Neck PainNCT05865951
Comparison of Isometric and Isotonic Strengthening Exercises in Chronic Neck Pain Patients.
A study testing Isometric Exercises and Isotonic Exercises in people with Neck Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
Study will be a Randomized clinical trial to check the effects of isometric and isotonic strength training exercises on patients with chronic neck pain. The data will be collected in a hospital setting where patients of chronic mechanical neck pain will be screened out for the fulfillment of eligibility criteria of… Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Isometric Exercises and Isotonic Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Apr 2023to 15 Sep 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 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- No discrimination against gender
- Age group 25-55 years
- Complain of chronic mechanical neck pain for more than 3 months
Who cannot join
- Spinal cord injury
- Malignancy
- Cervical fracture
- Any bony or soft tissue systemic disease
- Ankylosis spondylitis
- Craniovertebral disorders
- Any cervical deformity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Comparative Effects of Isometric and Isotonic Global Neck Muscles Strengthening Exercise Program on Pain, Range of Motion, Strength, Function, and Quality of Life in Patients With Chronic Mechanical Neck Pain.
Study will be a Randomized clinical trial to check the effects of isometric and isotonic strength training exercises on patients with chronic neck pain. The data will be collected in a hospital setting where patients of chronic mechanical neck pain will be screened out for the fulfillment of eligibility criteria of this study. After being eligible for this study their baseline outcome measures will be measured using Numeric pain rating scale, neck disability index, goniometer, dynamometer and short form 36 survey. Then they will be divided into two groups namely group A receiving isometric exercises with conventional treatment and group B receiving isotonic exercises with conventional treatment. Here conventional treatment includes thermotherapy, manual mobilisation of cervical and thoracic and trigger point therapy which will be a common treatment for both groups. The outcome measures will be measured later at 4th,8th and 12th week.
Read the detailed description
Chronic neck pain is a burden to health globally and is the major reason behind years of disability. This is due to the higher prevalence, persistence and recurrence.It is a frequent reason for visit to physical therapist or a physician. It is the major health concern for society these days with highest recurrence rate combined with its chronicity. The overall worldwide prevalence for it is 16.7% to 75.1%. There is scarce knowledge of use of isotonic neck muscles strengthening in clinical trials. Moreover the literature has not satisfied the long term effects of isometric and isotonic strength training exercises of cervical muscles on improving the health related quality of life and restoring the normal function of cervical spine.
The findings of current study will help to establish long term effects of isometric and isotonic strengthening exercises on pain, strength, function and quality of life in chronic mechanical neck pain patients.
Neck strength training exercises have shown to reduce neck muscle injuries in sports.Neck strength training has also proved beneficial in reducing neck pain as part of training.
The static muscle contractions of neck muscles of patient being seated with the resistance of palm of physiotherapist being standing will be performed in six cervical movements i.e. flexion, extension, right lateralflexion, left lateral flexion, right rotation, left rotation.
The dynamic muscle contractions of neck muscles will be performed using thera-band for resistance tied on the wall for all six movements of cervical spine.
- Conditions
- Neck Pain
- Being tested
- Isometric Exercises, Isotonic Exercises
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isometric ExercisesOther
Isometric (same length) strengthening exercises of the neck muscles will be performed.
Isotonic ExercisesOther
Isotonic strengthening exercises for the neck muscles will be performed.
| Study group | Role | What they receive |
|---|---|---|
| chronic neck pain and isometric exercises group: | Experimental | Group A performed exercises for 12 weeks. Participants performed isometric exercises along with conventional physical therapy treatment ( thermotherapy, manual mobilisation of cervical spine and trigger point therapy). All exercises were performed for 3 sessions per week for a period of 12 weeks. Receives: Other: Isometric Exercises |
| chronic neck pain and isotonic group | Active comparator | Group B performed exercises for 12 weeks. Participants performed isotonic exercises along with conventional physical therapy treatment ( thermotherapy, manual mobilisation of cervical spine and trigger point therapy). All exercises were performed for 3 sessions per week for a period of 12 weeks. Receives: Other: Isotonic Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale (NPRS):
It is a unidimensional outcome measure that is used for measuring intensity of chronic pain. It is a verbally administered scale rating from 0 to 10 where 10 quantifies worse pain intensity and 5 as a moderate intensity. The simplicity in pain scoring makes it a reliable scale with reliability 0.96 in literate and 0.95 in illiterate patients whereas validity ranges from 0.86 to 0.95.
