Neck PainNCT04610255
Dynamic Myofascial Release in Patients With Non-specific Neck Pain.
A study testing Assigned Interventions and Dynamic myofascial release in people with Neck Pain, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Assigned Interventions and Dynamic myofascial release
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2019to 20 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Maroof International Hospital
Islamabad, Fedral,Pakistan, 44000
About this study
Official title: Effects of Dynamic Myofascial Release in Patients With Non-specific Neck Pain.
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.
Read the 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.
- Conditions
- Neck Pain
- Being tested
- Assigned Interventions, Dynamic myofascial release
- Keywords
- Neck Pain, Myofascial Release, Dynamic Myofascial Release
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assigned InterventionsOther
- 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.
Dynamic myofascial releaseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Traditional physical therapy | Active comparator | Cervical isometrics and Muscle Stretching Receives: Other: Assigned Interventions |
| Dynamic myofascial release | Experimental | Experimental group was given Dynamic myofascial release along with the cervical isometrics and muscle stretching Receives: Other: Dynamic myofascial release |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 weeks
Secondary outcomes (2)
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
Measured: 2 weeks
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
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start1 Dec 2019
- Primary completion20 Dec 2020
- Study completion20 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shafaq Shahid, MSPT(OMPT), Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04610255
- Sponsor's protocol ID
- REC/00678 Haseeb Shah
- Status last verified
- Dec 2020
- First submitted
- 9 Oct 2020
- Last updated
- 22 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28025371McLean 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.
PubMed 20466711Ajimsha 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.
PubMed 25603749Rodriguez-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.
PubMed 29912003Arguisuelas 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.
PubMed 28441294Cathcart 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.
PubMed 30691766Ferraz 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.
PubMed 2213777Hawker 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.
PubMed 22588748
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dynamic Myofascial Release in Patients With Non-specific Neck Pain.
- ClinicalTrials.gov ID
- NCT04610255
- Acronym / sponsor ID
- REC/00678 Haseeb Shah
- Conditions
- Neck Pain
- Keywords
- Neck Pain, Myofascial Release, Dynamic Myofascial Release
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 20 Dec 2020 (actual)
- First posted
- 30 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional physical therapy | Active comparator | Other: Assigned InterventionsCervical isometrics and Muscle Stretching |
| Dynamic myofascial release | Experimental | Other: Dynamic myofascial releaseExperimental group was given Dynamic myofascial release along with the cervical isometrics and muscle stretching |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assigned Interventions* 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. | Other | Traditional physical therapy |
| Dynamic myofascial releaseDMFR 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. | Other | Dynamic myofascial release |
Primary outcome
Numeric pain rating scale
Time frame: 2 weeks
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
2 secondary outcomes
Inclinometer
Time frame: 2 weeks
Neck Disability Index
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
- Background: PubMed 28025371Cerezo-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.
- Background: PubMed 20466711McLean 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.
- Background: PubMed 25603749Ajimsha 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.
- Background: PubMed 29912003Rodriguez-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.
- Background: PubMed 28441294Arguisuelas 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.
- Background: PubMed 30691766Cathcart 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.
- Background: PubMed 2213777Ferraz 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.
- Background: PubMed 22588748Hawker 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shafaq Shahid, MSPT(OMPT) principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assigned Interventions and Dynamic myofascial release in people with Neck Pain, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric pain rating scale (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04610255, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2020.