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The Comparison of PIR and GT in Mechanical Neck Pain

Primary Purpose

Mechanical Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Graston technique
post isometric relaxation
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mechanical Neck Pain focused on measuring Post isometric relaxation, Graston technique, Mechanical neck pain

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Symptoms of Mechanical neck pain 4-12 weeks.
  • Neck pain rating on NPRS (4-8 )
  • Palpable pain on Active or latent trigger points

Exclusion Criteria:

  • signs of serious pathology (e.g., malignancy, inflammatory disorder, infection)
  • history of cervical spine surgery in previous 12 months
  • history of trauma or fractures in cervical spine
  • signs of cervical radiculopathy
  • Vascular syndromes such as basilar insufficiency.

Sites / Locations

  • Pakistan Railway General Hospital.

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

post isometric relaxation and exercises

Graston technique and exercises

Arm Description

Group A included Post Isometric Relaxation, 5 rep , 20% isometric contraction 10 sec , 20 sec of stretch hold beyond resistance barrier and conventional exercise program ; this program included Hot pack placed over the painful area in cervical region before the treatment ( 20 minutes).Strengthening exercises for deep neck flexors, rhomboids, lower trapezius and serratus anterior due to weak muscles (2 sets of 10 repetitions once a day) Stretching exercises for pectoralis muscles (20-second hold, 5 repetitions).This exercise protocol was for 4 weeks and 3 sessions per week. Measurements taken at baseline level and at the End of treatment, i.e. ROM, pain intensity by NPRS and PPT , functional disability.

Group B included Graston Technique to Upper Trapezius and Levator Scapulae.This instrumented-assisted soft tissue massage applied with deeper pressure to the area of concern.The protocol consist of Longitudinal stroking parallel to muscle fiber for 1min , spin over trigger points for 1 min using knob of instrument and fanning for 2 min Hot pack placed over the painful area in cervical region before the treatment ( 20 minutes).Strengthening exercises for deep neck flexors, rhomboids, lower trapezius and serratus anterior due to weak muscles (2 sets of 10 repetitions once a day) Stretching exercises for pectoralis muscles (20-second hold, 5 repetitions). This exercise protocol was for 4 weeks and 3 sessions per week. Measurements taken at baseline level and at the END of treatment , i.e. ROM, pain intensity by NPRS and PPT , functional disability.

Outcomes

Primary Outcome Measures

Numeric Pain Rating Scale (NPRS) for pain.
Numeric Pain Rating Scale (NPRS) for pain : is a unidimensional measure of pain intensity .The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable") Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. where 0 indicate no pain and 10 indicate severe pain.
Cervical range of motion by using Inclinometer
Measuring Cervical flexion, extension , Right side bending , left side bending , right rotation and Left rotation

Secondary Outcome Measures

Neck disability index for assessing functional status
It is a patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. The NDI has sufficient support and usefulness to retain its current status as the most commonly used self-report measure for neck pain
Algometry for assessing pressure pain threshold for trigger points.
Algometers are devices that can be used to identify the pressure and/or force eliciting a pressure-pain threshold on trigger points of upper trapezius and levator scapulae.

Full Information

First Posted
September 16, 2020
Last Updated
November 10, 2020
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04556955
Brief Title
The Comparison of PIR and GT in Mechanical Neck Pain
Official Title
Comparison of Post Isometric Relaxation and Graston Technique in Mechanical Neck Pain.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
April 4, 2020 (Actual)
Primary Completion Date
November 9, 2020 (Actual)
Study Completion Date
November 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this research is to compare the effects of post isometric relaxation and graston technique in mechanical neck pain. Post isometric relaxation and graston effects on pain , cervical range of motion and function. A randomized controlled trial was done at Max health hospital G-8 markaz Islamabad . The sample size was 20. The Participants were divided into two groups,10 participants in group A (post iso metric relaxation) and 10 in group B (Graston technique ) . The study duration was 6 months. Sampling technique applied was purposive sampling technique Randomized through sealed enveloped method . Only 18 to 50 years participants with mechanical neck pain were included in the study . Outcome measure Tools used in this study were Numerical pain rating scale (NPRS) ,inclinometer for cervical ROM, Algometer for pain pressure threshold and Neck disability index for assessing functional disability . Data analyzed through SPSS version 20.
Detailed Description
Among all Musculoskeletal disorders occuring in general population ,the neck pain is one of the most common disorder. It's prevalence ranges from 14.2% to 71% in the general population and more prevalent in adult women With the adult age of 15-74 years it's mean point prevalence becomes 7.6%. The child's et al concluded that the life time prevalence of neck pain is 22-70% Among computer workers it has been observed higher incidence , the studies predicted one year incidence of neck pain from 10.4% to 21.3%. Neck pain is defined as "the pain anywhere within the region bounded superiorly by superior nuchal line, inferiorly by an imaginary line through the tip of first thoracic spinous process and laterally by sagittal plane tangential to the lateral borders of the neck".. Postural and mechanical based symptoms occurs in Mechanical neck pain that are under the influence of many factors that's why difficult to understand.The evidence of studies suggests prolonged adapted posture and repetitive movements falls under the category of biomechanical factors that introduce neck pain whereas according to psychosocial stress associated with neck pain , in which over activity of trapezius muscle motor units monitored , due to increased mental and physical demand of work . That Results in Muscle spasm and pain , majorly caused by long time exposure to these stressors which can lead to functional disability , reduces activity level , anxiety , depression overall influence the quality of life of individual. Evidence supported by studies that , in subjects with mechanical neck pain may have trigger points in cervical muscles that include upper trapezius , levator scapulae and sternocleidomastoid muscles . When palpated elicited referred pain pattern , so responsible for major provoked symptoms of Mechanical neck pain. In the cervical region the upper trapezius , levator scapulae , scalene and sternocleidomastoid muscles are tend to be more tight and painful thus their lengthening is more prioritized. Along with the upper trapezius is considered as the most commonly involved muscle. The trigger points are defined as the taut bands of skeletal muscle tissues in hypersensitive areas that generates pain on palpation and shows tenderness on touch. In individual with Mechanical neck pain , the pain processes may involve muscular trigger points. According to shah et al it has been shown that Mechanical Neck Pain is associated with sensitization mechanisms, the algogenic substances and chemical mediators (potassium , serotonin, bradykinin ,histamine , prostaglandins and leukotrienes) that involved in tissue damage can also lead to peripheral transduction are present in higher level in active trigger points than latent trigger points. Literature Review :A Systemic review or Meta-analysis in 2017 by including 7 studies after screening 1169 articles to determine the impact of manual therapy and exercise therapy as combined treatment or delivered alone for the treatment of neck pain patients. They concluded that combined treatment were no more effective for improving outcomes. In 2018 done a metaanalysis conducted to determine the effects of thoracic manipulation on pain and disability in patients of chronic mechanical neck pain . The results describes that thrust manipulation was highly effective than non thrust manipulation for reducing pain and disability associated with mechanical neck pain patients In 2019 a systemic review of 47 randomized controlled trails studies conducted about treatment of chronic non specific neck pain majorly focused on efficacy , effectiveness and safety of manipulation , mobilization and multi-modal approaches.They also predicted that multi-modal approach may have more impact in decreasing pain and increasing function in patients with non specific neck pain. The study Results suggested that Adding Post isometric relaxation technique to the conventional physical therapy treatment program of chronic Mechanical Neck Pain was more effective in reducing pain and functional disability and increasing cervical ROM than the traditional treatment program alone. A study in 2016 suggested that for Muscle energy technique reduces the pain and functional disability higher than stretching technique. A study suggested that for reducing pain and increasing Range of motion Muscle energy technique was better than static stretching in treating patients with mechanical neck pain. According to an Randomized controlled trail study that compared the efficacy of spinal manipulative therapy and Graston technique for the treatment of non specific thoracic pain.There is no significant difference in outcome at any point for pain or disability when comparing Spinal manipulative Therapy , Graston Technique. According to an RCT , the Post Isometric Relaxation was highly beneficial for improving cervical ROM and reducing pain , associated disability in non specific neck pain patients then isometric exercises. According to comparative study in 2017, results suggested increase in neck mobility and reduction in pain , but concluded that Muscle energy technique was more beneficial than positional release technique in patient's with non-specific neck pain. In 2016 According to a study in patients with chronic mechanical neck pain .The outcome measure tools was Visual Analogue Scale for pain intensity , universal goniometer used to measure rotation and lateral flexion of neck muscles while function was determined by Neck Disability Index scale. Results showed improvement in both Proprioceptive Neuromuscular facilitation and Muscle Energy Technique .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mechanical Neck Pain
Keywords
Post isometric relaxation, Graston technique, Mechanical neck pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
post isometric relaxation and exercises
Arm Type
Placebo Comparator
Arm Description
Group A included Post Isometric Relaxation, 5 rep , 20% isometric contraction 10 sec , 20 sec of stretch hold beyond resistance barrier and conventional exercise program ; this program included Hot pack placed over the painful area in cervical region before the treatment ( 20 minutes).Strengthening exercises for deep neck flexors, rhomboids, lower trapezius and serratus anterior due to weak muscles (2 sets of 10 repetitions once a day) Stretching exercises for pectoralis muscles (20-second hold, 5 repetitions).This exercise protocol was for 4 weeks and 3 sessions per week. Measurements taken at baseline level and at the End of treatment, i.e. ROM, pain intensity by NPRS and PPT , functional disability.
Arm Title
Graston technique and exercises
Arm Type
Experimental
Arm Description
Group B included Graston Technique to Upper Trapezius and Levator Scapulae.This instrumented-assisted soft tissue massage applied with deeper pressure to the area of concern.The protocol consist of Longitudinal stroking parallel to muscle fiber for 1min , spin over trigger points for 1 min using knob of instrument and fanning for 2 min Hot pack placed over the painful area in cervical region before the treatment ( 20 minutes).Strengthening exercises for deep neck flexors, rhomboids, lower trapezius and serratus anterior due to weak muscles (2 sets of 10 repetitions once a day) Stretching exercises for pectoralis muscles (20-second hold, 5 repetitions). This exercise protocol was for 4 weeks and 3 sessions per week. Measurements taken at baseline level and at the END of treatment , i.e. ROM, pain intensity by NPRS and PPT , functional disability.
Intervention Type
Device
Intervention Name(s)
Graston technique
Intervention Description
Experimental group included Graston technique :The protocol consist of Longitudinal stroking parallel to muscle fiber for 1min , spin over trigger points for 1 min using knob of instrument and fanning for 2 min.
Intervention Type
Other
Intervention Name(s)
post isometric relaxation
Intervention Description
Post Isometric Relaxation, 5 rep , 20% isometric contraction 10 sec , 20 sec of stretch hold beyond resistance barrier
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale (NPRS) for pain.
Description
Numeric Pain Rating Scale (NPRS) for pain : is a unidimensional measure of pain intensity .The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable") Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. where 0 indicate no pain and 10 indicate severe pain.
Time Frame
12th day.
Title
Cervical range of motion by using Inclinometer
Description
Measuring Cervical flexion, extension , Right side bending , left side bending , right rotation and Left rotation
Time Frame
12th day
Secondary Outcome Measure Information:
Title
Neck disability index for assessing functional status
Description
It is a patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. The NDI has sufficient support and usefulness to retain its current status as the most commonly used self-report measure for neck pain
Time Frame
12th day
Title
Algometry for assessing pressure pain threshold for trigger points.
Description
Algometers are devices that can be used to identify the pressure and/or force eliciting a pressure-pain threshold on trigger points of upper trapezius and levator scapulae.
Time Frame
12th day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Symptoms of Mechanical neck pain 4-12 weeks. Neck pain rating on NPRS (4-8 ) Palpable pain on Active or latent trigger points Exclusion Criteria: signs of serious pathology (e.g., malignancy, inflammatory disorder, infection) history of cervical spine surgery in previous 12 months history of trauma or fractures in cervical spine signs of cervical radiculopathy Vascular syndromes such as basilar insufficiency.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lal Gul Khan
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pakistan Railway General Hospital.
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
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The Comparison of PIR and GT in Mechanical Neck Pain

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