About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Mulligan Upper Cervical Mobilization
Procedure/SurgeryManual 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).
Conventional Cervical Exercises and Diaphragmatic Breathing
BehavioralStandard 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).
Biofeedback-Guided Deep Cervical Flexor Training
BehavioralDeep 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
Secondary outcomes
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.
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.
Other outcomes
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.
Sponsors and contacts
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Al Hayah University In Cairo
Lead sponsor
Badr University
Collaborator