Chronic Neck PainNCT06707870
Comparison of Cervical Retraction Exercise and Facet Oscillatory Mobilization in Chronic Mechanical Neck Pain
A study testing Cervical retraction exercise and Facet oscillatory mobilization in people with Chronic Neck Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
To compare the effects of Cervical Retraction Exercise and Facet Oscillatory Mobilization in chronic Mechanical Neck pain. To compare the effects of Cervical Retraction Exercise and Facet Oscillatory Mobilization in chronic Mechanical Neck pain at improving Neck Disability. Read more about this study
- Who is it for?
- Ages 35 to 50 years
- Conditions the study is for
- Chronic Neck Pain
- What is being tested?
- Cervical retraction exercise and Facet oscillatory mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2024to 13 Dec 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants falling in this category would be recruited into the study.
- Participants were patients with a complaint of Chronic Mechanical neck pain (> 6 weeks).
- Neck Disability Index (NDI) score > 16%
- Age between 35-50 years, Both Male and Female
- NPRS score >3-6.
- Recurrent neck pain aggravated at least once in the month.
Show all 10Show fewer
- Painful Cervical ROM (Flexion <80 Extension<70 rotation<90 to both sides and lateral flexion <35 degree.
- Spurling test negative
- Patients willing to participates in the study after filling the consent form.
- Upper Limb Nerve tension test (Median, Radial, and Ulnar negative).
Who cannot join
- Participant failing to fall in this category would be excluded of the study.
- Cervical radiculopathy
- Cervical canal stenosis
- Severe neurological disorder
- Previous cervical surgery
- Recent history of fall/trauma to the cervical spine.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Khyber Teaching hospital
Peshawar, KPK, 25000
Dr Amman Ullah Nazir, PhD*, 03335330065, aman.nazir@riphah.edu.pk
Imran Amjad, PhD*, 051-5481826, imran.amjad@riphah.edu.pk
About this study
Official title: Compare the Effectiveness of Cervical Retraction Exercise and Facet Oscillatory Mobilization in Improving Pain, Ranges and Disability in Patients With Chronic Mechanical Neck Pain.
To compare the effects of Cervical Retraction Exercise and Facet Oscillatory Mobilization in chronic Mechanical Neck pain.
To compare the effects of Cervical Retraction Exercise and Facet Oscillatory Mobilization in chronic Mechanical Neck pain at improving Neck Disability.
To compare the effects of Cervical Retraction Exercise and Facet Oscillatory Mobilization in chronic Mechanical Neck pain at Improving Range of Motion The study design used for this literature would be Randomized Control Trial This study would include total 32 participants which would be divided into two groups, 16 each.
Read the detailed description
Neck pain is a common disorder in the general population leading to disability in terms of patient's physical, social and emotional well-being. Current data suggest that 22% to 70% of people experience neck pain at some point of their lives. In the developed world, the prevalence of the chronic neck pain is reported to be ranging from 7% to 22% among women and from 5% to 16% among men. Prevalence studies showed that cervical pain is more prevalent among middle-aged women compared to their male counterparts. When the duration of symptoms is greater than 12 weeks of evolution, it acquires the value of chronicity. Chronic neck pain, occurring in approximately 50% of the global population, has a substantial societal burden. Adults with neck pain commonly experience hyperalgesia of cervical muscles, as evidenced by a reduced pressure pain threshold. Neck pain incidence raises with age and is greatest in the third and fourth decades of life with more prevalence in females. The reduced range of neck motion (ROM) is another objective finding widely investigated in chronic neck pain. It could be argued that the optimal functioning of the cervical musculature is related to the ROM; changes in neck muscle activation that result in an altered stiffness distribution may affect cervical passive stability as well as the passive and active ROM. When evaluating a patient with neck pain, the physician must be alert for red flags in the history and physical examination that may indicate the need for urgent testing and intervention. NNP is a symptom with a multifactorial etiology, and studies show its strong correlation with depression, anxiety, headache, sedentary life, sleep disorders and smoking. Risk factors for developing NNP include cervical trauma such as whiplash, sports injuries and sedentary seated work(10) Musculoskeletal disorders occurring in the neck include neck pain, cervical strain, sprain, facet joint syndrome, ruptured cervical disk, and myofascial pain syndrome, common symptoms caused by these diseases include neck pain, decreased joint range of motion, and muscle over-tension. Neck pain, which is the most common in neck diseases, limits the range of motion of the neck and causes neck dysfunction by causing crepitation and stiffness of the neck. The