Head and Neck CancerNCT07313189
Stabilizer Pressure Biofeedback on Neck Dysfunction
A study testing Stabilizer pressure biofeedback plus traditional physical therapy and Traditional physical therapy in people with Head and Neck Cancer, run by Cairo University at 1 site in Egypt.
Trial summary
Fifty patients of both genders with age ranged from 30 - 50 years, suffering from neck dysfunction post neck dissection surgeries participated in this study. The participants were randomly selected from the National Cancer Institute, Cairo, Egypt. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Stabilizer pressure biofeedback plus traditional physical therapy and Traditional physical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Sep 2025to 15 Dec 2025
- 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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The subject selection was according to the following criteria:
- Patients' age ranged between 30-50 years.
- Both gender participated in this study.
- All patients suffered from neck dysfunction (neck pain, limited ROM and disability) following unilateral neck dissection surgeries.
- All patients suffered from moderate to severe pain (VAS score > 4).
- All patients undergone modified radical NDS or selective NDS.
- All patients began the treatment program 2 weeks post neck dissection surgeries
- All patients enrolled to the study had their informed consent.
Who cannot join
- 1- Neck pain due to other underlying conditions such as:
- Spinal fracture
- Osteoporosis
- Spinal cord compression
- Congenital postural deformities
- Inflammatory disorders of the spine
Show all 9Show fewer
- Spinal infections
- Significant neurological disorders
- Rheumatoid arthritis 2- Malignancy 3- Pregnancy 4- History of cervical spine surgery 5- Epilepsy or any psychological disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Stabilizer Pressure Biofeedback on Neck Dysfunction Post Neck Dissection Surgeries
Fifty patients of both genders with age ranged from 30 - 50 years, suffering from neck dysfunction post neck dissection surgeries participated in this study. The participants were randomly selected from the National Cancer Institute, Cairo, Egypt. They were randomly assigned into two equal groups, 25 patients each (study group and control group).
Group A :( Study Group) In this group of the study, received cranio-cervical flexion training utilizing stabilizer pressure biofeedback in addition to traditional physical therapy program (ROM exercises, stretching and strengthening exercises), 3 times a week for 6 weeks.
Group B :( Control Group) In this group of the study, received traditional physical therapy program (ROM exercises, stretching and strengthening exercises), 3 times a week for 6 weeks.
Read the detailed description
1-Subjects: Fifty patients of both genders with age ranged from 30 - 50 years, suffering from neck dysfunction post neck dissection surgeries participated in this study. The participants were randomly selected from the National Cancer Institute, Cairo, Egypt. They were randomly assigned into two equal groups, 25 patients each (study group and control group).
Group A :( Study Group) In this group of the study, received cranio-cervical flexion training utilizing stabilizer pressure biofeedback in addition to traditional physical therapy program (ROM exercises, stretching and strengthening exercises), 3 times a week for 6 weeks.
Group B :( Control Group) In this group of the study, received traditional physical therapy program (ROM exercises, stretching and strengthening exercises), 3 times a week for 6 weeks.
- Equipment:
Therapeutic equipment:
- Stabilizer pressure biofeedback Strength Training Protocol for Deep Cervical Flexors Using Pressure Biofeedback Unit (PBU):
- The air bag of the pressure biofeedback unit was placed under the occiput. Participants were instructed to perform a gentle nodding movement in order to reach five target pressure levels between 22 and 30 mmHg.
- Each pressure level was held for 10 seconds. The training program consisted of:
- 3 sets per session.
- 10 repetitions in each set.
- A rest period of two minutes was given between each set to prevent muscle fatigue.
- Participants received stabilizer pressure biofeedback training 3 sessions per week for 6 weeks.
- Traditional physical therapy program The traditional physical therapy program included range of motion exercises, stretching exercises, and strengthening exercises, three times a week for six weeks
Measurement equipment:
- Arabic version of neck disability index (NDI): The Neck Disability Index (NDI) is a self-reported questionnaire designed to assess the functional impact of neck pain on daily activities. It consists of 10 items covering aspects such as personal care, work, driving, and recreation, with each item scored on a 0-5 scale (0 = no disability, 5 = maximum disability). The total NDI score (ranging from 0 to 50) is calculated by summing the item scores, where higher scores indicate greater disability.
- Goniometer: A goniometer is a medical device used to measure the joint angles of the body, providing an objective assessment of a joint's range of motion (ROM). In this study, a standard, handheld goniometer will be used to measure cervical range of motion (CROM), which includes four primary movements: flexion (bending the neck forward), extension (bending the neck backward), lateral flexion (bending the neck to the side), and rotation (turning the head left or right).
- Stabilizer pressure biofeedback:
The pressure biofeedback device consists of a meter and a flat pocket pneumatic pump, which transfers the force created by deep cervical muscle contractions to the pressure biofeedback device, which measures the pressure in millimeters of mercury (mmHg). A stabilizer pressure biofeedback device will be used to monitor the constant contractile force of the deep neck muscles.
- Conditions
- Head and Neck Cancer
- Being tested
- Stabilizer pressure biofeedback plus traditional physical therapy, Traditional physical therapy
- Keywords
- Biofeedback, Neck dysfunction, Neck dissection surgeries
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stabilizer pressure biofeedback plus traditional physical therapyDevice
Stabilizer pressure biofeedback
Strength Training Protocol for Deep Cervical Flexors Using Pressure Biofeedback Unit (PBU):
- The air bag of the pressure biofeedback unit was placed under the occiput. Participants instructed to perform a gentle nodding movement in order to reach five target pressure levels between 22 and 30 mmHg.
- Each pressure level held for 10 seconds.
The training program will consist of:
- 3 sets per session.
- 10 repetitions in each set.
- A rest period of two minutes was given between each set to prevent muscle fatigue .
- Participants received stabilizer pressure biofeedback training 3 sessions per week for 6 weeks.
Traditional physical therapy program The traditional physical therapy program included range of motion exercises, stretching exercises, and strengthening exercises, three times a week for six weeks
Traditional physical therapyOther
Traditional physical therapy program The traditional physical therapy program included range of motion exercises, stretching exercises, and strengthening exercises, three times a week for six weeks .
| Study group | Role | What they receive |
|---|---|---|
| Stabilizer pressure biofeedback plus traditional physical therapy | Experimental | Stabilizer pressure biofeedback plus traditional physical therapy
Strength Training Protocol for Deep Cervical Flexors Using Pressure Biofeedback Unit (PBU):
* The air bag of the pressure biofeedback unit was placed under the occiput. Participants instructed to perform a gentle nodding movement in order to reach five target pressure levels between 22 and 30 mmHg.
* Each pressure level was held for 10 seconds.
The training program consisted of:
* 3 sets per session.
* 10 repetitions in each set.
* A rest period of two minutes was given between each set to prevent muscle fatigue .
* Participants received stabilizer pressure biofeedback training 3 sessions per week for 6 weeks.
The traditional physical therapy program included range of motion exercises, stretching exercises, and strengthening exercises, three times a week for six weeks Receives: Device: Stabilizer pressure biofeedback plus traditional physical therapy |
| Traditional physical therapy | Experimental | Traditional Physical Therapy Program The traditional physical therapy program included range of motion exercises, stretching exercises, and strengthening exercises, three times a week for six weeks Receives: Other: Traditional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Deep cervical flexors strength
Strength of DCFs was measured using PBU during the Cranio-Cervical Flexion Test (CCFT).
- The subject lied in a supine position on a firm plinth. A pressure biofeedback unit was placed under the suboccipital region, and the pressure cuff was inflated to 20 mmHg to support the natural cervical lordosis.
- The subject then instructed to perform a gentle head-nodding movement, similar to saying "yes," which is known as craniocervical flexion.
- The subject asked to gradually increase the pressure in increments up to a maximum of 10 mmHg above baseline (i.e., up to 30 mmHg), and hold each pressure level for 10 seconds. The highest pressure level that the subject was able to maintain steadily for 10 seconds was considered the strength level of the deep cervical flexors .
- Measurements were taken at baseline (pre-treatment) and after 6 weeks (post-treatment).
Measured: Measurements were taken at baseline (pre-treatment) and 6 weeks (post-treatment).
Secondary outcomes (2)
Cervical range of motion
All the cervical spinal ROM measurements were taken with the subject seated upright on a stable chair by goniometer
Measured: • Measurements were taken at baseline (pre-treatment) and 6 weeks (post-treatment).
