Neck PainNCT05649397
Effects of Cervical Spine Manipulation in Patients With Mechanical Neck Pain
A study testing cervical manipulation and conventional therapy in people with Neck Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
Mechanical neck pain is known as one of the most common disorders in musculoskeletal system. In elderly population, prevalence of neck pain ranges up to 38% while point prevalence and lifetime prevalence ranges from 6% to 22% and 14.2% to 71% respectively . Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- cervical manipulation and conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2022to 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with non-radiating neck pain of moderate intensity scoring 4-8 on the numeric pain rating scale (NPRS)
- Have a Neck Disability Index (NDI) score of 20% or greater (10 points or greater on a 0-to-50 scale)
- Patients who have cervical joint position error greater than 7.1 cm or 4.5 degrees
Who cannot join
- Patients with a positive history of trauma, fracture or surgery of the cervical spine .
- anatomical cervical spine abnormality
- presented with any neurological signs
- history of benign paroxysmal positional vertigo
- Neck pain with radiation to the arm and upper extremity .
- Diagnosed cases of torticollis, and scoliosis
- History of osteoporosis, Any cardiac disorder
- had participated in a neck exercise program in the past 6 months .
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah international hospital Sihala
Islamabad, Punjab Province
About this study
Official title: Effects of Cervical Spine Manipulation on Proprioception, Blood Pressure and Respiratory Rate in Patients With Mechanical Neck Pain
Mechanical neck pain is known as one of the most common disorders in musculoskeletal system. In elderly population, prevalence of neck pain ranges up to 38% while point prevalence and lifetime prevalence ranges from 6% to 22% and 14.2% to 71% respectively . Neck pain is defined by the international association for the study of pain as: "Pain perceived as arising from anywhere within the region bounded superiorly by superior nuchal line, inferior by transverse line through the tip of first thoracic spinous process, and laterally by sagittal plane tangential to the lateral border of neck" . There are variable causes of neck pain like trauma, infections, inflammatory conditions, musculoskeletal conditions, rheumatic diseases, and congenital diseases . There are varying degrees of disability and activity limitation caused by neck pain, like work productivity reduction and decrease quality of life . People who have a sedentary lifestyle, poor occupational postures, students with poor posture, people involved in occupation like computer programming, clerical job workers and desk job works are more likely to suffer from mechanical neck pain . Most common cause of mechanical neck pain is muscle tightness, Upper trapezius and levator scapulae are the most involved muscles
Read the detailed description
Neck pain can over time negatively affect the central processing of any afferent input received because it can create a disturbance in the proprioceptive input to the Central Nervous System. Vuillerme stated that cervical muscle proprioceptors are stimulated by painful electrical stimuli. Therefore, joint proprioception can be affected in patients with mechanical neck pain .
The conservative management of mechanical neck pain includes many treatment options like electrotherapy which includes moist heat, Transcutaneous Electrical Nerve Stimulation therapy and different manual therapy options like cervical and thoracic mobilization and manipulation, Natural Apophyseal Glides and Sustained Natural Apophyseal Glides, Cyriax technique, manual pressure release, ischemic compression and proprioceptive neuromuscular facilitation. Postural reeducation and strength training of weak muscle group has beneficial effects. Joint mobilization and manipulation are widely used as a treatment for mechanical neck pain, as cervical mobilizations which are low velocity passive oscillatory movements are used by 90% of physiotherapist and chiropractors to treat people with neck pain.
- Conditions
- Neck Pain
- Being tested
- cervical manipulation, conventional therapy
- Keywords
- pain, proprioception, blood pressure, respiratory rate, cervical manipulation
- Medical subject headings
- Neck Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cervical manipulationOther
provide a high velocity, low-amplitude manipulation to each subject's cervical spine.
conventional therapyOther
15 mins moist hot pack Neck Isometric exercise hold for 5-8 seconds and repeat 10 times Cervical range of motion 10 repetitions of movement in rotation within pain free range
| Study group | Role | What they receive |
|---|---|---|
| cervical manipulation | Experimental | in the cervical manipulation, provide a high velocity, low-amplitude manipulation to each subject's cervical spine. Receives: Other: cervical manipulation |
| conventional therapy | Active comparator | * 15 mins moist hot pack
* Neck Isometric exercise
* hold for 5-8 seconds and repeat 10 times
* Cervical range of motion
* 10 repetitions of movement in rotation within pain free range Receives: Other: conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Joint position sense test
A target is placed on a wall 90cm away from the patient, at the patient's head height in sitting. The target is typically 40cm in diameter with concentric circles in 1cm increments. A laser pointer or similar targeting device is mounted onto a lightweight headband is then placed on the patient's head. The patient is then asked to focus on finding natural resting head position so that the laser pointer is in line with the center or "bullseye" of the target. With eyes closed, the patient will actively move their head in one plane of motion and attempt to return to the starting position as accurately as possible.
Measured: four weeks
Digital sphygmomanometer
It is the most technologically advanced sphygmomanometer. It consists of an electronic sensor to measure the blood pressure and the readings are displayed on the digital monitor. To measure the blood pressure, the instrument measures the fluctuations of arteries
Measured: four weeks
Respiratory rate measurement
To measure the respiratory rate of a person, ask the person to rest quietly for a moment. Start a timer for 60 seconds and count every time they breathe. Use the second hand on your watch or a timer on your phone to keep track of the person's breathing for exactly 1 minute. Once the minute starts, count every time you see their chest rise .
Measured: four weeks
NPRS (Numeric Pain Rating Scale).
The Numeric Pain Rating Scale (NPRS) measures the subjective intensity of pain. The NPRS is an eleven-point scale from 0 to 10. "0" = no pain and "10" = the most intense pain imaginable while the NPRS exhibited moderate reliability
Measured: four weeks
NDI (U) (Neck Disability Index)
The neck disability index is a ten-item self-reported questionnaire that assesses pain and associated disability, with a total max score of 50 points. An Urdu version of neck disability index will be used in this study. An intra-class correlation coefficient (ICC) revealed excellent test-retest reliability for all items (ICC = 0.86-0.98) and total scores (ICC = 0.99) of the NDI-U
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start1 Dec 2022
- 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
- 30 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
- NCT05649397
- Sponsor's protocol ID
- REC- 01395 Hafsa Bint Bilal
- Status last verified
- Jul 2023
- First submitted
- 6 Dec 2022
- Last updated
- 27 Jul 2023
- 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 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cervical Spine Manipulation on Proprioception, Blood Pressure and Respiratory Rate in Patients With Mechanical Neck Pain
- ClinicalTrials.gov ID
- NCT05649397
- Acronym / sponsor ID
- REC- 01395 Hafsa Bint Bilal
- Conditions
- Neck Pain
- Keywords
- pain, proprioception, blood pressure, respiratory rate, cervical manipulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 10 Jul 2023 (actual)
- Study completion
- 10 Jul 2023 (actual)
- First posted
- 14 Dec 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 known as one of the most common disorders in musculoskeletal system. In elderly population, prevalence of neck pain ranges up to 38% while point prevalence and lifetime prevalence ranges from 6% to 22% and 14.2% to 71% respectively . Neck pain is defined by the international association for the study of pain as: "Pain perceived as arising from anywhere within the region bounded superiorly by superior nuchal line, inferior by transverse line through the tip of first thoracic spinous process, and laterally by sagittal plane tangential to the lateral border of neck" . There are variable causes of neck pain like trauma, infections, inflammatory conditions, musculoskeletal conditions, rheumatic diseases, and congenital diseases . There are varying degrees of disability and activity limitation caused by neck pain, like work productivity reduction and decrease quality of life . People who have a sedentary lifestyle, poor occupational postures, students with poor posture, people involved in occupation like computer programming, clerical job workers and desk job works are more likely to suffer from mechanical neck pain . Most common cause of mechanical neck pain is muscle tightness, Upper trapezius and levator scapulae are the most involved muscles
Detailed description
Neck pain can over time negatively affect the central processing of any afferent input received because it can create a disturbance in the proprioceptive input to the Central Nervous System. Vuillerme stated that cervical muscle proprioceptors are stimulated by painful electrical stimuli. Therefore, joint proprioception can be affected in patients with mechanical neck pain .
The conservative management of mechanical neck pain includes many treatment options like electrotherapy which includes moist heat, Transcutaneous Electrical Nerve Stimulation therapy and different manual therapy options like cervical and thoracic mobilization and manipulation, Natural Apophyseal Glides and Sustained Natural Apophyseal Glides, Cyriax technique, manual pressure release, ischemic compression and proprioceptive neuromuscular facilitation. Postural reeducation and strength training of weak muscle group has beneficial effects. Joint mobilization and manipulation are widely used as a treatment for mechanical neck pain, as cervical mobilizations which are low velocity passive oscillatory movements are used by 90% of physiotherapist and chiropractors to treat people with neck pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cervical manipulation | Experimental | Other: cervical manipulationin the cervical manipulation, provide a high velocity, low-amplitude manipulation to each subject's cervical spine. |
| conventional therapy | Active comparator | Other: conventional therapy* 15 mins moist hot pack * Neck Isometric exercise * hold for 5-8 seconds and repeat 10 times * Cervical range of motion * 10 repetitions of movement in rotation within pain free range |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with non-radiating neck pain of moderate intensity scoring 4-8 on the numeric pain rating scale (NPRS)
- Have a Neck Disability Index (NDI) score of 20% or greater (10 points or greater on a 0-to-50 scale)
- Patients who have cervical joint position error greater than 7.1 cm or 4.5 degrees
Key exclusion criteria (8 listed)
- Patients with a positive history of trauma, fracture or surgery of the cervical spine .
- anatomical cervical spine abnormality
- presented with any neurological signs
- history of benign paroxysmal positional vertigo
- Neck pain with radiation to the arm and upper extremity .
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 |
|---|---|---|
| cervical manipulationprovide a high velocity, low-amplitude manipulation to each subject's cervical spine. | Other | cervical manipulation |
| conventional therapy15 mins moist hot pack Neck Isometric exercise hold for 5-8 seconds and repeat 10 times Cervical range of motion 10 repetitions of movement in rotation within pain free range | Other | conventional therapy |
Primary outcome
Joint position sense test
Time frame: four weeks
A target is placed on a wall 90cm away from the patient, at the patient's head height in sitting. The target is typically 40cm in diameter with concentric circles in 1cm increments. A laser pointer or similar targeting device is mounted onto a lightweight headband is then placed on the patient's head. The patient is then asked to focus on finding natural resting head position so that the laser pointer is in line with the center or "bullseye" of the target. With eyes closed, the patient will actively move their head in one plane of motion and attempt to return to the starting position as accurately as possible.
Digital sphygmomanometer
Time frame: four weeks
It is the most technologically advanced sphygmomanometer. It consists of an electronic sensor to measure the blood pressure and the readings are displayed on the digital monitor. To measure the blood pressure, the instrument measures the fluctuations of arteries
Respiratory rate measurement
Time frame: four weeks
To measure the respiratory rate of a person, ask the person to rest quietly for a moment. Start a timer for 60 seconds and count every time they breathe. Use the second hand on your watch or a timer on your phone to keep track of the person's breathing for exactly 1 minute. Once the minute starts, count every time you see their chest rise .
NPRS (Numeric Pain Rating Scale).
Time frame: four weeks
The Numeric Pain Rating Scale (NPRS) measures the subjective intensity of pain. The NPRS is an eleven-point scale from 0 to 10. "0" = no pain and "10" = the most intense pain imaginable while the NPRS exhibited moderate reliability
NDI (U) (Neck Disability Index)
Time frame: four weeks
The neck disability index is a ten-item self-reported questionnaire that assesses pain and associated disability, with a total max score of 50 points. An Urdu version of neck disability index will be used in this study. An intra-class correlation coefficient (ICC) revealed excellent test-retest reliability for all items (ICC = 0.86-0.98) and total scores (ICC = 0.99) of the NDI-U
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 27 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Neck Pain
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Recruiting
Strain Counter Strain and Conventional Stretching in School-aged Children With Mechanical Neck Pain Due to Prolong Screen Use
Mechanical Neck Pain
Recruiting
Effects of Alexander Technique Versus Feldenkrais Somatic Training in Patients With Text Neck Syndrome
Text Neck Syndrome
Recruiting
Longitudinal Stripping Massage vs. Percussion Device for Neck Pain: Ultrasound Study.
Chronic Neck Pain
RecruitingPhase 2
Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot Study
Cancer Pain, Orofacial Pain
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 cervical manipulation and conventional therapy 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 8 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 27 Jul 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?
Joint position sense test (time frame: four weeks). The study lists 5 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 27 Jul 2023.