The Effect of Instrument-assisted Soft Tissue Mobilization Technique on Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

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.
    

Intervention name(s): Intrument-assisted soft tissue mobilization technique; Conventional Treatment
Intervention type(s): Procedure; Procedure
Intervention description(s): 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).; Hotpack, TENS, Ultrasound and Exercise will be applied as conventional treatment methods.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Conventional Treatment Conventional Treatment + Instrument-assisted soft tissue mobilization technique
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: neck pain; neck disability; Instrument-assisted soft tissue mobilization technique; conventional therapy