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RecruitingNCT07866040Updated Oct 8, 2026

Biofeedback Exercises Versus Mulligan Concept on Pain, Mobility, and Posture in Females With Mechanical Neck Pain

An interventional study of Mulligan Upper Cervical Mobilization and Conventional Cervical Exercises and Diaphragmatic Breathing in Neck Pain, Cervical Spine Dysfunction and Forward Head Posture, sponsored by Al Hayah University In Cairo. Recruiting at 1 site in Egypt. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-10-08.

Sponsored by Al Hayah University In Cairo · Not applicable, Interventional, and Treatment

Updated Oct 8, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

This study compares two physical therapy treatment approaches for females suffering from mechanical neck pain - pain in the neck that comes from the muscles, joints, or soft tissues rather than from nerve damage or disease. Mechanical neck pain is very common and can cause significant pain, stiffness, difficulty moving the head, and problems with daily activities.

Fifty adult females aged 18 to 45 years with mechanical neck pain lasting more than 4 weeks will be randomly divided into two equal groups. Group M (25 participants) will receive upper cervical spine manual therapy using the Mulligan mobilization technique, which involves gentle joint movements to restore normal neck joint motion, combined with standard cervical exercises. Group B (25 participants) will receive the same Group M treatment plus biofeedback-guided deep cervical flexor training. This additional exercise uses a pressure sensor placed behind the neck to help the patient learn to activate the deep stabilizing muscles of the neck, which are often weakened in people with neck pain.

Both groups will attend 3 treatment sessions per week for 4 consecutive weeks (12 sessions total). Each session lasts approximately 45 minutes. Before each session, all participants receive suboccipital release, myofascial release, and stretching exercises as preparation.

The researchers will measure pain intensity, upper cervical flexion range of motion, the flexion-rotation test (which assesses upper neck rotation), the Neck Disability Index (which measures how neck pain affects daily activities), and pressure pain threshold (which measures sensitivity to pressure over neck muscles). All measurements are taken before treatment begins and after the 4-week intervention period.

The study aims to determine whether adding biofeedback-guided deep cervical flexor training to the Mulligan manual therapy approach produces greater improvements in pain, neck mobility, disability, and muscle sensitivity compared to the Mulligan approach alone.

02

Conditions studied

  • Neck Pain
  • Cervical Spine Dysfunction
  • Forward Head Posture

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Keywords

  • Mechanical neck pain
  • Biofeedback
  • Deep cervical flexor
  • Mulligan concept
  • Cervical range of motion
03

In context

Neck Pain

1,232 studies on the registry are indexed under Neck Pain; 255 are open to participants now.

This study's planned enrollment of 50 is close to the median of 52 across 1,004 interventional studies indexed under Neck Pain.

Browse Neck Pain studies →

Lead sponsor

Al Hayah University In Cairo is the lead sponsor of 13 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Female adults aged 18 to 45 years
  • Diagnosed with mechanical neck pain (MNP) for more than 4 weeks duration
  • Able to understand and follow instructions related to physical assessments
  • No history of cervical spine surgery
  • Body Mass Index (BMI) between 18.5 and 29.9 kg/m²
  • Physically active or sedentary individuals, as assessed by baseline physical activity questionnaire
  • Screened for faulty postural alignment (visual inspection from front, side, and back in relaxed standing, including assessment for forward head posture, rounded shoulders, and asymmetries)
  • Willing to provide informed consent and participate in all study procedures

Exclusion criteria

Exclusion Criteria:

  • History of systemic diseases affecting musculoskeletal function (e.g., rheumatoid arthritis, fibromyalgia)
  • Current pregnancy or postpartum period
  • Recent trauma or fracture in the cervical or thoracolumbar spine
  • Use of medications that affect muscle performance or pain perception
  • Involvement in other physiotherapy or rehabilitation programs during the study period
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    Mulligan Manual Therapy + Conventional Exercises

    25 female participants. Receive upper cervical spine mobilization using the Mulligan concept (low-velocity, high-amplitude translatoric movements targeting C0-C1, C1-C2, and C2-C3 based on individual clinical findings), combined with conventional cervical exercises and diaphragmatic breathing exercises. Sessions include suboccipital release, myofascial release, and cervical stretching exercises (flexors, lateral flexors, extensors, rotators 3 reps × 30 sec each side) as warm-up and cool-down. Treatment is 3 sessions/week × 4 weeks (12 sessions), 45 minutes per session. Patients are encouraged to perform home exercises daily, 2-5 times per day.

    Procedure: Mulligan Upper Cervical Mobilization · Behavioral: Conventional Cervical Exercises and Diaphragmatic Breathing

  • Experimental
    Biofeedback DCF Training + Mulligan Manual Therapy + Conventional Exercises

    25 female participants. Receive the full Group M protocol (Mulligan upper cervical mobilization + conventional cervical exercises + diaphragmatic breathing + suboccipital release, myofascial release, and stretching) PLUS biofeedback-guided deep cervical flexor (DCF) training using the Stabilizer Pressure Biofeedback Unit. DCF training begins with craniocervical flexion exercise in crook lying at 30 mmHg baseline, progressing through five pressure levels (10-second holds, 3-5 second rest), 10 repetitions × 3 sets per session (2-minute rest between sets). Exercise progression includes bilateral and unilateral DCF contractions in supine and standing, and integration of superficial cervical muscle exercises with external resistance progressed unilaterally toward the more symptomatic side. Treatment is 3 sessions/week × 4 weeks (12 sessions), 45 minutes per session. Home exercises encouraged daily, 2-5 times per day.

