NCT05768438

Brief Summary

Cervical pain is one of the common problem among general population. However, cervical spondylosis may cause unavoidable neck pain and range limitations due to wear and tear changes in the cervical spine. This condition can further lead to dysfunction and neuro musculoskeletal symptoms. Literature suggests the use of Mulligan therapy, McKenzie exercises and Neural mobilizations in spondylosis. According to author's knowledge there is limited evidence regarding effects of specific treatment approach.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

December 5, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 14, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2024

Completed
Last Updated

March 14, 2023

Status Verified

March 1, 2023

Enrollment Period

1 year

First QC Date

February 17, 2023

Last Update Submit

March 13, 2023

Conditions

Keywords

Cervical spondylosisMcKenzieNPRSNDIMulligan with mobilizationUniversal goniometer

Outcome Measures

Primary Outcomes (1)

  • Change in pain intensity on Numerical Pain Rating Scale after four weeks.

    The Numerical Pain Rating Scale is a unidimensional measure of pain intensity, use to record patients' pain progression or compare pain severity between pains with similar condition. It is 0 to 10 number scale. Higher the score, severe will be the pain experienced.

    Baseline and 4 weeks.

Secondary Outcomes (2)

  • Change in functional disability assessed with Neck Disability Index after four weeks.

    Baseline and 4 weeks.

  • Change in range of motion assessed with universal goniometer after four weeks

    Baseline and 4 weeks.

Study Arms (2)

Mulligan with upper limb movement

EXPERIMENTAL

This study arm will receive following therapy .) Mulligan with upper limb movement.

Other: Mulligan with upper limb movement

Mckenzie exercises with neural mobilizations

EXPERIMENTAL

This study arm will receive following therapy .) McKenzie exercises with neural mobilizations

Other: McKenzie exercises with neural mobilizations

Interventions

Group A subjects will receive mulligan mobilizations with upper limb movement of the involved side. The patient will be in a sitting position and the therapist will stand beside the patient. The therapist will place one thumb overlapped by the other on one of the selected cervical and then the therapist will push down the spinous process of that specific vertebrae, the pressure will be sustained and the patient will actively abduct his/her arm, assistance will be provided if needed. Initially it will start from 10 repetitions and 1 set which will further progress up to 2 or 3 sets as per patient's tolerance with 60 seconds rest in between each set.

Mulligan with upper limb movement

The subjects of Group B will receive McKenzie exercises. Initially, it will start with retraction exercises. The frequency of exercises will be 10 to 15 repetitions followed by three to four sets with one second hold. On the second or third day, the cervical extension will be added. While in the second week the same set of exercises will be administered with the patient in a sitting position combined with application of over pressure at the end range by therapist. In the third week, extension and retraction exercises will be performed along with traction which will be applied by the therapist. Finally, in the fourth week all retraction and lateral flexion then neck rotation and the last one retraction with neck flexion will be added. Neural mobilizations will be given to patients in group B in supine lying. From proximal to distal, 20 oscillations (1 oscillation/ 1 second)

Mckenzie exercises with neural mobilizations

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years old adults.
  • Diagnosed and referred cases of cervical spondylosis and both males and females are included.
  • Unilateral radiculopathy pain C5-C8 and T1.
  • Individuals whose Spurling's and distraction test is positive.
  • Patients with NPRS \> 3/10 score.
  • Patients with ipsilateral cervical rotation less than 60 degrees.

You may not qualify if:

  • Individuals with history of;
  • cervical or shoulder girdle trauma.
  • any specific pathology or red flags (diplopia, dizziness, drop attacks, dysarthria, dysphagia)
  • cervical myelopathy
  • neoplastic lesions
  • vertebral artery insufficiency
  • upper cervical ligamentous instability,
  • spondylolisthesis
  • hypermobile cervical spine
  • cervical fracture inflammatory
  • cardiac or severe psychiatric disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hafsa Shehzadi

Karachi, Sindh, 74200, Pakistan

RECRUITING

MeSH Terms

Conditions

Spondylosis

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Hafsa Shehzadi, DPT

    DOW university

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hafsa Shehzadi, DPT

CONTACT

Saba A Ali, MSAPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 17, 2023

First Posted

March 14, 2023

Study Start

December 5, 2022

Primary Completion

December 5, 2023

Study Completion

January 5, 2024

Last Updated

March 14, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations