Neck PainNCT05061121
Effect of Sustained Natural Apophseal Glides and Myofascial Release on Chronic Non-specific Neck Pain
A study testing combined effect in people with Neck Pain, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of investigator's study is to combine and compare the two scientifically approved therapies for the CNSNP to investigate the short term and mid-term changes of the combination of these two manual techniques concerning pain, function, range of motion ROM and postural stability. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Pain
- What is being tested?
- combined effect
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2021to 1 Apr 2022
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age ranged from 20-45 years
- Current neck pain
- Neck pain continued for at least the last 12 week
- Pain with no obvious organic or pathologic cause.
- The patients diagnosed as chronic non-specific neck pain through an orthopedic specialist, diagnostic investigations including X rays and MRI failed to show obvious pathological findings
Who cannot join
- Irradiated neck pain
- Neck pain associated with vertigo
- Osteoporosis
- Diagnosed psychological disorders
- Vertebral fractures
- Tumors
Show all 11Show fewer
- Diagnosed metabolic diseases
- Previous neck surgery
- Red flags (night pain, severe muscle spasm, loss of
- involuntary weight, symptom mismatch)
- Physiotherapeutic treatment continued in the last 3 months
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Misr University For Science and Technology
El-Sheikh Zayed City, Giza Governorate, 3236101
About this study
Official title: Effect of Sustained Natural Apophyseal Glides and Myofascial Release on Chronic Non-specific Neck Pain : Randomized Controlled Trial
The aim of investigator's study is to combine and compare the two scientifically approved therapies for the CNSNP to investigate the short term and mid-term changes of the combination of these two manual techniques concerning pain, function, range of motion ROM and postural stability.
Read the detailed description
Neck pain NP is a recognized medical and socioeconomic problem, which is responsible for high treatment costs, sick leave, and individual suffering, in addition to being one of the main reasons for people to seek health care services .NP is widely spread in healthcare centers with a prevalence estimation of 288.7 million, in North Africa and the Middle East ranged between 3917.7 to 5022.4 per 100 000 populations in 2017. NP with symptoms duration exceeding 12 weeks is considered chronic.
Individuals who have chronic non-specific neck pain CNSNP have less quality of life, and more pain interference in their life. More over studies showed that patients with CNSNP subjects have poorer postural control than healthy subjects.
Alteration of the proprioception of the neck muscles and joints that play a master role in the cervical joint position and motor control of the head could be the primary cause of CNSNP . Studies have evaluated the effect of different manual techniques in cases of CNSNP checking mainly usefulness and effectiveness of these interventions on this clinical condition. However, there is less evidence in literature investigating the short and mid-term changes of these techniques.
Manual therapy, is a physical treatment primarily used by physical therapists, occupational therapists, manipulative therapy to treat musculoskeletal pain and disability; it is most commonly includes kneading , manipulation of the muscles and mobilization of joints .Many Studies investigating the effectiveness of manual therapies on CNSNP ,proving reduction of spinal excitability and pain sensitivity, enhancement of function and range of motion.
Brian Mulligan techniques are widely used for joint dysfunction by growing number of therapists and are an important addition to the field of Manual Therapy. Literature reveals many and diverse treatment approaches for chronic neck pain. Sustained natural apophyseal glides SNAGs are pain free spinal manual therapy treatment techniques involving concurrent accessory joint gliding and active physiological movement, with overpressure at end range, which are utilized for painful movement restrictions of the spine.
Mulligan's SNAGs is one of the most statistically proved in many studies that manual therapy technique affects proprioception, function, range of motion, pain.
On the other hand, Myofascial release which is a form of soft tissue therapy that is intended to reduce pain and increase mobility in patients that are suffering from chronic pain conditions. Myofascial release has shown effectiveness in reducing mechanical neck pain and in improving functional abilities by freeing restrictions of movement that originate in the soft tissues of the body.
Furthermore, as the focus of most previous studies has been to examine compare mulligan's SNAGs and Myofascial release separately, studies on their combination effects have been largely ignored. Both two techniques have shown efficacy, but since SNAGS and Myofascial release are different mechanisms of action, the time of their effects and their progression could be different.
The aim of investigators' study is to combine and compare the two scientifically approved therapies for the CNSNP to investigate the short term and mid-term changes of the combination of these two manual techniques concerning pain, function, range of motion ROM and postural stability.
