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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05191537
Other study ID # REC/Lhr/21/0127 Maryam
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2021
Est. completion date April 10, 2022

Study information

Verified date November 2022
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Data will be collected in Hussain Memorial Hospital by taking informed consent. Randomised clinical trial is conducted taking thirty patients of both genders with confirmed diagnoses of cervical radiculopathy, their ages ranged from 25 to 60. A cluster of winner to rule out patient with cervical radiculopathy. They will be randomly assigned into two groups by the lottery method. Group A will receive conventional treatment and of spinal mobilization with arm movement (intervention 1) Group B will receive conventional treatment and positional SNAGs (intervention 2). The treatment will be conducted at a frequency of three sessions per week for four weeks. Two values will be taken, one as baseline and the other at end of the session. Then follow up the patient to rule out which intervention is more effective than the other. Neck Disability Index, Numeric Pain Rating Scale and ROM will be used to measure outcomes.


Description:

the objective of the study is To compare the effect of spinal mobilization with arm movement and positional SNAGs on pain and disability in cervical radiculopathy patients. The study design will be Randomized ClinicalTrial The sampling Technique will be Consecutive sampling technique Tool: The Neck Disability Index (NDI): used for measuring functional improvement in the neck. Numeric Pain Rating Scale (NPRS): used for measuring pain. Inclinometer: used for measuring Range of motion of cervical region. Data will be collected in Hussain Memorial Hospital by taking informed consent. Randomised clinical trial is conducted taking thirty patients of both genders with confirmed diagnoses of cervical radiculopathy, their ages ranged from 25 to 60. A cluster of winner criteria will be used to rule out patient with cervical radiculopathy. They will be randomly assigned into two groups by the lottery method. Group A will receive conventional treatment and of spinal mobilization with arm movement (intervention 1) Group B will receive conventional treatment and positional SNAGs (intervention 2). The treatment will be conducted at a frequency of three sessions per week for four weeks. Two values will be taken, one as baseline and the other at end of the session. Then follow up the patient to rule out which intervention is more effective than the other. Neck Disability Index, Numeric Pain Rating Scale and ROM will be used to measure outcomes.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date April 10, 2022
Est. primary completion date April 1, 2022
Accepts healthy volunteers No
Gender All
Age group 25 Years to 60 Years
Eligibility INCLUSION CRITERIA - Symptoms duration more than 6 months. - Age 25 -60 - The patient has confirm the diagnosis of Radiculopathy of cervical origin, - VAS more than 5 - A cluster of Wainner 3 positive out of 4 EXCLUSION CRITERIA - Malignancy - Infection (such as osteomyelitis or diskettes) - Osteoporosis - Inflammatory arthritis - Fracture - Pregnancy - Uncontrolled hypertension or cardiovascular disease - Carotid or vertebral artery disease. - Trauma cases

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Sustained Natural Apophyseal Glides
The patient sits well supported in a chair. The cervical spine and head are set in a neutral position. A painless passive posterior to anterior (PA) glide is applied in the plane of the facets on either the spinous process or the articular pillar/cervical lamina. While the glide is sustained the patient actively moves their neck in the direction that previously produced the symptoms. If symptom-free, the patient applies over-pressure further into the movement restriction. 3-6 repetitions are performed
shoulder Mobilization with arm movement
The patient is seated. The therapist contacts the length of the spinous process with the medial aspect of the thumb. A transverse glide is applied by the therapist's index finger against the thumb contacting the spinous process. The direction of the glide is to the contralateral side of the pain. While the mobilisation is sustained the patient moves their arm through a pain-free abduction range. 3-5 sets of 6-10 repetitions may be performed.

Locations

Country Name City State
Pakistan Hussain Memorial Hospital Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (4)

Anandkumar S. The effect of sustained natural apophyseal glide (SNAG) combined with neurodynamics in the management of a patient with cervical radiculopathy: a case report. Physiother Theory Pract. 2015 Feb;31(2):140-5. doi: 10.3109/09593985.2014.971922. Epub 2014 Oct 20. — View Citation

Hee HT, Castro FP Jr, Majd ME, Holt RT, Myers L. Anterior/posterior lumbar fusion versus transforaminal lumbar interbody fusion: analysis of complications and predictive factors. J Spinal Disord. 2001 Dec;14(6):533-40. doi: 10.1097/00002517-200112000-00013. — View Citation

Krivickas LS, Wilbourn AJ. Peripheral nerve injuries in athletes: a case series of over 200 injuries. Semin Neurol. 2000;20(2):225-32. Review. — View Citation

Shafique S, Ahmad S, Shakil-Ur-Rehman S. Effect of Mulligan spinal mobilization with arm movement along with neurodynamics and manual traction in cervical radiculopathy patients: A randomized controlled trial. J Pak Med Assoc. 2019 Nov;69(11):1601-1604. doi: 10.5455/JPMA.297956.. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Numeric Pain Rating Scale (NPRS) The numeric pain rating scale (NPRS) is a measurement scale that is used to measure a characteristic or attitude of pain. it is a 0-10 point scale. 0 mean no pain and 10 mean unbearable pain. Change from Baseline for pain Assessment at 4 weeks. 4 weeks.
Primary Neck Disability Index(NDI) NDI questionnaire has been designed to give us information as to how your neck pain has affected your ability to manage in everyday life. It had 10 sections with total 50 scores. The test can be interpreted as a raw score, with a maximum score of 50, or as a percentage. 0 points or 0% means : no activity limitations , 50 points or 100% means complete activity limitation. Change from Baseline for disability Assessment at 4 weeks. 4 weeks.
Primary Inclinometer for range of motion It's a range measuring tool used for the Range of Motion of neck flexion, extension and rotation. If the angle increases its mean improving. Change from Baseline for Range of Motion Assessment at 4 weeks. 4 weeks.
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