Neck PainNCT05393973
Effects of Core Stability Versus Swiss Ball Exercise in Patients With Chronic Neck Pain
A study testing Core stability exercises along with conventional physical therapy and Swiss ball exercises along with the conventional physical therapy protocol in people with Neck Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
The study will be a randomized clinical trial to determine the effects of core stability versus swiss ball exercises on pain, range of motion and function in patients with chronic neck pain. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Core stability exercises along with conventional physical therapy and Swiss ball exercises along with the conventional physical therapy protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePakistan
- Study dates
- 30 May 2022to 30 Jan 2023
- 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • Both genders (male \& female)
- Age group 20-40 years
- History of neck pain for more than 3 months
Who cannot join
- History of any neck surgery
- Neoplasms
- Any systemic disease
- Bony disorders
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Bhawalpur Medical & Dental College, Bhawalpur
Chak Eighty-seven -Twelve Left, Punjab Province, 54000
About this study
Official title: Effects of Core Stability Versus Swiss Ball Exercise Program on Pain, Range of Motion and Function in Patients With Chronic Neck Pain
The study will be a randomized clinical trial to determine the effects of core stability versus swiss ball exercises on pain, range of motion and function in patients with chronic neck pain. A sample of 42 patients having neck pain since last 3 months will be taken from physical therapy department of "Bahawalpur medical \& dental hospital" and will be divided into two groups each with 21 patients. Patient of any gender(male or female) with no history of neck surgery or any systemic disease will be considered. Group A will receive core stability exercises along with conventional physical therapy while group B will receive swiss ball exercises along with the conventional physical therapy protocol. The conventional physical therapy protocol will include a hot pack, and cervical stretches. The session will be around 30-45 minutes for each patient with three sessions per week on alternate days. A total of four-week treatment regime will be given to the patients and an assessment of patient's pain, range of motion, and function with NPRS (numeric pain rating scale), goniometry, and NDI (neck disability index) will be done at the baseline and after 4 weeks of treatment, data will be analyzed by using SPSS version 21, after the completion of treatment at four weeks.
Read the detailed description
Chronic neck pain is one of the pains with the highest prevalence these days due to the imprecise daily life routine of people including students \& office workers etc. It is generally declared that pain and stiffness in neck occur due to faulty posture for prolonged periods of time against the gravity. Deep layered muscles e.g longus capitus, longus Colli, rectus capitus anterior \& rectus capitus lateralis provides the stability to neck if they are targeted it is believed that the observed problem can be cured. This study is aimed to compare two methods for stability of neck i.e. core stability exercises \& swiss ball exercises.
Until now many treatment options have been used for chronic neck pain e.g stretching, isometrics, fascia release, mobilization techniques etc, and in recent literature, it is seen that stability of neck muscles are emerging to alleviate chronic neck pain. This study is aiming to compare the effects of core stability exercises and swiss ball exercises.So, the latest , effective and economical options for treatment can be used by the physical therapists and can be guided to the patients in order to gain long-lasting effects.
- Conditions
- Neck Pain
- Being tested
- Core stability exercises along with conventional physical therapy, Swiss ball exercises along with the conventional physical therapy protocol
- Keywords
- Neck pain, Posture, Range of motion, Core Stability
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core stability exercises along with conventional physical therapyOther
Core stability exercises included neck isometric exercises(flexion, extension, lateral flexion, rotation), chin tuck, chin tuck into towel, cervical extension + 10 minutes hot pack+ 10 minutes stretching (cervical flexors, extensors, rotators), session will be of 30-40 minutes, three times a week, for 4 weeks duration.
Chin Tuck: In standing subject pulls back the chin( as if trying to make a double chin) while keeping the eyes level. This will be done for 15 repetitions.
