NCT05749835

Brief Summary

Cervical radiculopathy is a pain and/or sensorimotor deficit syndrome that is defined as being caused by compression of a cervical nerve root. The compression can occur as a result of disc herniation, Spondylosis, instability, trauma, or rarely, tumors. Thoracic spine manipulation (TSM) is defined as a high-velocity/low amplitude movement or "thrust" directed at any segment of the thoracic spine. Recent research has shown that Thoracic Joint Manipulation directed to the thoracic spine provides a therapeutic benefit to patients with neck pain and has been suggested as an appropriate strategy to minimize the risks associated with manipulation of the cervical spine

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

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

February 1, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2023

Completed
Last Updated

October 12, 2023

Status Verified

October 1, 2023

Enrollment Period

1.4 years

First QC Date

February 20, 2023

Last Update Submit

October 11, 2023

Conditions

Keywords

painthoracic manipulationsustained natural epiphyseal glidesneck disability index

Outcome Measures

Primary Outcomes (3)

  • NPRS (Numeric Pain Rating Scale).

    The Numeric Pain Rating Scale (NPRS) measures the subjective intensity of pain. The NPRS is an eleven-point scale from 0 to 10. "0" = no pain and "10" = the most intense pain imaginable.

    four weeks

  • Inclinometer

    Inclinometers are portable, lightweight, and inexpensive pieces of equipment that are used to measure range of motion, like goniometry. Inclinometers are used as a part of a physical examination. An intraclass correlation coefficient (ICC) was found to be between 0.87-0.95.

    four weeks

  • (Neck Disability Index) Urdu

    the neck disability index is a ten-item self-reported Questionnaire that assesses pain and associated disability, with a total max score of 50 points. An Urdu version of neck disability index will be used in this study. The total scores (ICC = 0.99) of the Neck Disability Index -Urdu.

    four weeks

Study Arms (2)

Thoracic Manipulation and Sustained Natural Apophyseal Glides and conventional therapy

EXPERIMENTAL

After the segmental mobility examination of thoracic spine, the therapist will apply a high-velocity, end range screw thrust to a restricted segment of the thoracic spine as described by Maitland et al

Other: Thoracic Manipulation and Sustained Natural Apophyseal Glides and conventional therapy

Sustained Natural Apophyseal Glides and conventional therapy

EXPERIMENTAL

Position of therapist: stands beside the patient, while his\\her head is cradled between your body and your right forearm (when you stand at his\\her right side). Gentle pressure is now applied in a ventral direction on the spinous process of C7 while the skull remains still due to the control of your right forearm. (The really gentle moving force to do this comes from your left arm via the thenar eminence over the little finger on the spine of C7).

Other: Sustained Natural Apophyseal Glides and conventional therapy

Interventions

After the segmental mobility examination of thoracic spine, the therapist will apply a high-velocity, end range screw thrust to a restricted segment of the thoracic spine as described by Maitland.

Thoracic Manipulation and Sustained Natural Apophyseal Glides and conventional therapy

Position of therapist: stands beside the patient, while his\\her head is cradled between your body and your right forearm (when you stand at his\\her right side). Gentle pressure is now applied in a ventral direction on the spinous process of C7 while the skull remains still due to the control of your right forearm. (The really gentle moving force to do this comes from your left arm via the thenar eminence over the little finger on the spine of C7).

Sustained Natural Apophyseal Glides and conventional therapy

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients complaint from pain in the cervical spine and pain or paresthesia traveling from the neck into a specific region of the arm, forearm or hand
  • Cervical Lateral flexion and rotation \<60 degree
  • Positive scores on 3 of 4 clinical tests: Spurling's test, upper-limb neurodynamic test/median nerve bias, cervical distraction test, and cervical rotation toward the symptomatic side of less than 60°
  • Hypomobility at T1- T5 thoracic vertebrae on springing test.

You may not qualify if:

  • Participants with a history of vertebro-basilary artery insufficiency.
  • Patient with history of cervical surgery or arthroplasty
  • Patients with a positive history of trauma, fracture or surgery of the cervical
  • spine
  • Diagnosed cases of Torticollis, and scoliosis
  • History of osteoporosis, Any heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Physiotherapy clinic Saidpur Road

Rawalpindi, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

RadiculopathyPain

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • maria Khalid, MSOMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2023

First Posted

March 1, 2023

Study Start

February 1, 2022

Primary Completion

July 10, 2023

Study Completion

July 10, 2023

Last Updated

October 12, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations