Protocol summary
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Study aim
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Evaluates the effectiveness of Mulligan techniques in reducing pain and improving mobility, strength, and function in cervical radiculopathy patients, with and without methylcobalamin. It also examines whether combining Mulligan techniques with methylcobalamin enhances nerve function recovery.
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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, Multan
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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 methylcobalamin via phonophoresis for 12 sessions over 4 weeks (3 times per week). Manual traction will last 10 minutes (10 sec pull, 5 sec rest), and phonophoresis will be applied for 5-7 minutes per session using 0.8 MHz frequency, 1.5 W/cm² intensity, and continuous 2:1 mode.
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Main outcome variables
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Immediate pain relief, improved mobility, and long-term nerve regeneration, reducing inflammation and promoting muscle and sensory recovery.
General information
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Reason for update
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Data missing
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20241220064105N2
Registration date:
2025-01-17, 1403/10/28
Registration timing:
prospective
Last update:
2025-02-21, 1403/12/03
Update count:
1
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Registration date
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2025-01-17, 1403/10/28
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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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2025-01-25, 1403/11/06
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Expected recruitment end date
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2025-04-25, 1404/02/05
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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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Formulation and evaluation of methylcobalamin gel with and without Phonophoresis and mulligan traction & mobilization in Cervical Radiculopathy
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Public title
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methylcobalamin gel with and without Phonophoresis and mulligan traction & mobilization in Cervical Radiculopathy
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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
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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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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2024-12-20, 1403/09/30
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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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4-week
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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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4-weeks
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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: will be treated with Mulligan traction and mobilization with methylcobalamin via phonophoresis. Manual traction will be given for 10 minutes with a pull for 10 sec and rest will be 5 sec. The duration of three treatment sessions (10-20 minutes) per week for 4-weeks, consisting of 12 treatment sessions in total. Methylcobalamin with Phonophoresis is commonly used with a frequency of about 0.8 MHz, intensity 1.5 W/cm2, and continuous mode 2:1. Methylcobalamin with phonophoresis will be applied for a 4-weeks period, 3 times per week and each session lasted for about5-7 minutes
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Category
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Rehabilitation
2
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Description
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Control group: will be treated with Mulligan traction and mobilization, Mulligan Manual traction will be given for 10 minutes with a pull for 10 sec and rest will be 5 sec. The duration of three treatment sessions ( 10-20 minutes) per week for four weeks, consisting of 12 treatment sessions in total. Mulligan SMWAM will be given to only patients by maintaining transverse glide with 10 repetitions in the first session increasing to 30 repetitions with the sets of 3 in further sessions. Subjects will be given Mulligan mobilizations (SNAGs). The duration of three treatment sessions ( 10-20 minutes) per week for four weeks, consisting of 12 treatment sessions in total.
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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/2/6/Iqra
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Is the source of funding the same sponsor organization/entity?
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Yes
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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