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Dynamic Myofascial Release in Patients With Non-specific Neck Pain.

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Assigned Interventions
Dynamic myofascial release
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Neck Pain, Myofascial Release, Dynamic Myofascial Release

Eligibility Criteria

35 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants had a complaint of non-specific pain in the neck with duration of at least 3 weeks.
  • The area of neck pain was defined to the cervical Region, with or without radiating to head or arms.
  • Patients with tight upper trapezius or levator scapulae or both with or without the presence of myofascial trigger points.

Exclusion Criteria:

  • NP due to traumatism, fractures, or whiplash;
  • Neoplasia, severe osteoporosis, infectious, or inflammatory processes.
  • Ppatient's with pacemakers, congenital anomalies, previous neck surgery, or pregnancy.
  • Patients who had received MRT in the previous month.

Sites / Locations

  • Maroof International Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Traditional physical therapy

Dynamic myofascial release

Arm Description

Cervical isometrics and Muscle Stretching

Experimental group was given Dynamic myofascial release along with the cervical isometrics and muscle stretching

Outcomes

Primary Outcome Measures

Numeric pain rating scale
The NPRS can be administered verbally or graphically for self-completion. The respondent is asked to indicate the numeric value on the segmented scale that best describes their pain intensity. High test-retest reliability has been observed (r = 0.96 and 0.95, respectively with minimum score 0 to maximum 10

Secondary Outcome Measures

Inclinometer
The instrument has an inclination needle, affected by gravity that is used to measure ranges of cervical spine, with ICCs ranging from .89 to .94
Neck Disability Index
The Neck Disability Index (NDI) is a 10-item questionnaire that measures a patient's self-reported neck pain related disability. It has been shown to have high "test-retest" reliability. The NDI has also been shown to be valid when comparing it to other pain and disability measures. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50

Full Information

First Posted
October 9, 2020
Last Updated
December 21, 2020
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04610255
Brief Title
Dynamic Myofascial Release in Patients With Non-specific Neck Pain.
Official Title
Effects of Dynamic Myofascial Release in Patients With Non-specific Neck Pain.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
December 20, 2020 (Actual)
Study Completion Date
December 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

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

5. Study Description

Brief Summary
Dynamic myofascial release is similar to joint mobilization (active physiological movements) to increase ROM with the myofascial release for fascia release. It differs from myofascial release in a way that it is a dynamic approach in which the patient is actively involved. In 2019 study was conducted on the effects of Dynamic myofascial release showing significant increase in all trunk ROMs and functional reach test in patients with chronic non-specific low back pain. To summarize, this study will going to see the effectiveness of dynamic myofascial release by addressing both fascia and active physiological movements and see the response of patient's pain level, cervical ROM, improvement in the ability to manage in activities of daily life. Furthermore this study helps to find out its effectiveness and its clinical importance in treating patients with neck pain, considering its significance of engaging multiple structures.
Detailed Description
Neck pain is one of the most common and painful musculoskeletal conditions. For the majority of the neck disorders there is an absence of an identifiable underlying disease or abnormal anatomical structure. As a consequence they are classified as 'non-specific'. The natural course of nonspecific neck pain remains unclear. While it is often self-limiting within a few weeks of onset, it can severely limit daily functioning, induce substantial medical consumption and result in prolonged sick leave and disability. As a consequence it places a heavy burden on individuals, employers and health care services." Non-specific neck pain, also referred to as mechanical neck pain, is diagnosed as cervical pain with or without radiation without a known pathological basis as the underlying cause of the complaints.Overall analysis revealed evidence that middle age and then adults, female gender, high job demands, low social or work support, being an ex-smoker, a history of low back disorders and a history of neck disorders predicts the future onset of neck pain. In recent years, several studies have emerged about myofascial pain syndrome among patients suffering from neck pain. Myofascial pain syndrome is the presentation of sensory, motor, and autonomic symptoms caused by Myofascial trigger points . In 2014 study concluded that the most prevalent active myofascial trigger points in the trapezius muscles were identified in 93.75% of the subjects, in the levator scapulae in 82.14%, and in the multifidi in 77.68% of the subjects. Myofascial trigger points in the splenius cervicis reached a prevalence of 62.5% . Myofascial release is a widely employed manual therapy treatment that involves specifically guided low load, long duration mechanical forces to manipulate the myofascial complex, intended to restore optimal length, decrease pain, and improve function. Myofascial release when used in conjunction with conventional treatment is said to be effective to provide immediate relief of pain and tissue tenderness. Myofascial release generally involves slow, sustained pressure applied to restricted fascial layers either directly (direct MFR technique) or indirectly (indirect MFR technique). Direct Myofascial release technique is thought to work directly over the restricted fascia: practitioners use knuckles or elbow or other tools to slowly sink into the fascia, and the pressure applied is a few kilograms of force to contact the restricted fascia, apply tension, or stretch the fascia. Indirect Myofascial release involves a gentle stretch guided along the path of least resistance until free movement is achieved. In 2018 study concluded in a study to see the effects of Myofascial release in patients with neck pain that both Myofascial release and Physical therapy multimodal programs provide improvement of pain in patients with neck pain. However, Myofascial release could be better than a Physical therapy multimodal program that includes Ultrasound , TENS, and massage. Overall, the improvement of pressure pain threshold provided by MFR was 20% greater than that provided by a Physical therapy multimodal program. In 2017 study found significant improvement in both pain and disability among patients with low back pain in response to myofascial release applied to the lumbar region. In 2018 study performed Myofascial release on thoracic spine and demonstrated that Myofascial release can be effective in increasing both local and distal Range of motion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Neck Pain, Myofascial Release, Dynamic Myofascial Release

