Neck PainROMNCT05138081
PNF Techniques Versus Stabilization Exercises of Trapezius Muscle PNF Techniques Verus Stabilization Exercises of Trapezius Muscle
A study testing PNF stretching and Stabilization in people with Neck Pain, run by University of Lahore at 1 site in Pakistan.
Trial summary
This project will compare the effects of Proprioceptive Neuromuscular Facilitation Stretching and Stabilization of Upper Trapezius on Pain, Range of Motion and Functional Disability in Mobile Phone User with mobile phone-induced Neck Pain. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- PNF stretching and Stabilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2021to 28 Dec 2021
- 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 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female, age range 18-30years with non-specific neck pain.
- Permanently mobile users spent more than 8 hours per day using their mobiles
- Participants are willing to participate in the research.
- Having constant or frequent neck pain of more than 4weeks duration.
Who cannot join
- Specific disorders of the cervical spine, such as disc prolapse, spinal stenosis, postoperative conditions in the neck and shoulder areas.
- History of severe trauma, instability, spasmodic torticollis, migraine (frequency more than twice per month).
- Peripheral nerve entrapment, fibromyalgia, hypermobility syndrome, shoulder diseases (tendonitis, bursitis, capsulitis).
- Inflammatory rheumatic diseases, severe psychiatric illness, and other diseases that prevent physical loading, pregnancy, and other on-going therapies.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
University of Lahore
Lahore, Punjab Province, 54000
University O Lahore, haiderullah@live.com
About this study
Official title: Comparative Effects of Proprioceptive Neuromuscular Facilitation Stretching and Stabilization Exercises of Upper Trapezius on Pain, Range of Motion and Functional Disability in Mobile Phone Users With Neck Pain
This project will compare the effects of Proprioceptive Neuromuscular Facilitation Stretching and Stabilization of Upper Trapezius on Pain, Range of Motion and Functional Disability in Mobile Phone User with mobile phone-induced Neck Pain. The population sample will be 50 divided randomly into two groups by concealed envelop method. Then I will collect data from the social security hospital Physiotherapy department, Lahore. Group A was given stretching exercises and Group B was given stabilization exercises (25 stretchings and 25stabilization). NDI and NPRS were used as an outcome measure to quantify the upper trapezius on pain, range of motion, and functional disability with non-specific neck pain.
Read the detailed description
This project will compare the effects of Proprioceptive Neuromuscular Facilitation Stretching and Stabilization of Upper Trapezius on Pain, Range of Motion and Functional Disability in Mobile Phone User with mobile phone-induced Neck Pain. The population sample will be 50 divided randomly into two groups by concealed envelop method. Then I will collect data from the social security hospital Physiotherapy department, Lahore. Group A was given stretching exercises and Group B was given stabilization exercises (25 stretchings and 25stabilization). NDI and NPRS were used as an outcome measure to quantify the upper trapezius on pain, range of motion, and functional disability with non-specific neck pain. Single blinding of accessor was done at the time of recording of outcome measures pre and post-treatment Baseline was 4th week and 8th week. Eighty female participants and twenty male participants in each group. The duration was 9 months. The 18-30 years age range of both males and females were considered. There was not any statistically significant difference between the two groups as p > 0.05. But within-group changes show that there was a significant change in baseline, 4th week, and 8th-week readings for NDI, NPRS, and ROM with p < 0.05.
- Conditions
- Neck Pain
- Being tested
- PNF stretching, Stabilization
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNF stretchingOther
Neck flexion pattern The therapist slightly pulled the chin so that it was lifted and causing the neck to extend. Commands such as "pull your chin in" and "look at your left hip" were given to the patient. Resistance was given against left rotation, flexion and lateral flexion along with the traction to the patient's chin.Neck extension pattern The therapists lightly pulled the chin so that the neck was flexed; head was rotated and tilted to the left. Commands such as "lift your chin and then "lift your head to look above were given to the patient. Passive resistance was provided against right rotation, extension and lateral flexion.
