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Effects Of Global Postural Re-Education (GPR) On Patients With Non-Specific Neck Pain.

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Global Positional Re-education
Conventional Physical Therapy Program
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Pain, Range of motion, Kinesiophobia, Forward head posture

Eligibility Criteria

25 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Chronic non-specific neck pain ≥ 3 months.
  • No prior medication and Physical Therapy interventions from last 3 months.
  • Pain: moderate level (6 on NPRS).

Exclusion Criteria:

  • History of any trauma .
  • History of any psychological condition.
  • Specific causes of Neck Pain (e.g., systemic, rheumatic, neuromuscular diseases).
  • Presence of central and peripheral neurological sign.
  • Spinal surgery

Sites / Locations

  • Islamabad Physiotherapy and Rehabilitation Centre (IPRC)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Global Positional Re-education

Conventional Physical Therapy Program

Arm Description

Global Positional Re-education

Conventional therapy will consist of a combination of manual techniques

Outcomes

Primary Outcome Measures

Numeric pain rating scale
The NPRS is an 11-point numeric scale, it is the segmented numeric version of the visual analog scale. Subjects will be asked to mark/select a whole number for 0-10 that best describes their perceived pain intensity of the last 24 hours. Assessment to be done at baseline, after 1st session, at 3rd week and at 6th week
Neck Disability Index
it is a 10-item self-report questionnaire that measures the patient's disability related to his/her neck pain. It is the most commonly used questionnaire for neck disability; its reliability and validity has been demonstrated in many literatures and languages. Assessment to be done at baseline, after 1st session, at 3rd week and at 6th week
Goniometer for Cervical Range of Motion
The active cervical range of motion (CROM) will be measured in sitting posture by using a universal goniometer, which consists of two arms; one that is stationary and one that is moveable. Assessment to be done at baseline, after 1st session, at 3rd week and at 6th week
Tampa Scale of Kinesiophobia
Tampa Scale of Kinesiophobia (TSK). TSK is a 17-items questionnaire based on the evaluation of fear of movement, fear of physical activity and fear of re-injury in patients suffering from chronic musculoskeletal pain. It is the most widely used fear avoidance behavior questionnaire with good level of reliability and validity as documented in different literatures. TSK is composed of 17 items with score ranging from 1to 4 for each item, ultimately having a total score ranging from 17-68.Assessment to be done at baseline, after 1st session, at 3rd week and at 6th week

Secondary Outcome Measures

Forward Head Posture:
Ruler method. This method involves measuring the distance from the wall to the tragus of the ear (Tragus to wall test) and from wall to the posterior aspect of acromion of shoulder by a ruler in standing position. The normal distance of Tragus to wall (TTW) in males is 10.55 cm and in females is 10.00 cm, whereas the normal distance of shoulder from wall in relaxed standing position should be less than 5 cm.Assessment to be done at baseline, after 1st session, at 3rd week and at 6th week
Global Perceived Effect Questionnaire:
Perceived effect of the intervention will be assessed by using the Global Perceived Effect Questionnaire (GPE), a 5-point Likert-type scale evaluating the subjective self-reported improvement or deterioration after the intervention. GPE is widely used in the physical therapy literature. Assessment to be done at baseline, after 1st session, at 3rd week and at 6th week

Full Information

First Posted
August 23, 2021
Last Updated
July 18, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05021497
Brief Title
Effects Of Global Postural Re-Education (GPR) On Patients With Non-Specific Neck Pain.
Official Title
Effects Of Global Postural Re-Education (GPR) On Patients With Non-Specific Neck Pain.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
February 15, 2021 (Actual)
Primary Completion Date
July 10, 2023 (Actual)
Study Completion Date
July 10, 2023 (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
Yes

5. Study Description

Brief Summary
Pain is an "unpleasant sensory and emotional experience (associated with actual or potential tissue damage". Chronic pain is a sensation of hyperalgia to muscles, ligaments and skin on both active and passive movements. Chronic pain has a tendency to prevent people from working and exercising
Detailed Description
Neck pain is a very common clinical condition which equals the economic, social cost and level of disability to that of low back pain.Mechanical neck pain that occurs without an identifiable underlying disease and anatomical abnormality is termed as "non-specific" neck pain (NS-NP).Mechanical neck pain commonly arises insidiously and is generally multifactorial in origin.Two most common complains associated with chronic specific and non-specific neck pain are Kinesiophobia (fear of movement) and Postural asymmetry (forward head posture). Medical, surgical and physical therapy treatments are recommended for addressing chronic non-specific neck pain. Within the scope of physical therapy conventional management consist of many different techniques such as therapeutic exercises, electrotherapy, Pilates, yoga and manual therapy. Manual therapy is among the most common used method for treating musculoskeletal conditions including chronic neck pain. Manual therapy consists of stretching techniques, joint mobilization/manipulation, isometric/dynamic strengthening exercises and fascial manipulation or release. Global Postural Re-education (GPR) is an alternative therapeutic strategy based on the concept that postural muscles are organized in the form of 'muscle chains' located on the anterior and posterior aspect of the spine. It involves the global stretching of the anti-gravitational muscles and the kinetic muscle chains.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Pain, Range of motion, Kinesiophobia, Forward head posture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Global Positional Re-education
Arm Type
Experimental
Arm Description
Global Positional Re-education
Arm Title
Conventional Physical Therapy Program
Arm Type
Active Comparator
Arm Description
Conventional therapy will consist of a combination of manual techniques
Intervention Type
Other
Intervention Name(s)
Global Positional Re-education
Intervention Description
A series of gentle active movements and postures aimed at realigning joints and stretching shortened muscles. GPR includes 8 therapeutic postures in lying, sitting and standing.
Intervention Type
Other
Intervention Name(s)
Conventional Physical Therapy Program
Intervention Description
Axial traction will be given for 5 minutes, followed by mobilization of the muscle fascia along with static stretching of the scalene, levator scapulae, upper trapezius, sternocleidomastoid and pectoralis minor muscles.
Primary Outcome Measure Information:
Title
Numeric pain rating scale
Description
The NPRS is an 11-point numeric scale, it is the segmented numeric version of the visual analog scale. Subjects will be asked to mark/select a whole number for 0-10 that best describes their perceived pain intensity of the last 24 hours. Assessment to be done at baseline, after 1st session, at 3rd week and at 6th week
Time Frame
six weeks
Title
Neck Disability Index
Description
it is a 10-item self-report questionnaire that measures the patient's disability related to his/her neck pain. It is the most commonly used questionnaire for neck disability; its reliability and validity has been demonstrated in many literatures and languages. Assessment to be done at baseline, after 1st session, at 3rd week and at 6th week
Time Frame
six weeks
Title
Goniometer for Cervical Range of Motion
Description
The active cervical range of motion (CROM) will be measured in sitting posture by using a universal goniometer, which consists of two arms; one that is stationary and one that is moveable. Assessment to be done at baseline, after 1st session, at 3rd week and at 6th week
Time Frame
six weeks
Title
Tampa Scale of Kinesiophobia
Description
Tampa Scale of Kinesiophobia (TSK). TSK is a 17-items questionnaire based on the evaluation of fear of movement, fear of physical activity and fear of re-injury in patients suffering from chronic musculoskeletal pain. It is the most widely used fear avoidance behavior questionnaire with good level of reliability and validity as documented in different literatures. TSK is composed of 17 items with score ranging from 1to 4 for each item, ultimately having a total score ranging from 17-68.Assessment to be done at baseline, after 1st session, at 3rd week and at 6th week
Time Frame
six weeks
Secondary Outcome Measure Information:
Title
Forward Head Posture:
Description
Ruler method. This method involves measuring the distance from the wall to the tragus of the ear (Tragus to wall test) and from wall to the posterior aspect of acromion of shoulder by a ruler in standing position. The normal distance of Tragus to wall (TTW) in males is 10.55 cm and in females is 10.00 cm, whereas the normal distance of shoulder from wall in relaxed standing position should be less than 5 cm.Assessment to be done at baseline, after 1st session, at 3rd week and at 6th week
Time Frame
six weeks
Title
Global Perceived Effect Questionnaire:
Description
Perceived effect of the intervention will be assessed by using the Global Perceived Effect Questionnaire (GPE), a 5-point Likert-type scale evaluating the subjective self-reported improvement or deterioration after the intervention. GPE is widely used in the physical therapy literature. Assessment to be done at baseline, after 1st session, at 3rd week and at 6th week
Time Frame
six week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic non-specific neck pain ≥ 3 months. No prior medication and Physical Therapy interventions from last 3 months. Pain: moderate level (6 on NPRS). Exclusion Criteria: History of any trauma . History of any psychological condition. Specific causes of Neck Pain (e.g., systemic, rheumatic, neuromuscular diseases). Presence of central and peripheral neurological sign. Spinal surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Khalid, MSOMPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Islamabad Physiotherapy and Rehabilitation Centre (IPRC)
City
Islamabad
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects Of Global Postural Re-Education (GPR) On Patients With Non-Specific Neck Pain.

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