Deep Neck Flexors TrainingNCT06107270
Effect of Deep Neck Flexors Biofeedback Training and Post Isometric Relaxation in Chronic Mechanical Neck Pain
A study testing pressure biofeedback, therapeutic ultra sound and infra red radiation in people with Deep Neck Flexors Training and Post Isometric Relaxation, run by Cairo University.
Trial summary
This study will be conducted to explore the superiority of effectiveness between Muscle energy technique combined with Deep Neck Flexors training, MET alone, or DNF training alone in terms of pain intensity, neck function, forward head posture, cervical range of motion and Deep Neck Flexors Muscles endurance in… Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Deep Neck Flexors Training, Post Isometric Relaxation
- What is being tested?
- pressure biofeedback, therapeutic ultra sound and infra red radiation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 1 Jun 2024
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age group 20-40 years of female and male patient.
- Patient with neck pain duration more than 3 months and less than one year.
- Subjects who could not maintain blood pressure at increments of 24 mmHg from the initial 20 mm Hg
- Patients who have moderate neck pain and disability scoring 15 to 24 from 50 on neck disability index. .
- Pain intensity more than 3 and less than 7 on visual analogue scale (VAS)
- CVA less than 49°
Who cannot join
- People with severe neck pain. (Disability scoring more than 25 on Neck Disability Index)
- If they are participated in a neck rehabilitation program over the last 6 months
- Major circulatory or respiratory disorder
- Pregnant women or 3 months postnatal
- Patient with structural instability and degenerative conditions of cervical spine.
- Body Mass Index more than 30.
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- Post traumatic or infective conditions.
- Any surgeries around cervical spine
- Vertigo patient
- Un-cooperative patient (Gupta et al., 2022).
Trial locations and contacts
No sites are listed yet.
Salwa Abdel-mageed, Doctoral contact
About this study
This study will be conducted to explore the superiority of effectiveness between Muscle energy technique combined with Deep Neck Flexors training, MET alone, or DNF training alone in terms of pain intensity, neck function, forward head posture, cervical range of motion and Deep Neck Flexors Muscles endurance in patients with chronic mechanical neck pain(CMNP).
Read the detailed description
Patients will be grouped into three groups; each group composed of 15 patients suffering from CMNP. The personal history of each patient who participated in the study will be collected, the patient will receive an oral explanation of the procedures and signed a consent form . The weight and height of each patient will be obtained using the standard weight scale. The pain intensity level will be assessed via a visual analogue scale (VAS). The disability level will be assessed via neck disability index (NDI). The forward head posture will be assessed via photographic method of Craniovertebral angle (CVA) and the angle will be calculated by using kinovea software. The range of motion will be assessed via universal goniometer (UG). The endurance of the neck muscles will be assessed via pressure biofeedback unit (PBU). Assessment will be done before treatment and after 12 treatment sessions.
- Being tested
- pressure biofeedback, therapeutic ultra sound, infra red radiation, post isometric relaxation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pressure biofeedbackDevice
uninflated pressure sensor will be kept below the neck suboccipital
therapeutic ultra soundDevice
continuous US waves of 1 MHz frequency and 1-1.5 W/cm2 power
infra red radiationDevice
(R 125, 250watt, Philips)
post isometric relaxationOther
sustained contraction followed by relaxation
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | (n=15) will be treated by Post Isometric Relaxation, infrared radiation and continuous ultrasound for 12 sessions (3 sessions per week for four weeks). Receives: Device: therapeutic ultra sound; Device: infra red radiation; Other: post isometric relaxation |
| Group B | Experimental | (n=15) will be treated by DNF training, infrared radiation and continuous ultrasound for 12 sessions (3 sessions per week for four weeks) Receives: Device: pressure biofeedback; Device: therapeutic ultra sound; Device: infra red radiation |
| Group C | Experimental | (n=15) will be treated by Post Isometric Relaxation combined DNF training, infrared radiation and continuous ultrasound for 12 sessions (3 sessions per week for four weeks) Receives: Device: pressure biofeedback; Device: therapeutic ultra sound; Device: infra red radiation; Other: post isometric relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain severity
Visual Analogue Scale It is a 10 cm or 100 mm psychometric response scale to measure pain intensity based on numerical values, anchored by a score of 0 no pain and score 10 worst pain The patient will be asked to place a horizontal mark on the continuous 10 cm line in which they could feel. A ruler will be then used to measure the distance from zero and the recorded number will be rounded to the nearest number Visual Analogue Scale .It is a 10 cm or 100 mm anchored by a score of 0 no pain and score 10 worst pain
Measured: 4 weeks
functional disability
Neck Disability Index . 0% means no activity limitation, and 50 points or 100% means complete activity limitation
Measured: 4 weeks
Deep Neck Flexors muscle endurance
Pressure biofeedback unit . used for muscular assessment of longus colli and longus capitus.
Measured: 4 weeks
Secondary outcomes (2)
craniovertebral angle (CVA)
Kinovea (version 0.9.5) will be used to calculate the CVA
Measured: 4 weeks
cervical range of motion
Universal goniometer.to measure the active cervical range of motion in all directions.