StabilizationOther
Stabilization exercises are shoulder rolls, shrugging, chin tuck, scapular retraction, cervical extension. This was done for 15 repetition
| Study group | Role | What they receive |
|---|---|---|
| PNF Stretching: Group A | Experimental | Routine physical therapy treatment Receives: Other: PNF stretching |
| Stabilization Exercises: Group B | Experimental | Routine physical therapy treatment Receives: Other: Stabilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical pain rating scale
Pain will be measured by Numeric Pain rating scale. 000. NPRS is one of the ways to quantify pain and is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 no pain to 10 worst imaginable pain. It has been shown that a composite scoring system including best, worse, and current level of pain. Pain by definition is an unpleasant sensation and emotional experience that is related to tissue damage
Measured: baseline, 4th week, 8th week
Secondary outcomes (1)
Functional Disability Index
The Neck Disability Index (NDI) is a self-report questionnaire used to determine how neck pain affects a patient's daily life and to assess the self-rated disability of patients with neck pain.
The Neck Disability Index (NDI) is a self-report questionnaire used to determine how neck pain 0affects a patient's daily life and to assess the self-rated disability of patients with neck pain.We currently know that the NDI consists of one factor - "physical disability" - although NDI scores correlate well with SF-36 mental component scores as well Functional disability has been defined as acquired difficulty in performing basic everyday tasks or more complex tasks needed for independent living. The Neck Disability Index (NDI) is a self-report questionnaire used to determine how neck pain affects a patient's daily life and to assess the self-rated disability of patients with neck pain
Measured: baseline, 4th week, 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start1 Mar 2021
- Primary completion1 Dec 2021 (estimated)
- Study completion28 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by University of LahoreThe 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
- Single group
- Model description
- parallel assignment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Iqra Ashraf, ms-msk, Principal investigator, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05138081
- Sponsor's protocol ID
- IRB-UOL-FAHS/862-1/2021
- Acronym
- ROM
- Status last verified
- Nov 2021
- First submitted
- 3 Nov 2021
- Last updated
- 30 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Amoudi M, Ayed A. Effectiveness of stretching exercise program among nurses with neck pain: Palestinian perspective. Sci Prog. 2021 Jul-Sep;104(3):368504211038163. doi: 10.1177/00368504211038163.
PubMed 34459689Javdaneh N, Molayei F, Kamranifraz N. Effect of adding motor imagery training to neck stabilization exercises on pain, disability and kinesiophobia in patients with chronic neck pain. Complement Ther Clin Pract. 2021 Feb;42:101263. doi: 10.1016/j.ctcp.2020.101263. Epub 2020 Nov 19.
PubMed 33276225Kuo YL, Lee TH, Tsai YJ. Evaluation of a Cervical Stabilization Exercise Program for Pain, Disability, and Physical Impairments in University Violinists with Nonspecific Neck Pain. Int J Environ Res Public Health. 2020 Jul 28;17(15):5430. doi: 10.3390/ijerph17155430.
PubMed 32731521Jung SI, Lee NK, Kang KW, Kim K, Lee DY. The effect of smartphone usage time on posture and respiratory function. J Phys Ther Sci. 2016 Jan;28(1):186-9. doi: 10.1589/jpts.28.186. Epub 2016 Jan 30.
PubMed 26957754
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Proprioceptive Neuromuscular Facilitation Stretching and Stabilization Exercises of Upper Trapezius on Pain, Range of Motion and Functional Disability in Mobile Phone Users With Neck Pain
- ClinicalTrials.gov ID
- NCT05138081
- Acronym / sponsor ID
- ROM / IRB-UOL-FAHS/862-1/2021
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 28 Dec 2021 (estimated)
- First posted
- 30 Nov 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.
This project will compare the effects of Proprioceptive Neuromuscular Facilitation Stretching and Stabilization of Upper Trapezius on Pain, Range of Motion and Functional Disability in Mobile Phone User with mobile phone-induced Neck Pain. The population sample will be 50 divided randomly into two groups by concealed envelop method. Then I will collect data from the social security hospital Physiotherapy department, Lahore. Group A was given stretching exercises and Group B was given stabilization exercises (25 stretchings and 25stabilization). NDI and NPRS were used as an outcome measure to quantify the upper trapezius on pain, range of motion, and functional disability with non-specific neck pain.
Detailed description
This project will compare the effects of Proprioceptive Neuromuscular Facilitation Stretching and Stabilization of Upper Trapezius on Pain, Range of Motion and Functional Disability in Mobile Phone User with mobile phone-induced Neck Pain. The population sample will be 50 divided randomly into two groups by concealed envelop method. Then I will collect data from the social security hospital Physiotherapy department, Lahore. Group A was given stretching exercises and Group B was given stabilization exercises (25 stretchings and 25stabilization). NDI and NPRS were used as an outcome measure to quantify the upper trapezius on pain, range of motion, and functional disability with non-specific neck pain. Single blinding of accessor was done at the time of recording of outcome measures pre and post-treatment Baseline was 4th week and 8th week. Eighty female participants and twenty male participants in each group. The duration was 9 months. The 18-30 years age range of both males and females were considered. There was not any statistically significant difference between the two groups as p > 0.05. But within-group changes show that there was a significant change in baseline, 4th week, and 8th-week readings for NDI, NPRS, and ROM with p < 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- parallel assignment
| Arm | Type | Receives |
|---|---|---|
| PNF Stretching: Group A | Experimental | Other: PNF stretchingRoutine physical therapy treatment |
| Stabilization Exercises: Group B | Experimental | Other: StabilizationRoutine physical therapy treatment |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male and female, age range 18-30years with non-specific neck pain.
Key exclusion criteria (4 listed)
- Specific disorders of the cervical spine, such as disc prolapse, spinal stenosis, postoperative conditions in the neck and shoulder areas.
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 |
|---|---|---|
| PNF stretchingNeck flexion pattern The therapist slightly pulled the chin so that it was lifted and causing the neck to extend. Commands such as "pull your chin in" and "look at your left hip" were given to the patient. Resistance was given against left rotation, flexion and lateral flexion along with the traction to the patient's chin.Neck extension pattern The therapists lightly pulled the chin so that the neck was flexed; head was rotated and tilted to the left. Commands such as "lift your chin and then "lift your head to look above were given to the patient. Passive resistance was provided against right rotation, extension and lateral flexion. | Other | PNF Stretching: Group A |
| StabilizationStabilization exercises are shoulder rolls, shrugging, chin tuck, scapular retraction, cervical extension. This was done for 15 repetition | Other | Stabilization Exercises: Group B |
Primary outcome
Numerical pain rating scale
Time frame: baseline, 4th week, 8th week
Pain will be measured by Numeric Pain rating scale. 000. NPRS is one of the ways to quantify pain and is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 no pain to 10 worst imaginable pain. It has been shown that a composite scoring system including best, worse, and current level of pain. Pain by definition is an unpleasant sensation and emotional experience that is related to tissue damage
1 secondary outcome
Functional Disability Index
Time frame: baseline, 4th week, 8th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
- Background: PubMed 34459689Amoudi M, Ayed A. Effectiveness of stretching exercise program among nurses with neck pain: Palestinian perspective. Sci Prog. 2021 Jul-Sep;104(3):368504211038163. doi: 10.1177/00368504211038163.
- Background: PubMed 33276225Javdaneh N, Molayei F, Kamranifraz N. Effect of adding motor imagery training to neck stabilization exercises on pain, disability and kinesiophobia in patients with chronic neck pain. Complement Ther Clin Pract. 2021 Feb;42:101263. doi: 10.1016/j.ctcp.2020.101263. Epub 2020 Nov 19.
- Background: PubMed 32731521Kuo YL, Lee TH, Tsai YJ. Evaluation of a Cervical Stabilization Exercise Program for Pain, Disability, and Physical Impairments in University Violinists with Nonspecific Neck Pain. Int J Environ Res Public Health. 2020 Jul 28;17(15):5430. doi: 10.3390/ijerph17155430.
- Background: PubMed 26957754Jung SI, Lee NK, Kang KW, Kim K, Lee DY. The effect of smartphone usage time on posture and respiratory function. J Phys Ther Sci. 2016 Jan;28(1):186-9. doi: 10.1589/jpts.28.186. Epub 2016 Jan 30.
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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.
Iqra Ashraf, ms-msk principal investigator
University of Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PNF stretching and Stabilization in people with Neck Pain, run by University of Lahore 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 30 Nov 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haiderullah khan, MS-MSK (03314127210, haiderullah@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical pain rating scale (time frame: baseline, 4th week, 8th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05138081, which also lists 4 linked publications.
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 30 Nov 2021.