Effects of Laser Guided Cervical Proprioceptive Exercises in Patients With Cervical Radiculopathy

June 11, 2024 updated by: Riphah International University

Effects of Laser Guided Cervical Proprioceptive Exercises on Pain, Range of Motion, Cervical Position Sense and Functional Disability in Patients With Cervical Radiculopathy

Cervical radiculopathy is a peripheral nervous system condition characterized by pathology of the cervical nerve root. Laser guided proprioceptive exercises shows positive impact in improving Joint sense error. The aim of this study is to investigate how proprioceptive exercises laser guided exercises, in addition to conventional exercises, affect cervical range of motion, pain, functional disability, and joint position sense error in patients with cervical radiculopathy. This randomized Controlled trial will be conducted at Islam central hospital, Sialkot. The sample size will consist of 52 participants. Participants who meet the inclusion criteria will be taken through a non-probability convenience sampling technique. 26 participants will be assigned to the group A and 26 participants to group B. Group A will receive laser guided exercises along with routine physical therapy whereas Group B will only receive routine physical therapy. All participants will receive a 50-minute session daily, 3 times a week for 3 weeks. Data will be collected using various assessment tools, Numeric pain rating scale will be use to assess the Pain, Bubble in-clinometer to assess Cervical range of motion, Laser tracker to assess Joint sense position error and Neck disability Index to assess functional disability. Pre-intervention assessment will be conducted before starting the treatment protocol and post assessment after 4 weeks of treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Cervical radiculopathy is a peripheral nervous system condition characterized by pathology of the cervical nerve root. Patients with cervical radiculopathy frequently appear with severe neck and arm pain as well as impaired functionality. Laser guided proprioceptive exercises shows positive impact in improving Joint sense error. The aim of this study is to investigate how proprioceptive exercises laser guided exercises, in addition to conventional exercises, affect cervical range of motion, pain, functional disability, and joint position sense error in patients with cervical radiculopathy.

This randomized Controlled trial will be conducted at Islam Central Hospital, Sialkot. The sample size will consist of 52 participants. Participants who meet the inclusion criteria will be taken through a non-probability convenience sampling technique. Participants will be randomly allocated to two groups using lottery methods. 26 participants will be assigned to the group A and 26 participants to group B. Group A will receive laser guided exercises along with routine physical therapy whereas Group B will only receive routine physical therapy. All participants will receive a 50-minute session daily, 3 times a week for 3 weeks.

Data will be collected using various assessment tools, Numeric pain rating scale will be use to assess the Pain, Bubble in-clinometer to assess Cervical range of motion, Laser tracker to assess Joint sense position error and Neck disability Index to assess functional disability. Pre-intervention assessment will be conducted before starting the treatment protocol and post assessment after 4 weeks of treatment. Data analysis will be performed using IBM SPSS version 26. Statistical significance will be set at P ≤ 0.05.The normality of data will be assessed through the Shapiro-Wilk test. The independent t-test will be used for between-group analysis, while for within-group analysis, paired T-test will be used. The difference between pre-treatment and post-treatment readings will be calculated by paired sample t-test for parametric data, whereas for non-parametric data, the Wilcoxon test will be used.

Keywords: Cervical Radiculopathy, Cervical Proprioception, Cervical joint position sense, Cervical Range of motion, Joint sense error, Neck disability index

Study Type

Interventional

Enrollment (Estimated)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Punjab
      • Sialkot, Punjab, Pakistan, 51310
        • Recruiting
        • Islam Central Hospital.
        • Contact:
        • Sub-Investigator:
          • Mishal Gul, DPT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 35 to 55 years.
  • Both Genders.
  • Patients with positive Spurling test .
  • Patients with positive Distraction test .
  • Radicular Symptoms in Upper Extremity. (Pain, tingling or numbness in fingers and hand, weakness in arms, shoulders and hand)
  • Numeric pain rate scale 3 to 7 (moderate)

Exclusion Criteria:

  • Patients with cervical surgery.
  • Congenital anomalies involving the cervical spine.
  • Any neurological disease (e.g, cerebellar disorders, multiple sclerosis, Parkinson's disease, syringomyelia)
  • Specific cause of cervical pain with previous medical diagnosis (e.g., traumatic, rheumatic or systemic pathology)
  • Known or suspected vestibular pathology, dizziness, sensory nerve pathways or vascular disorders (e.g., migraine, hypertension)
  • Patients suffering from Vertigo , and Vertebro basilar insufficiency (VBI).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laser Guided Proprioceptive Exercises + Routine therapy
Participants in Group A will receive Laser guided Proprioceptive exercises with routine physical therapy on alternate days (3 days a week) for 3 weeks. total number of sessions will be 9
Other: Laser guided proprioceptive exercises
Participants will receive Laser guided Proprioceptive exercises on alternate days (3 days a week) for 3 weeks. Total number of sessions will be 9
Other: Routine Physical therapy
Participants will receive routine physical therapy on alternate days (3 days a week) for 3 weeks. Total number of sessions will be 9
Active Comparator: Routine Therapy
Participants in Group B will receive routine physical therapy on alternate days (3 days a week) for 3 weeks. Total number of sessions will be 9.
Other: Routine Physical therapy
Participants will receive routine physical therapy on alternate days (3 days a week) for 3 weeks. Total number of sessions will be 9

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Pain Rating Scale.
Time Frame: 3 weeks
A numerical pain rating scale (NPRS) will be used to gauge the severity of neck pain. This is an 11-point scale, where 0 is the least amount of pain (for example, "no pain") and 10 is the greatest amount of pain.
3 weeks
Bubble In-clinometer
Time Frame: 3 weeks
Cervical Range of motion will be measured using a Bubble In-clinometer. The CROM measurements were taken while flexion, extension, left and right side bending, and left and right rotation.
3 weeks
Cervical Joint position sense error
Time Frame: 3 weeks
To measure the joint position sense error.
3 weeks
Neck Disability index
Time Frame: 3 weeks

We will measure the neck disability associated with pain using the neck disability index. (NDI-PT), which is valid and reliable with excellent internal consistency.

it consists of 10 items scored out of 5. Maximum total Score = 50 A score of 0-4 is interpreted as no neck disability, 5-14 as mild, 15-24 as moderate, 25-34 as severe, and over 34 as complete neck disability.
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Sabiha Arshad, M.phill, Riphah Intenational University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2023

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

July 10, 2024

Study Registration Dates

First Submitted

April 29, 2024

First Submitted That Met QC Criteria

May 1, 2024

First Posted (Actual)

May 2, 2024

Study Record Updates

Last Update Posted (Actual)

June 13, 2024

Last Update Submitted That Met QC Criteria

June 11, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR&AHS/23/02105

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cervical Radiculopathy

Clinical Trials on Laser guided proprioceptive exercises

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mali

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe