NCT05173636

Brief Summary

In the scientific literature, cervicobrachial pain is the presence of pain in the neck that radiates or refers to the arm. It is considered as common spine disorder with upper quadrant pain due to muscles, joints or intervertebral discs. This study aims to compare the effects of direct neural tissue technique that is cervical lateral glide mobilization along with indirect neural tissue mobilization technique that is thoracic mobilization on pain, range of motion, endurance of neck flexors and functional ability in patients with cervicobrachial pain.

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 Jun 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 30, 2021

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2022

Completed
Last Updated

February 2, 2022

Status Verified

February 1, 2022

Enrollment Period

7 months

First QC Date

December 13, 2021

Last Update Submit

February 1, 2022

Conditions

Keywords

PainRange of motionCervicobrachial painCervical lateral glideThoracic mobilization

Outcome Measures

Primary Outcomes (12)

  • Numeric pain rating scale for pain

    Numeric pain rating scale is used to capture the patient's level of pain. Patients will be asked to indicate the intensity of current, best, and worst levels of pain over the past 24 hours using an 11-point scale, ranging from 0 (no pain) to 10 (worst pain imaginable). This scale exhibit fair to moderate test-retest reliability and show adequate responsiveness in patients with neck pain. Assessment to be done at base line

    at base line

  • Numeric pain rating scale for pain

    Numeric pain rating scale is used to capture the patient's level of pain. Patients will be asked to indicate the intensity of current, best, and worst levels of pain over the past 24 hours using an 11-point scale, ranging from 0 (no pain) to 10 (worst pain imaginable). This scale exhibit fair to moderate test-retest reliability and show adequate responsiveness in patients with neck pain. Assessment to be done at 2nd week.

    at 2nd week

  • Numeric pain rating scale for pain

    Numeric pain rating scale is used to capture the patient's level of pain. Patients will be asked to indicate the intensity of current, best, and worst levels of pain over the past 24 hours using an 11-point scale, ranging from 0 (no pain) to 10 (worst pain imaginable). This scale exhibit fair to moderate test-retest reliability and show adequate responsiveness in patients with neck pain. Assessment to be done at 4th week.

    at 4th week

  • Northwick Park neck pain questionnaire (for physical function)

    Function will be measured by the Northwick Park Neck Pain Questionnaire that is divided into nine-five parts sections. The questionnaire is easy for patients to complete, simple to score and provides an objective measure to evaluate outcome in patients with acute or chronic neck pain. This questionnaire has been demonstrated to have short-term repeatability and long-term sensitivity to change. Assessment to be done at baseline.

    at baseline

  • Northwick Park neck pain questionnaire (for physical function)

    Function will be measured by the Northwick Park Neck Pain Questionnaire that is divided into nine-five parts sections. The questionnaire is easy for patients to complete, simple to score and provides an objective measure to evaluate outcome in patients with acute or chronic neck pain. This questionnaire has been demonstrated to have short-term repeatability and long-term sensitivity to change. Assessment to be done at 2nd week.

    at 2nd week

  • Northwick Park neck pain questionnaire (for physical function)

    Function will be measured by the Northwick Park Neck Pain Questionnaire that is divided into nine-five parts sections. The questionnaire is easy for patients to complete, simple to score and provides an objective measure to evaluate outcome in patients with acute or chronic neck pain. This questionnaire has been demonstrated to have short-term repeatability and long-term sensitivity to change. Assessment to be done at 4th week

    at 4th week

  • Cervical range of motion by Goniometer

    cervical range of motion will be measured by using universal goniometer. It is a reliable tool for assessing cervical range of motion in a clinical setting and is cheap. Assessment to be done at baseline.

    at baseline

  • Cervical range of motion by Goniometer

    cervical range of motion will be measured by using universal goniometer. It is a reliable tool for assessing cervical range of motion in a clinical setting and is cheap. Assessment to be done at 2nd week.

    at 2nd week

  • Cervical range of motion by Goniometer

    cervical range of motion will be measured by using universal goniometer. It is a reliable tool for assessing cervical range of motion in a clinical setting and is cheap. Assessment to be done at 4th week.

    at 4th week

  • Deep neck flexor endurance test

    Neck flexor endurance will be measured with deep neck flexor endurance test(Rectus Capitus Anterior, Rectus Capitus Lateralis, Longus Capitus, Longus Colli). It will be performed in a supine lying position by tucking patients chin in and lifting off table 1 inch. The examiner will look for substitution of the platysma or sterno-cleido mastoid muscle. The flexor endurance test showed good intertester and intratester reliability when two values were averaged and, thus, may represent a useful clinical tool for practitioners involved in treating and preventing neck pain. Assessment to be done at baseline.

    at baseline

  • Deep neck flexor endurance test

    Neck flexor endurance will be measured with deep neck flexor endurance test(Rectus Capitus Anterior, Rectus Capitus Lateralis, Longus Capitus, Longus Colli). It will be performed in a supine lying position by tucking patients chin in and lifting off table 1 inch. The examiner will look for substitution of the platysma or sterno-cleido mastoid muscle. The flexor endurance test showed good intertester and intratester reliability when two values were averaged and, thus, may represent a useful clinical tool for practitioners involved in treating and preventing neck pain. Assessment to be done at 2nd week.

    at 2nd week

  • Deep neck flexor endurance test

    Neck flexor endurance will be measured with deep neck flexor endurance test(Rectus Capitus Anterior, Rectus Capitus Lateralis, Longus Capitus, Longus Colli). It will be performed in a supine lying position by tucking patients chin in and lifting off table 1 inch. The examiner will look for substitution of the platysma or sterno-cleido mastoid muscle. The flexor endurance test showed good intertester and intratester reliability when two values were averaged and, thus, may represent a useful clinical tool for practitioners involved in treating and preventing neck pain. Assessment to be done at 4th week.

    at 4th week

Study Arms (2)

cervical lateral glide

EXPERIMENTAL

A cervical segmental contralateral lateral glide treatment technique is performed at 1 or more motion segments of the cervical spine (C5-T1), including the level(s) of the segmental motion restriction. With the patient in a supine position, the therapist cradled the head and neck above, and including, the level to be treated and performed a lateral translatory movement away from the involved side while minimizing gross cervical side flexion or rotation.

Other: cervical lateral glideOther: thoracic mobilization technique

thoracic mobilization

EXPERIMENTAL

A posteroanterior unilateral pressure will be applied over the transverse processes at T2-T5 on the ipsilateral side of pain in prone position.

Other: cervical lateral glideOther: thoracic mobilization technique

Interventions

A cervical segmental contralateral lateral glide treatment technique is performed at 1 or more motion segments of the cervical spine (C5-T1), including the level(s) of the segmental motion restriction. With the patient in a supine position, the therapist cradled the head and neck above, and including, the level to be treated and performed a lateral translatory movement away from the involved side while minimizing gross cervical side flexion or rotation.

cervical lateral glidethoracic mobilization

Participants in group B will be given cervical lateral glide along with thoracic mobilization technique in prone position.

cervical lateral glidethoracic mobilization

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Pain in upper quadrant associated with cervical spine eliciting unilateral neck pain.
  • Paresthesia and numbness in the neck and arm for at least three continuous months
  • Active movements of cervical spine (extension, lateral flexion to either side or ipsilateral rotations) and arm movements reproducing pain.
  • Symptom reproduction on passive movements in the same pattern as with active movements.
  • Elicitation of adverse response (in terms of range of movement and reproduction of symptoms) to neural tissue provocation testing of median, ulnar and radial nerves and subsequent symptom alteration with neural tissue differentiating maneuvers.
  • Tenderness at transverse processes of cervical spine (nerve roots), nerve trunks of median, ulnar and radial nerves at different anatomical locations in the course of respective neural tissue.
  • Hyperalgesic related cutaneous tissues on palpation (tender points).
  • Evidence of a related pathology (example: radiological evidence of cervical disc pathology in the vicinity of involved nerve roots or evidence of stenosis at cervical neural foramen as diagnosed by a qualified musculoskeletal Radiologist)
  • provoked or spontaneous paresthesia and pain with radicular distribution
  • Positive results in the following tests: Spurling, Distraction, and Upper Limb tension test.
  • Diagnosis will be based upon subjective presentation of patient's pain pattern which includes somatic referred pain and neurogenic radiating symptoms.

You may not qualify if:

  • Bilateral symptoms (due to unilateral nature of lateral glide mobilization technique).
  • History of spinal surgery
  • Systemic diseases besides neck pain.
  • Vertebral infections.
  • Presented red flags.
  • Used analgesics within 48 hours before initial assessment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benazir Bhutto Hospital

Rawalpindi, Punjab Province, 43600, Pakistan

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • maria khalid, MS OMPT

    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

December 13, 2021

First Posted

December 30, 2021

Study Start

June 30, 2021

Primary Completion

January 20, 2022

Study Completion

January 20, 2022

Last Updated

February 2, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations