Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04803669 |
Other study ID # |
09.2019.491 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 18, 2021 |
Est. completion date |
October 25, 2021 |
Study information
Verified date |
April 2022 |
Source |
Marmara University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.