Instrumental Soft Tissue Mobilization in Patients With Chronic Neck Pain
Primary Purpose
Neck Pain
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
instrumented- assisted soft tissue mobilization (IASTM)
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain
Eligibility Criteria
Inclusion Criteria, Exclusion Criteria:
Individuals aged 18-70 years with neck pain due to a nonspecific disorder for at least 3 months were included.
Individuals with history of cancer (within the last five years), pregnancy, serious skin disorders, previous neck surgery, disc prolapse, spondylolisthesis, vertebral fractures, spinal stenosis, arthritis, osteoporosis, recent neck trauma (within the last 48 hours), severe night pain, symptoms of infection, psychological disorder, and those who received therapy for neck pain in the last 6 months were not included.
Sites / Locations
- Aysegul Bostan
- Aysegul Bostan
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Combined Therapy (Instrumented Soft Tissue Mobilization)
Control Group (Exercise Therapy)
Arm Description
Outcomes
Primary Outcome Measures
Neck Flexor Muscle Endurance
Neck flexor endurance of the participants were evaluated with a stopwatch for holding their neck in lying position.
Secondary Outcome Measures
Nottingham Health Profile
NSP is a general health status questionnaire that measures the physical, emotional and social conditions of individuals. The questionnaire consists of 38 items and 6 sub-sections: physical mobility (8 items), pain (8 items), sleep (5 items), emotional reactions (9 items), social isolation (5 items) and energy level (3 items). consists of. Each item is answered as "yes" or "no". The score that can be obtained from each section varies between 0 and 100.
Neck Disability İndex
The index, which evaluates subjective symptoms and activities of daily living, consists of 10 parts (pain intensity, personal care, lifting, reading, headache, concentration, work life, driving, sleep and leisure activities). There are 6 options ranging from 0 to 5 points for each section. The total score ranges from 0 to 50 (0: no apology; 50: maximum disability), with a higher total score indicating an increased disability.
Visual Analog Scale
This scale consists of a 10 cm linear line. The starting point of the line is 0, no pain; the last point, 10, the most severe pain encountered in life; 5 means a moderate pain. The subjects were asked to rate the severity of their pain numerically on the scale.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04789265
Brief Title
Instrumental Soft Tissue Mobilization in Patients With Chronic Neck Pain
Official Title
Instrumental Soft Tissue Mobilization in Patients With Chronic Neck Pain: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
June 26, 2020 (Actual)
Primary Completion Date
October 5, 2020 (Actual)
Study Completion Date
December 11, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ayşegül BOSTAN
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In this study, it was planned to investigate the effectiveness of instrument-assisted soft tissue mobilisation (IASTM) in patients with chronic neck pain. Forty eight individuals with chronic neck pain between the ages of 18-70 were included in the study. Individuals were randomly divided into two groups as Combined Therapy (CT) (n = 24) and Exercise Therapy (ET) (n = 24) groups. All exercises were applied to the participants for 4 weeks, 3 times a week, by an experienced physiotherapist for 5 years under supervision. ET which included stretching and strengthening exercises involving the neck, shoulder and around the scapula muscles applied according to the tolerance of the individuals and targeted to be most beneficial in daily life activities.
CT in addition to the ET applied 3 times a week for 4 weeks, the participants received a total of 8 sessions of IASTM on the days they came to the treatment twice a week, before the ET. As soon as the participants came to the session, IASTM was applied first. Following the IASTM application, ET was applied in the same protocol and under the same therapist supervise with the ET group.
Before and after treatment, deep neck flexor muscle endurance (DNFME), pain severity with Visual Analogue Scale (VAS) and Brief Pain Inventory (BPI), functional status with Neck Disability Index (NDI), quality of life with Nottingham Health Profile (NHP) treatment and treatment satisfaction was evaluated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Combined Therapy (Instrumented Soft Tissue Mobilization)
Arm Type
Experimental
Arm Title
Control Group (Exercise Therapy)
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
instrumented- assisted soft tissue mobilization (IASTM)
Intervention Description
IASTM is a new, non-invasive, conservative therapeutic approach. Instead of the therapist's hands and fingers in treatment, these devices are used to provide contact mobilization power. AYDM intervention, such as friction, rubbing massage treatments, requires the therapist to apply a significant amount of pressure. The main purpose of IASTM is to eliminate scar tissue and to restore the normal function of the tissue following soft tissue regeneration.
Primary Outcome Measure Information:
Title
Neck Flexor Muscle Endurance
Description
Neck flexor endurance of the participants were evaluated with a stopwatch for holding their neck in lying position.
Time Frame
baseline to 4 weeks after
Secondary Outcome Measure Information:
Title
Nottingham Health Profile
Description
NSP is a general health status questionnaire that measures the physical, emotional and social conditions of individuals. The questionnaire consists of 38 items and 6 sub-sections: physical mobility (8 items), pain (8 items), sleep (5 items), emotional reactions (9 items), social isolation (5 items) and energy level (3 items). consists of. Each item is answered as "yes" or "no". The score that can be obtained from each section varies between 0 and 100.
Time Frame
baseline to 4 weeks after
Title
Neck Disability İndex
Description
The index, which evaluates subjective symptoms and activities of daily living, consists of 10 parts (pain intensity, personal care, lifting, reading, headache, concentration, work life, driving, sleep and leisure activities). There are 6 options ranging from 0 to 5 points for each section. The total score ranges from 0 to 50 (0: no apology; 50: maximum disability), with a higher total score indicating an increased disability.
Time Frame
baseline to 4 weeks after
Title
Visual Analog Scale
Description
This scale consists of a 10 cm linear line. The starting point of the line is 0, no pain; the last point, 10, the most severe pain encountered in life; 5 means a moderate pain. The subjects were asked to rate the severity of their pain numerically on the scale.
Time Frame
baseline to 4 weeks after
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria, Exclusion Criteria:
Individuals aged 18-70 years with neck pain due to a nonspecific disorder for at least 3 months were included.
Individuals with history of cancer (within the last five years), pregnancy, serious skin disorders, previous neck surgery, disc prolapse, spondylolisthesis, vertebral fractures, spinal stenosis, arthritis, osteoporosis, recent neck trauma (within the last 48 hours), severe night pain, symptoms of infection, psychological disorder, and those who received therapy for neck pain in the last 6 months were not included.
Facility Information:
Facility Name
Aysegul Bostan
City
Istanbul
State/Province
Beykoz
ZIP/Postal Code
5557694774
Country
Turkey
Facility Name
Aysegul Bostan
City
Istanbul
State/Province
Beykoz
Country
Turkey
12. IPD Sharing Statement
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Instrumental Soft Tissue Mobilization in Patients With Chronic Neck Pain
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