- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03813680
Passive Vertebral Mobilization and Propriocemptive Neuromuscular Techniques in Mechanical Neck Pain
Comparison Between Passive Vertebral Mobilization and Proprioceptive Neuromuscular Techniques in Managing Pain and Disability in Patients With Mechanical Neck Pain
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
Intervention / Treatment |
---|---|
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
|
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:
Thermotherapy with Hot Packs 15 minutes, Transcutaneous Electrical Nerve Stimulation (TENS) 15 minutes,Isometric neck exercises,Education on precautions and postural care
Other Names:
|
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
|
Thermotherapy with Hot Packs 15 minutes, Transcutaneous Electrical Nerve Stimulation (TENS) 15 minutes,Isometric neck exercises,Education on precautions and postural care
Other Names:
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:
|
Active Comparator: RPT(Routine Physiotherapy) group
This group included 30 participants.Routine physiotherapy comprising TENS, Hotpack/IRR, Isometric neck exercise and postural care.
|
Thermotherapy with Hot Packs 15 minutes, Transcutaneous Electrical Nerve Stimulation (TENS) 15 minutes,Isometric neck exercises,Education on precautions and postural care
Other Names:
|
What is the study measuring?
Primary Outcome Measures
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
Sponsor
Investigators
- Principal Investigator: Muhammad Ashfaq, Isra University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1402-PhD-003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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