NCT03813680

Brief Summary

This study was conducted to determine the effectiveness of Passive Vertebral Mobilization (PVM) and Proprioceptive Neuromuscular Techniques (PNF) in reducing pain, disability and improving quality of life in patients with Mechanical Neck Pain.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

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

September 20, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 23, 2019

Completed
Last Updated

March 11, 2021

Status Verified

March 1, 2021

Enrollment Period

2 years

First QC Date

January 13, 2019

Last Update Submit

March 10, 2021

Conditions

Keywords

Mechanical Neck PainPassive Vertebral MobilizationProprioceptive Neuromuscular Techniques (PNF)Quality of LifeDisabilityPain

Outcome Measures

Primary Outcomes (9)

  • Visual Analog Scale (PAIN)

    changes from baseline. Visual Analog Scale (VAS) is a 10 cm horizontal line, with 0 presenting No pain and 10 representing Worst Pain.

    4 weeks

  • ROM of Cervical spine (Flexion)

    changes from baseline

    4 weeks

  • ROM of Cervical spine (Extension)

    changes from baseline.Bubble inclinometer was used to measure ROM in sitting position

    4 weeks

  • ROM of Cervical spine (rotation rightward)

    changes from baseline.Bubble inclinometer was used to measure ROM in sitting position

    4 weeks

  • ROM of Cervical spine (rotation leftward)

    changes from baseline. Bubble inclinometer was used to measure ROM in sitting position

    4 weeks

  • ROM of Cervical spine (Side bending Right)

    changes from baseline.Bubble inclinometer was used to measure ROM in sitting position

    4 weeks

  • ROM of Cervical spine (Side bending Left)

    changes from baseline.Bubble inclinometer was used to measure ROM in sitting position

    4 weeks

  • Neck Flexors Muscle endurance

    changes from baseline. Neck Flexion holding time in supine lying position was measured in seconds with the help of stop watch.

    4 weeks

  • NDI (neck Disability Index)

    changes from baseline NDI is self rated index to measure pain and disability due to neck pain. Neck disability index consists of 10 questions addressing functional activities. There are 6 potential responses for each item, ranging from no disability (0) to total disability (5).The NDI is scored from 0 to 50 with higher score indication greater disability.

    4 weeks

Study Arms (3)

PVM group

ACTIVE COMPARATOR

This group included 30 participants. Passive vertebral mobilization was given along with routine physiotherapy comprising TENS, Hotpack/IRR, Isometric neck exercise and postural care

Other: Passive Vertebral MobilizationOther: Routine Physiotherapy

PNF group

ACTIVE COMPARATOR

This group included 30 participants. PNF exercise in the form of diagonal pattern neck movements was along with routine physiotherapy comprising TENS, Hotpack/IRR, Isometric neck exercise and postural care

Other: PNF exerciseOther: Routine Physiotherapy

RPT(Routine Physiotherapy) group

ACTIVE COMPARATOR

This group included 30 participants.Routine physiotherapy comprising TENS, Hotpack/IRR, Isometric neck exercise and postural care.

Other: Routine Physiotherapy

Interventions

Posteroanterior glides was given to cervical spine using Maitland method along with routine physiotherapy comprising thermotherapy with Hot Packs 15 minutes, Transcutaneous Electrical Nerve Stimulation (TENS) 15 minutes,Isometric neck exercises,Education on precautions and postural care

Also known as: Spinal mobilization
PVM group

The subjects was given PNF exercises comprising PNF diagonal patterns for neck along with routine physiotherapy comprising thermotherapy with Hot Packs 15 minutes, Transcutaneous Electrical Nerve Stimulation (TENS) 15 minutes,Isometric neck exercises,Education on precautions and postural care

Also known as: Proprioceptive Neuromuscular Facilitation
PNF group

Thermotherapy with Hot Packs 15 minutes, Transcutaneous Electrical Nerve Stimulation (TENS) 15 minutes,Isometric neck exercises,Education on precautions and postural care

Also known as: Routine Physical therapy (RPT)
PNF groupPVM groupRPT(Routine Physiotherapy) group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with mechanical neck pain having limited range of motion and muscle spasm and difficulty function between 18 to 60 years of age

You may not qualify if:

  • Patients diagnosed with rheumatoid arthritis, Ankylosing spondylitis or other systemic disease
  • Patients with cancer of the cervical spine
  • Patients with history of fracture of spine
  • Patients with any congenital anomaly of Cervical spine
  • Patients having whiplash disorder with in last four weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Ashfaq M, Babur MN, Malick WH, Hussain MA, Awan WA. Comparative effectiveness of proprioceptive neuromuscular facilitation and passive vertebral mobilization for neck disability in patients with mechanical neck pain: A randomized controlled trial. J Bodyw Mov Ther. 2022 Jul;31:16-21. doi: 10.1016/j.jbmt.2022.02.009. Epub 2022 Mar 18.

MeSH Terms

Conditions

Pain

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Muhammad Ashfaq

    Isra University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Control Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 13, 2019

First Posted

January 23, 2019

Study Start

September 20, 2015

Primary Completion

September 30, 2017

Study Completion

March 22, 2018

Last Updated

March 11, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share