Neck pain and disability
- The Arabic version of neck disability index (NDI) was used for assessment of neck pain and disability The Neck Disability Index (NDI) is a self-reported questionnaire designed to assess the functional impact of neck pain on daily activities. It consists of 10 items covering aspects such as personal care, work, driving, and recreation, with each item scored on a 0-5 scale (0 = no disability, 5 = maximum disability). The total NDI score (ranging from 0 to 50) is calculated by summing the item scores, where higher scores indicate greater disability
Measured: • The neck disability index was administered at baseline (pre-treatment) and 6 weeks post-intervention to monitor changes in functional impairment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start10 Sep 2025
- Primary completion20 Nov 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hager Hussein Noah abdelsamea Shaheen, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07313189
- Sponsor's protocol ID
- 2151997
- Status last verified
- Dec 2025
- First submitted
- 17 Dec 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Stabilizer Pressure Biofeedback on Neck Dysfunction Post Neck Dissection Surgeries
- ClinicalTrials.gov ID
- NCT07313189
- Acronym / sponsor ID
- 2151997
- Conditions
- Head and Neck Cancer
- Keywords
- Biofeedback, Neck dysfunction, Neck dissection surgeries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Sep 2025 (actual)
- Primary completion
- 20 Nov 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 31 Dec 2025 (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.
Fifty patients of both genders with age ranged from 30 - 50 years, suffering from neck dysfunction post neck dissection surgeries participated in this study. The participants were randomly selected from the National Cancer Institute, Cairo, Egypt. They were randomly assigned into two equal groups, 25 patients each (study group and control group).
Group A :( Study Group) In this group of the study, received cranio-cervical flexion training utilizing stabilizer pressure biofeedback in addition to traditional physical therapy program (ROM exercises, stretching and strengthening exercises), 3 times a week for 6 weeks.
Group B :( Control Group) In this group of the study, received traditional physical therapy program (ROM exercises, stretching and strengthening exercises), 3 times a week for 6 weeks.
Detailed description
1-Subjects: Fifty patients of both genders with age ranged from 30 - 50 years, suffering from neck dysfunction post neck dissection surgeries participated in this study. The participants were randomly selected from the National Cancer Institute, Cairo, Egypt. They were randomly assigned into two equal groups, 25 patients each (study group and control group).
Group A :( Study Group) In this group of the study, received cranio-cervical flexion training utilizing stabilizer pressure biofeedback in addition to traditional physical therapy program (ROM exercises, stretching and strengthening exercises), 3 times a week for 6 weeks.
Group B :( Control Group) In this group of the study, received traditional physical therapy program (ROM exercises, stretching and strengthening exercises), 3 times a week for 6 weeks.
- Equipment:
Therapeutic equipment:
- Stabilizer pressure biofeedback Strength Training Protocol for Deep Cervical Flexors Using Pressure Biofeedback Unit (PBU):
- The air bag of the pressure biofeedback unit was placed under the occiput. Participants were instructed to perform a gentle nodding movement in order to reach five target pressure levels between 22 and 30 mmHg.
- Each pressure level was held for 10 seconds. The training program consisted of:
- 3 sets per session.
- 10 repetitions in each set.
- A rest period of two minutes was given between each set to prevent muscle fatigue.
- Participants received stabilizer pressure biofeedback training 3 sessions per week for 6 weeks.
- Traditional physical therapy program The traditional physical therapy program included range of motion exercises, stretching exercises, and strengthening exercises, three times a week for six weeks
Measurement equipment:
- Arabic version of neck disability index (NDI): The Neck Disability Index (NDI) is a self-reported questionnaire designed to assess the functional impact of neck pain on daily activities. It consists of 10 items covering aspects such as personal care, work, driving, and recreation, with each item scored on a 0-5 scale (0 = no disability, 5 = maximum disability). The total NDI score (ranging from 0 to 50) is calculated by summing the item scores, where higher scores indicate greater disability.
- Goniometer: A goniometer is a medical device used to measure the joint angles of the body, providing an objective assessment of a joint's range of motion (ROM). In this study, a standard, handheld goniometer will be used to measure cervical range of motion (CROM), which includes four primary movements: flexion (bending the neck forward), extension (bending the neck backward), lateral flexion (bending the neck to the side), and rotation (turning the head left or right).
