NCT06028958

Brief Summary

Cervical radiculopathy is a common neurological disorder that is caused by compression of the nerve, inflammation of nerve roots, or space-occupying lesions. Cervical radiculopathy is the most common health-related problem worldwide. The conservative approach like education, specific exercises, and spinal manipulation is usually given for chronic cases with good outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 8, 2023

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2023

Completed
Last Updated

March 28, 2025

Status Verified

August 1, 2023

Enrollment Period

3 months

First QC Date

August 31, 2023

Last Update Submit

March 27, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Pain Intensity

    Neck pain will be assessed utilizing the 10cm Visual Analogue Scale. The members will register their current pain level by selecting any from 0(no pain) to 10(unbearable pain) presented ahead a level line.

    Pain intensity will be measured at baseline, and change in pain intensity will be measured at 1st week, and 2nd week of treatment..

  • Level of Functional Disability

    The level of Functional disability will be measured by using the neck disability index. It contains 10 readings including pain intensity, personal care, headache, lifting, reading, concentration, work, driving sleeping, and recreation. The questions are measured on a 6-point scale from 0 (no disability) to 5 (full disability). The numeric response for each item is summed for a score varying from 0 to 50.

    Change in Functional Status will be measured at baseline, at first week, and at second week of treatment.

Study Arms (2)

Neck Isometrics Exercises

ACTIVE COMPARATOR

This group of participants will receive neck isometric exercises along with routine physical therapy and a hot pack. In this regimen, the patient is commanded to apply minimal resistance on the physiotherapist's hand in front, back, and lateral positions. This resistance is applied for 10 sec with a 15 sec hold with 10-15 repetitions. The protocol will be given to the participants for two weeks. Each session will be of 40 minutes.

Other: Neck Isometrics Exercises

Global Posture Re-Education

EXPERIMENTAL

This group of participants will receive the Global Posture Re-Education technique with a hot pack. The protocol will be given to the participants for two weeks (1 session on an alternative day with the home plan). Each session will be of 40 minutes.

Other: Global Posture Re-Education

Interventions

Isometric exercises are tightening (contractions) of a specific muscle or group of muscles. During isometric exercises, the muscle doesn't noticeably change length. The affected joint also doesn't move. Isometric exercises help maintain strength.

Neck Isometrics Exercises

Global postural rehabilitation (GPR) is an approach that considers the body in its overall aspect. This technique aims to relax the envelope of the muscles (fascia) while relaxing the muscle chains to reduce the strain on the joints. The end result is a more suitable posture and less pain.

Global Posture Re-Education

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • to 35 years.
  • Both genders, Males and females
  • One-sided upper limb pain or numbness
  • Any 2 out of 4 tests are positive Spurling test, Distraction test, Ipsilateral cervical traction test, and Upper Limb test

You may not qualify if:

  • Bilateral upper limb pain
  • Previous history of cervical surgery
  • Cervical spine
  • Injection therapy in the past 2 weeks
  • Being Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Lahore

Lahore, Punjab Province, 5400, Pakistan

Location

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Ashfaq Dr Ahmed, PhD

    University of Lahore

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome accessor will be unaware of the treatment group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2023

First Posted

September 8, 2023

Study Start

July 1, 2023

Primary Completion

October 1, 2023

Study Completion

October 15, 2023

Last Updated

March 28, 2025

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL
Time Frame
It will be shared soon after publication

Locations