Mechanical Neck PainNCT05618951
Effects of Transverse Thoracic Mobilization With and Without Lower Trapezius Strengthening Exercises
A study testing Lower Trapezius Strengthening Exercises in people with Mechanical Neck Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
Mechanical neck pain is a common musculoskeletal problem, worldwide. Patients with neck pain often have subjective complaints of muscle stiffness, tension, or tightness in addition to their pain located between the occiput and the third thoracic vertebra Approximately 68% of the total population has experienced neck… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Mechanical Neck Pain
- What is being tested?
- Lower Trapezius Strengthening Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePakistan
- Study dates
- 18 Oct 2022to 31 Mar 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males and females between the age range of 18-40 years with mechanical neck pain for at least 3months.
- Examination- Symptoms provoked by neck movement and/or palpation of neck musculature.
- Trapezius Strength Test -To assess lower trapezius muscle strength, patient in prone with shoulder 120 degree abducted and resist the shoulder extension diagonally.
Who cannot join
- Osteoporosis
- Tumors
- Vertebral fractures
- Diagnosed psychological disorders
- Neck pain associated with vertigo
- History of cervical and thoracic spine injury
Show all 9Show fewer
- Cervical radiculopathy
- Traumatic neck injury
- Shoulder surgery
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Syed Medical Complex and Islam Hospital
Sialkot, Punjab Province, 51410
About this study
Official title: Effects of Transverse Thoracic Mobilization With and Without Lower Trapezius Strengthening Exercises on Pain, Disability and Range of Motion in Patients With Mechanical Neck Pain
Mechanical neck pain is a common musculoskeletal problem, worldwide. Patients with neck pain often have subjective complaints of muscle stiffness, tension, or tightness in addition to their pain located between the occiput and the third thoracic vertebra Approximately 68% of the total population has experienced neck pain at least once in their lifetime, and it easily transforms into a chronic state (that persists for more than 3 months). In today's society, this is conspicuous in many laborers due to the increased use of computers, where the neck and shoulders are maintained in static abnormal postures to look at the computer screens and become vulnerable to cause neck pain. The aim of the study is to determine the comparative effects of transverse thoracic mobilization with and without lower trapezius strengthening exercises on pain, disability and range of motion in patients with mechanical neck pain.
Read the detailed description
A Randomized controlled trial will be conducted in physiotherapy outpatient department of Syed Medical Complex and Islam Hospital, Sialkot. Non-probability consecutive sampling will be used to collect the data. Sample size of 20 subjects with age group between 18 to 40 years will be taken. Data will be collected by using tools Numeric Pain Rate Scale (NPRS) for pain, Neck Disability Index (NDI) for disability and Universal Goniometer (UG) for range of motion of neck. An informed consent will be taken. A total of 20 subjects will be selected by following inclusion and exclusion criteria and will equally divided in to two groups by random number generator table. Both groups will come thrice per week for a total of 4 weeks. The data will be analyzed using SPSS software version 25. After assessing normality of data by Shapiro-Wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups
- Conditions
- Mechanical Neck Pain
- Being tested
- Lower Trapezius Strengthening Exercises
- Keywords
- Neck Pain, Trapezius muscle, Muscle strength, Range of Motion
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower Trapezius Strengthening ExercisesOther
Also called Standardized Physical Therapy
Lower Trapezius strengthening exercise includes:
- Latissimus pull down
- Prone V- raise
- Modified Prone Cobra
| Study group | Role | What they receive |
|---|---|---|
| Group A: Lower Trapezius Strengthening Exercises | Experimental | Hot pack at neck area, upper trapezius stretching neck isometrics transverse mobilization glide and
Lower Trapezius strengthening exercise includes:
1. Latissimus pull down
2. Prone V- raise
3. Modified Prone Cobra and Standardized Physical Therapy treatment will be given as Hot pack at neck area, upper trapezius stretching, neck isometrics and transverse mobilization glide. Receives: Other: Lower Trapezius Strengthening Exercises |
| Group B: Standardized Physical Therapy | No intervention | Hot pack at neck area, upper trapezius stretching neck isometrics transverse mobilization glide Group B given Standardized Physical therapy management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rate Scale (NPRS)
The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults, including those with chronic pain. The NPRS is a segmented numeric version in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of pain.
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"). The NPRS takes <1 minute to complete The NPRS is a valid and reliable scale to measure pain intensity.
