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

Cervical Radiculopathy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06397196
• Other study ID #: REC/RCR&AHS/23/02105
• Status: Recruiting
• Phase: N/A
• Start date: December 10, 2023
• Est. completion date: July 10, 2024

Study information

• Verified date: June 2024
• Source: Riphah International University
• Contact: Iqbal Tariq, PhD
• Phone: 03458236752
• Email: iqbal.tariq[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: July 10, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 55 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cervical Radiculopathy
• Radiculopathy

Intervention

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
• 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

Locations

Country	Name	City	State
Pakistan	Islam Central Hospital.	Sialkot	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (6)

Borrella-Andres S, Marques-Garcia I, Lucha-Lopez MO, Fanlo-Mazas P, Hernandez-Secorun M, Perez-Bellmunt A, Tricas-Moreno JM, Hidalgo-Garcia C. Manual Therapy as a Management of Cervical Radiculopathy: A Systematic Review. Biomed Res Int. 2021 Jun 3;2021:9936981. doi: 10.1155/2021/9936981. eCollection 2021. — View Citation

Maharaj RG, Motilal S, Khan R, Rampersad F. A No-Cost, Bedside, Self-Traction Maneuver for Relief From Chronic Cervical Radiculopathy: A Case Report. Cureus. 2023 Aug 23;15(8):e43963. doi: 10.7759/cureus.43963. eCollection 2023 Aug. — View Citation

Manchikanti L, Knezevic NN, Navani A, Christo PJ, Limerick G, Calodney AK, Grider J, Harned ME, Cintron L, Gharibo CG, Shah S, Nampiaparampil DE, Candido KD, Soin A, Kaye AD, Kosanovic R, Magee TR, Beall DP, Atluri S, Gupta M, Helm Ii S, Wargo BW, Diwan S, Aydin SM, Boswell MV, Haney BW, Albers SL, Latchaw R, Abd-Elsayed A, Conn A, Hansen H, Simopoulos TT, Swicegood JR, Bryce DA, Singh V, Abdi S, Bakshi S, Buenaventura RM, Cabaret JA, Jameson J, Jha S, Kaye AM, Pasupuleti R, Rajput K, Sanapati MR, Sehgal N, Trescot AM, Racz GB, Gupta S, Sharma ML, Grami V, Parr AT, Knezevic E, Datta S, Patel KG, Tracy DH, Cordner HJ, Snook LT, Benyamin RM, Hirsch JA. Epidural Interventions in the Management of Chronic Spinal Pain: American Society of Interventional Pain Physicians (ASIPP) Comprehensive Evidence-Based Guidelines. Pain Physician. 2021 Jan;24(S1):S27-S208. — View Citation

Mendes-Fernandes T, Puente-Gonzalez AS, Marquez-Vera MA, Vila-Cha C, Mendez-Sanchez R. Effects of Global Postural Reeducation versus Specific Therapeutic Neck Exercises on Pain, Disability, Postural Control, and Neuromuscular Efficiency in Women with Chronic Nonspecific Neck Pain: Study Protocol for a Randomized, Parallel, Clinical Trial. Int J Environ Res Public Health. 2021 Oct 12;18(20):10704. doi: 10.3390/ijerph182010704. — View Citation

Pennetti A. A multimodal physical therapy approach utilizing the Maitland concept in the management of a patient with cervical and lumbar radiculitis and Ehlers-Danlos syndrome-hypermobility type: A case report. Physiother Theory Pract. 2018 Jul;34(7):559-568. doi: 10.1080/09593985.2017.1422207. Epub 2018 Jan 8. — View Citation

Savva C, Korakakis V, Efstathiou M, Karagiannis C. Cervical traction combined with neural mobilization for patients with cervical radiculopathy: A randomized controlled trial. J Bodyw Mov Ther. 2021 Apr;26:279-289. doi: 10.1016/j.jbmt.2020.08.019. Epub 2020 Sep 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric Pain Rating Scale.	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
Primary	Bubble In-clinometer	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
Primary	Neck Disability index	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
Primary	Cervical Joint position sense error	To measure the joint position sense error.	3 weeks