NCT04896749

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. .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 21, 2021

Completed
11 days until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2021

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2021

Completed
Last Updated

November 30, 2021

Status Verified

November 1, 2021

Enrollment Period

2 months

First QC Date

April 8, 2021

Last Update Submit

November 17, 2021

Conditions

Keywords

cervical radiculopathyneuromobilizationpaindisability

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

Group A/ Nerve mobilization group

EXPERIMENTAL

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

Group B/ Conventional physical therapy group

ACTIVE COMPARATOR

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

Other: Conventional physical therapy

Interventions

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 A/ Nerve mobilization group

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.

Also known as: Routine physical therapy
Group B/ Conventional physical therapy group

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with trauma of upper limb and cervical spine
  • Dizziness
  • Upper limb circulatory disturbance
  • Malignancy
  • Patients with bilateral symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Physical Therapy and Rehabilitation Clinic

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

RadiculopathyPain

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Momna Asghar, MSPTN

    University of Lahore

    PRINCIPAL INVESTIGATOR
  • Muhammad Haider Ullah Khan, MSPTN

    University of Lahore

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 8, 2021

First Posted

May 21, 2021

Study Start

June 1, 2021

Primary Completion

August 13, 2021

Study Completion

August 16, 2021

Last Updated

November 30, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will share

Information will be shared if needed for betterment and further clinical studies, however the patient's name and personal information will be kept hidden

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data will be available after the publication of the study for at least two years
Access Criteria
Data can be accessed by emailing the principal investigator

Locations