- Conditions
- Neck Pain
- Being tested
- combined effect
- Keywords
- CNSNP, SNAGs, MFR
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combined effectOther
Compare the short- and mid-term effects of Mulligan's SNAGs, Myofascial release, and their combination on pain intensity, pain pressure sensitivity, cervical function, range of motion (ROM) and postural stability in CNSNP patients
| Study group | Role | What they receive |
|---|---|---|
| sustained natural apophyseal glides | Experimental | Investigate the short- and mid-term effects of Mulligan's SNAGs on pain intensity, pain pressure sensitivity, cervical function, range of motion (ROM) and postural stability in CNSNP patients Receives: Other: combined effect |
| Myofascial release | Experimental | Investigate the short- and mid-term effects of Myofascial release on pain intensity, pain pressure sensitivity, cervical function, range of motion (ROM) and postural stability in CNSNP patients Receives: Other: combined effect |
| sustained natural apophyseal glides in addition to myofascial release | Experimental | Investigate the short- and mid-term effects of Mulligan's SNAGs combined with Myofascial release on pain intensity, pain pressure sensitivity, cervical function, range of motion (ROM) and postural stability in CNSNP patients Receives: Other: combined effect |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity VAS
visual analogue scale ,The pain VAS is a continuous scale formed of a horizontal (HVAS) or vertical (VVAS) line, 100 mm in length, ended with 2 verbal pain descriptor on either end one for each symptom extreme; "no pain" at the most left side of the line (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 /100-mm scale) on the rightest end
Measured: 15 mins
Pressure pain threshold PPT
pressure algometer ,The PPT represents a hybrid test, falling somewhere between self-reported paper-and-pencil type tools and objective diagnostic techniques
Measured: 30 mins
function
Neck Disability Index (NDI) This index consists of ten sections, including seven sections related to activities of daily living, two sections related to pain, and one section related to concentration. The score for each section is from 0 to 5, with 0 representing the highest level of function and 5 representing the lowest level of function. Total NDI-TH scores are shown as a percentage. A high score corresponds to a higher degree of disability. The internal consistency of the NDI-TH is high.
Measured: 15 mins
Range of motion
Cervical range of motion device (CROM) The CROM device is a reliable outcome tool for measuring upper cervical rotation. The clinical implications of these findings suggest that therapists can utilize the CROM device to more completely examine all planes of upper and full cervical mobility. It may also assist in identifying upper cervical ROM limitations associated with underlying cervical pathology or motion dysfunction
Measured: 30 mins
postural stability
Biodex Balance System (BBS) The Biodex balance system (BBS) uses a circular platform that is free to move in the anterior-posterior and medial-lateral axes simultaneously, which permits three measures to be obtained: an overall stability index (OSI), an anterior-posterior stability index (APSI), and a medial-lateral stability index (MLSI) will measure OSI ,APSI ,and MLSI
Measured: 30 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start1 Dec 2021
- Primary completion1 Mar 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 Cairo 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
- Model description
- Design of the study: Single-blinded randomized controlled trial design. Patients will be randomly assigned into 3 equal groups using the statistical package for social science (SPSS 20). Group A (Mulligan's SNAGs) Group B (Myofascial release) Group C (Mulligan's SNAGs + Myofascial release)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amal Ahmed Mohamed Morsi Abdel-Baky, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05061121
- Sponsor's protocol ID
- SNAGs and MFR
- Status last verified
- Sep 2022
- First submitted
- 31 Aug 2021
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bernal-Utrera C, Gonzalez-Gerez JJ, Anarte-Lazo E, Rodriguez-Blanco C. Manual therapy versus therapeutic exercise in non-specific chronic neck pain: a randomized controlled trial. Trials. 2020 Jul 28;21(1):682. doi: 10.1186/s13063-020-04610-w.
PubMed 32723399Binder A. The diagnosis and treatment of nonspecific neck pain and whiplash. Eura Medicophys. 2007 Mar;43(1):79-89.
PubMed 17369782Hidalgo B, Hall T, Bossert J, Dugeny A, Cagnie B, Pitance L. The efficacy of manual therapy and exercise for treating non-specific neck pain: A systematic review. J Back Musculoskelet Rehabil. 2017 Nov 6;30(6):1149-1169. doi: 10.3233/BMR-169615.
