NCT03585283

Brief Summary

Aim of this study is to investigate effectiveness of myofascial releasing on neck pain related to trigger points located on upper cervical region.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

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

First Submitted

Initial submission to the registry

June 20, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 13, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

August 12, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2019

Completed
Last Updated

March 21, 2019

Status Verified

March 1, 2019

Enrollment Period

7 months

First QC Date

June 20, 2018

Last Update Submit

March 20, 2019

Conditions

Keywords

Myofascial ReleaseManual Therapies

Outcome Measures

Primary Outcomes (1)

  • Assessment of Pain Pressure Threshold on Trigger Points with Algometer

    Trigger points will be located with palpation and with slight pressure most painful one will be marked. Pressure will be applied by researcher and patient will be informed to notify researcher immediately after starting to feel pain from pressure.

    12 weeks

Secondary Outcomes (4)

  • Neck Disability Index

    12 weeks

  • Assessment of Perceived Pain on Cervical Region

    12 weeks

  • Global Rating of Change Scale-Turkish Version

    12 weeks

  • Assessment of Cervical Active Range of Motion (ROM)

    12 weeks

Study Arms (2)

Myofascial Group

EXPERIMENTAL

Myofascial release will be applied by physiotherapist two times a week for four weeks which is a manual therapy technique includes stretching and compression of soft tissues according to fascial chains.Each session will be approximately 45 min long. Participant will be reevaluated 8 week later after last session for a follow-up assessment.

Other: Myofascial Group

Sham Group

SHAM COMPARATOR

Sham application will be applied two times a week for four weeks. Each session will be approximately 45 min long. Participant will be reevaluated 8 week later after last session for a follow-up assessment.

Other: Sham Group

Interventions

Manual myofascial release will be applied at prone position. Patient's upper thoracic and cervical region will be undressed. Researcher will use direct and indirect myofascial release techniques on upper thoracic and cervical region focusing on trigger point located muscles (most frequently m. trapezius)

Myofascial Group

Patient's upper thoracic and cervical region will be undressed. Researcher will place his hands on points that used for myofascial release however no pressure or release techniques will be used.

Sham Group

Eligibility Criteria

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

You may qualify if:

  • Non specific cervical pain
  • Symptoms should last longer than 4 weeks
  • Palpable trigger points on upper thoracic region

You may not qualify if:

  • Cervical radiculopathy
  • Previous manual therapy treatment history
  • Sensory or motor function loss
  • Rheumatologic diseases
  • Structural damage on cervical spina
  • Trauma history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abant Izzet Baysal University

Bolu, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Myofascial Pain SyndromesNeck Pain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Şebnem Avcı, Ph.D

    Abant Izzet Baysal University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Intervention group will receive myofascial release and control group will receive a sham therapy by using same treatment and handling position without applying myofascial release techniques. Participant will be evaluated at baseline, 4 weeks later and 12 week later by an another investigator who does not aware of groups.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients' information and contact will be obtained from physiatrist and willing participant's gender, age and pain onset data will be processed with a random number generator in order to form groups. Patients will divide randomly into two groups as intervention and control with a normal distribution of gender, age and pain onset.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ms.C Research Assistant

Study Record Dates

First Submitted

June 20, 2018

First Posted

July 13, 2018

Study Start

August 12, 2018

Primary Completion

March 20, 2019

Study Completion

March 20, 2019

Last Updated

March 21, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations