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Mulligan Mobilizations and McKenzie Exercises Along With Neural Mobilizations in Cervical Spondylosis

Primary Purpose

Spondylosis

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Mulligan with upper limb movement
McKenzie exercises with neural mobilizations
Sponsored by
Dow University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spondylosis focused on measuring Cervical spondylosis, McKenzie, NPRS, NDI, Mulligan with mobilization, Universal goniometer

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 40 - 60 years old adults. Diagnosed and referred cases of cervical spondylosis and both males and females are included. Unilateral radiculopathy pain C5-C8 and T1. Individuals whose Spurling's and distraction test is positive. Patients with NPRS > 3/10 score. Patients with ipsilateral cervical rotation less than 60 degrees. Exclusion Criteria: Individuals with history of; cervical or shoulder girdle trauma. any specific pathology or red flags (diplopia, dizziness, drop attacks, dysarthria, dysphagia) cervical myelopathy neoplastic lesions vertebral artery insufficiency upper cervical ligamentous instability, spondylolisthesis hypermobile cervical spine cervical fracture inflammatory cardiac or severe psychiatric disease.

Sites / Locations

  • Hafsa ShehzadiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Mulligan with upper limb movement

Mckenzie exercises with neural mobilizations

Arm Description

This study arm will receive following therapy .) Mulligan with upper limb movement.

This study arm will receive following therapy .) McKenzie exercises with neural mobilizations

Outcomes

Primary Outcome Measures

Change in pain intensity on Numerical Pain Rating Scale after four weeks.
The Numerical Pain Rating Scale is a unidimensional measure of pain intensity, use to record patients' pain progression or compare pain severity between pains with similar condition. It is 0 to 10 number scale. Higher the score, severe will be the pain experienced.

Secondary Outcome Measures

Change in functional disability assessed with Neck Disability Index after four weeks.
NDI is a condition specific or patient completed questionnaire comprising of 10 items to evaluate pain and functional status which is mostly used for reporting neck pain. Each item on scale is scored from 0-5, where all the scores are added to total points and interpreted as percentages i.e. 0 point or 0% means no activity limitation and 50 points or 100% means complete activity limitation.
Change in range of motion assessed with universal goniometer after four weeks
The universal goniometer is an instrument for the precise measurement of range of movement angles in degrees, especially one used to measure the angles before and after range of motion. Increase in the degree of angle suggests increase in range of movement.

Full Information

First Posted
February 17, 2023
Last Updated
March 13, 2023
Sponsor
Dow University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05768438
Brief Title
Mulligan Mobilizations and McKenzie Exercises Along With Neural Mobilizations in Cervical Spondylosis
Official Title
Effectiveness of Mulligan Mobilizations With Upper Limb Movement and McKenzie Exercises Along With Neural Mobilizations in Cervical Spondylosis - A Comparative Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 5, 2022 (Actual)
Primary Completion Date
December 5, 2023 (Anticipated)
Study Completion Date
January 5, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dow University of Health Sciences

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
Cervical pain is one of the common problem among general population. However, cervical spondylosis may cause unavoidable neck pain and range limitations due to wear and tear changes in the cervical spine. This condition can further lead to dysfunction and neuro musculoskeletal symptoms. Literature suggests the use of Mulligan therapy, McKenzie exercises and Neural mobilizations in spondylosis. According to author's knowledge there is limited evidence regarding effects of specific treatment approach.
Detailed Description
A randomized control trial will be conducted among 80 patients with cervical spondylosis having age group 40 to 60 years. The non-probability purposive sampling technique will be used to recruit on the basis of study criteria. The study settings will be Dow University of health sciences, Karachi Pakistan. After taking informed consent all the patients will be randomized into two groups (A, B). Group A will receive mulligan with upper limb movement of involved side, group B will receive McKenzie exercises and neural mobilizations. Patients will be evaluated at baseline and after four weeks of treatment by using a goniometer, numerical pain rating scale (NPRS), and neck disability index (NDI) for cervical range of motions, pain intensity and neck disability respectively. There will be twelve sessions of treatment with thrice a week. Duration of each session will be thirty minutes. All the data will be entered and analyzed through statistical package of social sciences version 24. Descriptive analysis will be performed for both continuous and categorical data. Inferential statistics will be performed to compare pain, disability index and range of motion between group and within group. The level of significance will be considered as 0.05.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spondylosis
Keywords
Cervical spondylosis, McKenzie, NPRS, NDI, Mulligan with mobilization, Universal goniometer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mulligan with upper limb movement
Arm Type
Experimental
Arm Description
This study arm will receive following therapy .) Mulligan with upper limb movement.
Arm Title
Mckenzie exercises with neural mobilizations
Arm Type
Experimental
Arm Description
This study arm will receive following therapy .) McKenzie exercises with neural mobilizations
Intervention Type
Other
Intervention Name(s)
Mulligan with upper limb movement
Intervention Description
Group A subjects will receive mulligan mobilizations with upper limb movement of the involved side. The patient will be in a sitting position and the therapist will stand beside the patient. The therapist will place one thumb overlapped by the other on one of the selected cervical and then the therapist will push down the spinous process of that specific vertebrae, the pressure will be sustained and the patient will actively abduct his/her arm, assistance will be provided if needed. Initially it will start from 10 repetitions and 1 set which will further progress up to 2 or 3 sets as per patient's tolerance with 60 seconds rest in between each set.
Intervention Type
Other
Intervention Name(s)
McKenzie exercises with neural mobilizations
Intervention Description
The subjects of Group B will receive McKenzie exercises. Initially, it will start with retraction exercises. The frequency of exercises will be 10 to 15 repetitions followed by three to four sets with one second hold. On the second or third day, the cervical extension will be added. While in the second week the same set of exercises will be administered with the patient in a sitting position combined with application of over pressure at the end range by therapist. In the third week, extension and retraction exercises will be performed along with traction which will be applied by the therapist. Finally, in the fourth week all retraction and lateral flexion then neck rotation and the last one retraction with neck flexion will be added. Neural mobilizations will be given to patients in group B in supine lying. From proximal to distal, 20 oscillations (1 oscillation/ 1 second)
Primary Outcome Measure Information:
Title
Change in pain intensity on Numerical Pain Rating Scale after four weeks.
Description
The Numerical Pain Rating Scale is a unidimensional measure of pain intensity, use to record patients' pain progression or compare pain severity between pains with similar condition. It is 0 to 10 number scale. Higher the score, severe will be the pain experienced.
Time Frame
Baseline and 4 weeks.
Secondary Outcome Measure Information:
Title
Change in functional disability assessed with Neck Disability Index after four weeks.
Description
NDI is a condition specific or patient completed questionnaire comprising of 10 items to evaluate pain and functional status which is mostly used for reporting neck pain. Each item on scale is scored from 0-5, where all the scores are added to total points and interpreted as percentages i.e. 0 point or 0% means no activity limitation and 50 points or 100% means complete activity limitation.
Time Frame
Baseline and 4 weeks.
Title
Change in range of motion assessed with universal goniometer after four weeks
Description
The universal goniometer is an instrument for the precise measurement of range of movement angles in degrees, especially one used to measure the angles before and after range of motion. Increase in the degree of angle suggests increase in range of movement.
Time Frame
Baseline and 4 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 40 - 60 years old adults. Diagnosed and referred cases of cervical spondylosis and both males and females are included. Unilateral radiculopathy pain C5-C8 and T1. Individuals whose Spurling's and distraction test is positive. Patients with NPRS > 3/10 score. Patients with ipsilateral cervical rotation less than 60 degrees. Exclusion Criteria: Individuals with history of; cervical or shoulder girdle trauma. any specific pathology or red flags (diplopia, dizziness, drop attacks, dysarthria, dysphagia) cervical myelopathy neoplastic lesions vertebral artery insufficiency upper cervical ligamentous instability, spondylolisthesis hypermobile cervical spine cervical fracture inflammatory cardiac or severe psychiatric disease.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hafsa Shehzadi, DPT
Phone
03112497040
Email
hafsashehzadi96@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Saba A Ali, MSAPT
Phone
030028867690
Email
saba.aijaz@duhs.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hafsa Shehzadi, DPT
Organizational Affiliation
DOW university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hafsa Shehzadi
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74200
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hafsa Shehzadi, DPT
Phone
03112497040
Email
hafsashehzadi96@gmail.com
First Name & Middle Initial & Last Name & Degree
Saba A Ali, MSAPT
Phone
0300-2886769
Email
saba.aijaz@duhs.edu.pk

12. IPD Sharing Statement

Plan to Share IPD
No

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Mulligan Mobilizations and McKenzie Exercises Along With Neural Mobilizations in Cervical Spondylosis

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