Forward Head PostureNCT06130969
Effects of Cervical Spine Retraction Exercise With and Without Diaphragmatic Breathing in Forward Head Posture.
A study testing Cervical Retraction Exercise, Diaphragmatic Breathing and Baseline Treatment in people with Forward Head Posture, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study aims to determine the effect of combining diaphragmatic exercises with cervical retraction exercise on pain, disability, active range of motions of cervical spine and craniovertebral angle in individuals with forward head posture. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Forward Head Posture
- What is being tested?
- Cervical Retraction Exercise, Diaphragmatic Breathing and Baseline Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 sitePakistan
- Study dates
- 10 May 2023to 10 Feb 2024
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Primary complaint of neck pain (pain on the posterior part of the cervical spine to the beginning of the thoracic area with or without pain in the shoulder girdle)
- Age from 20 to 35 years
- Both gender
- CVA <49° (16)
Who cannot join
- Any serious pathology such as tumor
- Had history of whiplash injury within 3 months of the examination,
- Underwent prior surgery to the cervical spine
- Currently using muscle relaxation medication.
- Degenerative conditions
- Exhibited positive neurologic signs consistent with nerve root compression.
- Patients with a history of respiratory disease, such as repeated bronchitis, pneumonia, asthma, pulmonary lymph nodes, pleurisy, cured tuberculosis and others
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Chiropractor & Physio Pain Relief Center
Lahore, Punjab Province, 54782
Mazhar, +923244936007, mehreenmazhar98@gmail.com
Aneeqa Manzoor, MS-OMPT
About this study
Official title: Effects of Cervical Spine Retraction Exercise With and Without Diaphragmatic Breathing on Pain, Disability and Craniovertebral Angle in Forward Head Posture.
This study aims to determine the effect of combining diaphragmatic exercises with cervical retraction exercise on pain, disability, active range of motions of cervical spine and craniovertebral angle in individuals with forward head posture.
Read the detailed description
Forward head posture altering breathing pattern is one of the most common musculoskeletal deformity. Diaphragmatic exercises can reduce pain and disability levels, and correct forward head posture (FHP) in patients with neck discomfort.
In this randomized clinical trial, fifty two participants displaying forward head posture (FHP) will be randomly assigned to one of the two intervention groups: the Diaphragmatic Exercises and Cervical Retraction Exercise Combined Group or the Cervical Retraction Exercise Alone Group. Randomization will be performed using a convenient random sampling method via sealed opaque envelopes. Each participant will receive a total of twelve treatment sessions over a four-week period. The efficacy of the interventions will be assessed at the beginning (first session), conclusion (twelfth session), and two weeks after completing the sessions. Outcome measures, including pain intensity, disability levels, cervical range of motion, and craniovertebral angle (CVA), will be evaluated using the Numeric Pain Rating Scale (NPRS), Neck Disability Index (NDI), universal goniometer and Image J software, respectively. Data will be analyzed using Statistical Package for the Social Sciences (SPSS) software version 26. Normality of data will be assessed using the Kolmogorov-Smirnov test. For within-group comparisons, either repeated measures ANOVA or the Friedman test will be used. To compare changes between the groups, the independent t-test or Mann-Whitney U test will be applied, depending on the data distribution. The analysis of these outcome measures will provide valuable insights into the impact of the interventions on participants' symptoms and postural alignment.
- Conditions
- Forward Head Posture
- Being tested
- Cervical Retraction Exercise, Diaphragmatic Breathing, Baseline Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical Retraction ExerciseOther
Participants will hold cervical retraction for 10 s up to 10 times. A break of 5 s will be provided per one movement and 30 s per one set. A total of three sets will be conducted. Therefore, the total exercise time will be <10 mints.
Diaphragmatic BreathingOther
The diaphragmatic exercise will be performed in a supine position with 40° trunk flexion while holding 2.5 kg on the abdomen in the first 5 sessions and then 5 kg in the second 5 sessions. Participants will perform 3 sets with 10 repetitions at a ratio of one second of inspiration to two seconds of expiration, three sets of 15 repetitions at a ratio of two seconds of inspiration to four seconds of expiration, and three sets of 20 repetitions at a ratio of three seconds of inspiration to six seconds of expiration. The rest between rests will be 60 s.
Baseline TreatmentOther
Hot fomentation will be given by applying cervical hot pack over the area in prone lying position for 10 mints and Isometric neck strengthening exercises (10 repetitions, each 5-second hold, 1 set) (20). • Nerve Stimulation (TENS) on the painful regions around the neck for 15 minutes with a TENS device. TENS parameters will be 150 μs square pulses with a frequency of 80 Hz.
The intensity of the current will be adjusted to produce no contraction.
- Posture education to keep upright posture during sitting.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Cervical Retraction exercise without diaphragmatic breathing along with baseline treatment Receives: Other: Cervical Retraction Exercise; Other: Baseline Treatment |
| Group B | Experimental | Cervical Retraction exercise with diaphragmatic breathing along with baseline treatment Receives: Other: Cervical Retraction Exercise; Other: Diaphragmatic Breathing; Other: Baseline Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Photogrammetry for Craniovertebral Angle (CVA) by image j software
CVA, can be measured using the lateral photos exposing C7 and the ear. The participants will maintain the natural head posture through the measurement method of self-balance posture. It is the angle made by the line that connects the seventh cervical spine with the tragus and the horizontal line of the seventh cervical spine in the sitting and standing positions. A CVA of <49° is characterized as FHP (3).
Image J is an image processing and analysis program that can read both image file formats and raw formats. It can display, edit, analyze, process, store, and print images, as well as measure distances and angles.
Measured: 6 weeks
Numeric pain rating scale (NPRS):
The NPRS is a subjective pain rating scale using an 11-point scale from 0 to 10, where 0 means 'no pain' and 10 means 'intolerable pain'. Participants select the whole number that best represents their level of pain.
Measured: 6 weeks
Neck disability index (NDI):
that restricts the activities of daily living (ADL); it also helps to determine self- assessed disability. NDI has 10 domains covering pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation. Scores range from 0 to 50, with 50 being the greatest levels of dysfunction.
Measured: 6 weeks
Goniometer for Cervical Range of motion (CROM)
Universal goniometer has fair inter-tester reliability ranging from 0.79-0.92. Validity of this tool is good i.e. 0.97-0.98 This tool is most commonly used in the clinical settings for evaluating joint ROM.
Measured: 6 weeks
Secondary outcomes (1)
Global rating of change (GRC)
GRC scale is used as an objective means to test the improvement of patient symptoms, to identify the intervention effect after treatment completion in clinical practice
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start10 May 2023
- Primary completion15 Jan 2024 (estimated)
- Study completion10 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Forward Head PostureStudies 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
- Participant
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ali Raza, Principal investigator, Riphah International UniversityAneeqa Manzoor, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06130969
- Sponsor's protocol ID
- REC/RCR & AHS/23/0155
- Status last verified
- Dec 2023
- First submitted
- 9 Nov 2023
- Last updated
- 27 Dec 2023
- 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 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cervical Spine Retraction Exercise With and Without Diaphragmatic Breathing on Pain, Disability and Craniovertebral Angle in Forward Head Posture.
- ClinicalTrials.gov ID
- NCT06130969
- Acronym / sponsor ID
- REC/RCR & AHS/23/0155
- Conditions
- Forward Head Posture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 May 2023 (actual)
- Primary completion
- 15 Jan 2024 (estimated)
- Study completion
- 10 Feb 2024 (estimated)
- First posted
- 14 Nov 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.
This study aims to determine the effect of combining diaphragmatic exercises with cervical retraction exercise on pain, disability, active range of motions of cervical spine and craniovertebral angle in individuals with forward head posture.
Detailed description
Forward head posture altering breathing pattern is one of the most common musculoskeletal deformity. Diaphragmatic exercises can reduce pain and disability levels, and correct forward head posture (FHP) in patients with neck discomfort.
In this randomized clinical trial, fifty two participants displaying forward head posture (FHP) will be randomly assigned to one of the two intervention groups: the Diaphragmatic Exercises and Cervical Retraction Exercise Combined Group or the Cervical Retraction Exercise Alone Group. Randomization will be performed using a convenient random sampling method via sealed opaque envelopes. Each participant will receive a total of twelve treatment sessions over a four-week period. The efficacy of the interventions will be assessed at the beginning (first session), conclusion (twelfth session), and two weeks after completing the sessions. Outcome measures, including pain intensity, disability levels, cervical range of motion, and craniovertebral angle (CVA), will be evaluated using the Numeric Pain Rating Scale (NPRS), Neck Disability Index (NDI), universal goniometer and Image J software, respectively. Data will be analyzed using Statistical Package for the Social Sciences (SPSS) software version 26. Normality of data will be assessed using the Kolmogorov-Smirnov test. For within-group comparisons, either repeated measures ANOVA or the Friedman test will be used. To compare changes between the groups, the independent t-test or Mann-Whitney U test will be applied, depending on the data distribution. The analysis of these outcome measures will provide valuable insights into the impact of the interventions on participants' symptoms and postural alignment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Cervical Retraction Exercise, Other: Baseline TreatmentCervical Retraction exercise without diaphragmatic breathing along with baseline treatment |
| Group B | Experimental | Other: Cervical Retraction Exercise, Other: Diaphragmatic Breathing, Other: Baseline TreatmentCervical Retraction exercise with diaphragmatic breathing along with baseline treatment |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Primary complaint of neck pain (pain on the posterior part of the cervical spine to the beginning of the thoracic area with or without pain in the shoulder girdle)
- Age from 20 to 35 years
- Both gender
- CVA <49° (16)
Key exclusion criteria (7 listed)
- Any serious pathology such as tumor
- Had history of whiplash injury within 3 months of the examination,
- Underwent prior surgery to the cervical spine
- Currently using muscle relaxation medication.
- Degenerative conditions
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 |
|---|---|---|
| Cervical Retraction ExerciseParticipants will hold cervical retraction for 10 s up to 10 times. A break of 5 s will be provided per one movement and 30 s per one set. A total of three sets will be conducted. Therefore, the total exercise time will be <10 mints. | Other | Group A, Group B |
| Diaphragmatic BreathingThe diaphragmatic exercise will be performed in a supine position with 40° trunk flexion while holding 2.5 kg on the abdomen in the first 5 sessions and then 5 kg in the second 5 sessions. Participants will perform 3 sets with 10 repetitions at a ratio of one second of inspiration to two seconds of expiration, three sets of 15 repetitions at a ratio of two seconds of inspiration to four seconds of expiration, and three sets of 20 repetitions at a ratio of three seconds of inspiration to six seconds of expiration. The rest between rests will be 60 s. | Other | Group B |
| Baseline TreatmentHot fomentation will be given by applying cervical hot pack over the area in prone lying position for 10 mints and Isometric neck strengthening exercises (10 repetitions, each 5-second hold, 1 set) (20). • Nerve Stimulation (TENS) on the painful regions around the neck for 15 minutes with a TENS device. TENS parameters will be 150 μs square pulses with a frequency of 80 Hz. The intensity of the current will be adjusted to produce no contraction. • Posture education to keep upright posture during sitting. | Other | Group A, Group B |
Primary outcome
Photogrammetry for Craniovertebral Angle (CVA) by image j software
Time frame: 6 weeks
CVA, can be measured using the lateral photos exposing C7 and the ear. The participants will maintain the natural head posture through the measurement method of self-balance posture. It is the angle made by the line that connects the seventh cervical spine with the tragus and the horizontal line of the seventh cervical spine in the sitting and standing positions. A CVA of <49° is characterized as FHP (3). Image J is an image processing and analysis program that can read both image file formats and raw formats. It can display, edit, analyze, process, store, and print images, as well as measure distances and angles.
Numeric pain rating scale (NPRS):
Time frame: 6 weeks
The NPRS is a subjective pain rating scale using an 11-point scale from 0 to 10, where 0 means 'no pain' and 10 means 'intolerable pain'. Participants select the whole number that best represents their level of pain.
Neck disability index (NDI):
Time frame: 6 weeks
that restricts the activities of daily living (ADL); it also helps to determine self- assessed disability. NDI has 10 domains covering pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation. Scores range from 0 to 50, with 50 being the greatest levels of dysfunction.
Goniometer for Cervical Range of motion (CROM)
Time frame: 6 weeks
Universal goniometer has fair inter-tester reliability ranging from 0.79-0.92. Validity of this tool is good i.e. 0.97-0.98 This tool is most commonly used in the clinical settings for evaluating joint ROM.
1 secondary outcome
Global rating of change (GRC)
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
- 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.
Ali Raza principal investigator
Riphah International University
Aneeqa Manzoor 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 Cervical Retraction Exercise, Diaphragmatic Breathing and Baseline Treatment in people with Forward Head Posture, 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 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: status not confirmed, as of the sponsor's last update on 27 Dec 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, PhD (+923324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Photogrammetry for Craniovertebral Angle (CVA) by image j software (time frame: 6 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 27 Dec 2023.