History
# Registration date Revision Id
3 2025-04-18, 1404/01/29 337789
2 2025-03-04, 1403/12/14 332519
1 2025-02-19, 1403/12/01 331038
Changes made to previous revision
This is the first revision

Protocol summary

Study aim
This study evaluates the comparative effects of camphor and clove oil massage with and without Mulligan Traction in cervical radiculopathy, focusing on pain relief, mobility improvement, and the therapeutic benefits of the oils in reducing inflammation, pain, and supporting nerve health.
Design
A comparative study with sample size 370, Randomly allocate the subjects into two groups. Intervention &control group
Settings and conduct
Muhammad physical therapy clinic and rehabilitation center, Both outcome assessors and data analyser will be blinded to group assignments to minimize bias in treatment delivery and outcome measurement.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 18–70y Uni-lateral upper-extremity pain, paresthesia, or numbness Loss of reflexes in the affected nerve root distribution Motor or sensory dysfunction (optional) Pain radiating to the arm cervical rotation range of motion less than 60 degrees Positive distraction test Positive Spurling's Exclusion criteria: Fractures Open wounds Patients with spinal cord compression Traumatic injuries Cancer
Intervention groups
Patients will receive Mulligan traction and mobilization with clove oil, camphor oil, via massage. Manual traction will last 10 minutes, with 10-second pulls and 5-second rests. Treatment will occur 3 times a week for 4 weeks, totaling 12 sessions. Mulligan SMWAM will be performed with 10-30 repetitions, and SNAG mobilizations will be applied. Clove oil, camphor oil, and methanol will be topically applied daily for 4 weeks, with each session lasting 5-6 minutes.
Main outcome variables
Immediate pain relief, mobility, and long-term nerve regeneration, inflammation and promoting muscle and sensory recovery.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20241220064105N3
Registration date: 2025-02-19, 1403/12/01
Registration timing: registered_while_recruiting

Last update: 2025-02-19, 1403/12/01
Update count: 2
Registration date
2025-02-19, 1403/12/01
Registrant information
Name
Komal Ammar Bukhari
Name of organization / entity
Muhammad Institute of Medical Sciences, Multan
Country
Pakistan
Phone
+92 314 6361728
Email address
komalbukhari608@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-01-28, 1403/11/09
Expected recruitment end date
2025-04-28, 1404/02/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Camphor and Clove Oil Massage with and without Mulligan Traction in Cervical Radiculopathy
Public title
Effectiveness of Camphor and Clove Oil Massage
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18–70y paresthesia, Uni-lateral upper-extremity pain or numbness Loss of reflexes in the affected nerve root distribution Motor or sensory dysfunction (optional) Pain radiating to the arm cervical rotation range of motion less than 60 degrees Positive distraction test Positive Spurling's
Exclusion criteria:
Fractures Open wounds Patients with spinal cord compression Traumatic injuries Cancer
Age
From 18 years old to 70 years old
Gender
Both
Phase
1-2
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 370
Randomization (investigator's opinion)
Randomized
Randomization description
This randomization will be done by Lottery method to ensure fairness. Medications will be given in numbered white boxes, each with a unique medication number. The treatment codes will be kept by the principal investigator.
Blinding (investigator's opinion)
Double blinded
Blinding description
"The statistical analyst and outcome assessor will be blinded to treatment allocation by using securely stored randomization codes, accessible only to an independent party. Data will be analyzed using anonymous identifiers, and group allocation will be revealed only after data collection and analysis are complete. This ensures minimization of bias.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Institutional Ethical Committee of Muhammad Institute of Medical and Allied Sciences
Street address
Bosan Road
City
Multan
Postal code
66000
Approval date
2025-01-22, 1403/11/03
Ethics committee reference number
MIMAS/01/8/Komal

Health conditions studied

1

Description of health condition studied
Cervical Radiculopathy
ICD-10 code
M50.1
ICD-10 code description
Cervical disc disorder with radiculopathy

Primary outcomes

1

Description
pain
Timepoint
4weeks
Method of measurement
NPRS

2

Description
Cervical Radiculopathy disorder
Timepoint
4weeks
Method of measurement
NDI

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients will receive Mulligan traction and mobilization with clove oil, camphor oil, and methanol via massage. Manual traction will last 10 minutes, with 10-second pulls and 5-second rests. Treatment will occur 3 times a week for 4 weeks, totaling 12 sessions. Mulligan SMWAM will be performed with 10-30 repetitions, and SNAG mobilizations will be applied. Clove oil, camphor oil, and methanol will be topically applied daily for 4 weeks, with each session lasting 5-6 minutes.
Category
Rehabilitation

2

Description
Control group: Patients will receive 12 treatment sessions over 4 weeks, with 3 sessions per week (10-20 minutes each). Mulligan manual traction will be applied for 10 minutes, with 10-second pulls and 5-second rests. Mulligan SMWAM will start with 10 repetitions in the first session, increasing to 30 repetitions in subsequent sessions. Mulligan SNAG mobilizations will also be provided.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
The Institutional Ethical Committee of Muhammad Institute of Medical and Allied Sciences
Full name of responsible person
Maliha Khalid Khan
Street address
Bosan Road
City
Multan
Postal code
66000
Phone
+92 314 6361728
Email
malihatareen1997@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Muhammad Instituite of Rehabilitation Sciences, Multan
Full name of responsible person
Qurat ul Ain
Street address
Bosan Road
City
Multan
Postal code
66000
Phone
+92 312 6862130
Email
qain0635@gmail.com
Grant name
Student
Grant code / Reference number
MIMAS/6/3/Ayesha
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Muhammad Instituite of Rehabilitation Sciences, Multan
Proportion provided by this source
70
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
Muhammad Instituite of Rehabilitation Sciences, Multan
Full name of responsible person
Maliha Khalid Khan
Position
Lecturer
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
Bosan Road
City
Multan
Province
Punjab
Postal code
66000
Phone
+92 312 6862130
Email
malihatareen1997@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Muhammad Instituite of Rehabilitation Sciences, Multan
Full name of responsible person
Komal Ammar Bukhari
Position
Lecturer
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
Bosan Road
City
Multan
Province
Punjab
Postal code
66000
Phone
+92 314 6361728
Email
komalbukhari608@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Muhammad Instituite of Rehabilitation Sciences, Multan
Full name of responsible person
Ayesha Mubeen
Position
Punjab
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Bosan Road
City
Multan
Province
Punjab
Postal code
66000
Phone
+92 306 1168328
Email
ayeshamubeenbwp03@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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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