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

NCT ID: NCT06397196

Last Updated: 2024-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-10

Study Completion Date

2024-07-10

Brief Summary

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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

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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

Conditions

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Cervical Radiculopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Laser guided proprioceptive exercises

Intervention Type OTHER

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

Intervention Type OTHER

Participants will receive routine physical therapy on alternate days (3 days a week) for 3 weeks. Total number of sessions will be 9

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.

Group Type ACTIVE_COMPARATOR

Routine Physical therapy

Intervention Type OTHER

Participants will receive routine physical therapy on alternate days (3 days a week) for 3 weeks. Total number of sessions will be 9

Interventions

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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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

35 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sabiha Arshad, M.phill

Role: PRINCIPAL_INVESTIGATOR

Riphah Intenational University

Locations

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Islam Central Hospital.

Sialkot, Punjab Province, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Iqbal Tariq, PhD

Role: CONTACT

03458236752

Facility Contacts

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Sabiha Arshad, M.phill

Role: primary

03248495979

References

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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.

Reference Type BACKGROUND
PMID: 33492918 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34189141 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33992259 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37746470 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34682453 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29308941 (View on PubMed)

Other Identifiers

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REC/RCR&AHS/23/02105

Identifier Type: -

Identifier Source: org_study_id

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