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Traditional physical therapy
Arm Type
Active Comparator
Arm Description
Cervical isometrics and Muscle Stretching
Arm Title
Dynamic myofascial release
Arm Type
Experimental
Arm Description
Experimental group was given Dynamic myofascial release along with the cervical isometrics and muscle stretching
Intervention Type
Other
Intervention Name(s)
Assigned Interventions
Intervention Description
Hot pack for 10 minutes TENS for 10 minutes Trigger point release if any found. Myofascial release Home plan for stretching exercises will be prescribed to the patient. Receive two weeks intervention plan, three sessions per week.
Intervention Type
Other
Intervention Name(s)
Dynamic myofascial release
Intervention Description
DMFR involves a manual application of low amplitude, long duration stretch to the fascia and muscle. Participants were instructed to relax as much as possible, and the therapist proceeded to smoothly move the joints in a diagonal or horizontal direction at a slow rate within the ROM. The therapist repeatedly pushed, pulled, or shook the joint area about three to five times for about 3 seconds with slight motion at the end of ROM. Conventional therapy will includes Hot pack for 10 minutes TENS for 10 minutes Trigger point release if any found. Myofascial release Home plan for stretching exercises will be prescribed to the patient. Receive two weeks intervention plan, three sessions per week.
Primary Outcome Measure Information:
Title
Numeric pain rating scale
Description
The NPRS can be administered verbally or graphically for self-completion. The respondent is asked to indicate the numeric value on the segmented scale that best describes their pain intensity. High test-retest reliability has been observed (r = 0.96 and 0.95, respectively with minimum score 0 to maximum 10
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Inclinometer
Description
The instrument has an inclination needle, affected by gravity that is used to measure ranges of cervical spine, with ICCs ranging from .89 to .94
Time Frame
2 weeks
Title
Neck Disability Index
Description
The Neck Disability Index (NDI) is a 10-item questionnaire that measures a patient's self-reported neck pain related disability. It has been shown to have high "test-retest" reliability. The NDI has also been shown to be valid when comparing it to other pain and disability measures. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants had a complaint of non-specific pain in the neck with duration of at least 3 weeks. The area of neck pain was defined to the cervical Region, with or without radiating to head or arms. Patients with tight upper trapezius or levator scapulae or both with or without the presence of myofascial trigger points. Exclusion Criteria: NP due to traumatism, fractures, or whiplash; Neoplasia, severe osteoporosis, infectious, or inflammatory processes. Ppatient's with pacemakers, congenital anomalies, previous neck surgery, or pregnancy. Patients who had received MRT in the previous month.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shafaq Shahid, MSPT(OMPT)
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maroof International Hospital
City
Islamabad
State/Province
Fedral,Pakistan
ZIP/Postal Code
44000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28025371
Citation
Cerezo-Tellez E, Torres-Lacomba M, Mayoral-Del Moral O, Sanchez-Sanchez B, Dommerholt J, Gutierrez-Ortega C. Prevalence of Myofascial Pain Syndrome in Chronic Non-Specific Neck Pain: A Population-Based Cross-Sectional Descriptive Study. Pain Med. 2016 Dec;17(12):2369-2377. doi: 10.1093/pm/pnw114. Epub 2016 Jun 20.
Results Reference
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PubMed Identifier
20466711
Citation
McLean SM, May S, Klaber-Moffett J, Sharp DM, Gardiner E. Risk factors for the onset of non-specific neck pain: a systematic review. J Epidemiol Community Health. 2010 Jul;64(7):565-72. doi: 10.1136/jech.2009.090720. Epub 2010 May 12.
Results Reference
background
PubMed Identifier
25603749
Citation
Ajimsha MS, Al-Mudahka NR, Al-Madzhar JA. Effectiveness of myofascial release: systematic review of randomized controlled trials. J Bodyw Mov Ther. 2015 Jan;19(1):102-12. doi: 10.1016/j.jbmt.2014.06.001. Epub 2014 Jun 13.
Results Reference
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PubMed Identifier
29912003
Citation
Rodriguez-Huguet M, Lomas-Vega R. Response to the Letter to the Editor on "Effects of Myofascial Release on Pressure Pain Thresholds in Patients With Neck Pain: A Single-Blind Randomized Controlled Trial". Am J Phys Med Rehabil. 2019 Jan;98(1):e4-e5. doi: 10.1097/PHM.0000000000000986. No abstract available.
Results Reference
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PubMed Identifier
28441294
Citation
Arguisuelas MD, Lison JF, Sanchez-Zuriaga D, Martinez-Hurtado I, Domenech-Fernandez J. Effects of Myofascial Release in Nonspecific Chronic Low Back Pain: A Randomized Clinical Trial. Spine (Phila Pa 1976). 2017 May 1;42(9):627-634. doi: 10.1097/BRS.0000000000001897.
Results Reference
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PubMed Identifier
30691766
Citation
Cathcart E, McSweeney T, Johnston R, Young H, Edwards DJ. Immediate biomechanical, systemic, and interoceptive effects of myofascial release on the thoracic spine: A randomised controlled trial. J Bodyw Mov Ther. 2019 Jan;23(1):74-81. doi: 10.1016/j.jbmt.2018.10.006. Epub 2018 Oct 24.
Results Reference
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PubMed Identifier
2213777
Citation
Ferraz MB, Quaresma MR, Aquino LR, Atra E, Tugwell P, Goldsmith CH. Reliability of pain scales in the assessment of literate and illiterate patients with rheumatoid arthritis. J Rheumatol. 1990 Aug;17(8):1022-4.
Results Reference
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PubMed Identifier
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Citation
Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.
Results Reference
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Dynamic Myofascial Release in Patients With Non-specific Neck Pain.

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