Measured: follow up at 4th week
Universal Goniometer (UG)
A goniometer is an instrument that measures the available range of motion at a joint. To measure the range of motion physical therapists most commonly use a goniometer. It is necessary that a single notation system is used in goniometry. The neutral zero method (0 to 180- degree system) is the most widely used method. The same goniometer should always be used to reduce the chances of instrumental error.
Measured: follow up at 4th week
Neck Disability Index (NDI)
This questionnaire has been designed to give information about neck pain and the ability to manage it in everyday life. Participants will answer every section and mark only the one box that applies in each section. If two or more statements are in any section related to the participant, mark only one box that is relevant closely. The questionnaire has 10 items concerning pain and activities of daily living, including personal care, lifting, reading, headaches, concentration, work status, driving, sleeping and recreation. Each item is scored out of 5 (with the 'no disability' response given a score of 0), giving a total score of for the questionnaire 50. Higher scores represent more significant disabilities. The result can be expressed as a percentage or raw scores (out of 50).
Measured: follow up at 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start18 Oct 2022
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Mechanical 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samrood Akram, Mphil, Principal investigator, Riphah International University,Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05618951
- Sponsor's protocol ID
- REC/RCR & AHS/22/0153 Salba
- Status last verified
- Apr 2023
- First submitted
- 8 Nov 2022
- Last updated
- 20 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee KW, Kim WH. Effect of thoracic manipulation and deep craniocervical flexor training on pain, mobility, strength, and disability of the neck of patients with chronic nonspecific neck pain: a randomized clinical trial. J Phys Ther Sci. 2016 Jan;28(1):175-80. doi: 10.1589/jpts.28.175. Epub 2016 Jan 30.
PubMed 26957752Rodriguez-Sanz J, Malo-Urries M, Lucha-Lopez MO, Lopez-de-Celis C, Perez-Bellmunt A, Corral-de-Toro J, Hidalgo-Garcia C. Comparison of an exercise program with and without manual therapy for patients with chronic neck pain and upper cervical rotation restriction. Randomized controlled trial. PeerJ. 2021 Nov 24;9:e12546. doi: 10.7717/peerj.12546. eCollection 2021.
PubMed 34900443Wan-Hee Lee I-KC, Hye-Kang Park. The Effectiveness of Selective Lower Trapezius Strengthening Exercises on Pain, Muscle Function, and Scapular Position in Patients with Rounded Shoulder and Chronic Neck Pain. Physical Therapy Rehabilitation Science. 2021;10:503-11.
Twinkle Y Dabholkar SY, Abichandani Deepa. Comparison of the efficacy of Maitland Thoracic Mobilization and Deep Neck Flexor Endurance Training Versus Only Deep Neck Flexor Endurance Training in Patients with Mechanical Neck Pain. Indian Journal of Physiotherapy and Occupational Therapy. 2014;8(3):6.
Lee KS, Lee JH. Effect of maitland mobilization in cervical and thoracic spine and therapeutic exercise on functional impairment in individuals with chronic neck pain. J Phys Ther Sci. 2017 Mar;29(3):531-535. doi: 10.1589/jpts.29.531. Epub 2017 Mar 22.
PubMed 28356648Howell ER. The association between neck pain, the Neck Disability Index and cervical ranges of motion: a narrative review. J Can Chiropr Assoc. 2011 Sep;55(3):211-21.
PubMed 21886283Park SH, Lee MM. Effects of Lower Trapezius Strengthening Exercises on Pain, Dysfunction, Posture Alignment, Muscle Thickness and Contraction Rate in Patients with Neck Pain; Randomized Controlled Trial. Med Sci Monit. 2020 Mar 23;26:e920208. doi: 10.12659/MSM.920208.
PubMed 32202262Cunha AC, Burke TN, Franca FJ, Marques AP. Effect of global posture reeducation and of static stretching on pain, range of motion, and quality of life in women with chronic neck pain: a randomized clinical trial. Clinics (Sao Paulo). 2008 Dec;63(6):763-70. doi: 10.1590/s1807-59322008000600010.
PubMed 19060998Sowmya. Isometric Neck Exercises versus Dynamic Neck Exercises in Chronic Neck Pain. ournal of Nursing and Health Science. 2014;3(2):32-43.
Behnoush B, Tavakoli N, Bazmi E, Nateghi Fard F, Pourgharib Shahi MH, Okazi A, Mokhtari T. Smartphone and Universal Goniometer for Measurement of Elbow Joint Motions: A Comparative Study. Asian J Sports Med. 2016 Jun 11;7(2):e30668. doi: 10.5812/asjsm.30668. eCollection 2016 Jun.
PubMed 27625754
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transverse Thoracic Mobilization With and Without Lower Trapezius Strengthening Exercises on Pain, Disability and Range of Motion in Patients With Mechanical Neck Pain
- ClinicalTrials.gov ID
- NCT05618951
- Acronym / sponsor ID
- REC/RCR & AHS/22/0153 Salba
- Conditions
- Mechanical Neck Pain
- Keywords
- Neck Pain, Trapezius muscle, Muscle strength, Range of Motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 16 Nov 2022 (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.
Mechanical neck pain is a common musculoskeletal problem, worldwide. Patients with neck pain often have subjective complaints of muscle stiffness, tension, or tightness in addition to their pain located between the occiput and the third thoracic vertebra Approximately 68% of the total population has experienced neck pain at least once in their lifetime, and it easily transforms into a chronic state (that persists for more than 3 months). In today's society, this is conspicuous in many laborers due to the increased use of computers, where the neck and shoulders are maintained in static abnormal postures to look at the computer screens and become vulnerable to cause neck pain. The aim of the study is to determine the comparative effects of transverse thoracic mobilization with and without lower trapezius strengthening exercises on pain, disability and range of motion in patients with mechanical neck pain.
Detailed description
A Randomized controlled trial will be conducted in physiotherapy outpatient department of Syed Medical Complex and Islam Hospital, Sialkot. Non-probability consecutive sampling will be used to collect the data. Sample size of 20 subjects with age group between 18 to 40 years will be taken. Data will be collected by using tools Numeric Pain Rate Scale (NPRS) for pain, Neck Disability Index (NDI) for disability and Universal Goniometer (UG) for range of motion of neck. An informed consent will be taken. A total of 20 subjects will be selected by following inclusion and exclusion criteria and will equally divided in to two groups by random number generator table. Both groups will come thrice per week for a total of 4 weeks. The data will be analyzed using SPSS software version 25. After assessing normality of data by Shapiro-Wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Lower Trapezius Strengthening Exercises | Experimental | Other: Lower Trapezius Strengthening ExercisesHot pack at neck area, upper trapezius stretching neck isometrics transverse mobilization glide and Lower Trapezius strengthening exercise includes: 1. Latissimus pull down 2. Prone V- raise 3. Modified Prone Cobra and Standardized Physical Therapy treatment will be given as Hot pack at neck area, upper trapezius stretching, neck isometrics and transverse mobilization glide. |
| Group B: Standardized Physical Therapy | No intervention | –Hot pack at neck area, upper trapezius stretching neck isometrics transverse mobilization glide Group B given Standardized Physical therapy management |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Males and females between the age range of 18-40 years with mechanical neck pain for at least 3months.
- Examination- Symptoms provoked by neck movement and/or palpation of neck musculature.
- Trapezius Strength Test -To assess lower trapezius muscle strength, patient in prone with shoulder 120 degree abducted and resist the shoulder extension diagonally.
Key exclusion criteria (9 listed)
- Osteoporosis
- Tumors
- Vertebral fractures
- Diagnosed psychological disorders
- Neck pain associated with vertigo
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 |
|---|---|---|
| Lower Trapezius Strengthening ExercisesAlso: Standardized Physical TherapyLower Trapezius strengthening exercise includes: 1. Latissimus pull down 2. Prone V- raise 3. Modified Prone Cobra | Other | Group A: Lower Trapezius Strengthening Exercises |
Primary outcome
Numeric Pain Rate Scale (NPRS)
Time frame: follow up at 4th week
The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults, including those with chronic pain. The NPRS is a segmented numeric version in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of pain. 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"). The NPRS takes <1 minute to complete The NPRS is a valid and reliable scale to measure pain intensity.
Universal Goniometer (UG)
Time frame: follow up at 4th week
A goniometer is an instrument that measures the available range of motion at a joint. To measure the range of motion physical therapists most commonly use a goniometer. It is necessary that a single notation system is used in goniometry. The neutral zero method (0 to 180- degree system) is the most widely used method. The same goniometer should always be used to reduce the chances of instrumental error.
Neck Disability Index (NDI)
Time frame: follow up at 4th week
This questionnaire has been designed to give information about neck pain and the ability to manage it in everyday life. Participants will answer every section and mark only the one box that applies in each section. If two or more statements are in any section related to the participant, mark only one box that is relevant closely. The questionnaire has 10 items concerning pain and activities of daily living, including personal care, lifting, reading, headaches, concentration, work status, driving, sleeping and recreation. Each item is scored out of 5 (with the 'no disability' response given a score of 0), giving a total score of for the questionnaire 50. Higher scores represent more significant disabilities. The result can be expressed as a percentage or raw scores (out of 50).
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 20 Apr 2023.
- Background: PubMed 26957752Lee KW, Kim WH. Effect of thoracic manipulation and deep craniocervical flexor training on pain, mobility, strength, and disability of the neck of patients with chronic nonspecific neck pain: a randomized clinical trial. J Phys Ther Sci. 2016 Jan;28(1):175-80. doi: 10.1589/jpts.28.175. Epub 2016 Jan 30.
- Background: PubMed 34900443Rodriguez-Sanz J, Malo-Urries M, Lucha-Lopez MO, Lopez-de-Celis C, Perez-Bellmunt A, Corral-de-Toro J, Hidalgo-Garcia C. Comparison of an exercise program with and without manual therapy for patients with chronic neck pain and upper cervical rotation restriction. Randomized controlled trial. PeerJ. 2021 Nov 24;9:e12546. doi: 10.7717/peerj.12546. eCollection 2021.
- BackgroundWan-Hee Lee I-KC, Hye-Kang Park. The Effectiveness of Selective Lower Trapezius Strengthening Exercises on Pain, Muscle Function, and Scapular Position in Patients with Rounded Shoulder and Chronic Neck Pain. Physical Therapy Rehabilitation Science. 2021;10:503-11.
- BackgroundTwinkle Y Dabholkar SY, Abichandani Deepa. Comparison of the efficacy of Maitland Thoracic Mobilization and Deep Neck Flexor Endurance Training Versus Only Deep Neck Flexor Endurance Training in Patients with Mechanical Neck Pain. Indian Journal of Physiotherapy and Occupational Therapy. 2014;8(3):6.
- Background: PubMed 28356648Lee KS, Lee JH. Effect of maitland mobilization in cervical and thoracic spine and therapeutic exercise on functional impairment in individuals with chronic neck pain. J Phys Ther Sci. 2017 Mar;29(3):531-535. doi: 10.1589/jpts.29.531. Epub 2017 Mar 22.
- Background: PubMed 21886283Howell ER. The association between neck pain, the Neck Disability Index and cervical ranges of motion: a narrative review. J Can Chiropr Assoc. 2011 Sep;55(3):211-21.
- Background: PubMed 32202262Park SH, Lee MM. Effects of Lower Trapezius Strengthening Exercises on Pain, Dysfunction, Posture Alignment, Muscle Thickness and Contraction Rate in Patients with Neck Pain; Randomized Controlled Trial. Med Sci Monit. 2020 Mar 23;26:e920208. doi: 10.12659/MSM.920208.
- Background: PubMed 19060998Cunha AC, Burke TN, Franca FJ, Marques AP. Effect of global posture reeducation and of static stretching on pain, range of motion, and quality of life in women with chronic neck pain: a randomized clinical trial. Clinics (Sao Paulo). 2008 Dec;63(6):763-70. doi: 10.1590/s1807-59322008000600010.
- BackgroundSowmya. Isometric Neck Exercises versus Dynamic Neck Exercises in Chronic Neck Pain. ournal of Nursing and Health Science. 2014;3(2):32-43.
- Background: PubMed 27625754Behnoush B, Tavakoli N, Bazmi E, Nateghi Fard F, Pourgharib Shahi MH, Okazi A, Mokhtari T. Smartphone and Universal Goniometer for Measurement of Elbow Joint Motions: A Comparative Study. Asian J Sports Med. 2016 Jun 11;7(2):e30668. doi: 10.5812/asjsm.30668. eCollection 2016 Jun.
- Individual participant dataSharing planned: No
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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.
Samrood Akram, Mphil principal investigator
Riphah International University,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 Lower Trapezius Strengthening Exercises in people with Mechanical 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 9 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 20 Apr 2023. 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 Rate Scale (NPRS) (time frame: follow up at 4th week). The study lists 3 primary outcomes in all. 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 NCT05618951, which also lists 10 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 20 Apr 2023.