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Comparison Of Mackenzie Exercise Program Versus Routine Physical Therapy Management in Chronic Mechanical Neck Pain

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Mckenzie exercise program
Conventional Physical therapy
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neck Pain

Eligibility Criteria

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

Inclusion Criteria: Both Gender Neck pain for at least 3 months Age 25-55 years old Exclusion Criteria: • History of trauma Vertebral Fracture Congenital disorder Ankylosing spondylitis Tumour Pott's Spine Any bony or soft tissue systemic disease

Sites / Locations

  • Services Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mckenzie exercise program

conventional physical therapy

Arm Description

Group A Week 0 : Hot pack for 15 minutes, mackenzie extension exercise program for cervical regions and mobilization with movement at cervical regions for improving flexion, extension, side flexion and rotation. 3 sets of painless glides of 10 repetitions were given, with 1 minute rest between sets. Week 2 & 4: Hot pack for 15 minutes, mckenzie exercise program at cervical region with the progression in repetition and MWM at cervical regions and then we will add progression.5 sets of painless glides of 10 repetitions were given, with 3 minute rest between sets. Week 3 & 6: Hot pack for 15 minutes, mckenzie exercise program for cervical region and MWM at cervical region . 5 sets of painless glides for 10 repetitions were given. Progression can be introduced by increasing number of repetitions performed exercises for 3 weeks.

A routine physical therapy(joint mobilization,hot pack and home exercise program) treatment and hot pack for 15 minutes.

Outcomes

Primary Outcome Measures

Numerical Rating Scale (NRS)
Patients are asked to circle the number on a Numerical Rating Scale (NRS) that best describes their level of discomfort between 0 and 10, 0 and 20, or 0 and 100. The lower limit often denotes "the least amount of suffering ," whereas zero typically denotes "no pain at all."
Universal Goniometer for range of motion measurement
The most popular and reliable approach for determining shoulder range of motion (ROM) is by utilizing a goniometer. A goniometer is a straightforward instrument that has two arms joined at a hinge. The goniometer's second arm would be used to measure the joint angle while the physiotherapist placed one arm of the patient against the patient's body
Neck disability index (NDI)
The Neck Disability Index (modification of the oswestry low back pain disability index) scale scores range from 0 to 5 and the total score is the sum of the item scores possible range 0 no pain to 100 maximal pain

Secondary Outcome Measures

Full Information

First Posted
April 18, 2023
Last Updated
September 15, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05865223
Brief Title
Comparison Of Mackenzie Exercise Program Versus Routine Physical Therapy Management in Chronic Mechanical Neck Pain
Official Title
Title Comparison Of Mackenzie Exercise Program Versus Routine Physical Therapy Management On Pain , Range Of Motion And Function in Patient With Chronic Mechanical Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
April 15, 2023 (Actual)
Primary Completion Date
August 20, 2023 (Actual)
Study Completion Date
August 30, 2023 (Actual)