Measured: 4 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 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Neck Flexors TrainingStudies 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
- Group A (n=15) will be treated by Post Isometric Relaxation, infrared radiation and continuous ultrasound for 12 sessions (3 sessions per week for four weeks). Group B (n=15) will be treated by DNF training, infrared radiation and continuous ultrasound for 12 sessions (3 sessions per week for four weeks) Group C (n=15) will be treated by Post Isometric Relaxation combined DNF training, infrared radiation and continuous ultrasound for 12 sessions (3 sessions per week for four weeks)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Mohammed Hamed Sherif, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06107270
- Sponsor's protocol ID
- DNFT+PIR technique
- Status last verified
- Oct 2023
- First submitted
- 19 Oct 2023
- Last updated
- 1 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Deep Neck Flexors Biofeedback Training and Post Isometric Relaxation in Chronic Mechanical Neck Pain
- ClinicalTrials.gov ID
- NCT06107270
- Acronym / sponsor ID
- DNFT+PIR technique
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 30 Oct 2023 (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.
This study will be conducted to explore the superiority of effectiveness between Muscle energy technique combined with Deep Neck Flexors training, MET alone, or DNF training alone in terms of pain intensity, neck function, forward head posture, cervical range of motion and Deep Neck Flexors Muscles endurance in patients with chronic mechanical neck pain(CMNP).
Detailed description
Patients will be grouped into three groups; each group composed of 15 patients suffering from CMNP. The personal history of each patient who participated in the study will be collected, the patient will receive an oral explanation of the procedures and signed a consent form . The weight and height of each patient will be obtained using the standard weight scale. The pain intensity level will be assessed via a visual analogue scale (VAS). The disability level will be assessed via neck disability index (NDI). The forward head posture will be assessed via photographic method of Craniovertebral angle (CVA) and the angle will be calculated by using kinovea software. The range of motion will be assessed via universal goniometer (UG). The endurance of the neck muscles will be assessed via pressure biofeedback unit (PBU). Assessment will be done before treatment and after 12 treatment sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Group A (n=15) will be treated by Post Isometric Relaxation, infrared radiation and continuous ultrasound for 12 sessions (3 sessions per week for four weeks). Group B (n=15) will be treated by DNF training, infrared radiation and continuous ultrasound for 12 sessions (3 sessions per week for four weeks) Group C (n=15) will be treated by Post Isometric Relaxation combined DNF training, infrared radiation and continuous ultrasound for 12 sessions (3 sessions per week for four weeks)
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: therapeutic ultra sound, Device: infra red radiation, Other: post isometric relaxation(n=15) will be treated by Post Isometric Relaxation, infrared radiation and continuous ultrasound for 12 sessions (3 sessions per week for four weeks). |
| Group B | Experimental | Device: pressure biofeedback, Device: therapeutic ultra sound, Device: infra red radiation(n=15) will be treated by DNF training, infrared radiation and continuous ultrasound for 12 sessions (3 sessions per week for four weeks) |
| Group C | Experimental | Device: pressure biofeedback, Device: therapeutic ultra sound, Device: infra red radiation, Other: post isometric relaxation(n=15) will be treated by Post Isometric Relaxation combined DNF training, infrared radiation and continuous ultrasound for 12 sessions (3 sessions per week for four weeks) |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age group 20-40 years of female and male patient.
- Patient with neck pain duration more than 3 months and less than one year.
- Subjects who could not maintain blood pressure at increments of 24 mmHg from the initial 20 mm Hg
- Patients who have moderate neck pain and disability scoring 15 to 24 from 50 on neck disability index. .
- Pain intensity more than 3 and less than 7 on visual analogue scale (VAS)
Key exclusion criteria (10 listed)
- People with severe neck pain. (Disability scoring more than 25 on Neck Disability Index)
- If they are participated in a neck rehabilitation program over the last 6 months
- Major circulatory or respiratory disorder
- Pregnant women or 3 months postnatal
- Patient with structural instability and degenerative conditions of cervical spine.
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 |
|---|---|---|
| pressure biofeedbackuninflated pressure sensor will be kept below the neck suboccipital | Device | Group B, Group C |
| therapeutic ultra soundcontinuous US waves of 1 MHz frequency and 1-1.5 W/cm2 power | Device | Group A, Group B, Group C |
| infra red radiation(R 125, 250watt, Philips) | Device | Group A, Group B, Group C |
| post isometric relaxationsustained contraction followed by relaxation | Other | Group A, Group C |
Primary outcome
pain severity
Time frame: 4 weeks
Visual Analogue Scale It is a 10 cm or 100 mm psychometric response scale to measure pain intensity based on numerical values, anchored by a score of 0 no pain and score 10 worst pain The patient will be asked to place a horizontal mark on the continuous 10 cm line in which they could feel. A ruler will be then used to measure the distance from zero and the recorded number will be rounded to the nearest number Visual Analogue Scale .It is a 10 cm or 100 mm anchored by a score of 0 no pain and score 10 worst pain
functional disability
Time frame: 4 weeks
Neck Disability Index . 0% means no activity limitation, and 50 points or 100% means complete activity limitation
Deep Neck Flexors muscle endurance
Time frame: 4 weeks
Pressure biofeedback unit . used for muscular assessment of longus colli and longus capitus.
2 secondary outcomes
craniovertebral angle (CVA)
Time frame: 4 weeks
cervical range of motion
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Deep Neck Flexors Training
Recruiting
Deep Cervical Flexor and Sensorimotor Training for Chronic Neck Pain
Mechanical Neck Pain
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.
Salwa Abdel-mageed, Doctoral contact
Questions about this trial
What is this clinical trial studying?
A study testing pressure biofeedback, therapeutic ultra sound and infra red radiation in people with Deep Neck Flexors Training and Post Isometric Relaxation, run by Cairo University.
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 6 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eman Sherif, Doctoral (01016493234, doctoremo87@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain severity (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Nov 2023.