Protocol summary

Study aim
To find out the effectiveness of McKenzie exercises compared to conventional physical therapy in patients with chronic non-specific neck pain.
Design
Randomised, superiority, parallel group trial with blinded outcome assessment. Randomisation was centralised and computerised with concealed randomisation sequence carried out at an external site
Settings and conduct
Physical therapy department of Hayatabad Medical Complex (HMC).
Participants/Inclusion and exclusion criteria
Inclusion Criteria: • Male and female individuals • Age 18 to 65 years • Having localized chronic non-specific neck pain from ≥ 3 months Exclusion Criteria: • Cervical radiating pain • History of the neck surgery in the past 12 months • History of spinal cord lesion • Diagnosed cases of serious pathologies like infection, inflammation or malignancy
Intervention groups
Control Group: The conventional physical therapy protocol will include active neck exercises, which consists of functional exercises, postural exercises, stretching, relaxation exercises and isometric neck exercises to increase strength or range of motion. Exercise therapy may also be preceded by massage (such as soft tissue release for 5 minutes), stretching, or physical therapy techniques like heat applications (such as hot pack for 10-15 minutes), interferential current, and transcutaneous electrical nerve stimulation (TENS) application. Experimental Group: The patient will be asked to keep their head as forward-facing as possible while moving it backward as much as they can. Making the movement as large as possible is crucial. After finishing, the patient goes back to their neutral rest position.
Main outcome variables
Numerical Pain Rating Scale (NPRS) for neck pain, Copenhagen neck functional disability scale (CNFDS) to measure neck functional activity and goniometer to measure cervical ROM.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230907059376N5
Registration date: 2024-06-08, 1403/03/19
Registration timing: prospective

Last update: 2024-06-08, 1403/03/19
Update count: 0
Registration date
2024-06-08, 1403/03/19
Registrant information
Name
Sarmad Khattak
Name of organization / entity
Rehman Medical Institute, Peshawar
Country
Pakistan
Phone
+92 91 5838666
Email address
sarmadkhattak007@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-15, 1403/03/26
Expected recruitment end date
2024-09-15, 1403/06/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Mckenzie neck exercise and conventional physical therapy in patients with chronic non-specific neck pain: A randomized controlled trial
Public title
Effectiveness of Mckenzie neck exercise and conventional physical therapy in patients with chronic non-specific neck pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male and female individuals• Age 18 to 65 years Having localized chronic, non-specific neck pain from ≥ 3 months
Exclusion criteria:
Cervical radiating pain History of the neck surgery in the past 12 months History of spinal cord lesion Diagnosed cases of serious pathologies like infection, inflammation or malignancy Individuals who have been clinically diagnosed with psychological disorders
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 26
Randomization (investigator's opinion)
Randomized
Randomization description
The participants will be randomly allocated to groups using the sealed envelope method. This technique ensures that the assignment is unbiased and that neither the participants nor the researchers can influence the group allocation. Each participant will draw an envelope containing their group assignment, maintaining the randomness and confidentiality of the process. This method is commonly used in clinical trials and research studies to ensure the integrity of the experimental design.
Blinding (investigator's opinion)
Single blinded
Blinding description
Only the assessor, who will assess pre and post scores, will be blind in current study
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
KMU AS&RB
Street address
5-B/2 Shaukat Khanum Rd, Phase 5 Hayatabad, Peshawar, Khyber Pakhtunkhwa
City
Peshawar
Postal code
25000
Approval date
2024-05-30, 1403/03/10
Ethics committee reference number
KMU/AS&RB/IPMR/MSPT/2024/07

Health conditions studied

1

Description of health condition studied
Chronic non specific neck pain
ICD-10 code
M54.2
ICD-10 code description
Cervicalgia

Primary outcomes

1

Description
Neck Pain intensity
Timepoint
Outcome measures will be used/measured at baseline and after the intervention
Method of measurement
Numeric Pain rating scale

Secondary outcomes

empty

Intervention groups

1

Description
Control group: Participants in this group will receive conventional therapy. Conventional physical therapy protocol will include active neck exercises, which consists of functional exercises, postural exercises, stretching, relaxation exercises and isometric neck exercises to increase strength or range of motion. Exercise therapy may also be preceded by massage (such as soft tissue release for 5 minutes), stretching, or physical therapy techniques like heat applications (such as hot pack for 10-15 minutes), interferential current, and transcutaneous electrical nerve stimulation (TENS) application. This protocol will be done thrice a week, with thirty-minute therapy sessions, with an overall of maximum of twelve sessions.
Category
Rehabilitation

2

Description
Intervention group: This group will receive McKenzie exercise for neck pain. The patient will be asked to keep their head as forward-facing as possible while moving it backward as much as they can. Making the movement as large as possible is crucial. After finishing, the patient goes back to their neutral rest position. Four sets of ten to fifteen repetitions of the exercise are to be performed, with a one-to-two-minute break in between.First Week of applying McKenzie Protocol:The patient will be supine with their head retracted or their chin thrust in. Under the occiput, a tiny pillow will be positioned to sustain a small amount of flexion. The patient will be instructed to position their head so that it was squarely over the girdle of their shoulders by pulling the neck and head posteriorly. After holding the final position for a brief moment, the subject will be free to settle into a resting position. Frequency: Four sets of ten to fifteen repetitions of this procedure will be performed, with one to three minutes of rest in between.Second Week of applying McKenzie Protocol:The therapist will progress the patient while they were seated by adding neck extension and applying overpressure with their chin at the end of the range of motion. Frequency: Four sets of this procedure will be performed, with a one to two minute break in between.Third Week of applying McKenzie Protocol:The patient will be positioned in such a way that their head will keep off the couch while lying supine. The therapist will apply the traction exercise of retraction and extension. All along the range of motion, the traction and extension will be maintained. Fourth Week of applying McKenzie Protocol:The patient will be instructed to get into short sitting. The therapist will then apply retraction with lateral flexion, neck rotation, and then pair the retraction and flexion of the neck with overpressure. Frequency: Four sets of 10 to 15 repetitions of this procedure will be performed, with a 1- to 2-minute rest period in between.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Physical Therapy Department, Hayatabad Medical Complex, Peshawar
Full name of responsible person
Muhammad Salman Khan
Street address
Phase 4 Hayatabad, Peshawar, Khyber Pakhtunkhwa, Pakistan
City
Peshawar
Postal code
25000
Phone
+92 91 9217140
Email
salmankhan9412@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Khyber Medical University, Peshawar
Full name of responsible person
Raheela Naz
Street address
F1 Phase-6 Rd, Phase 5 Hayatabad, Peshawar, Khyber Pakhtunkhwa
City
Peshawar
Postal code
25100
Phone
+92 91 5862514
Email
IPHSS@kmu.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khyber Medical University, Peshawar
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Khyber Medical University, Peshawar
Full name of responsible person
Atik Arsh
Position
Assitant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
F1 Phase-6 Rd, Phase 5 Hayatabad, Peshawar, Khyber Pakhtunkhwa 25100, Pakistan
City
Peshawar
Province
Khyber Pakhtunkhwa
Postal code
25000
Phone
+92 91 5862514
Email
aatikarsh@kmu.edu.pk

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rehman Medical Institute, Peshawar
Full name of responsible person
Muhammad Salman Khan
Position
Physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
XCRP+W7C, 5-B/2 Shaukat Khanum Rd, Phase 5 Hayatabad, Peshawar, Khyber Pakhtunkhwa 25000, Pakistan
City
Peshawar
Province
Khyber Pakhtunkhwa
Postal code
25000
Phone
+92 91 5838666
Email
salmankhan9412@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Rehman Medical Institute, Peshawar
Full name of responsible person
Raheela Naz
Position
Physical Therapist 1
Latest degree
Master
Other areas of specialty/work
Rehabilitation management
Street address
5-B/2 Shaukat Khanum Rd, Phase 5 Hayatabad, Peshawar, Khyber Pakhtunkhwa
City
Peshawar
Province
Khyber Pakhtunkhwa
Postal code
25000
Phone
+92 91 5838666
Email
raheela.naz@rmi.edu.pk

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Management of non specific neck pain through Mckenzie protocol will be the provided data title.
When the data will become available and for how long
After the completion of research data will be available for one year of time.
To whom data/document is available
Document will be available for the rehabilitation researchers, physiotherapy faculty and students.
Under which criteria data/document could be used
The participants registered with IRCT will have access to the data.
From where data/document is obtainable
Document will be available by contacting principal author Muhammad Salman Khan through email salmankhan9412@gmail.com
What processes are involved for a request to access data/document
The person registered with IRCT have to email the principal author.
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