Measured: up to 12 weeks
Universal GONIOMETER for Range of Motion
It is the device used for measuring range of motion of joints. One of the type of goniometer to be used in this study is universal goniometer with two arms, one arm is maintained at neutral position whereby the other arm moves with the moving part of body. The inter-observer reliability remains at 0.99 whereas validity being 0.97
Measured: up to 12 weeks
Hand-Held DYNAMOMETER for muscle strength measurement
Dynamometer is a hand-held device used to measure thestrength of muscles. It is to be placed as a resistance in the movement to quantify the muscle strength into force unit. It has reliability from 0.94 to 0.97.
Measured: up to 12 weeks
NECK DISABILITY INDEX (NDI):
It is a function specific questionnaire designed to measure thelevel of disability and restriction in activities of daily living. It comprises of 10 questions about daily living while the score is converted to percentage where 0% indicates no limitation in function while 50-100% indicates complete activity limitation. It has moderate test re-test reliability where ICC varies between 0.50 and 0.98, while it constructs a good validity.
Measured: up to 12 weeks
Secondary outcomes (1)
36-Item Short Form Survey (SF-36) for quality of life
This survey quantifies the quality of life. It comprises of 36questions related to health, physical activity and psychology. It has shown to be reliable and a valid questionnaire.Scores for the different domains are converted and pooled using a scoring key, for a total score indicating a range of low to high quality of life.SF-36 scores range from 0 (worst) to 100 (best).
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start15 Apr 2023
- Primary completion1 Sep 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Misha Butt, MS*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05865951
- Sponsor's protocol ID
- REC/RCR & AHS/23/0117
- Status last verified
- Mar 2024
- First submitted
- 18 Apr 2023
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Genebra CVDS, Maciel NM, Bento TPF, Simeao SFAP, Vitta A. Prevalence and factors associated with neck pain: a population-based study. Braz J Phys Ther. 2017 Jul-Aug;21(4):274-280. doi: 10.1016/j.bjpt.2017.05.005. Epub 2017 May 20.
PubMed 28602744Childs JD, Cleland JA, Elliott JM, Teyhen DS, Wainner RS, Whitman JM, Sopky BJ, Godges JJ, Flynn TW; American Physical Therapy Association. Neck pain: Clinical practice guidelines linked to the International Classification of Functioning, Disability, and Health from the Orthopedic Section of the American Physical Therapy Association. J Orthop Sports Phys Ther. 2008 Sep;38(9):A1-A34. doi: 10.2519/jospt.2008.0303. Epub 2008 Sep 1.
PubMed 18758050Berg HE, Berggren G, Tesch PA. Dynamic neck strength training effect on pain and function. Arch Phys Med Rehabil. 1994 Jun;75(6):661-5. doi: 10.1016/0003-9993(94)90189-9.
PubMed 8002765Hrysomallis C. Neck Muscular Strength, Training, Performance and Sport Injury Risk: A Review. Sports Med. 2016 Aug;46(8):1111-24. doi: 10.1007/s40279-016-0490-4.
PubMed 26861960Lin IH, Chang KH, Liou TH, Tsou CM, Huang YC. Progressive shoulder-neck exercise on cervical muscle functions in middle-aged and senior patients with chronic neck pain. Eur J Phys Rehabil Med. 2018 Feb;54(1):13-21. doi: 10.23736/S1973-9087.17.04658-5. Epub 2017 Jul 17.
PubMed 28714658Conley MS, Stone MH, Nimmons M, Dudley GA. Specificity of resistance training responses in neck muscle size and strength. Eur J Appl Physiol Occup Physiol. 1997;75(5):443-8. doi: 10.1007/s004210050186.
PubMed 9189733Salo PK, Hakkinen AH, Kautiainen H, Ylinen JJ. Effect of neck strength training on health-related quality of life in females with chronic neck pain: a randomized controlled 1-year follow-up study. Health Qual Life Outcomes. 2010 May 14;8:48. doi: 10.1186/1477-7525-8-48.
PubMed 20465854Hakkinen A, Kautiainen H, Hannonen P, Ylinen J. Strength training and stretching versus stretching only in the treatment of patients with chronic neck pain: a randomized one-year follow-up study. Clin Rehabil. 2008 Jul;22(7):592-600. doi: 10.1177/0269215507087486.
PubMed 18586810Gallego-Sendarrubias GM, Rodriguez-Sanz D, Calvo-Lobo C, Martin JL. Efficacy of dry needling as an adjunct to manual therapy for patients with chronic mechanical neck pain: a randomised clinical trial. Acupunct Med. 2020 Aug;38(4):244-254. doi: 10.1136/acupmed-2018-011682. Epub 2020 Mar 23.
