Neck PainNCT07866040
Biofeedback Exercises Versus Mulligan Concept on Pain, Mobility, and Posture in Females With Mechanical Neck Pain
A study testing Mulligan Upper Cervical Mobilization, Conventional Cervical Exercises and Diaphragmatic Breathing and Biofeedback-Guided Deep Cervical Flexor Training in people with Neck Pain and Cervical Spine Dysfunction, run by Al Hayah University In Cairo at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Neck Pain, Cervical Spine Dysfunction, Forward Head Posture
- What is being tested?
- Mulligan Upper Cervical Mobilization, Conventional Cervical Exercises and Diaphragmatic Breathing and Biofeedback-Guided Deep Cervical Flexor Training
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Oct 2026to 6 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Badr University
Badr, Cairo Governorate
Doha Afify, Ph.D, 01003169353 ext. +2, Doha.h.afifi@gmail.com
About this study
Official title: Comparative Effectiveness of Biofeedback Exercises and the Mulligan Concept on Pain, Cervical Mobility, and Posture in Females With Mechanical Neck Pain: A Randomized Controlled 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.
Read more
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.
- Conditions
- Neck Pain, Cervical Spine Dysfunction, Forward Head Posture
- Being tested
- Mulligan Upper Cervical Mobilization, Conventional Cervical Exercises and Diaphragmatic Breathing, Biofeedback-Guided Deep Cervical Flexor Training
- Keywords
- Mechanical neck pain, Biofeedback, Deep cervical flexor, Mulligan concept, Cervical range of motion
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mulligan Upper Cervical MobilizationProcedure or surgery
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).
Conventional Cervical Exercises and Diaphragmatic BreathingBehavioural
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).
Biofeedback-Guided Deep Cervical Flexor TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mulligan Manual Therapy + Conventional Exercises | Active comparator | 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. Receives: Procedure: Mulligan Upper Cervical Mobilization; Behavioral: Conventional Cervical Exercises and Diaphragmatic Breathing |
| Biofeedback DCF Training + Mulligan Manual Therapy + Conventional Exercises | Experimental | 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. Receives: Procedure: Mulligan Upper Cervical Mobilization; Behavioral: Conventional Cervical Exercises and Diaphragmatic Breathing; Behavioral: Biofeedback-Guided Deep Cervical Flexor Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 4 weeks (post-intervention)
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.
Measured: Baseline and 4 weeks (post-intervention)
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.
Measured: Baseline and 4 weeks (post-intervention)
Secondary outcomes (2)
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.
Measured: Baseline and 4 weeks (post-intervention)
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.
Measured: Baseline and 4 weeks (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start6 Oct 2026
- Primary completion6 Dec 2026 (estimated)
- Study completion6 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm parallel-group design. Participants are randomly allocated to one of two treatment arms and remain in their assigned arm for the entire study duration.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al Hayah University In Cairo
- Sponsor type
- University, hospital or other
- Collaborators
- Badr University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07866040
- Sponsor's protocol ID
- BUC-IRB00014233-61
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No