Role of Nerve Mobilizations in Decreasing Pain and Disability Among Patients With Cervical Radiculopathy

Role of Nerve Mobilizations in Decreasing Pain and Disability Among Patients With Cervical Radiculopathy: A Randomized Controlled Trial

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.

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Study Overview

• Status: Completed
• Conditions: Cervical Radiculopathy
• Intervention / Treatment: Other: Nerve mobilization; Other: Conventional physical therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54000
      • University Physical Therapy and Rehabilitation Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A/ Nerve mobilization group; 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.	Other: Nerve mobilization; 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.
Active Comparator: Group B/ Conventional physical therapy group; In this group, patients will receive routine physical therapy and also given home plan for cervical isometric exercises	Other: Conventional physical therapy; 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.; Other Names: Routine physical therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and at 4th week
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.	Baseline and at 4th week
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.	Baseline and at 4th week

Collaborators and Investigators

• Sponsor: University of Lahore
• Investigators: Principal Investigator: Momna Asghar, MSPTN, University of Lahore; Study Chair: Muhammad Haider Ullah Khan, MSPTN, University of Lahore

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): August 13, 2021
• Study Completion (Actual): August 16, 2021

Study Registration Dates

• First Submitted: April 8, 2021
• First Submitted That Met QC Criteria: May 17, 2021
• First Posted (Actual): May 21, 2021

Study Record Updates

• Last Update Posted (Actual): November 30, 2021
• Last Update Submitted That Met QC Criteria: November 17, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: pain; disability; cervical radiculopathy; neuromobilization
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Radiculopathy
• Other Study ID Numbers: IRB-UOL-FAHS/719-VI/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No