- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04803669
The Effect of Instrument-assisted Soft Tissue Mobilization Technique on Neck Pain (IASTM)
The Investigation of Instrument-assisted Soft Tissue Mobilization Technique on Pain and Disability in Patients With Cervical Neck Pain
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey, 34083
- Marmara University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Conventional Treatment Group
Includes Hotpack, TENS, Ultrasound and Exercise programs.
|
Hotpack, TENS, Ultrasound and Exercise will be applied as conventional treatment methods.
|
EXPERIMENTAL: IASTM Group
Inludes Hotpack, TENS, Ultrasound, Exercise program and Instrument-assisted Soft Tissue Mobilization Technique
|
Hotpack, TENS, Ultrasound and Exercise will be applied as conventional treatment methods.
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neck Pain Changing
Time Frame: Change from Baseline Neck Pain at 6. week
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neck Disability Changing
Time Frame: Change from Baseline Neck Disability at 6. week
|
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.
|
Change from Baseline Neck Disability at 6. week
|
Anxiety Changing
Time Frame: Change from Baseline Anxiety at 6. week
|
Anxiety will be evaluated with the Hospital Anxiety and Depression Scale.
High score means high anxiety.
|
Change from Baseline Anxiety at 6. week
|
Depression Changing
Time Frame: Change from Baseline Depression at 6. week
|
Depression will be evaluated with the Hospital Anxiety and Depression Scale.
High score means high depression.
|
Change from Baseline Depression at 6. week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Adem Aktürk, Medical Doktor (specialist), Istanbul Gelisim University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09.2019.491
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neck Pain
-
Hacettepe UniversityRecruitingNeck Pain | Cervical Pain | Neck Pain, Posterior | Neck Muscle Issue | Cervical Pain, PosteriorTurkey
-
Fatih TekinPamukkale UniversityCompletedChronic Neck Pain | Persistent Neck Pain | Neuroscience ApproachTurkey
-
Jeff Elias, MDRecruitingCancer of Head and Neck | Pain, Neck | Pain, FaceUnited States
-
Riphah International UniversityCompleted
-
Instituto Brasileiro de OsteopatiaCompletedNeck Pain | Pain, NeckBrazil
-
Riphah International UniversityCompletedCervical Pain | Mechanical Neck PainPakistan
-
Ankara UniversityCompleted
-
Josue Fernandez CarneroCentro Universitario La SalleCompleted
-
Sakarya UniversityUnknown
-
Royal College of Surgeons, IrelandNot yet recruitingNeck Pain Musculoskeletal
Clinical Trials on Conventional Treatment
-
University of AarhusGCP-unit at Aarhus University Hospital, Aarhus, Denmark; Danish Classical Homeopathy... and other collaboratorsCompleted
-
Aveiro UniversityFundação para a Ciência e a TecnologiaCompletedLower Respiratory Tract InfectionsPortugal
-
Riphah International UniversityCompletedOverweight | Low Back Pain, MechanicalPakistan
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityCompleted
-
Aveiro UniversityRecruiting
-
Daping Hospital and the Research Institute of Surgery...RecruitingAcute Respiratory Distress Syndrome (ARDS) | Red Blood Cells(RBC)China
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRecruitingSudden Sensorineural Hearing LossChina
-
Hangzhou Medical CollegeRecruitingAdolescent ScoliosisChina
-
Riphah International UniversityRecruitingAutism Spectrum DisorderPakistan