Protocol summary
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Study aim
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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.
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Design
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A comparative study with sample size 370, Randomly allocate the subjects into two groups. Intervention &control group
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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Patients will receive Mulligan traction and mobilization with clove oil, menthol, 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, and menthol will be topically applied daily for 4 weeks, with each session lasting 5-6 minutes.
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Main outcome variables
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Immediate pain relief, mobility, and long-term nerve regeneration, inflammation and promoting muscle and sensory recovery.
General information
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Reason for update
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data was missing
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20241220064105N3
Registration date:
2025-02-19, 1403/12/01
Registration timing:
registered_while_recruiting
Last update:
2025-04-28, 1404/02/08
Update count:
2
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Registration date
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2025-02-19, 1403/12/01
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2025-01-28, 1403/11/09
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Expected recruitment end date
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2025-04-28, 1404/02/08
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effectiveness of Clove Oil Massage with and without Mulligan Traction and mobilization techniques in Cervical Radiculopathy
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Public title
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Effectiveness of Clove Oil Massage
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 70 years old
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Gender
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Both
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Phase
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1-2
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Groups that have been masked
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- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
370
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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"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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2025-01-22, 1403/11/03
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Ethics committee reference number
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MIMAS/01/8/Komal
Health conditions studied
1
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Description of health condition studied
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Cervical Radiculopathy
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ICD-10 code
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M50.1
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ICD-10 code description
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Cervical disc disorder with radiculopathy
Primary outcomes
1
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Description
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pain
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Timepoint
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4weeks
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Method of measurement
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NPRS
2
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Description
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Cervical Radiculopathy disorder
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Timepoint
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4weeks
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Method of measurement
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NDI
Intervention groups
1
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Description
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Intervention group: Patients will receive Mulligan traction and mobilization with clove oil and menthol 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 and menthol will be topically applied daily for 4 weeks, with each session lasting 5-6 minutes.
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Category
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Rehabilitation
2
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Description
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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.
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Student
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Grant code / Reference number
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MIMAS/6/3/Ayesha
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Muhammad Instituite of Rehabilitation Sciences, Multan
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Proportion provided by this source
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70
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available