- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03585283
Effects of Myofascial Releasing on Neck Pain in Patients With Trigger Points
Effects of Myofascial Releasing on Neck Pain in Patients With Trigger Points: A Single Blinded, Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bolu, Turkey
- Abant Izzet Baysal University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Myofascial Group
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.
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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)
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Sham Comparator: Sham Group
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of Pain Pressure Threshold on Trigger Points with Algometer
Time Frame: 12 weeks
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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.
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neck Disability Index
Time Frame: 12 weeks
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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.
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12 weeks
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Assessment of Perceived Pain on Cervical Region
Time Frame: 12 weeks
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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).
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12 weeks
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Global Rating of Change Scale-Turkish Version
Time Frame: 12 weeks
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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.
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12 weeks
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Assessment of Cervical Active Range of Motion (ROM)
Time Frame: 12 weeks
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Patients cervical flexion, lateral flexin and rotation ROM's will be assessed with a goniometer.
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12 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Şebnem Avcı, Ph.D, Abant Izzet Baysal University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AbantIBU-Phys2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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