Neck PainNCT06340477
Effect of Thoracic SNAGS on Vitals Among Individuals With Forward Head Posture
A study testing Thoracic SNAGs with conventional therapy and conventional therapy in people with Neck Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
To determine how vitals (heart rate, blood pressure, respiratory rate, oxygen saturation) and craniovertebral angle will be affected by thoracic SNAGs in individuals with forward head posture. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Thoracic SNAGs with conventional therapy and conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2024to 1 Jul 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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both males and females
- Age 30-50yrs.
- Craniovertebral angle <50°
- Mild to moderate neck pain ranging between 3-6 on NPRS scale.
- Individuals with normal vitals:
- Heart rate (60-100 beats per minute)
Show all 10Show fewer
- Respiratory rate (12-20 breaths per minute)
- Systolic BP (100- 139mmHg)(30).
- Diastolic BP (70-89 mmHg) (30).
- Oxygen saturation ≥96%
Who cannot join
- History of cervical/thoracic spine surgery
- Cardiopulmonary disorder or Hypertension ≥140/90mmHg (30).
- Vertebral instability
- Smokers
- Any infection or tumor
Trial locations and contacts
1 site in 1 country.
About this study
To determine how vitals (heart rate, blood pressure, respiratory rate, oxygen saturation) and craniovertebral angle will be affected by thoracic SNAGs in individuals with forward head posture.
Read the detailed description
Forward head posture (FHP) leads to abnormal activation of neck muscles. This leads to respiratory complications and changes in blood pressure. Due to regional interdependence Upper thoracic spine can restrict the movement of cervical spine Thoracic spine is is closely related to Sympathetic nervous system. T1-T5 spinal sympathetic neurons provide sympathetic innervation to the vessels that supply to the heart tissues and upper portion of the body. Thus, thoracic mobilization can regulate main body vitals as well as other visceral activities that maintain homeostasis
There is a manual therapy technique called sustained natural apophyseal glides (SNAGs) in which patient performs active movements along with the passive movements performed by the physiotherapist. It not only has biomechanical efficacy which includes pain reduction and improvement in ROM, but it also has neurophysiologic effects. Previous studies lack to provide how thoracic SNAGs can affect vitals. Thus, this study aims to determine the effect of thoracic SNAGs on vital signs, including heart rate, blood pressure, respiratory rate, and oxygen saturation . Furthermore, this research will add to growing body of knowledge that how thoracic SNAGs can influence the correction of forward head posture
- Conditions
- Neck Pain
- Being tested
- Thoracic SNAGs with conventional therapy, conventional therapy
- Keywords
- Forward head posture, vitals, SNAGs, craniovertebral angle
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic SNAGs with conventional therapyOther
Thoracic (T1- T5) SNAGs 3 repetitions x 1 set, 2 days/week Hot pack for 10 minutes Stretching of upper trapezius, levator scapulae, 5 reps x 1 set x 15 sec hold 2 days/week and Pectoralis Major 10 reps x 1 set x 10 sec hold
Strengthening of deep neck flexors and shoulder retractors (rhomboids) 10 reps x 1 set x 10 sec hold 2 days/week 2 days/week
conventional therapyOther
Hot pack for 10 minutes Stretching of upper trapezius, levator scapulae, 5 reps x 1 set x 15 sec hold 2 days/week and Pectoralis Major 10 reps x 1 set x 10 sec hold
Strengthening of deep neck flexors and shoulder retractors (rhomboids) 10 reps x 1 set x 10 sec hold 2 days/week 2 days/week
| Study group | Role | What they receive |
|---|---|---|
| Thoracic SNAGs with conventional therapy | Experimental | Thoracic (T1- T5) SNAGs 3 repetitions x 1 set, 2 days/week Hot pack for 10 minutes Stretching of upper trapezius, levator scapulae, 5 reps x 1 set x 15 sec hold 2 days/week and Pectoralis Major 10 reps x 1 set x 10 sec hold
Strengthening of deep neck flexors and shoulder retractors (rhomboids) 10 reps x 1 set x 10 sec hold 2 days/week 2 days/week Receives: Other: Thoracic SNAGs with conventional therapy |
| Conventional therapy | Other | Hot pack for 10 minutes Stretching of upper trapezius, levator scapulae, 5 reps x 1 set x 15 sec hold 2 days/week and Pectoralis Major 10 reps x 1 set x 10 sec hold
Strengthening of deep neck flexors and shoulder retractors (rhomboids) 10 reps x 1 set x 10 sec hold 2 days/week 2 days/week Receives: Other: conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aneroid sphygmomanometer
Aneroid sphygmomanometer has more sensitivity and specificity (86.7% and 98.7%) than a digital device (80% and 67.7%) in the measurement of blood pressure, so it is considered to be more precise than a digital one
Measured: 4 weeks
Pulse oximeter
Hypoxemia can be ruled out by pulse oximeter. It has high reliability and validity for heart rate calculation with ICC> 0.93 in healthy individuals.
Measured: 4 weeks
Respiratory rate
Respiratory rate or the number of breaths per minute is defined as one breath to each movement of air in and out of the lungs. In general, the respiratory rate for an adult sits between 12 and 20 breaths per min. 60second count is more accurate than short duration i.e 15 and 30 second
Measured: 4 weeks
Secondary outcomes (3)
NPRS (Numeric Pain Rating Scale)
Numeric Pain Rating Scale (NPRS) measures the subjective intensity of pain. The NPRS is an eleven-point scale from 0 to 10. "0" = no pain and "10" = the most intense pain imaginable while the NPRS exhibited moderate reliability (ICC = 0.27-0.84)
Measured: 4 weeks
Inclinometer
An inclinometer is used to measure the range of motion (ROM) of joints. It has a housing that contains a sensor. The sensor is sensitive to gravity and measures the angle of the housing. The angle is then displayed on a digital display or a dial. It is placed on the joint and then move the joint through its range of motion. The angle of the inclinometer will change as the joint moves. The maximum angle reached is the ROM of the joint. ICC values of inclinometer range between 0.89-0.94 in measuring cervical range of motion including flexion, extension, lateral flexion, and rotation; making it a reliable tool.
Measured: 4 weeks
Photogrammetric method for craniovertebral angle
FHP can be measured by craniovertebral angle which measures natural head neck posture in the sagittal plane and is determined by the intersection of a line extending from tragus of ear to C7 and horizontal line passing through C7. Kinovea software will be used for measurement of Cranio vertebral angle. Inter-rater reliability ranged from an intraclass correlation coefficient value of 0.95 to 0.98, whereas the intrarater reliability ranged from an intraclass correlation coefficient value of 0.98 to 0.99
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start1 Mar 2024
- Primary completion10 Jun 2024
- Study completion1 Jul 2024
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
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- maria Khalid, MSOMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06340477
- Sponsor's protocol ID
- Mahnoor Arif/ REC -01802
- Status last verified
- Jul 2024
- First submitted
- 25 Mar 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Thoracic SNAGS on Vitals Among Individuals With Forward Head Posture
- ClinicalTrials.gov ID
- NCT06340477
- Acronym / sponsor ID
- Mahnoor Arif/ REC -01802
- Conditions
- Neck Pain
- Keywords
- Forward head posture, vitals, SNAGs, craniovertebral angle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 1 Apr 2024 (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.
To determine how vitals (heart rate, blood pressure, respiratory rate, oxygen saturation) and craniovertebral angle will be affected by thoracic SNAGs in individuals with forward head posture.
Detailed description
Forward head posture (FHP) leads to abnormal activation of neck muscles. This leads to respiratory complications and changes in blood pressure. Due to regional interdependence Upper thoracic spine can restrict the movement of cervical spine Thoracic spine is is closely related to Sympathetic nervous system. T1-T5 spinal sympathetic neurons provide sympathetic innervation to the vessels that supply to the heart tissues and upper portion of the body. Thus, thoracic mobilization can regulate main body vitals as well as other visceral activities that maintain homeostasis
There is a manual therapy technique called sustained natural apophyseal glides (SNAGs) in which patient performs active movements along with the passive movements performed by the physiotherapist. It not only has biomechanical efficacy which includes pain reduction and improvement in ROM, but it also has neurophysiologic effects. Previous studies lack to provide how thoracic SNAGs can affect vitals. Thus, this study aims to determine the effect of thoracic SNAGs on vital signs, including heart rate, blood pressure, respiratory rate, and oxygen saturation . Furthermore, this research will add to growing body of knowledge that how thoracic SNAGs can influence the correction of forward head posture
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracic SNAGs with conventional therapy | Experimental | Other: Thoracic SNAGs with conventional therapyThoracic (T1- T5) SNAGs 3 repetitions x 1 set, 2 days/week Hot pack for 10 minutes Stretching of upper trapezius, levator scapulae, 5 reps x 1 set x 15 sec hold 2 days/week and Pectoralis Major 10 reps x 1 set x 10 sec hold Strengthening of deep neck flexors and shoulder retractors (rhomboids) 10 reps x 1 set x 10 sec hold 2 days/week 2 days/week |
| Conventional therapy | Other | Other: conventional therapyHot pack for 10 minutes Stretching of upper trapezius, levator scapulae, 5 reps x 1 set x 15 sec hold 2 days/week and Pectoralis Major 10 reps x 1 set x 10 sec hold Strengthening of deep neck flexors and shoulder retractors (rhomboids) 10 reps x 1 set x 10 sec hold 2 days/week 2 days/week |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Both males and females
- Age 30-50yrs.
- Craniovertebral angle <50°
- Mild to moderate neck pain ranging between 3-6 on NPRS scale.
- Individuals with normal vitals:
Key exclusion criteria (5 listed)
- History of cervical/thoracic spine surgery
- Cardiopulmonary disorder or Hypertension ≥140/90mmHg (30).
- Vertebral instability
- Smokers
- Any infection or tumor
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 |
|---|---|---|
| Thoracic SNAGs with conventional therapyThoracic (T1- T5) SNAGs 3 repetitions x 1 set, 2 days/week Hot pack for 10 minutes Stretching of upper trapezius, levator scapulae, 5 reps x 1 set x 15 sec hold 2 days/week and Pectoralis Major 10 reps x 1 set x 10 sec hold Strengthening of deep neck flexors and shoulder retractors (rhomboids) 10 reps x 1 set x 10 sec hold 2 days/week 2 days/week | Other | Thoracic SNAGs with conventional therapy |
| conventional therapyHot pack for 10 minutes Stretching of upper trapezius, levator scapulae, 5 reps x 1 set x 15 sec hold 2 days/week and Pectoralis Major 10 reps x 1 set x 10 sec hold Strengthening of deep neck flexors and shoulder retractors (rhomboids) 10 reps x 1 set x 10 sec hold 2 days/week 2 days/week | Other | Conventional therapy |
Primary outcome
Aneroid sphygmomanometer
Time frame: 4 weeks
Aneroid sphygmomanometer has more sensitivity and specificity (86.7% and 98.7%) than a digital device (80% and 67.7%) in the measurement of blood pressure, so it is considered to be more precise than a digital one
Pulse oximeter
Time frame: 4 weeks
Hypoxemia can be ruled out by pulse oximeter. It has high reliability and validity for heart rate calculation with ICC> 0.93 in healthy individuals.
Respiratory rate
Time frame: 4 weeks
Respiratory rate or the number of breaths per minute is defined as one breath to each movement of air in and out of the lungs. In general, the respiratory rate for an adult sits between 12 and 20 breaths per min. 60second count is more accurate than short duration i.e 15 and 30 second
3 secondary outcomes
NPRS (Numeric Pain Rating Scale)
Time frame: 4 weeks
Inclinometer
Time frame: 4 weeks
Photogrammetric method for craniovertebral angle
Time frame: 4 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 23 Jul 2024.
- 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.
maria Khalid, MSOMPT 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 Thoracic SNAGs with conventional therapy and conventional therapy 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 10 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 23 Jul 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?
Aneroid sphygmomanometer (time frame: 4 weeks). 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?
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 23 Jul 2024.