Cervical extension: In a standing position, the subject grasps the base of the neck, with both hands while extending the neck as far as possible. This will be done for 15 repetitions
Swiss ball exercises along with the conventional physical therapy protocolOther
Swiss ball exercise will be executed in the following order, assume supine posture on the treatment bed by fully extending their legs and putting them back on the bed in the most comfortable posture with hands on the abdomen. Second, while in the supine posture, support the head with one hand and insert a small Swiss ball near the back of the head with the other hand. Third, after having contacted the ball to the area below the back of the head, slowly turn the head and neck in the shape of the number '8'. Fourth, after having set 3 repetitions of rotating the head and neck for 10 seconds and then taking 10 seconds of general resting as 1 set of exercise, a total of 3 sets of exercise were executed with 1 minute of general resting taken between each set of exercise. Then perform neck flexion, extension, side bending, and rotation, hold each movement for 10 seconds + Hot pack (10 minutes) + 10 minutes of cervical stretching. Perform the exercise three times a week for 4 weeks duration.
| Study group | Role | What they receive |
|---|---|---|
| Core stability exercises along with conventional physical therapy | Experimental | Core stability exercises Receives: Other: Core stability exercises along with conventional physical therapy |
| Swiss ball exercises along with the conventional physical therapy protocol | Experimental | Swiss ball exercises Receives: Other: Swiss ball exercises along with the conventional physical therapy protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
NPRS
Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. where 0 indicate no pain and 10 indicate severe pain.
Measured: 4th week
NDI
The NDI has become a standard instrument for measuring self-rated disability due to neck pain. Each of the 10 items scores from 0 to 5. The maximum score is 50
Measured: 4th week
Goniometric measurement of neck ROM
A goniometer is an instrument which measures the available range of motion at a joint.
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 posted26 May 2022
- Study start30 May 2022
- Primary completion30 Dec 2022
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 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
- NCT05393973
- Sponsor's protocol ID
- REC/RCR & AHS/22/0145 Yumna
- Status last verified
- Apr 2023
- First submitted
- 23 May 2022
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gupta BD, Aggarwal S, Gupta B, Gupta M, Gupta N. Effect of Deep Cervical Flexor Training vs. Conventional Isometric Training on Forward Head Posture, Pain, Neck Disability Index In Dentists Suffering from Chronic Neck Pain. J Clin Diagn Res. 2013 Oct;7(10):2261-4. doi: 10.7860/JCDR/2013/6072.3487. Epub 2013 Oct 5.
PubMed 24298492Hoy DG, Protani M, De R, Buchbinder R. The epidemiology of neck pain. Best Pract Res Clin Rheumatol. 2010 Dec;24(6):783-92. doi: 10.1016/j.berh.2011.01.019.
PubMed 21665126Kim BJ. Effects of Neck Stabilization and Swiss Ball Exercises on the Recovery from Fatigue of Neck Muscles in Turtle Neck Posture: Preliminary Experimental Study. Journal of International Academy of Physical Therapy Research. 2018;9(2):1498-507.
Noormohammadpour P, Kordi M, Mansournia MA, Akbari-Fakhrabadi M, Kordi R. The Role of a Multi-Step Core Stability Exercise Program in the Treatment of Nurses with Chronic Low Back Pain: A Single-Blinded Randomized Controlled Trial. Asian Spine J. 2018 Jun;12(3):490-502. doi: 10.4184/asj.2018.12.3.490. Epub 2018 Jun 4.
PubMed 29879777Rajalaxmi V, Manickam M, Srilakshmi M, Arunselvi J, Jayabarathi R, Anupreethi P, et al. The role of multistep core stability exercise with and without conventional neck exercises in the treatment of chronic non-specific neck pain a randomized controlled trial. Biomedicine. 2020;40(2):232-5.
He Y, Sun W, Zhao X, Ma M, Zheng Z, Xu L. Effects of core stability exercise for patients with neck pain: A protocol for systematic review and meta-analysis. Medicine (Baltimore). 2019 Nov;98(46):e17240. doi: 10.1097/MD.0000000000017240.
PubMed 31725601Ahn JA, Kim JH, Bendik AL, Shin JY. Effects of stabilization exercises with a Swiss ball on neck-shoulder pain and mobility of adults with prolonged exposure to VDTs. J Phys Ther Sci. 2015 Apr;27(4):981-4. doi: 10.1589/jpts.27.981. Epub 2015 Apr 30.
PubMed 25995537Cho H-Y, Park Y-J, Moon H-H, Park S-S, Kang G-M, Yoon W-Y, et al. The effect of swiss ball stabilisation exercise on deep and superficial cervical muscle and pain in patients with chronic neck pain. Indian Journal of Science and Technology. 2015;8:14.
Correa EC, Berzin F. Mouth Breathing Syndrome: cervical muscles recruitment during nasal inspiration before and after respiratory and postural exercises on Swiss Ball. Int J Pediatr Otorhinolaryngol. 2008 Sep;72(9):1335-43. doi: 10.1016/j.ijporl.2008.05.012. Epub 2008 Jul 7.
PubMed 18603307
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Core Stability Versus Swiss Ball Exercise Program on Pain, Range of Motion and Function in Patients With Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT05393973
- Acronym / sponsor ID
- REC/RCR & AHS/22/0145 Yumna
- Conditions
- Neck Pain
- Keywords
- Neck pain, Posture, Range of motion, Core Stability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 May 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 26 May 2022 (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.
The study will be a randomized clinical trial to determine the effects of core stability versus swiss ball exercises on pain, range of motion and function in patients with chronic neck pain. A sample of 42 patients having neck pain since last 3 months will be taken from physical therapy department of "Bahawalpur medical \& dental hospital" and will be divided into two groups each with 21 patients. Patient of any gender(male or female) with no history of neck surgery or any systemic disease will be considered. Group A will receive core stability exercises along with conventional physical therapy while group B will receive swiss ball exercises along with the conventional physical therapy protocol. The conventional physical therapy protocol will include a hot pack, and cervical stretches. The session will be around 30-45 minutes for each patient with three sessions per week on alternate days. A total of four-week treatment regime will be given to the patients and an assessment of patient's pain, range of motion, and function with NPRS (numeric pain rating scale), goniometry, and NDI (neck disability index) will be done at the baseline and after 4 weeks of treatment, data will be analyzed by using SPSS version 21, after the completion of treatment at four weeks.
Detailed description
Chronic neck pain is one of the pains with the highest prevalence these days due to the imprecise daily life routine of people including students \& office workers etc. It is generally declared that pain and stiffness in neck occur due to faulty posture for prolonged periods of time against the gravity. Deep layered muscles e.g longus capitus, longus Colli, rectus capitus anterior \& rectus capitus lateralis provides the stability to neck if they are targeted it is believed that the observed problem can be cured. This study is aimed to compare two methods for stability of neck i.e. core stability exercises \& swiss ball exercises.
Until now many treatment options have been used for chronic neck pain e.g stretching, isometrics, fascia release, mobilization techniques etc, and in recent literature, it is seen that stability of neck muscles are emerging to alleviate chronic neck pain. This study is aiming to compare the effects of core stability exercises and swiss ball exercises.So, the latest , effective and economical options for treatment can be used by the physical therapists and can be guided to the patients in order to gain long-lasting effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Core stability exercises along with conventional physical therapy | Experimental | Other: Core stability exercises along with conventional physical therapyCore stability exercises |
| Swiss ball exercises along with the conventional physical therapy protocol | Experimental | Other: Swiss ball exercises along with the conventional physical therapy protocolSwiss ball exercises |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- • Both genders (male \& female)
Key exclusion criteria (4 listed)
- History of any neck surgery
- Neoplasms
- Any systemic disease
- Bony disorders
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 |
|---|---|---|
| Core stability exercises along with conventional physical therapyCore stability exercises included neck isometric exercises(flexion, extension, lateral flexion, rotation), chin tuck, chin tuck into towel, cervical extension + 10 minutes hot pack+ 10 minutes stretching (cervical flexors, extensors, rotators), session will be of 30-40 minutes, three times a week, for 4 weeks duration. Chin Tuck: In standing subject pulls back the chin( as if trying to make a double chin) while keeping the eyes level. This will be done for 15 repetitions. Cervical extension: In a standing position, the subject grasps the base of the neck, with both hands while extending the neck as far as possible. This will be done for 15 repetitions | Other | Core stability exercises along with conventional physical therapy |
| Swiss ball exercises along with the conventional physical therapy protocolSwiss ball exercise will be executed in the following order, assume supine posture on the treatment bed by fully extending their legs and putting them back on the bed in the most comfortable posture with hands on the abdomen. Second, while in the supine posture, support the head with one hand and insert a small Swiss ball near the back of the head with the other hand. Third, after having contacted the ball to the area below the back of the head, slowly turn the head and neck in the shape of the number '8'. Fourth, after having set 3 repetitions of rotating the head and neck for 10 seconds and then taking 10 seconds of general resting as 1 set of exercise, a total of 3 sets of exercise were executed with 1 minute of general resting taken between each set of exercise. Then perform neck flexion, extension, side bending, and rotation, hold each movement for 10 seconds + Hot pack (10 minutes) + 10 minutes of cervical stretching. Perform the exercise three times a week for 4 weeks duration. | Other | Swiss ball exercises along with the conventional physical therapy protocol |
Primary outcome
NPRS
Time frame: 4th week
Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. where 0 indicate no pain and 10 indicate severe pain.
NDI
Time frame: 4th week
The NDI has become a standard instrument for measuring self-rated disability due to neck pain. Each of the 10 items scores from 0 to 5. The maximum score is 50
Goniometric measurement of neck ROM
Time frame: 4th Week
A goniometer is an instrument which measures the available range of motion at a joint.
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 19 Apr 2023.
- Background: PubMed 24298492Gupta BD, Aggarwal S, Gupta B, Gupta M, Gupta N. Effect of Deep Cervical Flexor Training vs. Conventional Isometric Training on Forward Head Posture, Pain, Neck Disability Index In Dentists Suffering from Chronic Neck Pain. J Clin Diagn Res. 2013 Oct;7(10):2261-4. doi: 10.7860/JCDR/2013/6072.3487. Epub 2013 Oct 5.
- Background: PubMed 21665126Hoy DG, Protani M, De R, Buchbinder R. The epidemiology of neck pain. Best Pract Res Clin Rheumatol. 2010 Dec;24(6):783-92. doi: 10.1016/j.berh.2011.01.019.
- BackgroundKim BJ. Effects of Neck Stabilization and Swiss Ball Exercises on the Recovery from Fatigue of Neck Muscles in Turtle Neck Posture: Preliminary Experimental Study. Journal of International Academy of Physical Therapy Research. 2018;9(2):1498-507.
- Background: PubMed 29879777Noormohammadpour P, Kordi M, Mansournia MA, Akbari-Fakhrabadi M, Kordi R. The Role of a Multi-Step Core Stability Exercise Program in the Treatment of Nurses with Chronic Low Back Pain: A Single-Blinded Randomized Controlled Trial. Asian Spine J. 2018 Jun;12(3):490-502. doi: 10.4184/asj.2018.12.3.490. Epub 2018 Jun 4.
- BackgroundRajalaxmi V, Manickam M, Srilakshmi M, Arunselvi J, Jayabarathi R, Anupreethi P, et al. The role of multistep core stability exercise with and without conventional neck exercises in the treatment of chronic non-specific neck pain a randomized controlled trial. Biomedicine. 2020;40(2):232-5.
- Background: PubMed 31725601He Y, Sun W, Zhao X, Ma M, Zheng Z, Xu L. Effects of core stability exercise for patients with neck pain: A protocol for systematic review and meta-analysis. Medicine (Baltimore). 2019 Nov;98(46):e17240. doi: 10.1097/MD.0000000000017240.
- Background: PubMed 25995537Ahn JA, Kim JH, Bendik AL, Shin JY. Effects of stabilization exercises with a Swiss ball on neck-shoulder pain and mobility of adults with prolonged exposure to VDTs. J Phys Ther Sci. 2015 Apr;27(4):981-4. doi: 10.1589/jpts.27.981. Epub 2015 Apr 30.
- BackgroundCho H-Y, Park Y-J, Moon H-H, Park S-S, Kang G-M, Yoon W-Y, et al. The effect of swiss ball stabilisation exercise on deep and superficial cervical muscle and pain in patients with chronic neck pain. Indian Journal of Science and Technology. 2015;8:14.
- Background: PubMed 18603307Correa EC, Berzin F. Mouth Breathing Syndrome: cervical muscles recruitment during nasal inspiration before and after respiratory and postural exercises on Swiss Ball. Int J Pediatr Otorhinolaryngol. 2008 Sep;72(9):1335-43. doi: 10.1016/j.ijporl.2008.05.012. Epub 2008 Jul 7.
- 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 Core stability exercises along with conventional physical therapy and Swiss ball exercises along with the conventional physical therapy protocol 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 3 inclusion and 4 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 19 Apr 2023. 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?
NPRS (time frame: 4th week). 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 NCT05393973, which also lists 9 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 19 Apr 2023.