PubMed 32202124Amjad M, Ur Rehman SS, Fatima G, Ikram M, Ghafoor S. Comparative effects of isometric and isotonic global neck muscles strengthening exercise programme on pain, range of motion, strength, function and quality of life in patients with chronic mechanical neck pain. J Pak Med Assoc. 2024 Oct;74(10):1843-1846. doi: 10.47391/JPMA.11378.
PubMed 39407381
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Comparative Effects of Isometric and Isotonic Global Neck Muscles Strengthening Exercise Program on Pain, Range of Motion, Strength, Function, and Quality of Life in Patients With Chronic Mechanical Neck Pain.
- ClinicalTrials.gov ID
- NCT05865951
- Acronym / sponsor ID
- REC/RCR & AHS/23/0117
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 19 May 2023 (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.
Study will be a Randomized clinical trial to check the effects of isometric and isotonic strength training exercises on patients with chronic neck pain. The data will be collected in a hospital setting where patients of chronic mechanical neck pain will be screened out for the fulfillment of eligibility criteria of this study. After being eligible for this study their baseline outcome measures will be measured using Numeric pain rating scale, neck disability index, goniometer, dynamometer and short form 36 survey. Then they will be divided into two groups namely group A receiving isometric exercises with conventional treatment and group B receiving isotonic exercises with conventional treatment. Here conventional treatment includes thermotherapy, manual mobilisation of cervical and thoracic and trigger point therapy which will be a common treatment for both groups. The outcome measures will be measured later at 4th,8th and 12th week.
Detailed description
Chronic neck pain is a burden to health globally and is the major reason behind years of disability. This is due to the higher prevalence, persistence and recurrence.It is a frequent reason for visit to physical therapist or a physician. It is the major health concern for society these days with highest recurrence rate combined with its chronicity. The overall worldwide prevalence for it is 16.7% to 75.1%. There is scarce knowledge of use of isotonic neck muscles strengthening in clinical trials. Moreover the literature has not satisfied the long term effects of isometric and isotonic strength training exercises of cervical muscles on improving the health related quality of life and restoring the normal function of cervical spine.
The findings of current study will help to establish long term effects of isometric and isotonic strengthening exercises on pain, strength, function and quality of life in chronic mechanical neck pain patients.
Neck strength training exercises have shown to reduce neck muscle injuries in sports.Neck strength training has also proved beneficial in reducing neck pain as part of training.
The static muscle contractions of neck muscles of patient being seated with the resistance of palm of physiotherapist being standing will be performed in six cervical movements i.e. flexion, extension, right lateralflexion, left lateral flexion, right rotation, left rotation.
The dynamic muscle contractions of neck muscles will be performed using thera-band for resistance tied on the wall for all six movements of cervical spine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chronic neck pain and isometric exercises group: | Experimental | Other: Isometric ExercisesGroup A performed exercises for 12 weeks. Participants performed isometric exercises along with conventional physical therapy treatment ( thermotherapy, manual mobilisation of cervical spine and trigger point therapy). All exercises were performed for 3 sessions per week for a period of 12 weeks. |
| chronic neck pain and isotonic group | Active comparator | Other: Isotonic ExercisesGroup B performed exercises for 12 weeks. Participants performed isotonic exercises along with conventional physical therapy treatment ( thermotherapy, manual mobilisation of cervical spine and trigger point therapy). All exercises were performed for 3 sessions per week for a period of 12 weeks. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- No discrimination against gender
- Age group 25-55 years
- Complain of chronic mechanical neck pain for more than 3 months
Key exclusion criteria (7 listed)
- Spinal cord injury
- Malignancy
- Cervical fracture
- Any bony or soft tissue systemic disease
- Ankylosis spondylitis
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 |
|---|---|---|
| Isometric ExercisesIsometric (same length) strengthening exercises of the neck muscles will be performed. | Other | chronic neck pain and isometric exercises group: |
| Isotonic ExercisesIsotonic strengthening exercises for the neck muscles will be performed. | Other | chronic neck pain and isotonic group |
Primary outcome
Numeric Pain Rating Scale (NPRS):
Time frame: up to 12 weeks
It is a unidimensional outcome measure that is used for measuring intensity of chronic pain. It is a verbally administered scale rating from 0 to 10 where 10 quantifies worse pain intensity and 5 as a moderate intensity. The simplicity in pain scoring makes it a reliable scale with reliability 0.96 in literate and 0.95 in illiterate patients whereas validity ranges from 0.86 to 0.95.
Universal GONIOMETER for Range of Motion
Time frame: up to 12 weeks
It is the device used for measuring range of motion of joints. One of the type of goniometer to be used in this study is universal goniometer with two arms, one arm is maintained at neutral position whereby the other arm moves with the moving part of body. The inter-observer reliability remains at 0.99 whereas validity being 0.97
Hand-Held DYNAMOMETER for muscle strength measurement
Time frame: up to 12 weeks
Dynamometer is a hand-held device used to measure thestrength of muscles. It is to be placed as a resistance in the movement to quantify the muscle strength into force unit. It has reliability from 0.94 to 0.97.
NECK DISABILITY INDEX (NDI):
Time frame: up to 12 weeks
It is a function specific questionnaire designed to measure thelevel of disability and restriction in activities of daily living. It comprises of 10 questions about daily living while the score is converted to percentage where 0% indicates no limitation in function while 50-100% indicates complete activity limitation. It has moderate test re-test reliability where ICC varies between 0.50 and 0.98, while it constructs a good validity.
1 secondary outcome
36-Item Short Form Survey (SF-36) for quality of life
Time frame: up to 12 weeks
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 5 Mar 2024.
- Background: PubMed 28602744Genebra CVDS, Maciel NM, Bento TPF, Simeao SFAP, Vitta A. Prevalence and factors associated with neck pain: a population-based study. Braz J Phys Ther. 2017 Jul-Aug;21(4):274-280. doi: 10.1016/j.bjpt.2017.05.005. Epub 2017 May 20.
- Background: PubMed 18758050Childs JD, Cleland JA, Elliott JM, Teyhen DS, Wainner RS, Whitman JM, Sopky BJ, Godges JJ, Flynn TW; American Physical Therapy Association. Neck pain: Clinical practice guidelines linked to the International Classification of Functioning, Disability, and Health from the Orthopedic Section of the American Physical Therapy Association. J Orthop Sports Phys Ther. 2008 Sep;38(9):A1-A34. doi: 10.2519/jospt.2008.0303. Epub 2008 Sep 1.
- Background: PubMed 8002765Berg HE, Berggren G, Tesch PA. Dynamic neck strength training effect on pain and function. Arch Phys Med Rehabil. 1994 Jun;75(6):661-5. doi: 10.1016/0003-9993(94)90189-9.
- Background: PubMed 26861960Hrysomallis C. Neck Muscular Strength, Training, Performance and Sport Injury Risk: A Review. Sports Med. 2016 Aug;46(8):1111-24. doi: 10.1007/s40279-016-0490-4.
- Background: PubMed 28714658Lin IH, Chang KH, Liou TH, Tsou CM, Huang YC. Progressive shoulder-neck exercise on cervical muscle functions in middle-aged and senior patients with chronic neck pain. Eur J Phys Rehabil Med. 2018 Feb;54(1):13-21. doi: 10.23736/S1973-9087.17.04658-5. Epub 2017 Jul 17.
- Background: PubMed 9189733Conley MS, Stone MH, Nimmons M, Dudley GA. Specificity of resistance training responses in neck muscle size and strength. Eur J Appl Physiol Occup Physiol. 1997;75(5):443-8. doi: 10.1007/s004210050186.
- Background: PubMed 20465854Salo PK, Hakkinen AH, Kautiainen H, Ylinen JJ. Effect of neck strength training on health-related quality of life in females with chronic neck pain: a randomized controlled 1-year follow-up study. Health Qual Life Outcomes. 2010 May 14;8:48. doi: 10.1186/1477-7525-8-48.
- Background: PubMed 18586810Hakkinen A, Kautiainen H, Hannonen P, Ylinen J. Strength training and stretching versus stretching only in the treatment of patients with chronic neck pain: a randomized one-year follow-up study. Clin Rehabil. 2008 Jul;22(7):592-600. doi: 10.1177/0269215507087486.
- Background: PubMed 32202124Gallego-Sendarrubias GM, Rodriguez-Sanz D, Calvo-Lobo C, Martin JL. Efficacy of dry needling as an adjunct to manual therapy for patients with chronic mechanical neck pain: a randomised clinical trial. Acupunct Med. 2020 Aug;38(4):244-254. doi: 10.1136/acupmed-2018-011682. Epub 2020 Mar 23.
- Derived from this study: PubMed 39407381Amjad M, Ur Rehman SS, Fatima G, Ikram M, Ghafoor S. Comparative effects of isometric and isotonic global neck muscles strengthening exercise programme on pain, range of motion, strength, function and quality of life in patients with chronic mechanical neck pain. J Pak Med Assoc. 2024 Oct;74(10):1843-1846. doi: 10.47391/JPMA.11378.
- 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.
Misha Butt, MS* 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 Isometric Exercises and Isotonic 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 3 inclusion and 7 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 5 Mar 2024. 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 (NPRS): (time frame: up to 12 weeks). The study lists 4 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 NCT05865951, which also lists 10 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 5 Mar 2024.