Role of Nerve Mobilizations in Decreasing Pain and Disability Among Patients With Cervical Radiculopathy
Primary Purpose
Cervical Radiculopathy
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Nerve mobilization
Conventional physical therapy
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Radiculopathy focused on measuring cervical radiculopathy, neuromobilization, pain, disability
Eligibility Criteria
Inclusion Criteria:
- Male and female patients with age between 20 to 45 years
- Patients having pain for more than 4 months
- Patients having positive upper limb neurodynamic test
- Patient with positive spurling test.
Exclusion Criteria:
- Patients with trauma of upper limb and cervical spine
- Dizziness
- Upper limb circulatory disturbance
- Malignancy
- Patients with bilateral symptoms
Sites / Locations
- University Physical Therapy and Rehabilitation Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group A/ Nerve mobilization group
Group B/ Conventional physical therapy group
Arm Description
In this group, patients will receive nerve mobilization exercises along with routine physical therapy. Patients will also be given home plan for cervical isometric exercises.
In this group, patients will receive routine physical therapy and also given home plan for cervical isometric exercises
Outcomes
Primary Outcome Measures
Upper extremity functional index (assessing change in ability to do activities with upper limb at baseline and at 4th week of treatment)
It is a patient reported outcome measure used to assess the functional impairment in individuals with upper limb dysfunction. Total score is 80. Greater the score, better the condition of patients.
Numeric pain rating scale (to assess change in pain at between baseline and at 4th week of treatment)
Used for scoring pain level of individual. it is scored 0 to ten.Zero being the lowest pain level, 10 being worst pain level.The patient is asked to make three pain ratings, corresponding to the pain experienced over the past 24 hours.
The average of the 3 ratings was used to represent the patient's level of pain over the previous 24 hours.
Neck Disability Index scale (to assess the change in disability due to neck pain at baseline and at 4th week of treatment)
This scale is used for accessing how the neck pain is affecting the ability to manage everyday life activities.The NDI can be scored as a raw score or doubled and expressed as a percent. Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain'. Points of total 10 questions are summed to a total score.Greater score indicates greater disability.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04896749
Brief Title
Role of Nerve Mobilizations in Decreasing Pain and Disability Among Patients With Cervical Radiculopathy
Official Title
Role of Nerve Mobilizations in Decreasing Pain and Disability Among Patients With Cervical Radiculopathy: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
August 13, 2021 (Actual)
Study Completion Date
August 16, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lahore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Objective of the study is to find out the effectiveness of nerve mobilization in patients with cervical radiculopathy. It is a single blinded randomized controlled trial using non-probability convenient sampling. Data is collected from University Physical therapy and Rehabilitation Clinic, University of Lahore, Pakistan.
Alternate hypothesis: There is a significant role of nerve mobilizations in decreasing pain and disability among patients with cervical radiculopathy.
Null hypothesis: There is no significant role of nerve mobilizations in decreasing pain and disability among patients with cervical radiculopathy.
.
Detailed Description
It will be a prospectively registered, parallel designed, randomized controlled trial with concealed allocation, conducted in University Physical Therapy and Rehabilitation Clinic, Lahore, Pakistan. Patients who met the eligibility criteria will be informed about the aim of the study. All eligible participants who will agree to participate in the study signed the consent form. Eligibility of the participants will be determined by the two members of the research team before the randomization. After baseline assessment, eligible patients will be randomly assigned (in a 1:1 ratio) into two groups (Group A and Group B). Randomization will be done by one of the research team members using fish bowl method. Randomization assignments will be kept in opaque, sealed envelopes and unsealed by the researchers after baseline testing. Outcome assessor will be masked to group allocation and patients will be instructed not to talk about the content of their exercise program during the post intervention visit and could contact their therapists in case of any problems during trial participation. Help of female physiotherapist will be taken for the female patients. The sample size was calculated as 76 participants (38 per group), allowing statistical power of 80%, an alpha level of 5% and attrition rate of 20% having mean difference of 1.1 and SD of 1.48 and 1.63.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Radiculopathy
Keywords
cervical radiculopathy, neuromobilization, pain, disability
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A/ Nerve mobilization group
Arm Type
Experimental
Arm Description
In this group, patients will receive nerve mobilization exercises along with routine physical therapy. Patients will also be given home plan for cervical isometric exercises.
Arm Title
Group B/ Conventional physical therapy group
Arm Type
Active Comparator
Arm Description
In this group, patients will receive routine physical therapy and also given home plan for cervical isometric exercises
Intervention Type
Other
Intervention Name(s)
Nerve mobilization
Intervention Description
Moist pack all over cervical spine for 10 minutes. TENS for 10 minutes at frequency of 60 Hz with 2 electrodes. Cervical traction for 10 minutes with 7 sec hold and 5 sec rest time. Cervical isometric exercises with 7 sec hold and 30 repetitions in each direction twice a day.
Median, ulnar and radial nerve stretch with 3 sets of 10 repetitions , with 3 sec hold at final stretched position.
Following nerve mobilizations are used in experimental group/group A:
Median Nerve: Glenohumeral abduction, wrist extension, supination, glenohumeral lateral rotation, elbow extension, neck lateral bending to opposite side. Radial Nerve: Glenohumeral depression, elbow extension, whole arm internal rotation, wrist flexion Ulnar Nerve: Wrist extension, forearm pronation elbow flexion, glenohumeral lateral rotation, glenohumeral depression, shoulder abduction each with 3 sets of 10 repetitions , with 3 sec hold at final stretched position.
Intervention Type
Other
Intervention Name(s)
Conventional physical therapy
Other Intervention Name(s)
Routine physical therapy
Intervention Description
Moist pack for 10 minutes. TENS for 10 minutes at frequency of 60 Hz with 2 electrodes. Cervical traction for 10 minutes with 7 sec hold and 5 sec rest time. Cervical isometric exercises with 7 sec hold and 30 repetitions in each direction twice a day.
Primary Outcome Measure Information:
Title
Upper extremity functional index (assessing change in ability to do activities with upper limb at baseline and at 4th week of treatment)
Description
It is a patient reported outcome measure used to assess the functional impairment in individuals with upper limb dysfunction. Total score is 80. Greater the score, better the condition of patients.
Time Frame
Baseline and at 4th week
Title
Numeric pain rating scale (to assess change in pain at between baseline and at 4th week of treatment)
Description
Used for scoring pain level of individual. it is scored 0 to ten.Zero being the lowest pain level, 10 being worst pain level.The patient is asked to make three pain ratings, corresponding to the pain experienced over the past 24 hours.
The average of the 3 ratings was used to represent the patient's level of pain over the previous 24 hours.
Time Frame
Baseline and at 4th week
Title
Neck Disability Index scale (to assess the change in disability due to neck pain at baseline and at 4th week of treatment)
Description
This scale is used for accessing how the neck pain is affecting the ability to manage everyday life activities.The NDI can be scored as a raw score or doubled and expressed as a percent. Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain'. Points of total 10 questions are summed to a total score.Greater score indicates greater disability.
Time Frame
Baseline and at 4th week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female patients with age between 20 to 45 years
Patients having pain for more than 4 months
Patients having positive upper limb neurodynamic test
Patient with positive spurling test.
Exclusion Criteria:
Patients with trauma of upper limb and cervical spine
Dizziness
Upper limb circulatory disturbance
Malignancy
Patients with bilateral symptoms
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Momna Asghar, MSPTN
Organizational Affiliation
University of Lahore
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Muhammad Haider Ullah Khan, MSPTN
Organizational Affiliation
University of Lahore
Official's Role
Study Chair
Facility Information:
Facility Name
University Physical Therapy and Rehabilitation Clinic
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Information will be shared if needed for betterment and further clinical studies, however the patient's name and personal information will be kept hidden
IPD Sharing Time Frame
Data will be available after the publication of the study for at least two years
IPD Sharing Access Criteria
Data can be accessed by emailing the principal investigator
Learn more about this trial
Role of Nerve Mobilizations in Decreasing Pain and Disability Among Patients With Cervical Radiculopathy
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