NCT06485921

Brief Summary

The purpose of this study was to evaluate the impact of Ischemic Compression (IC) and Instrument Assisted Soft Tissue Mobilization (IASTM) on pain, functionality, cervical range of motion, pressure pain threshold, and quality of life in patients suffering from nonspecific neck pain.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 1, 2024

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

June 27, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

July 3, 2024

Status Verified

June 1, 2024

Enrollment Period

3 months

First QC Date

June 27, 2024

Last Update Submit

July 2, 2024

Conditions

Keywords

Neck painTrigger pointExercisePhysical therapyManual therapy

Outcome Measures

Primary Outcomes (2)

  • Visual Analog Scale(VAS)

    VAS is a measurement tool commonly used to assess the intensity of pain or other symptoms. It consists of a horizontal line labeled with descriptive anchors at each end (e.g., 'no pain' to 'worst pain imaginable'). Patients mark on the line to indicate their subjective perception of symptom severity, with the distance from the starting point to the mark providing a quantitative measure. As the value on the scale increases, the perceived pain or symptom intensity also increases

    Six weeks

  • Neck Disability Index (NDI)

    NDI is a measurement tool used to assess functional limitations in the neck region. It is commonly employed in individuals experiencing neck pain to evaluate the extent of restrictions in daily activities. NDI allows patients to subjectively assess how much their neck pain affects their daily lives. The score on the scale indicates the degree of functional impairment experienced by the patient and is used to evaluate treatment outcomes. When the score decreases, it indicates a reduction in limitations.

    Six weeks

Secondary Outcomes (5)

  • The Work Role Functioning Questionnaire (WRFQ)

    Six weeks

  • Cervical range of motion

    Six weeks

  • Pain pressure threshold

    Six weeks

  • SF- 12 quality of life

    Six weeks

  • Global Rating of Change (GROC)

    Six weeks

Study Arms (3)

Ischemic compression GROUP

ACTIVE COMPARATOR

This group will receive 90 seconds of ischemic compression on myofascial trigger points in the trapezius, levator scapulae, supraspinatus, infraspinatus, and splenius cervicis, along with exercises and suggestions for workplace modifications.

Other: Ischemic compressionOther: Exercise and workplace modifications

Instrument assisted soft tissue mobilization Group

ACTIVE COMPARATOR

This group will receive 40 seconds of sweeping and 60 seconds of swiveling by instrument-assisted soft tissue mobilization on myofascial trigger points in the trapezius, levator scapulae, supraspinatus, infraspinatus, and splenius cervicis muscles, along with exercises and suggestions for workplace modifications.

Other: Instrument assisted soft tissue mobilization GroupOther: Exercise and workplace modifications

Control Group

EXPERIMENTAL

This group will only receive exercises and suggestions for workplace modifications.

Other: Exercise and workplace modifications

Interventions

Participants will received a total of 12 treatment sessions over 6 weeks, with 2 sessions per week.

Ischemic compression GROUP

Participants will received a total of 12 treatment sessions over 6 weeks, with 2 sessions per week.

Instrument assisted soft tissue mobilization Group

Participants will receive stretching and strengthening exercises for neck and scapular stabilizer muscles as a 6-week home program.

Control GroupInstrument assisted soft tissue mobilization GroupIschemic compression GROUP

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Having nonspecific neck pain and at least 3 myofascial trigger points in the back and neck muscles,
  • Pain duration exceeding 3 months,
  • Working with a computer for at least 20 hours per week for at least 1 year,
  • Pain intensity rated as at least 3 on the Visual Analog Scale (VAS),
  • Age between 18 and 50 years

You may not qualify if:

  • Use of anti-inflammatory, analgesic, anticoagulant, muscle relaxant, or antidepressant medications at the start of the study or within 1 week prior to the study,
  • History of cervical spine surgery or trauma,
  • Neck pain, including inflammatory rheumatic diseases,
  • Malignancy or structural deformity,
  • Coagulation disorders,
  • Presence of cervical radiculopathy or myelopathy,
  • Individuals who have undergone any physical therapy and rehabilitation interventions to the neck and back regions in the last three months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Health Sciences, Istanbul University-Cerrahpasa

Istanbul, Büyükçekmece, 34, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neck PainMotor Activity

Interventions

AcupressureExercise

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Mouna Khosravi, MSc

    aculty of Health Sciences, Istanbul University-Cerrahpasa, Büyükçekmece/Istanbul, Turkey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Three groups with conventional therapy control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Student

Study Record Dates

First Submitted

June 27, 2024

First Posted

July 3, 2024

Study Start

June 1, 2024

Primary Completion

September 1, 2024

Study Completion

October 1, 2024

Last Updated

July 3, 2024

Record last verified: 2024-06

Locations