Neck PainNCT06877728
Comparative Effect of Neck Isometrics and Deep Cervical Flexion Exercises on Neck Pain Among Breastfeeding Females.
A study testing Neck isometric exercises: 3 times weekly for 6 consecutive weeks (18 sessions) in people with Neck Pain and Range of Motion, run by Riphah International University at 1 site in Pakistan.
Trial summary
Neck pain is a common complaint among breastfeeding females, potentially attributed to sustained postures and muscle imbalance. Breastfeeding females experiencing neck pain, aged between 18-40 years, will be recruited through local healthcare facilities and community outreach. Read more about this study
- Who is it for?
- Ages 25 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Neck Pain, Range of Motion, Muscle Weakness
- What is being tested?
- Neck isometric exercises: 3 times weekly for 6 consecutive weeks (18 sessions)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Feb 2024to 15 Feb 2025
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between the ages of 25 to 40 years
- Mode of delivery (vaginal/c-section)
- Severe neck weakness (above grade III)
- Primigravida
Who cannot join
- Previous history of upper extremity musculoskeletal symptoms
- Radicular neck pain
- History of inflammatory disease (myelopathy)
- History of cervical fracture
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effect of Neck Isometrics and Deep Cervical Flexion Exercises on Neck Pain, Functional Disability, Range of Motion and Muscle Weakness Among Breastfeeding Females
Neck pain is a common complaint among breastfeeding females, potentially attributed to sustained postures and muscle imbalance. Breastfeeding females experiencing neck pain, aged between 18-40 years, will be recruited through local healthcare facilities and community outreach. The physical demands of breastfeeding, such as prolonged postures and repetitive movements, can contribute to the development of musculoskeletal issues in the cervical region.
Despite the prevalence of neck discomfort among breastfeeding females, there is a paucity of research exploring effective exercise interventions tailored to this specific population. Mothers' awareness of proper nursing positions during breastfeeding may have positive impact on the connection between mother and baby. Most typical positions for nursing a baby are cross cradle hold, cradle hold, side lying and football hold. Most common adapted breastfeeding position is cross cradle.
Read the detailed description
A randomized control trial will be conducted to assess and compare the effectiveness of neck isometrics and deep cervical flexion exercises in alleviating neck pain, reducing disability, improving range of motion, and addressing muscle weakness in breastfeeding females. A sample size of 48 lactating women will be taken. Data will be collected from private clinical setups of Bahawalpur by using (NPRS) Numeric Pain Rating Scale Questionnaire, (NDI) Neck Disability Index, Range of motion will be assessed by inclinometer and Muscle strength will be assessed by MMT. A written consent form will be taken from participants meeting inclusion criteria and will be randomly allocated into two groups of equal members. Group A will be given Neck Isometric Exercises and Conservative treatment for 30 min (3-4days/week) of duration for total 6 weeks.
Group B will be given Deep Cervical Flexion Exercises with conservative treatment. The interventions will be provided for 30 minutes for 3-4 Day/week for 6 weeks. All participants in both groups will be evaluated before and after the treatment programs. Outcome measures will be calculated after 6 weeks of intervention. Data will be analyzed by using SPSS 21
- Conditions
- Neck Pain, Range of Motion, Muscle Weakness, Breastfeeding
- Being tested
- Neck isometric exercises: 3 times weekly for 6 consecutive weeks (18 sessions)
- Keywords
- Neck pain, range of motion, Muscle weakness, Breastfeeding
- Medical subject headings
- Neck Pain, Muscle Weakness, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neck isometric exercises: 3 times weekly for 6 consecutive weeks (18 sessions)Other
Neck isometric exercises: 3 times weekly for 6 consecutive weeks (18 sessions) Duration: 10 to 15 repetitions with 3 sets, and 6 sec hold in flexion, extension and side flexion on both right and left.
| Study group | Role | What they receive |
|---|---|---|
| Isometric exercises with conservative treatment | Active comparator | Will receive Neck isometrics exercises with conservative treatment. Neck isometric exercises: 3 times weekly for 6 consecutive weeks (18 sessions) Duration: 10 to 15 repetitions with 3 sets, and 6 sec hold in flexion, extension and side flexion on both right and left. Receives: Other: Neck isometric exercises: 3 times weekly for 6 consecutive weeks (18 sessions) |
| Deep cervical flexion exercises with conservative treatment | Other | Will Deep cervical flexion exercises without conservative treatment. Deep cervical flexion exercises: 3 times weekly for 6 consecutive weeks (18 session) Duration: 10 to 15 repetitions with 3 sets, 30 sec rest given between each set. Exercise should target on deep cervical muscle rather than superficial muscle. Exercise should be conducted in supine position. Receives: Other: Neck isometric exercises: 3 times weekly for 6 consecutive weeks (18 sessions) |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Numeric Pain Rating Scale (NPRS)
A Numeric Pain Rating Scale (NPRS) is a commonly used self-report measure to assess pain intensity. It typically involves asking individuals to rate their pain on a numerical scale.
Below is a suggested format for a Numeric Pain Rating Scale questionnaire along with instructions and scoring guidelines. Scoring: Ask participants to circle the number on the scale that corresponds to their current pain intensity. The score is a single numeric value ranging from 0 to 10, with 0 indicating no pain and 10 indicating the worst imaginable pain.
The higher the score, the greater the perceived pain intensity. The NPRS is a widely used subjective pain measure that has good test-retest reliability (r=. 79-. 96)
Measured: 8 Weeks
NECK DISABILITY INDEX QUESTIONNARE
The Neck Disability Index (NDI) is a widely used self-report questionnaire designed to assess disability related to neck pain. The questionnaire consists of 10 items that measure various aspects of daily activities affected by neck pain. Each item is scored on a 0 to 5 scale, and the total score is expressed as a percentage, with 0 indicating "no disability" and 5 indicating "complete disability. Format: 10 items evaluating concerns relating to neck pain.
The participant selects the number that best describes their level of disability for each activity. The NDI has a fair to moderate test-retest reliability in patients with mechanical neck pain, intra class correlations can change between 0,50 and 0,98 (
Measured: 8 Weeks
INCLINOMETER NECK ROM:
An inclinometer is a device used to measure the range of motion (ROM) of joints, including the neck, an inclinometer is often applied to measure flexion, extension, lateral flexion, and rotation of the cervical spine. The digital inclinometer demonstrated excellent reliability (ICC=0.75-0.86), except for the right lateral flexion (ICC=0.74) and left rotation (ICC=0.72)
Measured: 8 Weeks
MANUAL MUSCLE TESTING FOR MUSCLE WEAKNESS:
Manual Muscle Testing (MMT) is a clinical and functional assessment technique used by healthcare professionals, such as physical therapists and physicians, to evaluate muscle strength and identify potential muscle weakness. It involves the application of resistance against a person's voluntary muscle contraction, and the resulting force is graded on a scale.
5/5: Normal strength (complete range of motion against gravity with full resistance) 4/5: Good strength (complete range of motion against gravity with moderate resistance) 3/5: Fair strength (complete range of motion against gravity with no resistance) 2/5: Poor strength (partial range of motion against gravity) 1/5: Trace movement (a flicker or trace of movement, but no joint motion) 0/5: No movement (complete paralysis)(
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start15 Feb 2024
- Primary completion15 Feb 2025
- Study completion15 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- 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
- Model description
- participants received scar mobilization combined with kinesio tapping
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Faiza Taufiq, PP-DPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06877728
- Sponsor's protocol ID
- S23C14G92015
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effect of Neck Isometrics and Deep Cervical Flexion Exercises on Neck Pain, Functional Disability, Range of Motion and Muscle Weakness Among Breastfeeding Females
- ClinicalTrials.gov ID
- NCT06877728
- Acronym / sponsor ID
- S23C14G92015
- Conditions
- Neck Pain, Range of Motion, Muscle Weakness, Breastfeeding
- Keywords
- Neck pain, range of motion, Muscle weakness, Breastfeeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 15 Feb 2025 (actual)
- Study completion
- 15 Feb 2025 (actual)
- First posted
- 14 Mar 2025 (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.
Neck pain is a common complaint among breastfeeding females, potentially attributed to sustained postures and muscle imbalance. Breastfeeding females experiencing neck pain, aged between 18-40 years, will be recruited through local healthcare facilities and community outreach. The physical demands of breastfeeding, such as prolonged postures and repetitive movements, can contribute to the development of musculoskeletal issues in the cervical region.
Despite the prevalence of neck discomfort among breastfeeding females, there is a paucity of research exploring effective exercise interventions tailored to this specific population. Mothers' awareness of proper nursing positions during breastfeeding may have positive impact on the connection between mother and baby. Most typical positions for nursing a baby are cross cradle hold, cradle hold, side lying and football hold. Most common adapted breastfeeding position is cross cradle.
Detailed description
A randomized control trial will be conducted to assess and compare the effectiveness of neck isometrics and deep cervical flexion exercises in alleviating neck pain, reducing disability, improving range of motion, and addressing muscle weakness in breastfeeding females. A sample size of 48 lactating women will be taken. Data will be collected from private clinical setups of Bahawalpur by using (NPRS) Numeric Pain Rating Scale Questionnaire, (NDI) Neck Disability Index, Range of motion will be assessed by inclinometer and Muscle strength will be assessed by MMT. A written consent form will be taken from participants meeting inclusion criteria and will be randomly allocated into two groups of equal members. Group A will be given Neck Isometric Exercises and Conservative treatment for 30 min (3-4days/week) of duration for total 6 weeks.
Group B will be given Deep Cervical Flexion Exercises with conservative treatment. The interventions will be provided for 30 minutes for 3-4 Day/week for 6 weeks. All participants in both groups will be evaluated before and after the treatment programs. Outcome measures will be calculated after 6 weeks of intervention. Data will be analyzed by using SPSS 21
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- participants received scar mobilization combined with kinesio tapping
| Arm | Type | Receives |
|---|---|---|
| Isometric exercises with conservative treatment | Active comparator | Other: Neck isometric exercises: 3 times weekly for 6 consecutive weeks (18 sessions)Will receive Neck isometrics exercises with conservative treatment. Neck isometric exercises: 3 times weekly for 6 consecutive weeks (18 sessions) Duration: 10 to 15 repetitions with 3 sets, and 6 sec hold in flexion, extension and side flexion on both right and left. |
| Deep cervical flexion exercises with conservative treatment | Other | Other: Neck isometric exercises: 3 times weekly for 6 consecutive weeks (18 sessions)Will Deep cervical flexion exercises without conservative treatment. Deep cervical flexion exercises: 3 times weekly for 6 consecutive weeks (18 session) Duration: 10 to 15 repetitions with 3 sets, 30 sec rest given between each set. Exercise should target on deep cervical muscle rather than superficial muscle. Exercise should be conducted in supine position. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Between the ages of 25 to 40 years
- Mode of delivery (vaginal/c-section)
- Severe neck weakness (above grade III)
- Primigravida
Key exclusion criteria (4 listed)
- Previous history of upper extremity musculoskeletal symptoms
- Radicular neck pain
- History of inflammatory disease (myelopathy)
- History of cervical fracture
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 |
|---|---|---|
| Neck isometric exercises: 3 times weekly for 6 consecutive weeks (18 sessions)Neck isometric exercises: 3 times weekly for 6 consecutive weeks (18 sessions) Duration: 10 to 15 repetitions with 3 sets, and 6 sec hold in flexion, extension and side flexion on both right and left. | Other | Deep cervical flexion exercises with conservative treatment, Isometric exercises with conservative treatment |
Primary outcome
1. Numeric Pain Rating Scale (NPRS)
Time frame: 8 Weeks
A Numeric Pain Rating Scale (NPRS) is a commonly used self-report measure to assess pain intensity. It typically involves asking individuals to rate their pain on a numerical scale. Below is a suggested format for a Numeric Pain Rating Scale questionnaire along with instructions and scoring guidelines. Scoring: Ask participants to circle the number on the scale that corresponds to their current pain intensity. The score is a single numeric value ranging from 0 to 10, with 0 indicating no pain and 10 indicating the worst imaginable pain. The higher the score, the greater the perceived pain intensity. The NPRS is a widely used subjective pain measure that has good test-retest reliability (r=. 79-. 96)
NECK DISABILITY INDEX QUESTIONNARE
Time frame: 8 Weeks
The Neck Disability Index (NDI) is a widely used self-report questionnaire designed to assess disability related to neck pain. The questionnaire consists of 10 items that measure various aspects of daily activities affected by neck pain. Each item is scored on a 0 to 5 scale, and the total score is expressed as a percentage, with 0 indicating "no disability" and 5 indicating "complete disability. Format: 10 items evaluating concerns relating to neck pain. The participant selects the number that best describes their level of disability for each activity. The NDI has a fair to moderate test-retest reliability in patients with mechanical neck pain, intra class correlations can change between 0,50 and 0,98 (
INCLINOMETER NECK ROM:
Time frame: 8 Weeks
An inclinometer is a device used to measure the range of motion (ROM) of joints, including the neck, an inclinometer is often applied to measure flexion, extension, lateral flexion, and rotation of the cervical spine. The digital inclinometer demonstrated excellent reliability (ICC=0.75-0.86), except for the right lateral flexion (ICC=0.74) and left rotation (ICC=0.72)
MANUAL MUSCLE TESTING FOR MUSCLE WEAKNESS:
Time frame: 8 Weeks
Manual Muscle Testing (MMT) is a clinical and functional assessment technique used by healthcare professionals, such as physical therapists and physicians, to evaluate muscle strength and identify potential muscle weakness. It involves the application of resistance against a person's voluntary muscle contraction, and the resulting force is graded on a scale. 5/5: Normal strength (complete range of motion against gravity with full resistance) 4/5: Good strength (complete range of motion against gravity with moderate resistance) 3/5: Fair strength (complete range of motion against gravity with no resistance) 2/5: Poor strength (partial range of motion against gravity) 1/5: Trace movement (a flicker or trace of movement, but no joint motion) 0/5: No movement (complete paralysis)(
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 14 Mar 2025.
- 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.
Faiza Taufiq, PP-DPT 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 Neck isometric exercises: 3 times weekly for 6 consecutive weeks (18 sessions) in people with Neck Pain and Range of Motion, 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 4 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 14 Mar 2025. 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?
1. Numeric Pain Rating Scale (NPRS) (time frame: 8 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?
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 14 Mar 2025.