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COMPARATIVE EFFECT OF UPPER THORACIC SPINE MOBILIZATION WITH MOBILITY EXERCISES AND UPPER CERVICAL SPINE MOBILIZATION WITH STABILIZATION EXERCISES IN MECHANICAL NECK PAIN

Protocol summary

Study aim
To evaluate effects of upper thoracic spine mobilization with mobility exercises and upper cervical spine mobilization with stabilization exercises in reducing pain, improving cervical ROM and function in treating patients with mechanical neck pain.
Design
Single Blinded Randomized Clinical Design
Settings and conduct
Faisal Hospital Faisalabad Mujahid Hospital Faisalabad Bin Inam Physical Therapy & Chiropractic Rehab Clinic Faisalabad Pro Health Wellness Center Faisalabad
Participants/Inclusion and exclusion criteria
Inclusion Criteria: • Male and female both genders • Age ranging from 20-40 years • Primary complaint of neck pain from past 12 weeks • Pain rating of more than 2 on NPRS • Reduced cervical ROM in extension, rotation and side bending • Neck Disability Index score of 20% or more i.e. 10 points or more on 0 to 50 scale Exclusion Criteria: • Previous history of trauma or surgery to cervical or thoracic spine, whiplash injury • Presence of neurological deficits • Presence of bilateral upper extremity symptoms • Cervical myelopathy or nerve root pathology • Patients with positive Lhermitte’s sign • Vascular diseases of head and neck • Presence of any red flags e.g. fracture, tumor • Any symptoms of CNS involvement • Patients with psychological disorders or those who can’t comprehend given instructions.
Intervention groups
Treatment will be provided for 2 times a week for 4 weeks for both groups. Group A will perform upper thoracic mobilization and mobility exercise.
Main outcome variables
Numerical Pain Rating Scale Universal Goniometer Neck Disability Index

General information

Reason for update
Acronym
MNP
IRCT registration information
IRCT registration number: IRCT20210630051741N1
Registration date: 2021-08-01, 1400/05/10
Registration timing: registered_while_recruiting

Last update: 2021-08-01, 1400/05/10
Update count: 0
Registration date
2021-08-01, 1400/05/10
Registrant information
Name
Dr. Ramesha Tahir Alvi
Name of organization / entity
The University of Faisalabad
Country
Pakistan
Phone
+92 41 8502460
Email address
ramisha.alvi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-15, 1400/03/25
Expected recruitment end date
2021-10-15, 1400/07/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
COMPARATIVE EFFECT OF UPPER THORACIC SPINE MOBILIZATION WITH MOBILITY EXERCISES AND UPPER CERVICAL SPINE MOBILIZATION WITH STABILIZATION EXERCISES IN MECHANICAL NECK PAIN
Public title
COMPARATIVE EFFECT OF UPPER THORACIC SPINE MOBILIZATION WITH MOBILITY EXERCISES AND UPPER CERVICAL SPINE MOBILIZATION WITH STABILIZATION EXERCISES IN MECHANICAL NECK PAIN
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
• Male and female both genders • Age ranging from 20-40 years • Primary complaint of neck pain from past 12 weeks • Pain rating of more than 2 on NPRS • Reduced cervical ROM in extension, rotation and side bending • Neck Disability Index score of 20% or more i.e. 10 points or more on 0 to 50 scale • Commitment to comply with treatment plans
Exclusion criteria:
• Previous history of trauma or surgery to cervical or thoracic spine, whiplash injury • Presence of neurological deficits • Presence of bilateral upper extremity symptoms • Cervical myelopathy or nerve root pathology • Patients with positive Lhermitte’s sign • Vascular diseases of head and neck • Presence of any red flags e.g. fracture, tumor, osteoporosis, rheumatoid arthritis, metabolic diseases, blood pressure at rest more than 140/90 mm Hg, chronic history of corticosteroid use • Any symptoms of central nervous system (CNS) involvement e.g. hyperreflexia, sensory deficits and muscle atrophy in hands, nystagmus, unsteadiness in gait, loss of visual acuity, abnormal facial sensation, dysgeusia, positive pathological reflexes • Patients with psychological disorders or those who can’t comprehend given instructions.
Age
From 20 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 36
More than 1 sample in each individual
Number of samples in each individual: 18
Patients will be randomly assigned into two groups. Each group will comprise of 18 patients.
Randomization (investigator's opinion)
Randomized
Randomization description
Non-probability purposive sampling technique will be utilized for collecting sample and sample will be allocated to treatment group A and B by using online randomization generator. 2 sets of 18 unique numbers per set Range: From 1 to 36— Sorted from Least to Greatest Group A: Thoracic Mobilization and Mobility Exercise [1,2,6,7,10,11,15,17,18,19,20,22,23,24,29,32,33,35] Group B: Cervical Mobilization and Stabilization Exercise [3,4,5,8,9,12,13,14,16,21,25,26,27,28,30,31,32,34, 36]
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients will be kept blind through allocation concealment to treatment group. Patients will be unaware of their respective group treatment plans.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical Committee of The University of Faisalabad
Street address
Sargodha Rd, University Town, Faisalabad, Punjab 38000
City
Faisalabad
Postal code
38000
Approval date
2021-05-17, 1400/02/27
Ethics committee reference number
TUF/DR/MSPP/295

