NCT05503602

Brief Summary

Neck pain is in fourth place among the pathologies that result in the state of disability. Acute neck pain improves greatly within 2 months, while neck pain that persists for more than 3 months takes the form of chronic neck pain. Pain adversely affects people's activities of daily living. Treatment applications such as electrotherapy, hot and cold applications are applied for purposes such as reducing pain and muscle spasm and correcting functions. In addition to such treatment options, instrument-assisted soft tissue mobilization (IASTM) and foam roller therapy have been started to be applied in many disease groups in recent years and have attracted great attention. iASTM and Foam Roller is a technique that involves the use of tools in disorders of musculoskeletal pathology and to help heal soft tissues. The aim of this study is to investigate the effects of foam roller technique with instrument-assisted soft tissue mobilization technique in individuals of different ages with chronic non-specific neck pain. According to the data obtained, the techniques the investigators will use, together with physiotherapy programs, contribute to the treatment of individuals with chronic non-specific neck pain and to the literature.is expected to provide.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

December 1, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 16, 2022

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

October 1, 2024

Status Verified

September 1, 2024

Enrollment Period

9 months

First QC Date

August 12, 2022

Last Update Submit

September 30, 2024

Conditions

Outcome Measures

Primary Outcomes (9)

  • Muscle Strength Assessment

    A digital muscle dynamometer will be used to evaluate the muscle strength of the patients.

    Pre-treatment assessment.

  • Muscle Strength Assessment

    A digital muscle dynamometer will be used to evaluate the muscle strength of the patients.

    Second evaluation immediately after the end of 4 weeks of treatment.

  • Muscle Strength Assessment

    A digital muscle dynamometer will be used to evaluate the muscle strength of the patients.

    Control evaluation 1 month after the end of treatment (third evaluation).

  • Flexibility Assessment

    A tape measure will be used to assess patients' flexibility. The ear-shoulder, chin-sternum (proximal end) and chin-wall distances of the patients will be measured with a tape measure.

    Pre-treatment assessment.

  • Flexibility Assessment

    A tape measure will be used to assess patients' flexibility. The ear-shoulder, chin-sternum (proximal end) and chin-wall distances of the patients will be measured with a tape measure.

    Second evaluation immediately after the end of 4 weeks of treatment.

  • Flexibility Assessment

    A tape measure will be used to assess patients' flexibility. The ear-shoulder, chin-sternum (proximal end) and chin-wall distances of the patients will be measured with a tape measure.

    Control evaluation 1 month after the end of treatment (third evaluation).

  • Pain Assessment

    Visual Analog Scale (VAS) will be used to evaluate the pain of individuals.

    Pre-treatment assessment.

  • Pain Assessment

    Visual Analog Scale (VAS) will be used to evaluate the pain of individuals.

    Second evaluation immediately after the end of 4 weeks of treatment.

  • Pain Assessment

    Visual Analog Scale (VAS) will be used to evaluate the pain of individuals.

    Control evaluation 1 month after the end of treatment (third evaluation).

Secondary Outcomes (9)

  • Functional Status Assessment Questionnaire

    Pre-treatment assessment.

  • Functional Status Assessment Questionnaire

    Second evaluation immediately after the end of 4 weeks of treatment.

  • Functional Status Assessment Questionnaire

    Control evaluation 1 month after the end of treatment (third evaluation).

  • Joint Range of Motion Assessment

    Pre-treatment assessment.

  • Joint Range of Motion Assessment

    Second evaluation immediately after the end of 4 weeks of treatment.

  • +4 more secondary outcomes

Study Arms (3)

Control Group

OTHER

An average of 20 people will be taken into the control group.

Other: Classical Physiotherapy

IASTM Treatment Group

EXPERIMENTAL

An average of 20 people will receive IASTM application treatment.

Other: IASTM Technique Application

Foam Roller Treatment Group

EXPERIMENTAL

An average of 20 people will receive Foam Roller application treatment.

Other: Foam Roller Technique Application

Interventions

Only classical physiotherapy application, 5 sessions per week for 4 weeks.

Control Group

Instrument-assisted soft tissue mobilization application 2 sessions per week together with 3 sessions of classical physiotherapy per week for 4 weeks. IASTM application; A total of 4 minutes will be applied to the sternocleidomastoideus, levator scapula, scalene muscles and upper part of the trapezius for a total of 4 minutes (2 minutes to the right, 2 minutes to the left region).

IASTM Treatment Group

2 sessions of foam roller technique per week along with 3 sessions of classical physiotherapy per week for 4 weeks. Foam roller application; A total of 4 minutes will be applied to the sternocleidomastoideus, levator scapula, scalene muscles and upper part of the trapezius for a total of 4 minutes (2 minutes to the right, 2 minutes to the left region).

Foam Roller Treatment Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Consists of individuals between the ages of 18-60,
  • Being diagnosed with chronic non-specific neck pain,
  • Having a score of at least 4 on the visual analog scale (VAS) of the mean neck pain intensity,
  • Having non-specific neck pain at least 5 days a week for the last 12 weeks,
  • To be deemed appropriate by the physical therapy physician for early physiotherapy treatment after the diagnosis of chronic non-specific neck pain.

You may not qualify if:

  • Individuals with a history of cervical spine surgery, cervical trauma, central nervous system diseases, cervical radiculopathy, acute inflammation and malignancy,
  • Having neck pain due to specific causes (disc protrusion, radicular syndrome, whiplash, congenital deformity of the spine, spinal canal stenosis and neoplasm),
  • Individuals with inflammatory rheumatic disease, active oncological disease, affective disorder, addiction and psychosis,
  • Individuals who have undergone invasive treatment of the spine in the last 4 weeks or spine surgery in the previous 12 months,
  • Individuals from the chronic neck pain group who are currently receiving treatment or have a neck injury resulting in a spinal fracture,
  • Individuals who have started a new treatment for neck pain in the past month or are planning to start a new treatment within 9 weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu University

Malatya, 44280, Turkey (Türkiye)

Location

Study Officials

  • Muhammed Üsame TAŞ, Lecturer

    Inonu University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 12, 2022

First Posted

August 16, 2022

Study Start

December 1, 2021

Primary Completion

September 1, 2022

Study Completion

October 1, 2022

Last Updated

October 1, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations