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Effects of Maitland's Antero-Posterior Versus Lateral Mobilizations on Cardiovascular Responses

Primary Purpose

Neck Pain

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
MAITLAND'S ANTEROPOSTERIOR(AP) MOBILIZATION
MAITLAND'S LATERAL MOBILIZATION
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Maitland mobilization

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • movement coordination impairment
  • athletes
  • unable to read and write

Sites / Locations

  • Rawal General Hospital RawalpindiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

MAITLAND'S ANTEROPOSTERIOR(AP) MOBILIZATION

MAITLAND'S LATERAL MOBILIZATION

Arm Description

Patients in this group will receive Maitland's Antero-Posterior Mobilization.

Patients in this group will receive Maitland's Lateral Mobilization.

Outcomes

Primary Outcome Measures

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
OMRON Automatic heart rate Monitor
The Omron is an automatic digital device for professional heart rate range of 40 -180 beats/min
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])
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 .

Secondary Outcome Measures

Full Information

First Posted
December 29, 2021
Last Updated
April 15, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05186584
Brief Title
Effects of Maitland's Antero-Posterior Versus Lateral Mobilizations on Cardiovascular Responses
Official Title
Effects of Maitland's Antero-posterior Versus Lateral Mobilizations on Cardiovascular Responses in Non-Specific Chronic Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
April 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Maitland mobilization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MAITLAND'S ANTEROPOSTERIOR(AP) MOBILIZATION
Arm Type
Experimental
Arm Description
Patients in this group will receive Maitland's Antero-Posterior Mobilization.
Arm Title
MAITLAND'S LATERAL MOBILIZATION
Arm Type
Experimental
Arm Description
Patients in this group will receive Maitland's Lateral Mobilization.
Intervention Type
Other
Intervention Name(s)
MAITLAND'S ANTEROPOSTERIOR(AP) MOBILIZATION
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
MAITLAND'S LATERAL MOBILIZATION
Intervention Description
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.
Primary Outcome Measure Information:
Title
OMRON Automatic Blood Pressure Monitor
Description
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
Time Frame
2 Weeks
Title
OMRON Automatic heart rate Monitor
Description
The Omron is an automatic digital device for professional heart rate range of 40 -180 beats/min
Time Frame
2 Weeks
Title
Numeric Pain Rating Scale (NPRS)
Description
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])
Time Frame
2 Weeks
Title
Global Rating of Change (GROC)
Description
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 .
Time Frame
2 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 movement coordination impairment athletes unable to read and write
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Waqar Ahmed Awan, PhD
Phone
+92-3335348846
Email
waqar.ahmed@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Waqar Ahmed Awan, PhD
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rawal General Hospital Rawalpindi
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
44000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sajjad Ali, MS-OMPT
Phone
+923145757092
Email
Sajjad.ali@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
MS-OMPT*
First Name & Middle Initial & Last Name & Degree
Ayesha Afsar

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Maitland's Antero-Posterior Versus Lateral Mobilizations on Cardiovascular Responses

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