Instrumental Soft Tissue Mobilization in Patients With Chronic Neck Pain

Neck Pain Clinical Trial

Official title:

Instrumental Soft Tissue Mobilization in Patients With Chronic Neck Pain: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04789265
• Other study ID #: 10376522
• Status: Completed
• Phase: N/A
• Start date: June 26, 2020
• Est. completion date: December 11, 2020

Study information

• Verified date: May 2021
• Source: Medipol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 11, 2020
• Est. primary completion date: October 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neck Pain

Intervention

Other:
• instrumented- assisted soft tissue mobilization (IASTM)
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.

Locations

Country	Name	City	State
Turkey	Aysegul Bostan	Istanbul	Beykoz
Turkey	Aysegul Bostan	Istanbul	Beykoz

Sponsors (1)

Lead Sponsor	Collaborator
Aysegül BOSTAN

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neck Flexor Muscle Endurance	Neck flexor endurance of the participants were evaluated with a stopwatch for holding their neck in lying position.	baseline to 4 weeks after
Secondary	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.	baseline to 4 weeks after
Secondary	Neck Disability Index	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.	baseline to 4 weeks after
Secondary	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.	baseline to 4 weeks after