: The study started with the approval of the Ethics Committee of Marmara University Faculty of Medicine with the 09.2019.491 protocol number. Twenty-four patients who were diagnosed with cervical disc herniation (bulging, protrusion) based on radiological evaluation and who achieved 100% continuity in the treatment program will be included in the study. A similar study was taken as a reference when calculating the sample size. Randomization: Participants will be randomized and divided into two groups using online randomization software. Conventional treatment methods will be applied to "Conventional Treatment Group", and IASTM will be applied to "IASTM Group" participants in addition to the conventional treatment protocol. Conventional treatment will be applied to both groups for 4 weeks, 5 days a week. Interventions: Conventional treatment protocol was determined as hot pack application, electrotherapy agents, and exercise program. Hotpack intervention will be made on the neck and upper back area by wrapping in hot water bags and a towel for 25 minutes. The electrotherapy program consists of transcutaneous electrical stimulation (TENS) and ultrasound (US). Conventional TENS; 2 channels and 4 electrodes on the neck and upper trapezius muscle; It will be applied for 25 minutes (Acutens Brand, frequency 100 Hz, wave width 200 ms, 1-100 mA current). The current intensity will be adjusted in a way that does not cause discomfort for the patient. US will be applied at an intensity of 1-2.5 W / cm2 and a frequency of 1 MHz for 5 minutes to increase circulation in deep tissues. After the electrotherapy application, the patients will be given an exercise program under the supervision of a physiotherapist for 25 minutes. This program consists of deep flexor and extensor strengthening, posture, stretching, and mobilization exercises with elastic bands. The instrument-assisted soft tissue mobilization technique will be applied over the superficial and deep fascia region between C1-T1 neck-shoulder segments. The instrument used is made of stainless steel and will be applied using a brushing technique parallel to the muscle fibers (applications at an angle of 30 °). A water-based gel will be used to prevent adverse effects on the tissue due to friction. This technique will be applied as 2 sessions per week and 5 minutes per session, 8 sessions in total for 4 weeks. Assessment: Sociodemographic Data Form: Patients' gender, age, body mass index, and time of pain onset will be noted. Visual Analogue Scale: The Visual Analogue Scale (VAS) is an easy-to-apply and reliable assessment scale used to determine the pain level of patients. VAS was created to digitize values that are not expressed numerically. Scoring is made between 0-10 points. "0" represents the absence of pain, "10" represents the presence of unbearable pain. Using VAS, participants will be questioned for additional information such as the time of onset of neck pain, its frequency, rest, and activity pain. Copenhagen Neck Functional Disability Scale: It is a valid and reliable scale that evaluates the disability of patients due to neck pain. The scale consists of 15 items. The items are answered as "Yes, No, Sometimes" and scored between 0-2 points. The total score is between 0 and 30 points. If the total score is "0", it means "no neck pain and disability", "30" means "maximum neck pain and disability". Hospital Anxiety and Depression Scale: It includes anxiety and depression subscales. The scale consists of 14 items in total. Even-numbered items evaluate depression, and odd-numbered items assess anxiety. Answers are in four-point Likert format and are scored between 0 and 3. The cut-off point for the anxiety subscale of the scale was reported to be 10 and 7 for the depression subscale. Statistical Analysis: The data obtained in the study will be evaluated with SPSS 11.0 statistical program at an 80% confidence interval and p <0.05 significance level. The normal distribution of the data will be examined with the Kolmogorov Smirnov test and histogram curves.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
neck pain, neck disability, Instrument-assisted soft tissue mobilization technique, conventional therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Conventional Treatment Conventional Treatment + Instrument-assisted soft tissue mobilization technique
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional Treatment Group
Arm Type
Active Comparator
Arm Description
Includes Hotpack, TENS, Ultrasound and Exercise programs.
Arm Title
IASTM Group
Arm Type
Experimental
Arm Description
Inludes Hotpack, TENS, Ultrasound, Exercise program and Instrument-assisted Soft Tissue Mobilization Technique
Intervention Type
Procedure
Intervention Name(s)
Intrument-assisted soft tissue mobilization technique
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
Conventional Treatment
Intervention Description
Hotpack, TENS, Ultrasound and Exercise will be applied as conventional treatment methods.
Primary Outcome Measure Information:
Title
Neck Pain Changing
Description
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.
Time Frame
Change from Baseline Neck Pain at 6. week
Secondary Outcome Measure Information:
Title
Neck Disability Changing
Description
Disability will be assessed by the Copenhagen Neck Functional Disability Scale. The scale is scored between 0-30. "0" means no disability, "30" means maximum neck pain and disability.
Time Frame
Change from Baseline Neck Disability at 6. week
Title
Anxiety Changing
Description
Anxiety will be evaluated with the Hospital Anxiety and Depression Scale. High score means high anxiety.
Time Frame
Change from Baseline Anxiety at 6. week
Title
Depression Changing
Description
Depression will be evaluated with the Hospital Anxiety and Depression Scale. High score means high depression.
Time Frame
Change from Baseline Depression at 6. week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Having bulging or protruding cervical disc herniation, Pain severity> 2 according to VAS, Having neck pain complaint for at least three months Exclusion Criteria: Having any neck-shoulder area injury or surgery, Using cortisone medication, Having extrusion and sequestered disc herniation, Being diagnosed with fibromyalgia, Having malignancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adem Aktürk, Medical Doktor (specialist)
Organizational Affiliation
İstanbul Gelişim University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mehmet Özkeskin, PhD
Organizational Affiliation
Ege University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marmara University
City
Istanbul
ZIP/Postal Code
34083
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Instrument-assisted Soft Tissue Mobilization Technique on Neck Pain

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