structural arrangement of the cervical spine makes it susceptible to mechanical changes, often triggered by degenerative shifts and improper posture, resulting in prevalent neck discomfort, with a 54% prevalence rate over 6 months. There are many methods of diagnosis both radiological and manual testing. Radiological tests include X.RAY, MRI, and CT. while manual testing includes compression and traction tests to rule out neurological or joint dysfunction. Palpation to check tenderness and manual muscle testing for neck muscles strength. Physical therapy interventions for chronic neck pain include diverse treatment approaches including manual therapy, isometrics, heating modalities stretching etc. that not only reduces pain but also increases functional ability of patient. From physiotherapist point of view it's important to use an effective manual technique that provides us with highest pain relief, improve mobility and maximum functional restoration and NAGS and SNAGS by brain mulligan are an effective approach. Cervical retraction exercise is performed with patients either in sitting or standing in an upright position while pushing their chin backward and simultaneously raising their head within the pain-free range (3 seconds). In manual therapy, joints are assessed and treated relying on the current knowledge about their kinematics, however, only limited information is available about the upper cervical spine and how its kinematics are influenced by manual mobilization. In terms of preference of techniques for the management of neck pain, exercise therapy and manual therapy are mostly applied by physiotherapists. Manual therapy techniques include joint mobilization and soft tissue mobilization techniques. Restoration of joint arthrokinematics is achieved by joint mobilizations, whereas soft tissue techniques, such as muscle energy techniques (MET) and static stretching, focus on flexibility of soft tissues, like extensibility of muscle and connective tissues. Conventional static stretching is commonly applied in the management of neck pain and other mechanical disorders, but it directs effect only on the passive component of muscle, like connective tissues or perimysium, whereas METs focus on the active component of muscle tone in addition to the passive component.
- Conditions
- Chronic Neck Pain
- Being tested
- Cervical retraction exercise, Facet oscillatory mobilization
- Keywords
- Chronic neck pain, Facet oscillatory mobilization, Cervical retraction exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical retraction exerciseOther
Neck retraction exercises are performed on patients either in sitting or standing in an upright position while pushing their chin backward and simultaneously raising their head within the pain-free range (3 seconds hold)of 10 repetitions in each session at sitting position. Conventional treatment (TENS (2 to 10 Hz),10 mints, Heating pad, stretching of tight muscles Trapezius and SCM)should be included.
The patients will received 20-30-minute sessions on 3 alternate days for two consecutive weeks, making it a total of 6 sessions. Patients were advised to revisit after 4 weeks (1 month from the baseline) for follow-up.
Facet oscillatory mobilizationOther
Facet joint oscillatory mobilization on the cervical spine C2-C7(6 to 10 repetitions in each session) in the sitting position.
Conventional treatment (TENS (2 to 10 Hz) 10 mints, Heating pad, stretching of tight muscles Trapezius and SCM) should be included.
The patients will received 20-30-minute sessions on 3 alternate days for two consecutive weeks, making it a total of 6 sessions. Patients were advised to revisit after 4 weeks (1 month from the baseline) for follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Cervical retraction exercise | Experimental | Cervical retraction exercise Receives: Other: Cervical retraction exercise |
| Facet oscillatory mobilization | Experimental | Facet oscillatory mobilization Receives: Other: Facet oscillatory mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck disability index
This questionnaire has been designed to give us information as to how your neck pain has affected your ability to manage in everyday life.
Score: /50 Transform to percentage score x 100 = %points. It has 7 items for daily living, 2 for pain and 1 for concentration. Each item is rated from 0 to 5. Total score is presented in percentage. Higher score tells greater disability while 0 means no disability. Total score is 50. In cervical radiculopathy patients it has moderate test retest reliability ICC= 0.68 .The NDI has a fair to moderate test-retest reliability in patients with mechanical neck pain but also for patients with cervical radiculopathy. The NDI has a good construct validity.
Measured: 6 weeks
Numerical pain rating scale
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her 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") High test-retest reliability has been observed in both literate and illiterate patients with rheumatoid arthritis (r = 0.96 and 0.95, respectively) before and after medical consultation.