    Procedure: Mulligan Upper Cervical Mobilization · Behavioral: Conventional Cervical Exercises and Diaphragmatic Breathing · Behavioral: Biofeedback-Guided Deep Cervical Flexor Training

Interventions

  • ProcedureMulligan Upper Cervical Mobilization

    Manual therapy using low-velocity, high-amplitude mobilization techniques based on the Mulligan concept. Translatoric mobilization movements are applied to restore mobility of the upper cervical joints: occipital-atlas (C0-C1), atlas-axis (C1-C2), and axis-C3 (C2-C3) segments. Techniques are tailored to each patient's clinical findings and follow IFOMPT recommendations. Techniques include upper cervical translatoric dorsal glide (C0-C1), ventral-cranial glide (C2-C3) in supine, and upper cervical translatoric dorsal glide (C1-C2).

  • BehavioralConventional Cervical Exercises and Diaphragmatic Breathing

    Standard cervical exercise program including diaphragmatic breathing exercises. Session preparation includes suboccipital release, myofascial release, and cervical muscle stretching (flexors, lateral flexors, extensors, and rotators 3 repetitions × 30 seconds each side) performed as warm-up and cool-down. Patients are instructed to perform self-treatment home exercises daily (2-5 times per day).

  • BehavioralBiofeedback-Guided Deep Cervical Flexor Training

    Deep cervical flexor (DCF) retraining using the Stabilizer Pressure Biofeedback Unit (Chattanooga, TN, USA). Patient positioned in crook lying with the pressure sensor inflated to 30 mmHg beneath the occiput. The patient performs a slow nodding action to progressively target five pressure levels (2 mmHg increments up to 30 mmHg maximum), holding each contraction for 10 seconds with 3-5 second rest intervals. Protocol: 10 repetitions × 3 sets per session, 2-minute rest between sets, 3 days/week for 4 weeks. Exercise progression includes: bilateral DCF contraction in supine, bilateral DCF contraction in standing, unilateral contraction with cervical inclination in supine, unilateral contraction with cervical rotation in supine.

06

What researchers measure

Primary outcomes

  1. Upper Cervical Flexion Range of Motion

    Active upper cervical flexion range of motion measured in degrees using a Cervical Range of Motion (CROM) device with the patient in standing position.

    Time frame: Baseline and 4 weeks (post-intervention)

  2. Flexion-Rotation Test (Upper Cervical Rotation Range)

    The flexion-rotation test measures upper cervical rotation, predominantly at C1-C2. The participant lies supine; the evaluator passively flexes the cervical spine to maximum flexion and then rotates the head to each side until symptom onset or a firm end-feel is encountered. Range measured in degrees using a CROM device. Three measurements taken for each direction, mean recorded. Range to the more restricted (+) and less restricted (-) side documented. ICC: 0.93-0.96.

    Time frame: Baseline and 4 weeks (post-intervention)

  3. Back Pain and Body Posture Evaluation Instrument (Back PEI)

    Pain intensity assessed using the expanded Back Pain and Body Posture Evaluation Instrument for adults (Back PEI-A). This validated instrument evaluates back and cervical pain through questions related to pain presence, frequency, intensity, physical exercise habits, and life habits. Higher scores indicate greater pain and postural dysfunction.

    Time frame: Baseline and 4 weeks (post-intervention)

Secondary outcomes

  1. Neck Disability Index (NDI)

    Self-reported neck-specific disability. The NDI assesses how neck pain affects daily activities across 10 sections. Total score: 0 (best) to 50 (worst). Classification: mild (5-14), moderate (15-24), severe (25-34), complete (≥35). ICC: 0.979.

    Time frame: Baseline and 4 weeks (post-intervention)

  2. Pressure Pain Threshold (PPT)

    PPT measured using a digital manual dynamometer with 1-cm² rubber disk (range: 0-5 kg, accuracy: 0.05 kg). PPT defined as the point where pressure sensation changes to pain. Assessed bilaterally at five sites: upper trapezius, sternocleidomastoid, suboccipital, levator scapulae, and anterior scalene muscles. Three measurements per site in random sequence, 30-second intervals. Values in kg/cm². ICC: 0.74-0.98. Same examiner for all measurements.

    Time frame: Baseline and 4 weeks (post-intervention)

Other outcomes

  1. Craniocervical Flexion Test (CCFT) Deep Cervical Flexor Activation

    Measures isolated activation of the deep cervical flexor muscles using the Stabilizer Pressure Biofeedback Unit. Evaluates activation and endurance through five progressive pressure increases of 2 mmHg up to 30 mmHg. Patient advances to next level after successfully holding a level three times. Highest level achieved is recorded.

    Time frame: Baseline and 4 weeks (post-intervention)

07

Study locations

1 of 1 sites recruiting
  • Badr University
    Badr, Cairo Governorate, Egypt
    Recruiting
08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 8, 2026
Show all 1 update
  1. Oct 8, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07866040
Lead sponsor
Al Hayah University In Cairo
Collaborators
Badr University
Responsible party
Sponsor
First posted
Oct 8, 2026
Start date
Oct 6, 2026
Primary completion
Dec 6, 2026 (estimated)
Completion
Dec 6, 2026 (estimated)
Last update
Oct 8, 2026

Study contacts

Doha H. Mostafa Afify, Ph.D
Contact
Doha.h.afifi@gmail.com
01003169353 ext. +2

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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