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
No

5. Study Description

Brief Summary
Study will be a Randomized clinical trial to check comparison of mckenzie exercise program versus routine physical therapy management on pain, range of motion and function in patients with chronic neck pain so that we can devise a treatment protocol.Total fifty subjects will be included in this study .Out of total 25 will be randomly allocated via lottery method in group 1 and 25 will be allocated in group 2. Group 1 will receive mckenzie exercise program and routine physical therapy(Joint mobilization, hot pack for 15 minutes and home exercise program) while Group 2 will receive only routine physical therapy (Joint mobilization , hot pack for 15 min and home exercise program). All patients will be treated for 12 sessions, two sessions per week for 6 weeks. Neck pain and disability index consist of two parts, part one which assesses pain severity and part two which assesses functional disability. Study setting will be services hospital. Assesment will be done at 0 week, 4week, 8week and 12weeks. Data was analysed by using SPSS version 26.
Detailed Description
Neck pain is a key public health issue that affects the human beings with reduction productivity and quality of life and produced significant socioeconomic burden on society.The purpose of this study to determine the effectiveness of Mckenzie exercise program and routine physical therapy management on pain range of motion and function in patient with chronic mechanical neck pain. Patients of both gender, neck pain for at least 3 months and age 25-55 years will be included. Patients having history of trauma, vertebral fracture, congenital disorder, ankylosing spondylitis, tumour, pott's disease and any bony or soft tissue systematic disease will be excluded. The main objective of this study is to evaluate pain level and effect of Mackenzie protocol for individuals suffering from chronic neck pain. The tools used will be Neck disability index score (NDI), Numeric Pain Rating Scale (NPRS) and Goniometer for outcome measure pain, range of motion and function. Study will be conducted into 2 groups, each group will have 12 patients and comparisons of two groups will be evaluated. One group will receive Mckenzie exercise program and Routine physical therapy (Joint Mobilization, Hot pack and home exercise program) for 12 weeks and 2 days a week for 40 min each session and other group will receive Routine physical therapy (Joint mobilization, Hot pack and home exercise plan) for 12 weeks and 2 days a week for 30 min each session. Assessment will be done at 0 weeks, 4 week, 8 week and 12 week.Both groups received hot packs for 15 minutes for warming up.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mckenzie exercise program
Arm Type
Experimental
Arm Description
Group A Week 0 : Hot pack for 15 minutes, mackenzie extension exercise program for cervical regions and mobilization with movement at cervical regions for improving flexion, extension, side flexion and rotation. 3 sets of painless glides of 10 repetitions were given, with 1 minute rest between sets. Week 2 & 4: Hot pack for 15 minutes, mckenzie exercise program at cervical region with the progression in repetition and MWM at cervical regions and then we will add progression.5 sets of painless glides of 10 repetitions were given, with 3 minute rest between sets. Week 3 & 6: Hot pack for 15 minutes, mckenzie exercise program for cervical region and MWM at cervical region . 5 sets of painless glides for 10 repetitions were given. Progression can be introduced by increasing number of repetitions performed exercises for 3 weeks.
Arm Title
conventional physical therapy
Arm Type
Active Comparator
Arm Description
A routine physical therapy(joint mobilization,hot pack and home exercise program) treatment and hot pack for 15 minutes.
Intervention Type
Other
Intervention Name(s)
Mckenzie exercise program
Intervention Description
MacKenzie extension exercise program for cervical spine
Intervention Type
Other
Intervention Name(s)
Conventional Physical therapy
Intervention Description
hot pack for 15 minutes will be given followed by joint mobilization,and home exercise program.
Primary Outcome Measure Information:
Title
Numerical Rating Scale (NRS)
Description
Patients are asked to circle the number on a Numerical Rating Scale (NRS) that best describes their level of discomfort between 0 and 10, 0 and 20, or 0 and 100. The lower limit often denotes "the least amount of suffering ," whereas zero typically denotes "no pain at all."
Time Frame
up to 12 weeks
Title
Universal Goniometer for range of motion measurement
Description
The most popular and reliable approach for determining shoulder range of motion (ROM) is by utilizing a goniometer. A goniometer is a straightforward instrument that has two arms joined at a hinge. The goniometer's second arm would be used to measure the joint angle while the physiotherapist placed one arm of the patient against the patient's body
Time Frame
up to 12 weeks
Title
Neck disability index (NDI)
Description
The Neck Disability Index (modification of the oswestry low back pain disability index) scale scores range from 0 to 5 and the total score is the sum of the item scores possible range 0 no pain to 100 maximal pain
Time Frame
up to 12 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: Both Gender Neck pain for at least 3 months Age 25-55 years old Exclusion Criteria: • History of trauma Vertebral Fracture Congenital disorder Ankylosing spondylitis Tumour Pott's Spine Any bony or soft tissue systemic disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zanam Nasir, MS*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Services Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54700
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35587064
Citation
Abdel-Aziem AA, Mohamed RR, Draz AH, Azab AR, Hegazy FA, Diab RH. The effect of McKenzie protocol vs. deep neck flexor and scapulothoracic exercises in subjects with chronic neck pain - a randomized controlled study. Eur Rev Med Pharmacol Sci. 2022 May;26(9):3138-3150. doi: 10.26355/eurrev_202205_28731.
Results Reference
background
PubMed Identifier
12358121
Citation
Guez M, Hildingsson C, Nilsson M, Toolanen G. The prevalence of neck pain: a population-based study from northern Sweden. Acta Orthop Scand. 2002 Aug;73(4):455-9. doi: 10.1080/00016470216329.
Results Reference
background
PubMed Identifier
29332752
Citation
Farooq MN, Mohseni-Bandpei MA, Gilani SA, Ashfaq M, Mahmood Q. The effects of neck mobilization in patients with chronic neck pain: A randomized controlled trial. J Bodyw Mov Ther. 2018 Jan;22(1):24-31. doi: 10.1016/j.jbmt.2017.03.007. Epub 2017 Mar 4.
Results Reference
background
PubMed Identifier
31654125
Citation
Letafatkar A, Rabiei P, Alamooti G, Bertozzi L, Farivar N, Afshari M. Effect of therapeutic exercise routine on pain, disability, posture, and health status in dentists with chronic neck pain: a randomized controlled trial. Int Arch Occup Environ Health. 2020 Apr;93(3):281-290. doi: 10.1007/s00420-019-01480-x. Epub 2019 Oct 25.
Results Reference
background
PubMed Identifier
12948344
Citation
Swenson RS. Therapeutic modalities in the management of nonspecific neck pain. Phys Med Rehabil Clin N Am. 2003 Aug;14(3):605-27. doi: 10.1016/s1047-9651(03)00038-x.
Results Reference
background
PubMed Identifier
12201614
Citation
Kjellman G, Oberg B. A randomized clinical trial comparing general exercise, McKenzie treatment and a control group in patients with neck pain. J Rehabil Med. 2002 Jul;34(4):183-90. doi: 10.1080/16501970213233.
Results Reference
background

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Comparison Of Mackenzie Exercise Program Versus Routine Physical Therapy Management in Chronic Mechanical Neck Pain

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