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

Not Applicable

Recruiting

• Conditions: Cervical Radiculopathy
• Interventions: Other: Laser guided proprioceptive exercises; Other: Routine Physical therapy

• Registration Number: NCT06397196
• Lead Sponsor: Riphah International University

Brief Summary

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.

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 Timeline

• Study Start: 2023-12-10
• Study First Submitted: 2024-04-29
• Study First Submitted QC: 2024-05-01
• Study First Posted: 2024-05-02
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-11
• Last Update Posted: 2024-06-13
• Primary Completion: 2024-06-30
• Study Completion: 2024-07-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 52

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)

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser Guided Proprioceptive Exercises + Routine therapy	Routine Physical 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
Laser Guided Proprioceptive Exercises + Routine therapy	Laser guided proprioceptive exercises	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
Routine Therapy	Routine Physical 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.

Primary Outcome Measures

Name	Time	Method
Numeric Pain Rating Scale.	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.
Neck Disability index	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.
Cervical Joint position sense error	3 weeks	To measure the joint position sense error.
Bubble In-clinometer	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.

Trial Locations

Locations (1)

Islam Central Hospital.; 🇵🇰 Sialkot, Punjab, Pakistan