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NCT Number: NCT04896749

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

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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Key information

Conditions

Cervical Radiculopathy Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Radiculopathy Signs and Symptoms

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Physical Therapy and Rehabilitation Clinic

Lahore, Punjab Province, 54000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nerve mobilization

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.

Conventional physical therapy

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.

Other names: Routine physical therapy

Primary outcomes

  1. Upper extremity functional index (assessing change in ability to do activities with upper limb at baseline and at 4th week of treatment)

    Time frame: Baseline and at 4th week

    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.

  2. Numeric pain rating scale (to assess change in pain at between baseline and at 4th week of treatment)

    Time frame: Baseline and at 4th week

    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.

  3. Neck Disability Index scale (to assess the change in disability due to neck pain at baseline and at 4th week of treatment)

    Time frame: Baseline and at 4th week

    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.

Sponsors and collaborators

Lead sponsor

University of Lahore

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 21, 2021
Registry last updated
Nov 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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