PubMed 28826164Gonzalez Rueda V, Lopez de Celis C, Barra Lopez ME, Carrasco Uribarren A, Castillo Tomas S, Hidalgo Garcia C. Effectiveness of a specific manual approach to the suboccipital region in patients with chronic mechanical neck pain and rotation deficit in the upper cervical spine: study protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2017 Sep 5;18(1):384. doi: 10.1186/s12891-017-1744-5.
PubMed 28870191
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sustained Natural Apophyseal Glides and Myofascial Release on Chronic Non-specific Neck Pain : Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05061121
- Acronym / sponsor ID
- SNAGs and MFR
- Conditions
- Neck Pain
- Keywords
- CNSNP, SNAGs, MFR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 29 Sep 2021 (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.
The aim of investigator's study is to combine and compare the two scientifically approved therapies for the CNSNP to investigate the short term and mid-term changes of the combination of these two manual techniques concerning pain, function, range of motion ROM and postural stability.
Detailed description
Neck pain NP is a recognized medical and socioeconomic problem, which is responsible for high treatment costs, sick leave, and individual suffering, in addition to being one of the main reasons for people to seek health care services .NP is widely spread in healthcare centers with a prevalence estimation of 288.7 million, in North Africa and the Middle East ranged between 3917.7 to 5022.4 per 100 000 populations in 2017. NP with symptoms duration exceeding 12 weeks is considered chronic.
Individuals who have chronic non-specific neck pain CNSNP have less quality of life, and more pain interference in their life. More over studies showed that patients with CNSNP subjects have poorer postural control than healthy subjects.
Alteration of the proprioception of the neck muscles and joints that play a master role in the cervical joint position and motor control of the head could be the primary cause of CNSNP . Studies have evaluated the effect of different manual techniques in cases of CNSNP checking mainly usefulness and effectiveness of these interventions on this clinical condition. However, there is less evidence in literature investigating the short and mid-term changes of these techniques.
Manual therapy, is a physical treatment primarily used by physical therapists, occupational therapists, manipulative therapy to treat musculoskeletal pain and disability; it is most commonly includes kneading , manipulation of the muscles and mobilization of joints .Many Studies investigating the effectiveness of manual therapies on CNSNP ,proving reduction of spinal excitability and pain sensitivity, enhancement of function and range of motion.
Brian Mulligan techniques are widely used for joint dysfunction by growing number of therapists and are an important addition to the field of Manual Therapy. Literature reveals many and diverse treatment approaches for chronic neck pain. Sustained natural apophyseal glides SNAGs are pain free spinal manual therapy treatment techniques involving concurrent accessory joint gliding and active physiological movement, with overpressure at end range, which are utilized for painful movement restrictions of the spine.
Mulligan's SNAGs is one of the most statistically proved in many studies that manual therapy technique affects proprioception, function, range of motion, pain.
On the other hand, Myofascial release which is a form of soft tissue therapy that is intended to reduce pain and increase mobility in patients that are suffering from chronic pain conditions. Myofascial release has shown effectiveness in reducing mechanical neck pain and in improving functional abilities by freeing restrictions of movement that originate in the soft tissues of the body.
Furthermore, as the focus of most previous studies has been to examine compare mulligan's SNAGs and Myofascial release separately, studies on their combination effects have been largely ignored. Both two techniques have shown efficacy, but since SNAGS and Myofascial release are different mechanisms of action, the time of their effects and their progression could be different.
The aim of investigators' study is to combine and compare the two scientifically approved therapies for the CNSNP to investigate the short term and mid-term changes of the combination of these two manual techniques concerning pain, function, range of motion ROM and postural stability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Design of the study: Single-blinded randomized controlled trial design. Patients will be randomly assigned into 3 equal groups using the statistical package for social science (SPSS 20). Group A (Mulligan's SNAGs) Group B (Myofascial release) Group C (Mulligan's SNAGs + Myofascial release)
| Arm | Type | Receives |
|---|---|---|
| sustained natural apophyseal glides | Experimental | Other: combined effectInvestigate the short- and mid-term effects of Mulligan's SNAGs on pain intensity, pain pressure sensitivity, cervical function, range of motion (ROM) and postural stability in CNSNP patients |
| Myofascial release | Experimental | Other: combined effectInvestigate the short- and mid-term effects of Myofascial release on pain intensity, pain pressure sensitivity, cervical function, range of motion (ROM) and postural stability in CNSNP patients |
| sustained natural apophyseal glides in addition to myofascial release | Experimental | Other: combined effectInvestigate the short- and mid-term effects of Mulligan's SNAGs combined with Myofascial release on pain intensity, pain pressure sensitivity, cervical function, range of motion (ROM) and postural stability in CNSNP patients |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age ranged from 20-45 years
- Current neck pain
- Neck pain continued for at least the last 12 week
- Pain with no obvious organic or pathologic cause.
