search
Back to results

Effects of Myofascial Releasing on Neck Pain in Patients With Trigger Points

Primary Purpose

Trigger Point Pain, Myofascial, Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Myofascial Group
Sham Group
Sponsored by
Abant Izzet Baysal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trigger Point Pain, Myofascial focused on measuring Myofascial Release, Manual Therapies

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Abant Izzet Baysal University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Myofascial Group

Sham Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Neck Disability Index
The Neck Disability Index will be used to record perceived disability according to patients with neck pain. Neck disability index is a 10 question self administrated questionaire. Each question scored from 0-5 for a total of 50 point.
Assessment of Perceived Pain on Cervical Region
Visual analog scale (VAS) will be used to assess patients' pain while doing neck rotations. Patients will mark their perceived pain on a 10 cm horizontal line. Left side of line considered as 0 (no pain at all) and right side considered as 10 (most intense pain experienced so far).
Global Rating of Change Scale-Turkish Version
Patients global perception on effects of treatment will be assessed with a 9 aspect scale. 5 was considered as no change from the baseline and 1-4 indicate decline in symptoms and 6-9 indicate improvement.
Assessment of Cervical Active Range of Motion (ROM)
Patients cervical flexion, lateral flexin and rotation ROM's will be assessed with a goniometer.

Full Information

First Posted
June 20, 2018
Last Updated
March 20, 2019
Sponsor
Abant Izzet Baysal University
search

1. Study Identification

Unique Protocol Identification Number
NCT03585283
Brief Title
Effects of Myofascial Releasing on Neck Pain in Patients With Trigger Points
Official Title
Effects of Myofascial Releasing on Neck Pain in Patients With Trigger Points: A Single Blinded, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
August 12, 2018 (Actual)
Primary Completion Date
March 20, 2019 (Actual)
Study Completion Date
March 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Abant Izzet Baysal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Neck pain is the second most common musculoskeletal pain after lumbar pain. Prevalence is 27.2% female and 17.4% in male population. Approximately 1/3 of acute onset neck aches become chronic. It causes increasing the cost of treatment and also the loss of labor. Myofascial pain is usually considered caused by myofascial trigger points. The trigger points in the neck muscles have been associated with a possible source of referred facial and cranial pain. Mechanical neck pain is a non-radicular pain caused by local musculoskeletal structures and is characterized by a spasm of the cervical muscles. Posture, emotional stress, cold and fatigue are etiologic causes, and pain is also reflected to the cervical, occipital and scapular regions depending on the severity of muscle spasm and the presence of trigger point in myofascial pain syndrome. Myofascial releasing is a specific type of passive soft tissue mobilization. Triggers points often considered as a pathology that occurs after excessive load or trauma on soft tissue which disturbs blood circulation. Fascial restriction can be found with triggers points and taut band. In this study effects of myofascial release on triggers points will be investigated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigger Point Pain, Myofascial, Neck Pain
Keywords
Myofascial Release, Manual Therapies

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Myofascial Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham Group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Myofascial Group
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Sham Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assessment of Pain Pressure Threshold on Trigger Points with Algometer
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Neck Disability Index
Description
The Neck Disability Index will be used to record perceived disability according to patients with neck pain. Neck disability index is a 10 question self administrated questionaire. Each question scored from 0-5 for a total of 50 point.
Time Frame
12 weeks
Title
Assessment of Perceived Pain on Cervical Region
Description
Visual analog scale (VAS) will be used to assess patients' pain while doing neck rotations. Patients will mark their perceived pain on a 10 cm horizontal line. Left side of line considered as 0 (no pain at all) and right side considered as 10 (most intense pain experienced so far).
Time Frame
12 weeks
Title
Global Rating of Change Scale-Turkish Version
Description
Patients global perception on effects of treatment will be assessed with a 9 aspect scale. 5 was considered as no change from the baseline and 1-4 indicate decline in symptoms and 6-9 indicate improvement.
Time Frame
12 weeks
Title
Assessment of Cervical Active Range of Motion (ROM)
Description
Patients cervical flexion, lateral flexin and rotation ROM's will be assessed with a goniometer.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Non specific cervical pain Symptoms should last longer than 4 weeks Palpable trigger points on upper thoracic region Exclusion Criteria: Cervical radiculopathy Previous manual therapy treatment history Sensory or motor function loss Rheumatologic diseases Structural damage on cervical spina Trauma history
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Şebnem Avcı, Ph.D
Organizational Affiliation
Abant Izzet Baysal University
Official's Role
Study Director
Facility Information:
Facility Name
Abant Izzet Baysal University
City
Bolu
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Myofascial Releasing on Neck Pain in Patients With Trigger Points

We'll reach out to this number within 24 hrs