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

NCT ID: NCT04896749

Last Updated: 2021-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2021-08-16

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.

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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.

Conditions

Cervical Radiculopathy

Keywords

cervical radiculopathy; neuromobilization; pain; disability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Nerve mobilization

Intervention Type: OTHER

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.

Group B/ Conventional physical therapy group

In this group, patients will receive routine physical therapy and also given home plan for cervical isometric exercises

Group Type: ACTIVE_COMPARATOR

Conventional physical therapy

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Routine physical therapy

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Lahore

OTHER

Sponsor Role: lead

Responsible Party

Momna Asghar

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Momna Asghar, MSPTN

Role: PRINCIPAL_INVESTIGATOR

University of Lahore

Muhammad Haider Ullah Khan, MSPTN

Role: STUDY_CHAIR

University of Lahore

Locations

University Physical Therapy and Rehabilitation Clinic

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

IRB-UOL-FAHS/719-VI/2020

Identifier Type: -

Identifier Source: org_study_id