Clinical trial NCT06397196: Effects of Laser Guided Cervical Proprioceptive Exercises in Patients With Cervical Radiculopathy
Official title: Effects of Laser Guided Cervical Proprioceptive Exercises on Pain, Range of Motion, Cervical Position Sense and Functional Disability in Patients With Cervical Radiculopathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Radiculopathy
Keywords: Cervical Range of motion
Joint Sense Position
Neck Pain
Cervical Proprioception
Neck Disability
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-05-02
Enrollment: 52
Sex: ALL
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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).

Primary outcomes:
measure: Numeric Pain Rating Scale.
timeFrame: 3 weeks
measure: Bubble In-clinometer
timeFrame: 3 weeks
measure: Neck Disability index
timeFrame: 3 weeks
measure: Cervical Joint position sense error
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sialkot
country: Pakistan
facility: Islam Central Hospital.
state: Punjab
Study officials:
affiliation: Riphah Intenational University
name: Sabiha Arshad, M.phill
role: PRINCIPAL_INVESTIGATOR
References:
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