Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12624001327572
Ethics application status
Approved
Date submitted
12/08/2024
Date registered
31/10/2024
Date last updated
31/10/2024
Date data sharing statement initially provided
31/10/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Intermittent Mechanical Cervical Traction VS Maitland Mobilization On Pain and Range of Motion In Patients with Cervical Spondylosis.
Scientific title
Intermittent Mechanical Cervical Traction VS Maitland Mobilization On Pain and Range of Motion In Patients with Cervical Spondylosis.
Secondary ID [1] 312614 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervical Spondylosis 334548 0
Condition category
Condition code
Physical Medicine / Rehabilitation 331154 331154 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In group A, patients will receive mechanical cervical traction.
Physiotherapist will apply it.
2 sessions per week for 6 weeks.
Mechanical traction is a therapeutic intervention wherein a mechanical device is employed to administer a controlled and mild tensile strain to the cervical region.
Assume a supine position on a horizontal plane. Position the traction apparatus beneath the cervical region and upper thoracic region. Modify the parameters of the traction apparatus to ensure that the applied force is conducive to a comfortable experience. Please remain calm and permit the traction machine to perform its intended function. Commence with a brief duration of traction, specifically spanning a period of 10 minutes with 10 seconds of traction and 5 seconds relax.
Intervention code [1] 329122 0
Rehabilitation
Comparator / control treatment
In the group B, participants will receive the cervical mobilization. The patient assumed a prone position while the therapist will position themselves at the head of the patient. The subject's thumbs will position in opposition at the hypo mobile cervical vertebra facet level, and a unilateral posterior anterior (PA) oscillatory pressure will be administered utilising Grade II and Grade III Maitland's manual therapy procedures. The oscillatory mobilisation will be executed at a frequency of 2 Hz for a duration of 2 minutes, and this process will be repeated three times. The duration of rest intervals between each mobilisation will be one minute. In this group every patient will receive 2 sessions per week with time period of 10 minutes followed.
6 weeks treatment session.
Control group
Active

Outcomes
Primary outcome [1] 338908 0
Cervical Spondylosis-Range of Motion
Assessment method [1] 338908 0
Goniometer
Timepoint [1] 338908 0
1st week(Primary Timepoint), 3rd week, 6th week Post- Baseline
Primary outcome [2] 338909 0
Cervical Spondylosis-Pain
Assessment method [2] 338909 0
Neck Disability Index, Visual Analogue Scale This will be assessed as a composite outcome’
Timepoint [2] 338909 0
1st week, 3rd week, 6th week(Primary timepoint) Post-Baseline
Secondary outcome [1] 437889 0
Nil
Assessment method [1] 437889 0
Nil
Timepoint [1] 437889 0
Nil

Eligibility
Key inclusion criteria
• Gender: Male and Female
• Ages between 30-55 years(Ali et al., 2015).
• Patients diagnosed with Cervical Spondylosis of grade I-III
• Patients diagnosed through Spurling Test
Minimum age
30 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients with Whiplash Injury
• Neck Pain associated with Disc Herniation
• Patients with history of cervical region fracture.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Concealed.
Sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The lottery method of randomization will be employed..
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
21/12/2023
Date of last participant enrolment
Anticipated
Actual
20/05/2024
Date of last data collection
Anticipated
Actual
29/06/2024
Sample size
Target
82
Accrual to date
Final
68
Recruitment outside Australia
Country [1] 26481 0
Pakistan
State/province [1] 26481 0
Punjab

Funding & Sponsors
Funding source category [1] 317045 0
Self funded/Unfunded
Name [1] 317045 0
Ifra Aimen
Country [1] 317045 0
Pakistan
Primary sponsor type
Individual
Name
Ifra Aimen- Sharif Medical City Hospital
Country
Pakistan
Secondary sponsor category [1] 319291 0
None
Name [1] 319291 0
Country [1] 319291 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315799 0
University Of Lahore-Faculty Of Allied Health Sciences
Ethics committee address [1] 315799 0
Ethics committee country [1] 315799 0
Pakistan
Date submitted for ethics approval [1] 315799 0
13/11/2023
Approval date [1] 315799 0
12/12/2023
Ethics approval number [1] 315799 0
REC-UOL-613-12-2023

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 135834 0
Miss Ifra Aimen
Address 135834 0
Sharif Medical City Hospital, Sharif Medical City Rd off Raiwand Road, Jati Umrah Lahore, Punjab 55150, Pakistan
Country 135834 0
Pakistan
Phone 135834 0
+923341069001
Email 135834 0
drifraaimen@gmail.com
Contact person for public queries
Name 135835 0
Ifra Aimen
Address 135835 0
Sharif Medical City Hospital, Sharif Medical City Rd off Raiwand Road, Jati Umrah Lahore, Punjab 55150, Pakistan
Country 135835 0
Pakistan
Phone 135835 0
+923341069001
Email 135835 0
drifraaimen@gmail.com
Contact person for scientific queries
Name 135836 0
Ifra Aimen
Address 135836 0
Sharif Medical City Hospital, Sharif Medical City Rd off Raiwand Road, Jati Umrah Lahore, Punjab 55150, Pakistan
Country 135836 0
Pakistan
Phone 135836 0
+923341069001
Email 135836 0
drifraaimen@gmail.com

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.