- The patients diagnosed as chronic non-specific neck pain through an orthopedic specialist, diagnostic investigations including X rays and MRI failed to show obvious pathological findings
Key exclusion criteria (11 listed)
- Irradiated neck pain
- Neck pain associated with vertigo
- Osteoporosis
- Diagnosed psychological disorders
- Vertebral fractures
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 |
|---|---|---|
| combined effectCompare the short- and mid-term effects of Mulligan's SNAGs, Myofascial release, and their combination on pain intensity, pain pressure sensitivity, cervical function, range of motion (ROM) and postural stability in CNSNP patients | Other | Myofascial release, sustained natural apophyseal glides, sustained natural apophyseal glides in addition to myofascial release |
Primary outcome
pain intensity VAS
Time frame: 15 mins
visual analogue scale ,The pain VAS is a continuous scale formed of a horizontal (HVAS) or vertical (VVAS) line, 100 mm in length, ended with 2 verbal pain descriptor on either end one for each symptom extreme; "no pain" at the most left side of the line (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 /100-mm scale) on the rightest end
Pressure pain threshold PPT
Time frame: 30 mins
pressure algometer ,The PPT represents a hybrid test, falling somewhere between self-reported paper-and-pencil type tools and objective diagnostic techniques
function
Time frame: 15 mins
Neck Disability Index (NDI) This index consists of ten sections, including seven sections related to activities of daily living, two sections related to pain, and one section related to concentration. The score for each section is from 0 to 5, with 0 representing the highest level of function and 5 representing the lowest level of function. Total NDI-TH scores are shown as a percentage. A high score corresponds to a higher degree of disability. The internal consistency of the NDI-TH is high.
Range of motion
Time frame: 30 mins
Cervical range of motion device (CROM) The CROM device is a reliable outcome tool for measuring upper cervical rotation. The clinical implications of these findings suggest that therapists can utilize the CROM device to more completely examine all planes of upper and full cervical mobility. It may also assist in identifying upper cervical ROM limitations associated with underlying cervical pathology or motion dysfunction
postural stability
Time frame: 30 mins
Biodex Balance System (BBS) The Biodex balance system (BBS) uses a circular platform that is free to move in the anterior-posterior and medial-lateral axes simultaneously, which permits three measures to be obtained: an overall stability index (OSI), an anterior-posterior stability index (APSI), and a medial-lateral stability index (MLSI) will measure OSI ,APSI ,and MLSI
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 7 Sep 2022.
- Background: PubMed 32723399Bernal-Utrera C, Gonzalez-Gerez JJ, Anarte-Lazo E, Rodriguez-Blanco C. Manual therapy versus therapeutic exercise in non-specific chronic neck pain: a randomized controlled trial. Trials. 2020 Jul 28;21(1):682. doi: 10.1186/s13063-020-04610-w.
- Background: PubMed 17369782Binder A. The diagnosis and treatment of nonspecific neck pain and whiplash. Eura Medicophys. 2007 Mar;43(1):79-89.
- Background: PubMed 28826164Hidalgo B, Hall T, Bossert J, Dugeny A, Cagnie B, Pitance L. The efficacy of manual therapy and exercise for treating non-specific neck pain: A systematic review. J Back Musculoskelet Rehabil. 2017 Nov 6;30(6):1149-1169. doi: 10.3233/BMR-169615.
- Background: PubMed 28870191Gonzalez Rueda V, Lopez de Celis C, Barra Lopez ME, Carrasco Uribarren A, Castillo Tomas S, Hidalgo Garcia C. Effectiveness of a specific manual approach to the suboccipital region in patients with chronic mechanical neck pain and rotation deficit in the upper cervical spine: study protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2017 Sep 5;18(1):384. doi: 10.1186/s12891-017-1744-5.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing combined effect in people with Neck Pain, run by Cairo University at 1 site in Egypt.
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 5 inclusion and 11 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 7 Sep 2022. 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 Egypt. 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?
pain intensity VAS (time frame: 15 mins). The study lists 5 primary outcomes in all. 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 NCT05061121, which also lists 4 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 7 Sep 2022.