Protocol summary

Study aim
To find out the outcomes of traction versus positional pain relief phenomenon in the managmnet of non specific neck pain.
Design
It was single blind, parallel group, single center randomized clinical trial with sample size of 42 patients enrolled between November 2017 to April 2018.
Settings and conduct
It was single blind, parallel group, single center randomized clinical trial, The study was conducted at Ittefaq Hospital Lahore.
Participants/Inclusion and exclusion criteria
Patients with Age 25-55 years of both Genders, Presenting with complaint of non-specific neck pain. and Limitation of Cervical Spine Range of Motion were included And • Patient with red flag sign, cervical injury, radiating pain, advanced degenerative changes, history of headache and vertigo, any Systemic Illness(e.g. Rheumatism) and altered Mental status were excluded from the study.
Intervention groups
Group A: Patients in this group were treated with neck isometrics, hot packs for 10 minutes and cervical traction for three times a week for four weeks. Group B: Patients in this group were treated with neck isometrics, hot packs for 10 minutes and Pain release phenomenon techniques 10×20 sec for three times a week for four weeks..
Main outcome variables
outcomes were measured as scores of visual Analogue Scale for Pain, Neck disability index for Functional outcomes and Range of motion.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201031049207N3
Registration date: 2020-12-22, 1399/10/02
Registration timing: retrospective

Last update: 2020-12-22, 1399/10/02
Update count: 0
Registration date
2020-12-22, 1399/10/02
Registrant information
Name
Wajida Perveen
Name of organization / entity
Sialkot college of Physical Therapy, Amin Welfare &Teaching Hospital, defence Road, Sialkot Pakistan
Country
Pakistan
Phone
+92 52 3250520
Email address
drwajidaperveenpt@scptamc.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-02, 1396/08/11
Expected recruitment end date
2018-04-29, 1397/02/09
Actual recruitment start date
2017-11-02, 1396/08/11
Actual recruitment end date
2018-04-29, 1397/02/09
Trial completion date
2018-05-05, 1397/02/15
Scientific title
Comparative Study of Cervical Traction and Positional Pain Release Phenomenon in the Management of Non Specific Neck Pain: A Randomised Clinical Trial
Public title
The effects of Positional Pain Release Phenomenon in Non Specific Neck Pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 25-55 years Patients of both Genders. Presenting with complaint of non-specific neck pain Limitation of Cervical Spine Range of Motion
Exclusion criteria:
Patient with red flag sign. Patients with cervical injury. Patients with radiating pain. Patients with advanced degenerative changes. Patients with headache and vertigo. Patients with any Systemic Illness(e.g. Rheumatism) Patient with altered Mental status
Age
From 22 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 42
Actual sample size reached: 42
Randomization (investigator's opinion)
Randomized
Randomization description
The patients who met eligibility criteria's and signed the informed consent document were enrolled in the study. They were divided into two groups by using lottery method . No. of paper cards were equal to total sample size, odd Numbers were allocated to Group A and even number were allocated to Group B. Each patient were requested to draw a paper card from the box and after that patients were recruited into either Group A or Group B. In group-A patients were treated with neck isometrics with hot packs for 10 minutes and cervical traction. In group-B patients were treated with neck isometrics with hot packs for 10 minutes and Pain release phenomenon techniques 10×20 sec.
Blinding (investigator's opinion)
Single blinded
Blinding description
Assessor Blind: Data safety was ensured by assigning Specific Identity numbers and all consent, readings forms were placed in locker to blind Assessors.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
SCPT-IRB
Street address
Umer Street
City
Sialkot
Postal code
51310
Approval date
2017-10-10, 1396/07/18
Ethics committee reference number
SCPT-IRB-DPT- 037-2017

Health conditions studied

1

Description of health condition studied
Non Specific Neck Pain
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain: Measured on visual analogue pain scale (VAS).
Timepoint
Before 1st treatment session and after last treatment session
Method of measurement
Recorded subjectively on VAS scoring chart.

2

Description
Functional outcome using neck disability index (NDI)
Timepoint
Before 1st treatment session and after last treatment session
Method of measurement
Recorded subjectively on NDI scoring chart.

3

Description
Range of motion
Timepoint
Before 1st treatment session and after last treatment session
Method of measurement
Measured objectively using Goniometer.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group A: Cervical traction group. Patients in this group were treated with neck isometrics, hot packs for 10 minutes and cervical traction for three times a week for four weeks.
Category
Treatment - Other

2

Description
Intervention group B: Positional Pain release phenomenon Group. Patients in this group were treated with neck isometrics, hot packs for 10 minutes and Pain release phenomenon techniques 10×20 sec for three times a week for four weeks.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Physiotherapy Department, Ittefaq Hospital,Lahore
Full name of responsible person
Samara Ashfaq
Street address
Feeroze pur Road
City
Lahore
Postal code
54000
Phone
+92 42 35881981
Email
info@ittefaqhospital.com
Web page address
https://www.ittefaqhospital.com/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Riphah International University, Lahore
Full name of responsible person
Muqadas chaudary
Street address
28-M,Quaid-e Azam, Industrial Estate Kot Lakhpat
City
Lahore
Postal code
54000
Phone
+92 42 35126110
Email
info@riphah.edu.pk
Web page address
https://lahore.riphah.edu.pk/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
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
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Independent Medical College
Full name of responsible person
Sahreen Anwar
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Jinnah Colony
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 2617122
Email
sahreenanwar@yahoo.com
Web page address
http://www.imc.edu.pk/

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Management & Technology
Full name of responsible person
Muqudas Chaudary
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Township
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 35212801
Email
muqadas.ahaudary@umt.edu.pk
Web page address
https://www.umt.edu.pk/

Person responsible for updating data

Contact
Name of organization / entity
Sialkot College of Physical Therapy, Amin Welfare & teaching Hospital
Full name of responsible person
Wajida Perveen
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Umer Street
City
Sialkot
Province
Punjab
Postal code
51310
Phone
+92 52 3250520
Email
wjda_noor@yahoo.com
Web page address
https://scholar.google.com/citations?user=7IAZykkAAAAJ&hl=en

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not 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
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Comparative Study of Cervical Traction and Positional Pain Release Phenomenon in the Management of Non Specific Neck Pain: A Randomised Clinical Trial
When the data will become available and for how long
after Publication for one year.
To whom data/document is available
Muqadas Chaudary
Under which criteria data/document could be used
for Citation.
From where data/document is obtainable
with Principal Investigator.
What processes are involved for a request to access data/document
A formal Email request.
Comments
Loading...