NCT05191537

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

December 29, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 13, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2022

Completed
Last Updated

November 28, 2022

Status Verified

November 1, 2022

Enrollment Period

4 months

First QC Date

December 29, 2021

Last Update Submit

November 24, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

  • 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.

  • 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.

Study Arms (2)

spinal mobilization with arm movement

EXPERIMENTAL

conventional treatment and of spinal mobilization with arm movement

Other: shoulder Mobilization with arm movement

positional SNAGs

ACTIVE COMPARATOR

conventional treatment and positional SNAGs

Other: Sustained Natural Apophyseal Glides

Interventions

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

positional SNAGs

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.

spinal mobilization with arm movement

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Symptoms duration more than 6 months.
  • Age 25 -60
  • The patient has confirm the diagnosis of Radiculopathy of cervical origin,
  • VAS more than 5

You may not qualify if:

  • Malignancy
  • Infection (such as osteomyelitis or diskettes)
  • Osteoporosis
  • Inflammatory arthritis
  • Fracture
  • Pregnancy
  • Uncontrolled hypertension or cardiovascular disease
  • Carotid or vertebral artery disease.
  • Trauma cases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hussain Memorial Hospital

Lahore, Punjab Province, 54700, Pakistan

Location

Related Publications (4)

  • Krivickas LS, Wilbourn AJ. Peripheral nerve injuries in athletes: a case series of over 200 injuries. Semin Neurol. 2000;20(2):225-32. doi: 10.1055/s-2000-9832.

    PMID: 10946743BACKGROUND
  • 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.

    PMID: 11723406BACKGROUND
  • 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.

    PMID: 25329587BACKGROUND
  • 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..

    PMID: 31740863BACKGROUND

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • muhammad sanaullah, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2021

First Posted

January 13, 2022

Study Start

December 1, 2021

Primary Completion

April 1, 2022

Study Completion

April 10, 2022

Last Updated

November 28, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations