Cervical SpondylosisNCT07814833
Effectiveness of Pressure Biofeedback-Assisted Deep Cervical Flexor Training With and Without Scapular Stabilization Exercises on Pain, Range of Motion and Neck Disability in Cervical Spondylosis
A study testing Pressure Biofeedback-Assisted Deep Cervical Flexor Training, Scapular Stabilization Exercises and Standard Physiotherapy in people with Cervical Spondylosis, run by Ibadat International University, Islamabad at 1 site in Pakistan.
Trial summary
This randomized controlled trial will evaluate the effectiveness of pressure biofeedback-assisted deep cervical flexor training with and without scapular stabilization exercises in patients with cervical spondylosis. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Cervical Spondylosis
- What is being tested?
- Pressure Biofeedback-Assisted Deep Cervical Flexor Training, Scapular Stabilization Exercises and Standard Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 3 Jun 2026to 24 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both genders aged 40-60 years.
- Presence of chronic neck pain for ≥3 months with NPRS ≥3.
- Radiologically confirmed cervical spondylosis, including cervical spine X-ray showing disc space narrowing and/or osteophyte formation.
- Ability to perform active cervical and shoulder movements without neurological deficits.
- Willingness to participate in the study and comply with the intervention protocol.
Who cannot join
- History of cervical spine surgery or trauma in the past 6 months.
- Severe neurological involvement, including cervical myelopathy or severe radiculopathy with motor weakness, gait disturbance, or bowel/bladder involvement.
- Inflammatory or systemic musculoskeletal disorders, e.g., rheumatoid arthritis or ankylosing spondylitis.
- Current participation in structured neck/shoulder rehabilitation programs.
- Uncontrolled medical conditions contraindicating exercise, e.g., uncontrolled hypertension or cardiovascular disease.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Hope Physiotherapy Clinic
Rawalpindi, Punjab Province
Nida Khan, 0331-0404000, knida816@gmail.com
About this study
This randomized controlled trial will evaluate the effectiveness of pressure biofeedback-assisted deep cervical flexor training with and without scapular stabilization exercises in patients with cervical spondylosis. The study will compare the effects of the two treatment approaches on pain intensity, cervical range of motion and neck disability.
Read the detailed description
Participants with radiologically confirmed cervical spondylosis will be recruited according to predefined inclusion and exclusion criteria. A total of 44 participants will be recruited, with 22 participants allocated to each group after accounting for an anticipated 10% loss to follow-up. Participants will be randomly allocated using the sealed envelope method into two groups. Group A will receive pressure biofeedback-assisted deep cervical flexor training combined with scapular stabilization exercises and standard physiotherapy. Group B will receive pressure biofeedback-assisted deep cervical flexor training without scapular stabilization exercises, along with standard physiotherapy. Treatment will be provided three times per week for four weeks, with each session lasting approximately 30-40 minutes. Outcomes will be assessed at baseline and after completion of the four-week intervention.
- Conditions
- Cervical Spondylosis
- Being tested
- Pressure Biofeedback-Assisted Deep Cervical Flexor Training, Scapular Stabilization Exercises, Standard Physiotherapy
- Medical subject headings
- Spondylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure Biofeedback-Assisted Deep Cervical Flexor TrainingOther
Deep cervical flexor (DCF) training will be performed using a pressure biofeedback unit to facilitate selective activation of the longus colli and longus capitis. Participants will lie supine with hips and knees flexed, with the cuff placed beneath the cervical spine at C4-C5 and inflated to a baseline pressure of 20 mmHg. Gentle cranio-cervical flexion will be performed by nodding and drawing the chin inward while maintaining head contact with the surface and avoiding compensatory superficial muscle activation. Target pressure will progress from 22 mmHg in Week 1 to 24, 26, and 28 mmHg in Weeks 2-4, respectively. Training will consist of 3 sets of 10 repetitions, with 5-second holds in Week 1 progressing to 10-second holds thereafter and 30-60 seconds of rest between sets. Arm lifts will be added in Week 3 and leg marching in Week 4. The intervention will be administered three times weekly for four consecutive weeks.
Scapular Stabilization ExercisesOther
Scapular stabilization exercises will be performed progressively for 4 weeks to improve scapular control, alignment, and stabilizer strength. In Week 1, seated scapular retraction and depression will be performed for 3 sets of 10 repetitions with 5-second holds and 60 seconds rest. In Week 2, scapular retraction will progress using light TheraBand resistance for 3 sets of 10 repetitions with controlled movement. In Week 3, wall slides and prone Y and T raises will be performed for 3 sets of 8-10 repetitions. In Week 4, scapular stabilization with shoulder flexion and abduction will be performed for 3 sets of 10 repetitions. All exercises will emphasize controlled movement, neutral alignment, and avoidance of compensatory shoulder or trunk movements. Sessions will be conducted three times weekly.
Standard PhysiotherapyOther
Standard physiotherapy will include therapeutic exercises and postural management techniques aimed at reducing pain, improving cervical mobility, flexibility, and functional performance. Cervical range-of-motion exercises including flexion, extension, lateral flexion, and rotation will be performed within a pain-free range for 10 repetitions in each direction. Stretching exercises for the upper trapezius, levator scapulae, and pectoral muscles will be performed for 20-30 seconds for 3 repetitions. Cervical isometric strengthening exercises including flexion, extension, and lateral flexion will be performed with a 5-10-second hold for 10 repetitions. Postural education and ergonomic advice will also be provided, including instructions regarding proper sitting posture, appropriate head and neck positioning, and avoidance of prolonged static postures. Standard physiotherapy will be provided for approximately 10-15 minutes per session, three times weekly for four consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Pressure Biofeedback-Assisted Deep Cervical Flexor Training + Scapular Stabilization Exerci | Experimental | Not described Receives: Other: Pressure Biofeedback-Assisted Deep Cervical Flexor Training; Other: Scapular Stabilization Exercises; Other: Standard Physiotherapy |
| Group B: Pressure Biofeedback-Assisted Deep Cervical Flexor Training + Standard Physiotherapy | Active comparator | Not described Receives: Other: Pressure Biofeedback-Assisted Deep Cervical Flexor Training; Other: Standard Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Disability - Neck Disability Index (NDI)
Measure: Functional disability related to neck pain measured using the Neck Disability Index.
Measured: Baseline and 4 weeks of treatment.
Pain Intensity - Numeric Pain Rating Scale (NPRS)
Neck pain intensity measured using the 0-10 Numeric Pain Rating Scale.
Measured: Baseline and 4 weeks of treatment
Universal Goniometer
Measure: Cervical Range of Motion - Cervical flexion, extension, right/left lateral flexion, and right/left rotation.
Measured: Baseline and 4 weeks of treatment.
Secondary outcomes (1)
The Neck Flexor Endurance Test
Measure: Cervical flexor muscle endurance.
Measured: Baseline and 4 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start3 Jun 2026
- Primary completion15 Sep 2026 (estimated)
- Study completion24 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical SpondylosisStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ibadat International University, Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07814833
- Sponsor's protocol ID
- IIUI/RERC/ADT/2026/06/342
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
• Tsiringakis G, Dimitriadis Z, Triantafylloy E, McLean S. Motor control training of deep neck flexors with pressure biofeedback improves pain and disability in patients with neck pain: a systematic review and meta-analysis. Musculoskeletal Science and Practice. 2020;50:102220. • Saleh MSM, Rehab NI, Sharaf MAF. Effect of deep cervical flexors training on neck proprioception, pain, muscle strength and dizziness in patients with cervical spondylosis: A randomized controlled trial. Phys Ther Rehabil. 2018;5(1):14. • Fatima I, Ashraf A, Khalid K. Effectiveness of thoracic manipulation versus scapular stabilization exercises on pain and functional disability in cervical spondylosis. Journal of Nursing and Allied Health. 2024;2(01). • Ashfaq R, Riaz H. Effect of Pressure biofeedback training on deep cervical flexors endurance in patients with mechanical neck pain: A randomized controlled trial. Pakistan Journal of Medical Sciences. 2021;37(2):550. • Modarresi S, et al. A systematic review and synthesis of psychometric properties of the numeric pain rating scale and the visual analog scale for use in people with neck pain. The Clinical Journal of Pain. 2022;38(2):132-148.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Pressure Biofeedback-Assisted Deep Cervical Flexor Training With and Without Scapular Stabilization Exercises on Pain, Range of Motion and Neck Disability in Cervical Spondylosis
- ClinicalTrials.gov ID
- NCT07814833
- Acronym / sponsor ID
- IIUI/RERC/ADT/2026/06/342
- Conditions
- Cervical Spondylosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Ibadat International University, IslamabadUniversity, hospital or other
- Study start
- 3 Jun 2026 (actual)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 24 Sep 2026 (estimated)
- First posted
- 11 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial will evaluate the effectiveness of pressure biofeedback-assisted deep cervical flexor training with and without scapular stabilization exercises in patients with cervical spondylosis. The study will compare the effects of the two treatment approaches on pain intensity, cervical range of motion and neck disability.
Detailed description
Participants with radiologically confirmed cervical spondylosis will be recruited according to predefined inclusion and exclusion criteria. A total of 44 participants will be recruited, with 22 participants allocated to each group after accounting for an anticipated 10% loss to follow-up. Participants will be randomly allocated using the sealed envelope method into two groups. Group A will receive pressure biofeedback-assisted deep cervical flexor training combined with scapular stabilization exercises and standard physiotherapy. Group B will receive pressure biofeedback-assisted deep cervical flexor training without scapular stabilization exercises, along with standard physiotherapy. Treatment will be provided three times per week for four weeks, with each session lasting approximately 30-40 minutes. Outcomes will be assessed at baseline and after completion of the four-week intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Pressure Biofeedback-Assisted Deep Cervical Flexor Training + Scapular Stabilization Exerci | Experimental | Other: Pressure Biofeedback-Assisted Deep Cervical Flexor Training, Other: Scapular Stabilization Exercises, Other: Standard Physiotherapy |
| Group B: Pressure Biofeedback-Assisted Deep Cervical Flexor Training + Standard Physiotherapy | Active comparator | Other: Pressure Biofeedback-Assisted Deep Cervical Flexor Training, Other: Standard Physiotherapy |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Both genders aged 40-60 years.
- Presence of chronic neck pain for ≥3 months with NPRS ≥3.
- Radiologically confirmed cervical spondylosis, including cervical spine X-ray showing disc space narrowing and/or osteophyte formation.
- Ability to perform active cervical and shoulder movements without neurological deficits.
- Willingness to participate in the study and comply with the intervention protocol.
Key exclusion criteria (5 listed)
- History of cervical spine surgery or trauma in the past 6 months.
- Severe neurological involvement, including cervical myelopathy or severe radiculopathy with motor weakness, gait disturbance, or bowel/bladder involvement.
- Inflammatory or systemic musculoskeletal disorders, e.g., rheumatoid arthritis or ankylosing spondylitis.
- Current participation in structured neck/shoulder rehabilitation programs.
- Uncontrolled medical conditions contraindicating exercise, e.g., uncontrolled hypertension or cardiovascular disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pressure Biofeedback-Assisted Deep Cervical Flexor TrainingDeep cervical flexor (DCF) training will be performed using a pressure biofeedback unit to facilitate selective activation of the longus colli and longus capitis. Participants will lie supine with hips and knees flexed, with the cuff placed beneath the cervical spine at C4-C5 and inflated to a baseline pressure of 20 mmHg. Gentle cranio-cervical flexion will be performed by nodding and drawing the chin inward while maintaining head contact with the surface and avoiding compensatory superficial muscle activation. Target pressure will progress from 22 mmHg in Week 1 to 24, 26, and 28 mmHg in Weeks 2-4, respectively. Training will consist of 3 sets of 10 repetitions, with 5-second holds in Week 1 progressing to 10-second holds thereafter and 30-60 seconds of rest between sets. Arm lifts will be added in Week 3 and leg marching in Week 4. The intervention will be administered three times weekly for four consecutive weeks. | Other | Group A: Pressure Biofeedback-Assisted Deep Cervical Flexor Training + Scapular Stabilization Exerci, Group B: Pressure Biofeedback-Assisted Deep Cervical Flexor Training + Standard Physiotherapy |
| Scapular Stabilization ExercisesScapular stabilization exercises will be performed progressively for 4 weeks to improve scapular control, alignment, and stabilizer strength. In Week 1, seated scapular retraction and depression will be performed for 3 sets of 10 repetitions with 5-second holds and 60 seconds rest. In Week 2, scapular retraction will progress using light TheraBand resistance for 3 sets of 10 repetitions with controlled movement. In Week 3, wall slides and prone Y and T raises will be performed for 3 sets of 8-10 repetitions. In Week 4, scapular stabilization with shoulder flexion and abduction will be performed for 3 sets of 10 repetitions. All exercises will emphasize controlled movement, neutral alignment, and avoidance of compensatory shoulder or trunk movements. Sessions will be conducted three times weekly. | Other | Group A: Pressure Biofeedback-Assisted Deep Cervical Flexor Training + Scapular Stabilization Exerci |
| Standard PhysiotherapyStandard physiotherapy will include therapeutic exercises and postural management techniques aimed at reducing pain, improving cervical mobility, flexibility, and functional performance. Cervical range-of-motion exercises including flexion, extension, lateral flexion, and rotation will be performed within a pain-free range for 10 repetitions in each direction. Stretching exercises for the upper trapezius, levator scapulae, and pectoral muscles will be performed for 20-30 seconds for 3 repetitions. Cervical isometric strengthening exercises including flexion, extension, and lateral flexion will be performed with a 5-10-second hold for 10 repetitions. Postural education and ergonomic advice will also be provided, including instructions regarding proper sitting posture, appropriate head and neck positioning, and avoidance of prolonged static postures. Standard physiotherapy will be provided for approximately 10-15 minutes per session, three times weekly for four consecutive weeks. | Other | Group A: Pressure Biofeedback-Assisted Deep Cervical Flexor Training + Scapular Stabilization Exerci, Group B: Pressure Biofeedback-Assisted Deep Cervical Flexor Training + Standard Physiotherapy |
Primary outcome
Neck Disability - Neck Disability Index (NDI)
Time frame: Baseline and 4 weeks of treatment.
Measure: Functional disability related to neck pain measured using the Neck Disability Index.
Pain Intensity - Numeric Pain Rating Scale (NPRS)
Time frame: Baseline and 4 weeks of treatment
Neck pain intensity measured using the 0-10 Numeric Pain Rating Scale.
Universal Goniometer
Time frame: Baseline and 4 weeks of treatment.
Measure: Cervical Range of Motion - Cervical flexion, extension, right/left lateral flexion, and right/left rotation.
1 secondary outcome
The Neck Flexor Endurance Test
Time frame: Baseline and 4 weeks of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Background• Tsiringakis G, Dimitriadis Z, Triantafylloy E, McLean S. Motor control training of deep neck flexors with pressure biofeedback improves pain and disability in patients with neck pain: a systematic review and meta-analysis. Musculoskeletal Science and Practice. 2020;50:102220. • Saleh MSM, Rehab NI, Sharaf MAF. Effect of deep cervical flexors training on neck proprioception, pain, muscle strength and dizziness in patients with cervical spondylosis: A randomized controlled trial. Phys Ther Rehabil. 2018;5(1):14. • Fatima I, Ashraf A, Khalid K. Effectiveness of thoracic manipulation versus scapular stabilization exercises on pain and functional disability in cervical spondylosis. Journal of Nursing and Allied Health. 2024;2(01). • Ashfaq R, Riaz H. Effect of Pressure biofeedback training on deep cervical flexors endurance in patients with mechanical neck pain: A randomized controlled trial. Pakistan Journal of Medical Sciences. 2021;37(2):550. • Modarresi S, et al. A systematic review and synthesis of psychometric properties of the numeric pain rating scale and the visual analog scale for use in people with neck pain. The Clinical Journal of Pain. 2022;38(2):132-148.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pressure Biofeedback-Assisted Deep Cervical Flexor Training, Scapular Stabilization Exercises and Standard Physiotherapy in people with Cervical Spondylosis, run by Ibadat International University, Islamabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aqsa Anwar (0321-5172551, aqsaanwer.pt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck Disability - Neck Disability Index (NDI) (time frame: Baseline and 4 weeks of treatment.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07814833, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.