Neck PainNCT05021497
Effects Of Global Postural Re-Education (GPR) On Patients With Non-Specific Neck Pain.
A study testing Global Positional Re-education and Conventional Physical Therapy Program in people with Neck Pain, run by Riphah International University at 1 site in Pakistan.
Trial 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 Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Global Positional Re-education and Conventional Physical Therapy Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Feb 2021to 10 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Chronic non-specific neck pain ≥ 3 months.
- No prior medication and Physical Therapy interventions from last 3 months.
- Pain: moderate level (6 on NPRS).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Islamabad Physiotherapy and Rehabilitation Centre (IPRC)
Islamabad, Punjab Province, 46000
About this study
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
Read the 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.
- Conditions
- Neck Pain
- Being tested
- Global Positional Re-education, Conventional Physical Therapy Program
- Keywords
- Pain, Range of motion, Kinesiophobia, Forward head posture
- Medical subject headings
- Neck Pain, Pain, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Global Positional Re-educationOther
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.
Conventional Physical Therapy ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Global Positional Re-education | Experimental | Global Positional Re-education Receives: Other: Global Positional Re-education |
| Conventional Physical Therapy Program | Active comparator | Conventional therapy will consist of a combination of manual techniques Receives: Other: Conventional Physical Therapy Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: six weeks
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
Measured: six weeks
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
Measured: six weeks
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
Measured: six weeks
Secondary outcomes (2)
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
Measured: six weeks
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
Measured: six week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start15 Feb 2021
- Primary completion10 Jul 2023
- Study completion10 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Khalid, MSOMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05021497
- Sponsor's protocol ID
- REC/00941 Faisal Saeed
- Status last verified
- Dec 2024
- First submitted
- 23 Aug 2021
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Global Postural Re-Education (GPR) On Patients With Non-Specific Neck Pain.
- ClinicalTrials.gov ID
- NCT05021497
- Acronym / sponsor ID
- REC/00941 Faisal Saeed
- Conditions
- Neck Pain
- Keywords
- Pain, Range of motion, Kinesiophobia, Forward head posture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 10 Jul 2023 (actual)
- Study completion
- 10 Jul 2023 (actual)
- First posted
- 25 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Global Positional Re-education | Experimental | Other: Global Positional Re-educationGlobal Positional Re-education |
| Conventional Physical Therapy Program | Active comparator | Other: Conventional Physical Therapy ProgramConventional therapy will consist of a combination of manual techniques |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Chronic non-specific neck pain ≥ 3 months.
- No prior medication and Physical Therapy interventions from last 3 months.
- Pain: moderate level (6 on NPRS).
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Global Positional Re-educationA 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. | Other | Global Positional Re-education |
| Conventional Physical Therapy ProgramAxial 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. | Other | Conventional Physical Therapy Program |
Primary outcome
Numeric pain rating scale
Time frame: six weeks
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
Time frame: six weeks
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
Time frame: six weeks
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
Time frame: six weeks
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
2 secondary outcomes
Forward Head Posture:
Time frame: six weeks
Global Perceived Effect Questionnaire:
Time frame: six week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Neck Pain
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Longitudinal Stripping Massage vs. Percussion Device for Neck Pain: Ultrasound Study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Khalid, MSOMPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Global Positional Re-education and Conventional Physical Therapy Program in people with Neck Pain, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric pain rating scale (time frame: six weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.