- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07426614
McKenzie Exercises Along With Neurodynamic Mobilization Exercises in Patients With Cervical Radiculopathy
Effects of McKenzie Exercises Along With Neurodynamic Mobilization Exercises on Pain, Range of Motion and Functional Disability in Patients With Cervical Radiculopathy
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 540000
- Sehat Medical Complex
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age limit 35-50 Years.
- Both male and female participants.
- Median nerve related symptoms.
- Participants presenting with unilateral C5-C7 cervical radiculopathy associated with a posterolateral cervical disc bulge were included in the study.
- Ipsilateral neck rotation, Spurling's test, median nerve neurodynamic testing, and ULNTT were considered positive if they reproduced unilateral C5-C7 radicular arm pain and negative if they did not.
- Pain reported as greater than 4-9/10 on the NPRS, persisting for more than 3 months.
- Neck Disability Index score 20-80.
- Participants demonstrating moderate restriction in cervical range of motion, defined as flexion <40°, extension <50°, lateral flexion <35°, and rotation <70°, were included.
Exclusion Criteria:
- A cervical spine fracture.
- Spondylolisthesis, subluxation, and cervical instability
- Radicular symptoms in both upper extremities.
- TB, cancer, heart illness, osteoporosis.
- Prolapsed intervertebral disc, neurological problems, any trauma or localized infection in the neck area.
- Upper motor neuron disease, cervical stenosis, and bone and joint metabolic diseases.
- Hyperelasticity and Thoracic outlet syndrome
- Hyper lordotic if exceeds than normal angle
- Psychiatric conditions including sadness and phobia/obsession.
- Individuals who have had cervical spine surgery within a year.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Neurodynamic Mobilization exercises with Standardized Physiotherapy treatment
|
The neural mobilization approach used in this group involved moving the median nerve for ten repetitions, each held for three seconds.
Hot pack for 10 minutes. TENS for 10 minutes. Cervical traction for 15 minutes 7% of body weight with 4 seconds hold to progression to 7 seconds hold and 5 second rest. Superficial neck muscles (upper trapezius, Levator scapulae, Pect. Major) stretching for 3 times with 30 seconds hold and Neck isometrics 10 times with 6 seconds hold . |
|
Experimental: McKenzie exercises along with Neurodynamic Mobilization exercises with Standardi
|
The neural mobilization approach used in this group involved moving the median nerve for ten repetitions, each held for three seconds.
Hot pack for 10 minutes. TENS for 10 minutes. Cervical traction for 15 minutes 7% of body weight with 4 seconds hold to progression to 7 seconds hold and 5 second rest. Superficial neck muscles (upper trapezius, Levator scapulae, Pect. Major) stretching for 3 times with 30 seconds hold and Neck isometrics 10 times with 6 seconds hold . First Week: The patient is lying supine with their head retracted or their chin tucked. For a little flexion, place a little pillow beneath the occiput. Patient pulls head and neck posteriorly, maintaining end position for 1 second, then relaxes. Second Week: Patient in sitting position. Progression with neck extension and chin tuck. Therapist applies overpressure at end of motion. Third Week: Patient in supine, head extended beyond couch edge. Therapist performs retraction and extension exercises with traction, maintaining traction through full range of motion. Fourth Week: Patient in sitting. Progression with combined movements: retraction with lateral flexion, neck rotation, and final combination of retraction and neck flexion with overpressure. 3-4 sets and 10-15 repititions. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neck Disability Index
Time Frame: From enrollment to the end of treatment at 4 weeks
|
The Neck Disability Index (NDI) is a self-administered tool that is employed to evaluate the functional impairment in people with neck pains.
The instrument consists of ten questions which refer to daily activities; every question will be rated out of 0-5 scale, and finally there will be a total mark out of 0 -50.
High scores indicate an increased amount of disability hence making NDI useful in assessing the impact of neck discomfort on the quality of life of patients and guide therapeutic decision making.
When used in measuring functional disability in cervical radiculopathy, the NDI demonstrates strong levels of reliability.
The psychometric integrity of the instrument is also supported by internal consistency where a Cronbach alpha of between approximately 0.80 and 0.90 is shown.
