- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06866821
Spinal Mobilization and PNF Comparison on Pain, Disability in Patients With Cervical Radiculopathy
Comparison of Mulligan's Spinal Mobilization With Proprioceptive Neuromuscular Facilitation Technique on Pain, Disability and Range of Motion in Patients With Cervical Radiculopathy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Cervical radiculopathy is a clinical situation in which reflex, motor, and sensory alterations e.g. radicular pain, paresthesia, or numbness might be present and might be increased by neck bad postures and movements. Due to sustained forward head and neck posture and repetitive movements, cervical pain and numbness is becoming common in office, bank and online workers. The cervical radiculopathy new cases report yearly is almost 107.3 per 1 lac for men and 63.5 per 1 lac for women. It is essential to find new efficient methods of cervical radiculopathy physical therapy management.
Males and females of age 21-50 years old added in this study. Screening tests will include upper limb tension tests (ULTT), spurling (compression) test and distraction test. Subjects randomly assigned into two groups by lottery method. Experimental group (N=19) received Mulligan's spinal mobilization with arm movements (SMWAMs) and proprioceptive neuromuscular facilitation (PNF) contract-relax technique and control group (N=19) received Proprioceptive neuromuscular facilitation (PNF) contract-relax technique and standard physical therapy protocol including passive stretching exercises (3 sets of 10 repetitions) and isometric strengthening exercises (2 sets of 10 repetitions). Outcome measures included numeric pain rating scale (NPRS) for pain, neck disability index (NDI) for functional disability and goniometer for range of motion (ROM). Data analyzed by statistical package for social sciences (SPSS 26) software.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54000
- Riphah International University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Both males, females of 21 years to 50 years old
- Patients already diagnosed by orthopedicians
- Patients with positive screening (upper limb tension, spurling & distraction) tests
Exclusion Criteria:
- History of trauma, fracture and previous surgery
- Any pathological condition, spinal instability and tumor
- VBI (Vertebral-Basillar Insufficiency) and cervical instability/spondylolisthesis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group (SMWAM's and PNF C-R Technique)
Experimental group received Mulligan's Spinal Mobilization with Arm Movements and Proprioceptive Neuromuscular Facilitation contract-relax technique.
|
Treatment provided 3 days every week in 6 total weeks with 1 meeting per day, 3 bunches of 10 times repeat and resting period of one minute among bunches. This group received Mulligan's spinal mobilization with arm movement and proprioceptive neuromuscular facilitatin contract-relax technique. Previous to mobilization, all patients got hot pack (10 minutes) and active range of motion warm up exercises (2 sets of 10 repetitions) and did isometric neck exercise as a home plan of care. Mobilisation (22) was done depending on the side of involvement, the corresponding spinous process would be mobilised combined with different movements of shoulder (flexion/ abduction/ horizontal abduction/ horizontal adduction). Proprioceptive neuro-muscular facilitation contract relax technique performed with 3 repetitions in each cervical movement (flexion, extension, lateral flexion and rotation) (27). |
|
Experimental: Control Group (PNF C-R Technique and PT Protocol)
Control group received Proprioceptive Neuromuscular Facilitation Contract-relax Technique and Physical Therapy protocol.
|
Treatment provided 3 days every week in 6 weeks with 1 meeting per day, 5 clusters of 3 times repeat and resting period of one minute among clusters. Regime of training involved PNF (proprioceptive neuromuscular facilitation) contract-relax method along with the standard physical therapy protocol which includes passive stretching (3 sets of 10 repetitions) and isometric strengthening exercises (2 sets of 10 repetitions). Proprioceptive neuro-muscular facilitation contract relax technique performed with 3 repetitions in each cervical movement (flexion, extension, lateral flexion and rotation) (27). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain by Numeric Pain Rating Scale
Time Frame: 6 weeks
|
This was used for pain intensity assessment.
Patient rested on stool or chair and ordered to score resting pain extent in between 0 and 10 range; 0 means without pain and 10 means much high pain as possible in 10cm numbers line.
|
6 weeks
|
|
Neck level of disability by Neck Disability Index
Time Frame: 6 weeks
|
Neck disability Index was used for functional disability of neck assessment.
NDI is a 10-items questionnaire that assesses the effect of neck signs and symptoms on daily living functional activities.
Every item is marked from range 0 to 5, along with total score from 0 to 50 range and maximum scores means maximum disability.
NDI has reliability acceptable in the self-perceptual disability assessment and an MCID (minimal clinically important difference) of 8.5 points in cervical radiculopathy patients.
|
6 weeks
|
|
Cervical Range of Motion by Goniometer
Time Frame: 6 weeks
|
Goniometer was used for active cervical spine range of the motion (flexion, extension, rotation, side bending) assessment.
Side bending, rotation measured on the symptomatic and asymptomatic both sides.
|
6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Muhammad Azeem, Riphah International University
Publications and helpful links
General Publications
- Kamal AS, Zakaria HM, Elsamra MK, Gaballah MA, Elrewainy RM. EFFICACY OF PROPRIOCEPTIVE TRAINING PARADIGM ON CERVICAL RADICULOPATHY. Assessment. 2023;1000(2):12.
- Gashi AI, Kovačič T, Gashi F, Azemi A. The effect of proprioceptive neuromuscular facilitation technique on treating cervical radiculopathy. Journal of Physical Education and Sport. 2023;23(3):722-9.
- Taneja D, Saharan A, Ranjeeta W, Sharma M, Saharan M, Dubey S, et al. Effect of Mulligan's Smwam among Subjects with UnilateralCervical Radiculopathy. Eduzone: International Peer Reviewed/Refereed Multidisciplinary Journal. 2023;12(1):11-22.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Muhammad Azeem
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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