Effects of Sustained Natural Apophyseal Glides with and without Thoracic Postural Correction Techniques on Pain, Range of Motion and Disability in Patients with Mechanical Neck Pain
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General information
Not blinded
Single blinded
notblsingl
1
1
empty
28
28
empty
2023-03-05, 1401/12/14
2023-03-05 00:00:00
empty
2023-06-25, 1402/04/04
2023-06-25 00:00:00
empty
2023-08-05, 1402/05/14
2023-08-05 00:00:00
empty
Trial has been completed.
Trial has been completed.
Individuals having localized pain or stiffness in spine or both combined b/w C3 to C7 without upper limbs radiculopathy
Patients with chronic neck pain >3 months
Pain reported on NPRS score ˃3 in neck region with limited or painful range of motion
Individuals having localized pain or stiffness in spine or both combined b/w C3 to C7 without upper limbs radiculopathy
Patients with chronic neck pain >3 months
Pain reported on NPRS score ˃3 in neck region with limited or painful range of motion
Painful and limited cervical range of motion
Individuals having localized pain or stiffness in spine or both combined b/w C3 to C7 without upper limbs radiculopathy Patients with chronic neck pain >3 months Pain reported on NPRS score ˃3 in neck region with limited or painful range of motion Painful and limited cervical range of motion
As per the inclusion and exclusion criteria of the study, patients will be divided into two groups randomly by using a non-probability convenience sampling technique.
Patients will be assigned to either control or treatment group by random selection using a computer-generated table of random numbers. These numbers will be placed inside sealed envelopes. Another individual, who is not involved in the research, will then open these envelopes and assign the patients to their respective groups based on the instructions provided.
As per the inclusion and exclusion criteria of the study, patientsPatients will be divided into two groups randomlyassigned to either control or treatment group by random selection using a noncomputer-probability convenience sampling techniquegenerated table of random numbers. These numbers will be placed inside sealed envelopes. Another individual, who is not involved in the research, will then open these envelopes and assign the patients to their respective groups based on the instructions provided.
A skilled and experienced physiotherapist, who is not connected to the study, will making assessments on outcomes or gathering data on outcome variables.
A skilled and experienced physiotherapist, who is not connected to the study, will making assessments on outcomes or gathering data on outcome variables.
Protocol summary
Study aim
To determine the effects of Sustained Natural Apophyseal Glides with and without thoracic postural correction techniques on mechanical neck pain
Design
The study design will be a Randomized Controlled Trial with a parallel group design of 28 patients.
Settings and conduct
The study setting will be International Therapy Services ITS Clinic, Lahore. The sample would be taken by using a non-probability convenience sampling technique.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
• Individuals having localized pain or stiffness in the spine or both combined b/w
C3 to C7 without upper limbs radiculopathy
• Patients with chronic neck pain >3 months
• Pain reported on NPRS score ˃3 in the neck region with a limited or painful range
Exclusion Criteria:
• Tuberculosis, carcinoma, heart disease, osteoporosis.
• Neural disorders
• Any trauma or localized infection in the neck region,
cervical stenosis, metabolic diseases in bone and joint.
• Hyper flexibility
• Open sores
• Ongoing radiotherapy, chemotherapy, steroid therapy, or anticoagulants.
• Allergy to hot pack
• Patients with a history of surgery in the cervical spine region within a year
Intervention groups
Group A will receive combination of a sustained facet glide with movement applied at the facet joints between cervical C3 to C7.
Group B will receive sustained natural apophyseal glides same as group A along thoracic postural correction technique. Thoracic postural correction technique includes active as well as therapist-facilitated stretches.
Main outcome variables
Pain, Range of Motion and Disability
General information
Reason for update
Trial has been completed.
Acronym
IRCT registration information
IRCT registration number:IRCT20190717044238N5
Registration date:2023-03-06, 1401/12/15
Registration timing:registered_while_recruiting
Last update:2023-09-24, 1402/07/02
Update count:1
Registration date
2023-03-06, 1401/12/15
Registrant information
Name
Fareeha Amjad
Name of organization / entity
The University of Lahore
Country
Pakistan
Phone
+92 42 99200600
Email address
fari_fairy22@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-01, 1401/12/10
Expected recruitment end date
2023-06-30, 1402/04/09
Actual recruitment start date
2023-03-05, 1401/12/14
Actual recruitment end date
2023-06-25, 1402/04/04
Trial completion date
2023-08-05, 1402/05/14
Scientific title
Effects of Sustained Natural Apophyseal Glides with and without Thoracic Postural Correction Techniques on Pain, Range of Motion and Disability in Patients with Mechanical Neck Pain
Public title
Sustained Natural Apophyseal Glides and Thoracic Posture Correction Technique on Mechanical Neck Pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Individuals having localized pain or stiffness in spine or both combined b/w C3 to C7 without upper limbs radiculopathy
Patients with chronic neck pain >3 months
Pain reported on NPRS score ˃3 in neck region with limited or painful range of motion
Painful and limited cervical range of motion
Exclusion criteria:
Tuberculosis, carcinoma, heart disease, osteoporosis
Neural disorders
Any trauma or localized infection in neck region, cervical stenosis, metabolic diseases in bone and joint
Hyper flexibility
Open sores
Ongoing radiotherapy, chemotherapy, steroid therapy or anticoagulants
Allergy to hot pack
Patients with history of surgery in cervical spine region with in a year
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
28
Actual sample size reached:
28
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be assigned to either control or treatment group by random selection using a computer-generated table of random numbers. These numbers will be placed inside sealed envelopes. Another individual, who is not involved in the research, will then open these envelopes and assign the patients to their respective groups based on the instructions provided.
