- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03652831
Effect of Soft Tissue Mobilization With and Without Neural Mobilization in Cervical Radiculopathy
Study Overview
Status
Conditions
Detailed Description
soft tissue mobilization and neural mobilization both treatments are used to treat cervical radiculopathy but they work differently.
Soft tissue mobilization include traction which decompresses the nerve and stretches the surrounding muscles along with help to reduce pain and tingling sensation. whereas hot pack helps to increase blood circulation and warm up muscles and isometric exercises provide strengthening and build endurance.
Neural mobilization technique is different for all 3 nerves i.e Radial, ulnar and median. neural mobilization technique target the single nerve which is being compressed and showing symptoms.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with age 18 to 55years
- Patients having pain more than 3months
- Radiating pain in one of the upper limb
- Spurling's test positive
Exclusion Criteria:
- Traumatic injury of upper limb or cervical spine
- Vertebral artery test positive(dizziness, vomiting, diplopia, drop attacks etc)
- Patient asymptomatic for pain but symptomatic for tingling and paraesthesia
- Circulatory disturbance of upper extremity
- Known history of high level of spinal cord injury and malignancy
- Thoracic Outlet syndrome
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Soft Tissues mobilization with Neural mobilization
Soft Tissue Mobilization with Neural mobilization group will be assessed by spurling test and than will involved in treatment protocol i.e Cervical Traction, Hot packs, Post Isometric Relaxation Techniques and Neural mobilization Techniques which involve Median, Radial and Ulnar Nerve Mobilization. Frequency for neural mobilization is 3 sets of 10 repetitions for each and duration of 15minute. Participant will be scheduled to attend 12 treatment session (3 sessions every week for 4 weeks, 50mints each session) |
Cervical Traction for 15mints 7%of body weight with 7 second hold time and 5 second rest time.
Frequency for neural mobilization is 3 sets of 10 repetitions for each and duration of 15minute. Participant will be scheduled to attend 12 treatment session (3 sessions every week for 4 weeks, 50mints each session) |
|
Active Comparator: Soft Tissues mobilization without Neural mobilization
Soft Tissue Mobilization with Neural mobilization group will be assessed by spurling test and than will involved in treatment protocol i.e Cervical Traction, Hot packs, Post Isometric Relaxation Techniques. Participant will be scheduled to attend 12 treatment session (3 sessions every week for 4 weeks, 35mints each session) |
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity
Time Frame: 4weeks
|
Pain intensity in one of the upper limb is measured by Numeric pain scale in which "0" shows No pain while "10" shows worst pain.
|
4weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recurrence of pain and Neck disability
Time Frame: 4weeks
|
Neck disability index scale used to measure ability to manage neck pain in everyday life in terms of: Pain intensity, Personal care, Lifting, Reading, Headaches, and Concentration.
In which "0" shows disability and "5" shows normal.
|
4weeks
|
|
Neck Range of Motion
Time Frame: 4weeks
|
Range of motion of the cervical spine and upper extremity (any of the upper limb) measured by Goniometer.
Values deviated from standard values are considered as abnormal.
The DASH Outcome Measure is scored as: the disability/symptom section (30 items, scored 1-5) where "1" shows No difficulty and "5" shows maximal difficulty
|
4weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
- IIRS-IUISB/Mphil/002
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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