Passive Vertebral Mobilization and Propriocemptive Neuromuscular Techniques in Mechanical Neck Pain

March 10, 2021 updated by: Muhammad Ashfaq, Isra University

Comparison Between Passive Vertebral Mobilization and Proprioceptive Neuromuscular Techniques in Managing Pain and Disability in Patients With Mechanical Neck Pain

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Neck Pain is very common and is now considered a public health issue. It poses significant health and economic burden, being a frequent cause of disability. A significant proportion of direct health care costs associated with neck disorders are attributable to visits to health care providers, to sick leave, and to the related loss of productive capacity. Mechanical neck pain affects between 45-54% of people in the general population .This can result in severe pain and disability. Mechanical neck pain described as a reduction in the mobility of cervical spinal segment is often the focus of manipulative physical therapy interventions. Most neck pain is not attributed to diseases but rather caused by muscular and postural condition. The cervical pain is a mechanical problem .It is therefore sense that a mechanical treatment works better than pharmacological treatment.

Cervical spine often impairs flexibility of key muscles related to cervical spine . Stretching exercise is beneficial for increasing flexibility as well as muscle performance.

The normal function of cervical spine is complex and requires a large variety of activities to be coordinated in order for an individual to perform daily activities with the least amount of strain and potential injury. When the dysfunction develops in the cervical spine, a chain reaction may develop which can affect the whole neck and even the entire body.

Commonly used approaches to treatment include rest, therapeutic massage, application of physical agents like heat, cold, TENS, and ultrasonic various types of mobilizations, manipulations (by physical therapists, chiropractors, osteopaths and others), therapeutic exercises, postural care and off course medication and surgical interventions. However, studies of their effectiveness have generally been short-term and inconclusive. The aim of the study is to compare which treatment either Passive Vertebral Mobilization or Proprioceptive Neuromuscular Facilitation, whether itself or in combination, is more effective and beneficial in the treatment of mechanical neck pain.

Several studies have been reported to determine the effectiveness of manual therapy/ passive vertebral mobilization but with largely inconclusive results. However there are few studies if any to compare PNF exercise with PVM in terms of their effectiveness. PNF are simple and requiring low level expertise as compare to PVM.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: PVM group
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 Mobilization
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
Other Names:
  • Spinal mobilization
Other: Routine Physiotherapy
Thermotherapy with Hot Packs 15 minutes, Transcutaneous Electrical Nerve Stimulation (TENS) 15 minutes,Isometric neck exercises,Education on precautions and postural care
Other Names:
  • Routine Physical therapy (RPT)
Active Comparator: PNF group
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: Routine Physiotherapy
Thermotherapy with Hot Packs 15 minutes, Transcutaneous Electrical Nerve Stimulation (TENS) 15 minutes,Isometric neck exercises,Education on precautions and postural care
Other Names:
  • Routine Physical therapy (RPT)
Other: PNF exercise
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
Other Names:
  • Proprioceptive Neuromuscular Facilitation
Active Comparator: RPT(Routine Physiotherapy) group
This group included 30 participants.Routine physiotherapy comprising TENS, Hotpack/IRR, Isometric neck exercise and postural care.
Other: Routine Physiotherapy
Thermotherapy with Hot Packs 15 minutes, Transcutaneous Electrical Nerve Stimulation (TENS) 15 minutes,Isometric neck exercises,Education on precautions and postural care
Other Names:
  • Routine Physical therapy (RPT)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (PAIN)
Time Frame: 4 weeks
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)
Time Frame: 4 weeks
changes from baseline
4 weeks
ROM of Cervical spine (Extension)
Time Frame: 4 weeks
changes from baseline.Bubble inclinometer was used to measure ROM in sitting position
4 weeks
ROM of Cervical spine (rotation rightward)
Time Frame: 4 weeks
changes from baseline.Bubble inclinometer was used to measure ROM in sitting position
4 weeks
ROM of Cervical spine (rotation leftward)
Time Frame: 4 weeks
changes from baseline. Bubble inclinometer was used to measure ROM in sitting position
4 weeks
ROM of Cervical spine (Side bending Right)
Time Frame: 4 weeks
changes from baseline.Bubble inclinometer was used to measure ROM in sitting position
4 weeks
ROM of Cervical spine (Side bending Left)
Time Frame: 4 weeks
changes from baseline.Bubble inclinometer was used to measure ROM in sitting position
4 weeks
Neck Flexors Muscle endurance
Time Frame: 4 weeks
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)
Time Frame: 4 weeks

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Isra University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Muhammad Ashfaq, Isra University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 20, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 22, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 11, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1402-PhD-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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