Neck PainNCT04674891
Cervical Stabilization Exercises on Respiratory Strength in Chronic Neck Pain
A study testing baseline physical therapy treatment and Cervical Stabilization exercises in people with Neck Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
This project was a Randomized control trial conducted to check the effects of Cervical Stabilization Exercises on Respiratory Strength in Chronic Neck Pain Patients with Forward Head Posture, duration of study was of 6 months, convenient sampling was done, subject following eligibility criteria from Jinnah Hospital… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- baseline physical therapy treatment and Cervical Stabilization exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Mar 2020to 30 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic neck pain for more than 3 months.
- Mild neck disability (NDI score 5-15)
Who cannot join
- Neck pain secondary to trauma
- Deformities of thoracic region or vertebral column
- History of any thoracic or vertebral column surgery.
- History of smoking
- Patients with any other serious pathology/red flags
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Cervical Stabilization Exercises on Respiratory Strength in Chronic Neck Pain Patients With Forward Head Posture
This project was a Randomized control trial conducted to check the effects of Cervical Stabilization Exercises on Respiratory Strength in Chronic Neck Pain Patients with Forward Head Posture, duration of study was of 6 months, convenient sampling was done, subject following eligibility criteria from Jinnah Hospital Lahore, were randomly allocated in two groups via lottery method, baseline assessment was done, Group A participants were given baseline treatment protocol for 4 weeks which included 3 sessions per week. Heating Pad applied for 15 min and TENS (Transcutaneous Electric Nerve Stimulation) for 10 min. After that Cervical isometric exercises performed in sitting (10sec hold, 10 to 15 reps). Group B was experimental group and participants were given baseline treatment in addition to Cervical Stabilization exercises for 4 weeks which included 3 sessions per week. The baseline measurement was taken on day one for Numeric Pain Rating Scale (NRPS) and Neck Disability Index (NDI). Forward head posture assessed by measuring Cranio Vertebral Angle (CVA). Respiratory muscle strengths measured by Spirometer and SBC (single breath count). All the measurements repeated at the end of fourth week. Data was analyzed by using SPSS version 20.
Read the detailed description
Extensive usage of electronic gadgets in today's life leads to the musculoskeletal problems among which neck pain is the most common problem reported to physicians, orthopedics and physical therapists. Even before reporting to clinics there is long history of using over the counter pain killers. Pain avoidance behaviors let the cervical spine stiff so much that a clinician help is sought. There is huge literature regarding the management of chronic neck pain and yet after the decades of research there are gaps in treatment options. In modern age of health care, it is common goal of every healthcare to make patient self-sufficient as early as possible. The self-care models have tremendous advantages. The current study has compared the effects of cervical stabilization exercises and isometric exercises. The current study was novel in a way that there is limited literature about treating Chronic Neck Pain Patients with effects of physiotherapy on respiratory strength in improving forward head posture. All the methods were employed to see if they improve ranges along with accompanying pain and disability.
- Conditions
- Neck Pain
- Being tested
- baseline physical therapy treatment, Cervical Stabilization exercises
- Keywords
- NDI, NPRS, CVA, SBC
- Medical subject headings
- Neck Pain, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
baseline physical therapy treatmentOther
Group A was control group and the patients received Conventional treatment protocol for 4 weeks which included 3 sessions per week. Patients received hot pack for 15 min and TENS (Transcutaneous Electric Nerve Stimulation) for 10 min. After that Cervical isometric exercises will be performed in sitting (10sec hold,10 to 15 reps)
Cervical Stabilization exercisesOther
Group B was experimental group and received baseline physiotherapy treatment in addition to Cervical Stabilization exercises. Pillow was placed beneath cervical spine in supine position and guided patients to nod head as though they said 'yes' and asked them to hold for 10 seconds. 10 repetitions were done before progressing to the next target level.
4 weeks (3 sessions per week)
- Hot pack: 10 min
- TENS: 10 min
- Cervical isometric exercises in sitting (10sec hold,10 to 15 reps)
- Cervical Stabilization exercises (10 sec hold, 10 reps)
On eligible participants baseline assessment was taken on day 1, post intervention assessment was taken at the end of 4th week.
| Study group | Role | What they receive |
|---|---|---|
| baseline physical therapy treatment | Active comparator | baseline physical therapy treatment ,Control group- Group A Receives: Other: baseline physical therapy treatment |
| Cervical Stabilization exercises | Experimental | baseline physical therapy treatment along with Cervical Stabilization exercises- Experimental Group- Group B Receives: Other: Cervical Stabilization exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain rating scale
The NPRS is the segmented numeric version of visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of pain. The common format is a horizontal bar or line. Similar to VAS, the NPRS is anchored by terms describing pain severity extremes.
Measured: 4th week
Secondary outcomes (1)
Neck disability Index
Methods of assessment for such disability, especially those targeted at activities of daily living which are most affected by neck pain, questionnaire 10-item scaled entitled the Neck Disability Index (NDI)
Measured: 4th Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start30 Mar 2020
- Primary completion30 Dec 2020
- Study completion30 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Syed Shakil Ur Rehman, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04674891
- Sponsor's protocol ID
- REC/LHR/20/1048 Tooba Arif
- Status last verified
- Mar 2021
- First submitted
- 16 Dec 2020
- Last updated
- 8 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Miranda IF, Wagner Neto ES, Dhein W, Brodt GA, Loss JF. Individuals With Chronic Neck Pain Have Lower Neck Strength Than Healthy Controls: A Systematic Review With Meta-Analysis. J Manipulative Physiol Ther. 2019 Oct;42(8):608-622. doi: 10.1016/j.jmpt.2018.12.008. Epub 2019 Nov 23.
PubMed 31771837Migliarese S, White E. Review of Forward-Head Posture and Vestibular Deficits in Older Adults. Current Geriatrics Reports. 2019;8(3):194-201.
Gurudut P, Welling A, Chodankar A. Effect of self-care exercises in forward head posture on craniovertebral angle and craniocervical flexion endurance: A pilot study. Indian Journal of Physical Therapy and Research. 2020;2(1):25.
Son K-k, Cynn H-S, Lee J-H, Park D-H, Kim B-B. Effects of Deep Cervical Flexor Exercise with Visual Guide on Muscle Activity and Craniovertebral Angle in Subjects with Forward Head Posture. Korean Society of Physical Medicine. 2019;14(2):53-61.
Koseki T, Kakizaki F, Hayashi S, Nishida N, Itoh M. Effect of forward head posture on thoracic shape and respiratory function. J Phys Ther Sci. 2019 Jan;31(1):63-68. doi: 10.1589/jpts.31.63. Epub 2019 Jan 10.
PubMed 30774207Mathur H, Khan SA, Siddiqui ZA. Effect of forward head posture on swallowing: Review of Literature. 2019
Herman PM, Vernon H, Hurwitz EL, Shekelle PG, Whitley MD, Coulter ID. Clinical Scenarios for Which Cervical Mobilization and Manipulation Are Considered by an Expert Panel to Be Appropriate (and Inappropriate) for Patients With Chronic Neck Pain. Clin J Pain. 2020 Apr;36(4):273-280. doi: 10.1097/AJP.0000000000000800.
PubMed 31985500Alsultan F, De Nunzio AM, Rushton A, Heneghan NR, Falla D. Variability of neck and trunk movement during single- and dual-task gait in people with chronic neck pain. Clin Biomech (Bristol). 2020 Feb;72:31-36. doi: 10.1016/j.clinbiomech.2019.11.019. Epub 2019 Nov 28.
PubMed 31809920Storto CJ, Garcez AS, Suzuki H, Cusmanich KG, Elkenawy I, Moon W, Suzuki SS. Assessment of respiratory muscle strength and airflow before and after microimplant-assisted rapid palatal expansion. Angle Orthod. 2019 Sep;89(5):713-720. doi: 10.2319/070518-504.1. Epub 2019 Mar 21.
PubMed 30896250Kalita J, Kumar M, Misra UK. Serial single breath count is a reliable tool for monitoring respiratory functions in Guillain-Barre Syndrome. J Clin Neurosci. 2020 Feb;72:50-56. doi: 10.1016/j.jocn.2020.01.032. Epub 2020 Jan 22.
PubMed 31982274Uysal SC, Tuzun EH, Eker L, Angin E. Effectiveness of the muscle energy technique on respiratory muscle strength and endurance in patients with fibromyalgia. J Back Musculoskelet Rehabil. 2019;32(3):411-419. doi: 10.3233/BMR-181287.
PubMed 30475751Pawaria S, SuDhan DS, Kalra S. Effectiveness of Cervical Stabilisation Exercises on Respiratory Strength in Chronic Neck Pain Patients with Forward Head Posture-A Pilot Study. Journal of Clinical and Diagnostic Research. 2019;13(4).
Lee H-j, Park H-s, Park J-m. The Effects of Cervical Stabilization Exercise on Neck Pain, Range of Motion, and Deep Cervical Muscle Strength in Patients With Chronic Neck Pain. The Journal of Korean Academy of Orthopedic Manual Physical Therapy. 2019;25(1):9-19
Lee MH, Jang SH. The effects of the neck stabilization exercise on the muscle activity of trunk respiratory muscles and maximum voluntary ventilation of chronic stroke patients. J Back Musculoskelet Rehabil. 2019;32(6):863-868. doi: 10.3233/BMR-170839.
PubMed 30958329Kim G-C, HwangBo P-N. Effects of cervical stabilization exercise using pressure biofeedback on neck pain, forward head posture and acoustic characteristics of chronic neck pain patients with forward head posture. Korean Society of Physical Medicine. 2019;14(1):121-9.
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cervical Stabilization Exercises on Respiratory Strength in Chronic Neck Pain Patients With Forward Head Posture
- ClinicalTrials.gov ID
- NCT04674891
- Acronym / sponsor ID
- REC/LHR/20/1048 Tooba Arif
- Conditions
- Neck Pain
- Keywords
- NDI, NPRS, CVA, SBC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 Mar 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 19 Dec 2020 (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 project was a Randomized control trial conducted to check the effects of Cervical Stabilization Exercises on Respiratory Strength in Chronic Neck Pain Patients with Forward Head Posture, duration of study was of 6 months, convenient sampling was done, subject following eligibility criteria from Jinnah Hospital Lahore, were randomly allocated in two groups via lottery method, baseline assessment was done, Group A participants were given baseline treatment protocol for 4 weeks which included 3 sessions per week. Heating Pad applied for 15 min and TENS (Transcutaneous Electric Nerve Stimulation) for 10 min. After that Cervical isometric exercises performed in sitting (10sec hold, 10 to 15 reps). Group B was experimental group and participants were given baseline treatment in addition to Cervical Stabilization exercises for 4 weeks which included 3 sessions per week. The baseline measurement was taken on day one for Numeric Pain Rating Scale (NRPS) and Neck Disability Index (NDI). Forward head posture assessed by measuring Cranio Vertebral Angle (CVA). Respiratory muscle strengths measured by Spirometer and SBC (single breath count). All the measurements repeated at the end of fourth week. Data was analyzed by using SPSS version 20.
Detailed description
Extensive usage of electronic gadgets in today's life leads to the musculoskeletal problems among which neck pain is the most common problem reported to physicians, orthopedics and physical therapists. Even before reporting to clinics there is long history of using over the counter pain killers. Pain avoidance behaviors let the cervical spine stiff so much that a clinician help is sought. There is huge literature regarding the management of chronic neck pain and yet after the decades of research there are gaps in treatment options. In modern age of health care, it is common goal of every healthcare to make patient self-sufficient as early as possible. The self-care models have tremendous advantages. The current study has compared the effects of cervical stabilization exercises and isometric exercises. The current study was novel in a way that there is limited literature about treating Chronic Neck Pain Patients with effects of physiotherapy on respiratory strength in improving forward head posture. All the methods were employed to see if they improve ranges along with accompanying pain and disability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| baseline physical therapy treatment | Active comparator | Other: baseline physical therapy treatmentbaseline physical therapy treatment ,Control group- Group A |
| Cervical Stabilization exercises | Experimental | Other: Cervical Stabilization exercisesbaseline physical therapy treatment along with Cervical Stabilization exercises- Experimental Group- Group B |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with chronic neck pain for more than 3 months.
- Mild neck disability (NDI score 5-15)
Key exclusion criteria (5 listed)
- Neck pain secondary to trauma
- Deformities of thoracic region or vertebral column
- History of any thoracic or vertebral column surgery.
- History of smoking
- Patients with any other serious pathology/red flags
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 |
|---|---|---|
| baseline physical therapy treatmentGroup A was control group and the patients received Conventional treatment protocol for 4 weeks which included 3 sessions per week. Patients received hot pack for 15 min and TENS (Transcutaneous Electric Nerve Stimulation) for 10 min. After that Cervical isometric exercises will be performed in sitting (10sec hold,10 to 15 reps) | Other | baseline physical therapy treatment |
| Cervical Stabilization exercisesGroup B was experimental group and received baseline physiotherapy treatment in addition to Cervical Stabilization exercises. Pillow was placed beneath cervical spine in supine position and guided patients to nod head as though they said 'yes' and asked them to hold for 10 seconds. 10 repetitions were done before progressing to the next target level. 4 weeks (3 sessions per week) * Hot pack: 10 min * TENS: 10 min * Cervical isometric exercises in sitting (10sec hold,10 to 15 reps) * Cervical Stabilization exercises (10 sec hold, 10 reps) On eligible participants baseline assessment was taken on day 1, post intervention assessment was taken at the end of 4th week. | Other | Cervical Stabilization exercises |
Primary outcome
Numeric Pain rating scale
Time frame: 4th week
The NPRS is the segmented numeric version of visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of pain. The common format is a horizontal bar or line. Similar to VAS, the NPRS is anchored by terms describing pain severity extremes.
1 secondary outcome
Neck disability Index
Time frame: 4th Week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
- Background: PubMed 31771837Miranda IF, Wagner Neto ES, Dhein W, Brodt GA, Loss JF. Individuals With Chronic Neck Pain Have Lower Neck Strength Than Healthy Controls: A Systematic Review With Meta-Analysis. J Manipulative Physiol Ther. 2019 Oct;42(8):608-622. doi: 10.1016/j.jmpt.2018.12.008. Epub 2019 Nov 23.
- BackgroundMigliarese S, White E. Review of Forward-Head Posture and Vestibular Deficits in Older Adults. Current Geriatrics Reports. 2019;8(3):194-201.
- BackgroundGurudut P, Welling A, Chodankar A. Effect of self-care exercises in forward head posture on craniovertebral angle and craniocervical flexion endurance: A pilot study. Indian Journal of Physical Therapy and Research. 2020;2(1):25.
- BackgroundSon K-k, Cynn H-S, Lee J-H, Park D-H, Kim B-B. Effects of Deep Cervical Flexor Exercise with Visual Guide on Muscle Activity and Craniovertebral Angle in Subjects with Forward Head Posture. Korean Society of Physical Medicine. 2019;14(2):53-61.
- Background: PubMed 30774207Koseki T, Kakizaki F, Hayashi S, Nishida N, Itoh M. Effect of forward head posture on thoracic shape and respiratory function. J Phys Ther Sci. 2019 Jan;31(1):63-68. doi: 10.1589/jpts.31.63. Epub 2019 Jan 10.
- BackgroundMathur H, Khan SA, Siddiqui ZA. Effect of forward head posture on swallowing: Review of Literature. 2019
- Background: PubMed 31985500Herman PM, Vernon H, Hurwitz EL, Shekelle PG, Whitley MD, Coulter ID. Clinical Scenarios for Which Cervical Mobilization and Manipulation Are Considered by an Expert Panel to Be Appropriate (and Inappropriate) for Patients With Chronic Neck Pain. Clin J Pain. 2020 Apr;36(4):273-280. doi: 10.1097/AJP.0000000000000800.
- Background: PubMed 31809920Alsultan F, De Nunzio AM, Rushton A, Heneghan NR, Falla D. Variability of neck and trunk movement during single- and dual-task gait in people with chronic neck pain. Clin Biomech (Bristol). 2020 Feb;72:31-36. doi: 10.1016/j.clinbiomech.2019.11.019. Epub 2019 Nov 28.
- Background: PubMed 30896250Storto CJ, Garcez AS, Suzuki H, Cusmanich KG, Elkenawy I, Moon W, Suzuki SS. Assessment of respiratory muscle strength and airflow before and after microimplant-assisted rapid palatal expansion. Angle Orthod. 2019 Sep;89(5):713-720. doi: 10.2319/070518-504.1. Epub 2019 Mar 21.
- Background: PubMed 31982274Kalita J, Kumar M, Misra UK. Serial single breath count is a reliable tool for monitoring respiratory functions in Guillain-Barre Syndrome. J Clin Neurosci. 2020 Feb;72:50-56. doi: 10.1016/j.jocn.2020.01.032. Epub 2020 Jan 22.
- Background: PubMed 30475751Uysal SC, Tuzun EH, Eker L, Angin E. Effectiveness of the muscle energy technique on respiratory muscle strength and endurance in patients with fibromyalgia. J Back Musculoskelet Rehabil. 2019;32(3):411-419. doi: 10.3233/BMR-181287.
- BackgroundPawaria S, SuDhan DS, Kalra S. Effectiveness of Cervical Stabilisation Exercises on Respiratory Strength in Chronic Neck Pain Patients with Forward Head Posture-A Pilot Study. Journal of Clinical and Diagnostic Research. 2019;13(4).
- 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. This study is not recruiting at the moment.
Syed Shakil Ur Rehman principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing baseline physical therapy treatment and Cervical Stabilization exercises in people with Neck Pain, run by Riphah International University 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 2 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: finished, as of the sponsor's last update on 8 Mar 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain rating scale (time frame: 4th week). 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 NCT04674891, which also lists 16 linked publications.
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 8 Mar 2021; AzTrials last refreshed its copy on 6 Nov 2026.