Health conditions studied

1

Description of health condition studied
Mechanical neck pain can be defined as pain in neck or shoulder area aggravated by prolonged posture and movement of neck and palpation of neck musculature.
ICD-10 code
M54. 2
ICD-10 code description
Code M54. 2 is the diagnosis code used for Cervicalgia (Neck Pain). A disorder characterized by marked discomfort sensation in the neck area.Discomfort or more intense forms of pain that are localized to the cervical region. This term generally refers to

Primary outcomes

1

Description
The numerical pain rating scale was utilized to measure intensity of pain. Pain Intensity was rated on 0-10 scale at a horizontal bar. NPRS consists of 11 points, which range from 0= no pain, 1-4= mild pain, 4-7= moderate pain 7-10= severe pain
Timepoint
5 timepoints including Baseline, 1st week post treatment, 2nd week post treatment, 3rd week post treatment, 4th week post treatment
Method of measurement
Numerical Pain Rating Scale will be utilized to assess pain.

2

Description
Universal Goniometer will be used to measure Cervical ROM.
Timepoint
5 timepoints including Baseline, 1st week post treatment, 2nd week post treatment, 3rd week post treatment, 4th week post treatment
Method of measurement
Universal Goniometer will be used to measure Cervical ROM.

Secondary outcomes

1

Description
It is a questionnaire which measures the functional ability of the patient. Each item is scored on a 0 to 5 rating scale, in which zero means no pain and 5 means worst imaginable pain. All the points are summed to give a total score, which can be interpreted as 0 points= no activity limitations,0-4 points = no disability, 5-14 points = mild disability, 15-24 points = moderate disability, 25-34 points = severe disability, 35-50 points = complete disability 50 points =complete activity limitation
Timepoint
2 timepoints including Baseline and 4th week post treatment
Method of measurement
Neck Disability Index will be used to measure neck disability.

Intervention groups

1

Description
Intervention group:
Category
Rehabilitation

2

Description
Intervention group:
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Faisal Hospital Faisalabad
Full name of responsible person
Dr. Qurat-ul-Ain
Street address
673-A Lower Canal Rd E, Block A People's Colony No 1, Faisalabad, Punjab
City
Faisalabad
Postal code
38000
Phone
+92 41 8536999
Email
fihsfsd@outlook.com
Web page address

2

Recruitment center
Name of recruitment center
Mujahid Hospital Faisalabad
Full name of responsible person
Dr. Muqaddas
Street address
Green Belt Rd, Saddar Block Z Madina Town, Faisalabad, Punjab 38000
City
Faisalabad
Postal code
38000
Phone
+92 41 8541364
Email
mujahidhospital@gmail.com

3

Recruitment center
Name of recruitment center
Bin Inam Physical Therapy & Chiropractic Rehab Clinic Faisalabad
Full name of responsible person
Dr Awais Bin Inam
Street address
342b Satayana Rd, near ideal sweets, D Ground Block B People's Colony No 1, Faisalabad, Punjab
City
Faisalabad
Postal code
38000
Phone
+92 41 8719828
Email
bininamgroup@gmail.com
Web page address

4

Recruitment center
Name of recruitment center
Pro Health Wellness Center Faisalabad
Full name of responsible person
Dr. Samraiz Mughal
Street address
Circle Club, Kashmir Rd, Malikpur, Faisalabad, Punjab
City
Faisalabad
Postal code
38000
Phone
+92 41 8757701
Email
drsamraiz@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Dr. Sidra Majeed; PT
Street address
Sargodha Rd, University Town, Faisalabad, Punjab 38000
City
Faisalabad
Postal code
38000
Phone
+92 41 8868326
Email
info@tuf.edu.pk
Web page address
https://www.tuf.edu.pk/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Self financed
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
Other

Person responsible for general inquiries

Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Dr. Ramesha Tahir; PT
Position
Priniciple Investigator/Student
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
9-Y-B, Block Madina Town, Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 8502460
Email
ramisha.alvi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Dr. Ramesha Tahir; PT
Position
Priniciple Investigator/Student
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
9-Y-B, Block Madina Town, Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 8502460
Email
ramisha.alvi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Dr. Ramesha Tahir; PT
Position
Priniciple Investigator/Student
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
9-Y-B, Block Madina Town, Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 8502460
Email
ramisha.alvi@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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