Stabilizer Pressure Biofeedback on Neck Dysfunction

NCT07313189 | Completed

• 1 other identifier: 2151997
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Head and Neck Cancer

Keywords

Biofeedback; Neck dysfunction; Neck dissection surgeries

Outcome Measures

Primary Outcomes (1)

• 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).

  Measurements were taken at baseline (pre-treatment) and 6 weeks (post-treatment).

Secondary Outcomes (2)

• Cervical range of motion

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

• Neck pain and disability

  • The neck disability index was administered at baseline (pre-treatment) and 6 weeks post-intervention to monitor changes in functional impairment

Study Arms (2)

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

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

Other: Traditional physical therapy

Interventions

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

Stabilizer pressure biofeedback plus traditional physical therapy

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 .

Traditional physical therapy

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy

Giza, 12613, Egypt

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Demonstrator at Department of Surgery and Burn - Faculty of Physical Therapy - Cairo University

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: December 31, 2025
• Study Start: September 10, 2025
• Primary Completion: November 20, 2025
• Study Completion: December 15, 2025
• Last Updated: January 5, 2026

Record last verified: 2025-12

Locations

EG (1)