Blinding (investigator's opinion)
Single blinded
Blinding description
A skilled and experienced physiotherapist, who is not connected to the study, will making assessments on outcomes or gathering data on outcome variables.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Riphah College of Rehabilitation and Allied Health Sciences Lahore
Neck Disability Index is a self-report questionnaire designed to determine how neck pain affects a patient’s daily life and the disability of patients with neck pain. It consists of 10 questions that ask about activities of daily living. More the score, the more significant the disability. The sample questionnaire is attached at the end. Four sections relate to subjective symptoms, and the remaining 6 sections relate to activities of daily living. Each unit is scored from 0 to 5 points, giving a maximum score of 50. The total score of the neck disability index ranges from 0 to 50 points
2
Description
Pain
Timepoint
6 weeks
Method of measurement
Patient level of pain will be assessed using this scale. This scale ranges from 0 to 10. 0 indicates “no pain” and 10 indicates “worst pain”
3
Description
Range of motion
Timepoint
6 weeks
Method of measurement
Changes from the Baseline ROM range of Motion of Cervical spine will be taken with the Help of Goniometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Group A will receive conventional therapy (Hot pack and Transcutaneous Electrical Nerve Stimulation) along sustained natural apophyseal glides. Sustained facet glide with movement will be applied at the facet joint between cervical C3 to C7. It will be performed in sitting or standing position of the patient. Sustained Natural Apophyseal Glides involves application of accessory passive glide to cervical vertebrae by a physiotherapist while the patient will simultaneously perform an active movement. Glide given is in the direction of the plane of facet joints, and technique is usually performed in weight-bearing position like standing, sitting etc. Patients in control group will receive treatment for alternate days, 3 days a week for 6 weeks
Category
Treatment - Other
2
Description
Intervention group: Group B will receive conventional therapy same as group A with sustained natural apophyseal glides and thoracic posture correction technique. Thoracic postural correction technique includes active as well as therapist-facilitated stretches. Active stretches will be thoracic extension in sitting, Wall angle stretch and Corner stretch, while the therapist-facilitated stretches will be seated mid-thoracic stretch and prone mid thoracic stretch. Stretches will be maintained for 15- 20 seconds with 10 repetitions of each stretch per session. Patients in control group will receive treatment for alternate days, 3 days a week for 6 weeks.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
International Therapy Services
Full name of responsible person
Dr. Tayyab Malik
Street address
International Therapy Services UET Lahore
City
Lahore
Postal code
54000
Phone
+92 306 2149648
Email
itsclinicpak@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Riphah International University Lahore
Full name of responsible person
Dr. Fareeha Amjad
Street address
Riphah Quaid e Azam Campus, 28-M Quaid-e-Azam industrial Estate, kot lakhpat, Lahore
City
Lahore
Postal code
54000
Phone
+92 334 3372779
Email
fari_fairy22@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Riphah International University Lahore
Proportion provided by this source
100
Public or private sector
Private
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
Riphah International University
Full name of responsible person
Rameen Qayyum
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
26-D Architect Society Lahore
City
Lahore
Province
Punjab
Postal code
54782
Phone
+92 322 4109195
Email
rameenqayyum95@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Dr. Fareeha Amjad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Riphah International University Madar e Millat Road, Quaid e Azam Industrial Estate Lahore, Punjab
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 334 3372779
Email
fari_fairy22@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Riphah International University, Lahore
Full name of responsible person
Rameen Qayyum
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
26D Architect Society Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 322 4109195
Email
rameenqayyum95@gmail.com
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
No - There is not 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
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Consent Form in its original format with no information about any participant study protocol- how the intervention was given to both groups
When the data will become available and for how long
Data would be available after the completion of the research at the end of 2023
To whom data/document is available
People working in an academic and clinical setting can have access to the above-mentioned information/documents
Under which criteria data/document could be used
Data can only be used for Research Purposes
From where data/document is obtainable
Data can be asked for at the following email address: rameenqayyum95@gmail.com
What processes are involved for a request to access data/document
One can ask for data at the given email address and it would be provided after knowing the general implications of sharing that particular data.