0-4: Minimal Disability, 5-14: Mild Disability, 15-24: Moderate Disability, 25-34: Severe Disability, 35-50: Complete Disability
|
From enrollment to the end of treatment at 4 weeks
|
|
Numeric Pain Rating Scale
Time Frame: From enrollment to the end of treatment at 4 weeks
|
The Numerical Pain Rating Scale (NPRS) is used to assess a patient's level of pain, ranging from 0 to 10, whereas 0 denotes "no pain" and 10 represents the "worst imaginable pain."
It is widely used tool in both clinical and research settings.
The National Pain Research Scale (NPRS) has good test-retest reliability as revealed by the correlation coefficients of 0.95 to 0.96 and thus validates the reliability and consistency of the pain intensity measures.
|
From enrollment to the end of treatment at 4 weeks
|
|
ROM Cervical Spine (Flexion)
Time Frame: From enrollment to the end of treatment at 4 weeks
|
Changes in cervical spine flexion ROM at baseline and 4th week of intervention was measured using goniometer
|
From enrollment to the end of treatment at 4 weeks
|
|
ROM Cervical Spine (Extension)
Time Frame: From enrollment to the end of treatment at 4 weeks.
|
Changes in cervical spine flexion ROM at baseline and 4th week of intervention was measured using goniometer.
|
From enrollment to the end of treatment at 4 weeks.
|
|
ROM Cervical Spine (Lateral Flexion)
Time Frame: From enrollment to the end of treatment at 4 weeks
|
Changes in cervical spine flexion ROM at baseline and 4th week of intervention was measured using goniometer.
|
From enrollment to the end of treatment at 4 weeks
|
|
ROM Cervical Spine (Rotations)
Time Frame: From enrollment to the end of treatment at 4 weeks
|
Changes in cervical spine flexion ROM at baseline and 4th week of intervention was measured using goniometer.
|
From enrollment to the end of treatment at 4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Naila Kanwal, Riphah International University
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/24/0178
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cervical Radiculopathy
-
Zonguldak Bulent Ecevit UniversityNot yet recruitingCervical Radiculopathy | Cervical Radiculopathy at C5 Nerve Root | Cervical Radiculopathy at C6 Nerve Root | Cervical Radiculopathy at C7 Nerve RootTurkey (Türkiye)
-
Elite College of Management Sciences, Gujranwala...CompletedCervical Radiculopathy | Cervical Radicular PainPakistan
-
Riphah International UniversityCompletedCervical Radiculopathy | CervicalPakistan
-
Guang'anmen Hospital of China Academy of Chinese...Not yet recruitingCervical Spondylotic Radiculopathy
-
Marmara UniversityRecruitingCervical Radiculopathy | Cervical Radicular Pain | ProprioceptionTurkey (Türkiye)
-
Cairo UniversityCompletedCervical Radiculopathy | Disc Herniation | Cervical Radiculopathy at C5 Nerve Root | Cervical Radiculopathy at C6 Nerve Root | Cervical Radiculopathy at C7 Nerve RootEgypt
-
William Beaumont HospitalsCamber Spine TechnologiesTerminatedCervical Radiculopathy | Cervical Disc DiseaseUnited States
-
Gazi UniversityRecruitingCervical Radiculopathy | Cervical Radicular Pain | Cervical Radiculitis | Cervical Root SyndromeTurkey
-
Delta University for Science and TechnologyNot yet recruiting
-
Shin Kong Wu Ho-Su Memorial HospitalRecruitingCervical RadiculopathyTaiwan
Clinical Trials on Neural Mobilization exercises:
-
Riphah International UniversityCompletedDiabetic Peripheral Neuropathic PainPakistan
-
Aveiro UniversityActive, not recruitingChronic Musculoskeletal PainPortugal
-
University of Gran RosarioNot yet recruiting
-
Mohammed Al-GhamdiCompleted
-
Riphah International UniversityCompleted
-
Dow University of Health SciencesRecruiting
-
Cairo UniversityCompleted
-
Isra UniversityUnknown
-
Istinye UniversityNot yet recruitingLow Back Pain | Leg Pain and/or Back Pain