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

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ClinicalTrials.gov Identifier: NCT03585283
Recruitment Status : Completed
First Posted : July 13, 2018
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Ramazan KURUL, Abant Izzet Baysal University

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.

Condition or disease Intervention/treatment Phase
Trigger Point Pain, Myofascial Neck Pain Other: Myofascial Group Other: Sham Group Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Double (Participant, Outcomes 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.

Primary Purpose: Treatment
Official Title: Effects of Myofascial Releasing on Neck Pain in Patients With Trigger Points: A Single Blinded, Randomized Controlled Trial
Actual Study Start Date : August 12, 2018
Actual Primary Completion Date : March 20, 2019
Actual Study Completion Date : March 20, 2019

Resource links provided by the National Library of Medicine


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.
Other: Myofascial Group
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)

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.
Other: Sham 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.




Primary Outcome Measures :
  1. Assessment of Pain Pressure Threshold on Trigger Points with Algometer [ Time Frame: 12 weeks ]
    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 :
  1. Neck Disability Index [ Time Frame: 12 weeks ]
    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.

  2. Assessment of Perceived Pain on Cervical Region [ Time Frame: 12 weeks ]
    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).

  3. Global Rating of Change Scale-Turkish Version [ Time Frame: 12 weeks ]
    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.

  4. Assessment of Cervical Active Range of Motion (ROM) [ Time Frame: 12 weeks ]
    Patients cervical flexion, lateral flexin and rotation ROM's will be assessed with a goniometer.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03585283


Locations
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Turkey
Abant Izzet Baysal University
Bolu, Turkey
Sponsors and Collaborators
Abant Izzet Baysal University
Investigators
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Study Director: Şebnem Avcı, Ph.D Abant Izzet Baysal University

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Responsible Party: Ramazan KURUL, Ms.C Research Assistant, Abant Izzet Baysal University
ClinicalTrials.gov Identifier: NCT03585283     History of Changes
Other Study ID Numbers: AbantIBU-Phys2
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ramazan KURUL, Abant Izzet Baysal University:
Myofascial Release
Manual Therapies

Additional relevant MeSH terms:
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Neck Pain
Myofascial Pain Syndromes
Pain
Neurologic Manifestations
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases