Neck PainNCT05186584
Effects of Maitland's Antero-Posterior Versus Lateral Mobilizations on Cardiovascular Responses
A study testing MAITLAND'S ANTEROPOSTERIOR(AP) MOBILIZATION and MAITLAND'S LATERAL MOBILIZATION in people with Neck Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study will be a randomized control trial and will be conducted in Polyclinic Hospital Islamabad \& Rawal Dental and General Hospital Rawalpindi. A sample of 62 participants will be taken. 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?
- MAITLAND'S ANTEROPOSTERIOR(AP) MOBILIZATION and MAITLAND'S LATERAL MOBILIZATION
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2021to Apr 2022
- 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
- Participants falling in this category would be recruited into the study.
- Age 25 to 55 years
- Pain in neck with no known cause for > 3 months
- Resting systolic blood pressure between 90 to 139 mmHg
- resting diastolic blood pressure between 60 to 88 mmHg
- resting heart rate between 60 to 100 beats/min
- no prior exposure to antero-posterior and lateral mobilizations
Who cannot join
- Participants falling in this category would be excluded from the study.
- age <25 and >55
- current smokers
- history of fainting spells, diabetes mellitus, spinal surgery and whiplash injury( in last 6 months)
- taking medications for blood thinning, diabetes mellitus
- having neurologic or cardiovascular disease, radiating pain, cervicogenic headaches
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- movement coordination impairment
- athletes
- unable to read and write
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Rawal General Hospital Rawalpindi
Rawalpindi, Punjab Province, 44000
Sajjad Ali, MS-OMPT, +923145757092, Sajjad.ali@riphah.edu.pk
MS-OMPT*
About this study
Official title: Effects of Maitland's Antero-posterior Versus Lateral Mobilizations on Cardiovascular Responses in Non-Specific Chronic Neck Pain
This study will be a randomized control trial and will be conducted in Polyclinic Hospital Islamabad \& Rawal Dental and General Hospital Rawalpindi. A sample of 62 participants will be taken. Patients will be divided into two equal groups of 31 participants in each group, group Randomization will be done through flip coin method. Patients in group A will receive Maitland's antero-posterior Mobilization, while Patients in group B will receive Maitland's lateral mobilizations. 4 sessions of treatment will be given for 2 weeks with interval of 3 days, 4 days and 7 days between 1st \& 2nd session, 2nd \& 3rd session and 3rd \& 4th session, respectively. The outcome measures will be OMRON Automatic Blood Pressure Monitor, Numeric pain rating scale(NPRS) and Global Rating of Change questionare will be measured at baseline and at the end of 4th session. Data will be analyzed by SPSS 25.
- Conditions
- Neck Pain
- Being tested
- MAITLAND'S ANTEROPOSTERIOR(AP) MOBILIZATION, MAITLAND'S LATERAL MOBILIZATION
- Keywords
- Maitland mobilization
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAITLAND'S ANTEROPOSTERIOR(AP) MOBILIZATIONOther
Group A will receive the 5 sets of 10 seconds Grade 1 mobilizations with a rate of 15 oscillations each set (total 75 oscillations) for AP mobilizations at most symptomatic segment, with 10 seconds rest between sets. Most symptomatic segment is that segment of cervical spine at which patient will feel greatest pain by palpation.
For AP mobilizations, patient will lye supine and therapist will stand by his head. Therapist will make broad contact with the thumb, at the costal process of the vertebrae to be mobilized and spread fingers around adjacent neck for stability. Shoulder will be positioned above the joint being treated. Gentle oscillatory Anteroposterior pressure will be performed by the therapist's arm and trunk.
MAITLAND'S LATERAL MOBILIZATIONOther
Group B will receive the same sets (i.e. 5 sets of 10 seconds Grade 1 mobilizations with a rate of 15 oscillations each set) for lateral mobilizations at most symptomatic segment, with 10 sec rest between each set. For lateral mobilization, patient will lye supine and therapist will stand by his head. Therapist will place the anterolateral aspect 2nd metacarpophalangeal joint over the lateral aspect of transverse process of most symptomatic segment. Gentle lateral oscillations towards the asymptomatic side will be provided by the therapist.
| Study group | Role | What they receive |
|---|---|---|
| MAITLAND'S ANTEROPOSTERIOR(AP) MOBILIZATION | Experimental | Patients in this group will receive Maitland's Antero-Posterior Mobilization. Receives: Other: MAITLAND'S ANTEROPOSTERIOR(AP) MOBILIZATION |
| MAITLAND'S LATERAL MOBILIZATION | Experimental | Patients in this group will receive Maitland's Lateral Mobilization. Receives: Other: MAITLAND'S LATERAL MOBILIZATION |
What is being measured
The primary outcome is the main question the study is designed to answer.
OMRON Automatic Blood Pressure Monitor
The Omron is an automatic digital device for professional blood pressure measurement at the upper arm level. It measures BP range of 0-299 mmHg
Measured: 2 Weeks
OMRON Automatic heart rate Monitor
The Omron is an automatic digital device for professional heart rate range of 40 -180 beats/min
Measured: 2 Weeks
Numeric Pain Rating Scale (NPRS)
It is a tool used for measuring intensity of pain. Patient select numeric from (0-10) that reflects his/her pain intensity. The reliability of tool is ICC = 0.67; [0.27 to 0.84])
Measured: 2 Weeks
Global Rating of Change (GROC)
It is a scale commonly used in clinical research, particularly in the musculoskseletal area to measure a patient's improvement or deterioration over time, to determine the effect of an intervention .
Measured: 2 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 Dec 2021
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (estimated)
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
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Waqar Ahmed Awan, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05186584
- Sponsor's protocol ID
- Ayesha Afsar
- Status last verified
- Apr 2022
- First submitted
- 29 Dec 2021
- Last updated
- 18 Apr 2022
- 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 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Maitland's Antero-posterior Versus Lateral Mobilizations on Cardiovascular Responses in Non-Specific Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT05186584
- Acronym / sponsor ID
- Ayesha Afsar
- Conditions
- Neck Pain
- Keywords
- Maitland mobilization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 11 Jan 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.
This study will be a randomized control trial and will be conducted in Polyclinic Hospital Islamabad \& Rawal Dental and General Hospital Rawalpindi. A sample of 62 participants will be taken. Patients will be divided into two equal groups of 31 participants in each group, group Randomization will be done through flip coin method. Patients in group A will receive Maitland's antero-posterior Mobilization, while Patients in group B will receive Maitland's lateral mobilizations. 4 sessions of treatment will be given for 2 weeks with interval of 3 days, 4 days and 7 days between 1st \& 2nd session, 2nd \& 3rd session and 3rd \& 4th session, respectively. The outcome measures will be OMRON Automatic Blood Pressure Monitor, Numeric pain rating scale(NPRS) and Global Rating of Change questionare will be measured at baseline and at the end of 4th session. Data will be analyzed by SPSS 25.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MAITLAND'S ANTEROPOSTERIOR(AP) MOBILIZATION | Experimental | Other: MAITLAND'S ANTEROPOSTERIOR(AP) MOBILIZATIONPatients in this group will receive Maitland's Antero-Posterior Mobilization. |
| MAITLAND'S LATERAL MOBILIZATION | Experimental | Other: MAITLAND'S LATERAL MOBILIZATIONPatients in this group will receive Maitland's Lateral Mobilization. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Participants falling in this category would be recruited into the study.
- Age 25 to 55 years
- Pain in neck with no known cause for > 3 months
- Resting systolic blood pressure between 90 to 139 mmHg
- resting diastolic blood pressure between 60 to 88 mmHg
Key exclusion criteria (9 listed)
- Participants falling in this category would be excluded from the study.
- age <25 and >55
- current smokers
- history of fainting spells, diabetes mellitus, spinal surgery and whiplash injury( in last 6 months)
- taking medications for blood thinning, diabetes mellitus
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 |
|---|---|---|
| MAITLAND'S ANTEROPOSTERIOR(AP) MOBILIZATIONGroup A will receive the 5 sets of 10 seconds Grade 1 mobilizations with a rate of 15 oscillations each set (total 75 oscillations) for AP mobilizations at most symptomatic segment, with 10 seconds rest between sets. Most symptomatic segment is that segment of cervical spine at which patient will feel greatest pain by palpation. For AP mobilizations, patient will lye supine and therapist will stand by his head. Therapist will make broad contact with the thumb, at the costal process of the vertebrae to be mobilized and spread fingers around adjacent neck for stability. Shoulder will be positioned above the joint being treated. Gentle oscillatory Anteroposterior pressure will be performed by the therapist's arm and trunk. | Other | MAITLAND'S ANTEROPOSTERIOR(AP) MOBILIZATION |
| MAITLAND'S LATERAL MOBILIZATIONGroup B will receive the same sets (i.e. 5 sets of 10 seconds Grade 1 mobilizations with a rate of 15 oscillations each set) for lateral mobilizations at most symptomatic segment, with 10 sec rest between each set. For lateral mobilization, patient will lye supine and therapist will stand by his head. Therapist will place the anterolateral aspect 2nd metacarpophalangeal joint over the lateral aspect of transverse process of most symptomatic segment. Gentle lateral oscillations towards the asymptomatic side will be provided by the therapist. | Other | MAITLAND'S LATERAL MOBILIZATION |
Primary outcome
OMRON Automatic Blood Pressure Monitor
Time frame: 2 Weeks
The Omron is an automatic digital device for professional blood pressure measurement at the upper arm level. It measures BP range of 0-299 mmHg
OMRON Automatic heart rate Monitor
Time frame: 2 Weeks
The Omron is an automatic digital device for professional heart rate range of 40 -180 beats/min
Numeric Pain Rating Scale (NPRS)
Time frame: 2 Weeks
It is a tool used for measuring intensity of pain. Patient select numeric from (0-10) that reflects his/her pain intensity. The reliability of tool is ICC = 0.67; [0.27 to 0.84])
Global Rating of Change (GROC)
Time frame: 2 Weeks
It is a scale commonly used in clinical research, particularly in the musculoskseletal area to measure a patient's improvement or deterioration over time, to determine the effect of an intervention .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2022.
- 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.
Waqar Ahmed Awan, PhD 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 MAITLAND'S ANTEROPOSTERIOR(AP) MOBILIZATION and MAITLAND'S LATERAL MOBILIZATION 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 7 inclusion and 9 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 18 Apr 2022. 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 Waqar Ahmed Awan, PhD (+92-3335348846, waqar.ahmed@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OMRON Automatic Blood Pressure Monitor (time frame: 2 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 18 Apr 2022.