Stabilizer Pressure Biofeedback on Neck Dysfunction

Cairo University (CU)

Status: Completed

Conditions: Head and Neck Cancer

Treatments: Device: Stabilizer pressure biofeedback plus traditional physical therapy; Other: Traditional physical therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07313189

2151997

Details and patient eligibility

About

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.

Full 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.

2) Equipment:

Therapeutic equipment:

1. 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.

2. 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:

1. 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.

2. 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).

3. 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.

Enrollment: 50 patients

Sex: All

Ages: 30 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The subject selection was according to the following criteria:

  1. Patients' age ranged between 30-50 years.
  2. Both gender participated in this study.
  3. All patients suffered from neck dysfunction (neck pain, limited ROM and disability) following unilateral neck dissection surgeries.
  4. All patients suffered from moderate to severe pain (VAS score > 4).
  5. All patients undergone modified radical NDS or selective NDS.
  6. All patients began the treatment program 2 weeks post neck dissection surgeries
  7. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Stabilizer pressure biofeedback plus traditional physical therapy

Experimental group

Description:

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

Treatment:

Device: Stabilizer pressure biofeedback plus traditional physical therapy

Traditional physical therapy

Experimental group

Description:

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

Treatment:

Other: Traditional physical therapy