NCT04789265

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 26, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 9, 2021

Completed
Last Updated

May 26, 2021

Status Verified

May 1, 2021

Enrollment Period

3 months

First QC Date

March 2, 2021

Last Update Submit

May 24, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Nottingham Health Profile

    baseline to 4 weeks after

  • Neck Disability İndex

    baseline to 4 weeks after

  • Visual Analog Scale

    baseline to 4 weeks after

Study Arms (2)

Combined Therapy (Instrumented Soft Tissue Mobilization)

EXPERIMENTAL
Other: instrumented- assisted soft tissue mobilization (IASTM)

Control Group (Exercise Therapy)

NO INTERVENTION

Interventions

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.

Combined Therapy (Instrumented Soft Tissue Mobilization)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aysegul Bostan

Istanbul, Beykoz, 5557694774, Turkey (Türkiye)

Location

Aysegul Bostan

Istanbul, Beykoz, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
physiotherapist, research assistant

Study Record Dates

First Submitted

March 2, 2021

First Posted

March 9, 2021

Study Start

June 26, 2020

Primary Completion

October 5, 2020

Study Completion

December 11, 2020

Last Updated

May 26, 2021

Record last verified: 2021-05

Locations