- Stabilizer pressure biofeedback:
The pressure biofeedback device consists of a meter and a flat pocket pneumatic pump, which transfers the force created by deep cervical muscle contractions to the pressure biofeedback device, which measures the pressure in millimeters of mercury (mmHg). A stabilizer pressure biofeedback device will be used to monitor the constant contractile force of the deep neck muscles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stabilizer pressure biofeedback plus traditional physical therapy | Experimental | Device: Stabilizer pressure biofeedback plus traditional physical therapyStabilizer pressure biofeedback plus traditional physical therapy Strength Training Protocol for Deep Cervical Flexors Using Pressure Biofeedback Unit (PBU): * The air bag of the pressure biofeedback unit was placed under the occiput. Participants instructed to perform a gentle nodding movement in order to reach five target pressure levels between 22 and 30 mmHg. * Each pressure level was held for 10 seconds. The training program consisted of: * 3 sets per session. * 10 repetitions in each set. * A rest period of two minutes was given between each set to prevent muscle fatigue . * Participants received stabilizer pressure biofeedback training 3 sessions per week for 6 weeks. The traditional physical therapy program included range of motion exercises, stretching exercises, and strengthening exercises, three times a week for six weeks |
| Traditional physical therapy | Experimental | Other: Traditional physical therapyTraditional Physical Therapy Program The traditional physical therapy program included range of motion exercises, stretching exercises, and strengthening exercises, three times a week for six weeks |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- The subject selection was according to the following criteria:
Key exclusion criteria (9 listed)
- 1- Neck pain due to other underlying conditions such as:
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 |
|---|---|---|
| Stabilizer pressure biofeedback plus traditional physical therapyStabilizer pressure biofeedback Strength Training Protocol for Deep Cervical Flexors Using Pressure Biofeedback Unit (PBU): * The air bag of the pressure biofeedback unit was placed under the occiput. Participants instructed to perform a gentle nodding movement in order to reach five target pressure levels between 22 and 30 mmHg. * Each pressure level held for 10 seconds. The training program will consist of: * 3 sets per session. * 10 repetitions in each set. * A rest period of two minutes was given between each set to prevent muscle fatigue . * Participants received stabilizer pressure biofeedback training 3 sessions per week for 6 weeks. Traditional physical therapy program The traditional physical therapy program included range of motion exercises, stretching exercises, and strengthening exercises, three times a week for six weeks | Device | Stabilizer pressure biofeedback plus traditional physical therapy |
| Traditional physical therapyTraditional physical therapy program The traditional physical therapy program included range of motion exercises, stretching exercises, and strengthening exercises, three times a week for six weeks . | Other | Traditional physical therapy |
Primary outcome
Deep cervical flexors strength
Time frame: Measurements were taken at baseline (pre-treatment) and 6 weeks (post-treatment).
Strength of DCFs was measured using PBU during the Cranio-Cervical Flexion Test (CCFT). * The subject lied in a supine position on a firm plinth. A pressure biofeedback unit was placed under the suboccipital region, and the pressure cuff was inflated to 20 mmHg to support the natural cervical lordosis. * The subject then instructed to perform a gentle head-nodding movement, similar to saying "yes," which is known as craniocervical flexion. * The subject asked to gradually increase the pressure in increments up to a maximum of 10 mmHg above baseline (i.e., up to 30 mmHg), and hold each pressure level for 10 seconds. The highest pressure level that the subject was able to maintain steadily for 10 seconds was considered the strength level of the deep cervical flexors . * Measurements were taken at baseline (pre-treatment) and after 6 weeks (post-treatment).
2 secondary outcomes
Cervical range of motion
Time frame: • Measurements were taken at baseline (pre-treatment) and 6 weeks (post-treatment).
Neck pain and disability
Time frame: • The neck disability index was administered at baseline (pre-treatment) and 6 weeks post-intervention to monitor changes in functional impairment
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 5 Jan 2026.
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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 Stabilizer pressure biofeedback plus traditional physical therapy and Traditional physical therapy in people with Head and Neck Cancer, 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 8 inclusion and 9 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 5 Jan 2026. 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?
Deep cervical flexors strength (time frame: Measurements were taken at baseline (pre-treatment) and 6 weeks (post-treatment).). 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 5 Jan 2026.