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Completed

NCT Number: NCT07313189

Stabilizer Pressure Biofeedback on Neck Dysfunction

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.

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Therapy

Giza, 12613, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 1- Neck pain due to other underlying conditions such as:
  • Spinal fracture
  • Osteoporosis
  • Spinal cord compression
  • Congenital postural deformities
  • Inflammatory disorders of the spine
  • Spinal infections
  • Significant neurological disorders
  • Rheumatoid arthritis 2- Malignancy 3- Pregnancy 4- History of cervical spine surgery 5- Epilepsy or any psychological disorders

Treatment and study plan

Stabilizer pressure biofeedback plus traditional physical therapy

Device

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 therapy

Other

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 .

Primary outcomes

  1. 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).

Secondary outcomes

  1. Cervical range of motion

    Time frame: • Measurements were taken at baseline (pre-treatment) and 6 weeks (post-treatment).

    All the cervical spinal ROM measurements were taken with the subject seated upright on a stable chair by goniometer

  2. 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

    • 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effect of Stabilizer Pressure Biofeedback on Neck Dysfunction Post Neck Dissection Surgeries

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 31, 2025
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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