Measured: 6 weeks
Inclinometer
An inclinometer is a device used to measure angles. It is commonly used in physiotherapy to measure the range of motion (ROM) of joints and very similar to a goniometer.
The digital inclinometer demonstrated excellent reliability (ICC=0.75-0.86), except for the right lateral flexion (ICC=0.74) and left rotation (ICC=0.72).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start1 May 2024
- Primary completion13 Dec 2024 (estimated)
- Study completion13 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Faheem Ullah Jan, MS-OMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06707870
- Sponsor's protocol ID
- Riphah/RCRAHS/REC/MS-PT/01931
- Status last verified
- Nov 2024
- First submitted
- 25 Nov 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alansari SM, Youssef EF, Shanb AA. Efficacy of manual therapy on psychological status and pain in patients with neck pain. A randomized clinical trial. Saudi Med J. 2021 Jan;42(1):82-90. doi: 10.15537/smj.2021.1.25589.
PubMed 33399175Phadke A, Bedekar N, Shyam A, Sancheti P. Effect of muscle energy technique and static stretching on pain and functional disability in patients with mechanical neck pain: A randomized controlled trial. Hong Kong Physiother J. 2016 Apr 14;35:5-11. doi: 10.1016/j.hkpj.2015.12.002. eCollection 2016 Dec.
PubMed 30931028
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare the Effectiveness of Cervical Retraction Exercise and Facet Oscillatory Mobilization in Improving Pain, Ranges and Disability in Patients With Chronic Mechanical Neck Pain.
- ClinicalTrials.gov ID
- NCT06707870
- Acronym / sponsor ID
- Riphah/RCRAHS/REC/MS-PT/01931
- Conditions
- Chronic Neck Pain
- Keywords
- Chronic neck pain, Facet oscillatory mobilization, Cervical retraction exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 13 Dec 2024 (estimated)
- Study completion
- 13 Dec 2024 (estimated)
- First posted
- 27 Nov 2024 (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.
To compare the effects of Cervical Retraction Exercise and Facet Oscillatory Mobilization in chronic Mechanical Neck pain.
To compare the effects of Cervical Retraction Exercise and Facet Oscillatory Mobilization in chronic Mechanical Neck pain at improving Neck Disability.
To compare the effects of Cervical Retraction Exercise and Facet Oscillatory Mobilization in chronic Mechanical Neck pain at Improving Range of Motion The study design used for this literature would be Randomized Control Trial This study would include total 32 participants which would be divided into two groups, 16 each.
Detailed description
Neck pain is a common disorder in the general population leading to disability in terms of patient's physical, social and emotional well-being. Current data suggest that 22% to 70% of people experience neck pain at some point of their lives. In the developed world, the prevalence of the chronic neck pain is reported to be ranging from 7% to 22% among women and from 5% to 16% among men. Prevalence studies showed that cervical pain is more prevalent among middle-aged women compared to their male counterparts. When the duration of symptoms is greater than 12 weeks of evolution, it acquires the value of chronicity. Chronic neck pain, occurring in approximately 50% of the global population, has a substantial societal burden. Adults with neck pain commonly experience hyperalgesia of cervical muscles, as evidenced by a reduced pressure pain threshold. Neck pain incidence raises with age and is greatest in the third and fourth decades of life with more prevalence in females. The reduced range of neck motion (ROM) is another objective finding widely investigated in chronic neck pain. It could be argued that the optimal functioning of the cervical musculature is related to the ROM; changes in neck muscle activation that result in an altered stiffness distribution may affect cervical passive stability as well as the passive and active ROM. When evaluating a patient with neck pain, the physician must be alert for red flags in the history and physical examination that may indicate the need for urgent testing and intervention. NNP is a symptom with a multifactorial etiology, and studies show its strong correlation with depression, anxiety, headache, sedentary life, sleep disorders and smoking. Risk factors for developing NNP include cervical trauma such as whiplash, sports injuries and sedentary seated work(10) Musculoskeletal disorders occurring in the neck include neck pain, cervical strain, sprain, facet joint syndrome, ruptured cervical disk, and myofascial pain syndrome, common symptoms caused by these diseases include neck pain, decreased joint range of motion, and muscle over-tension. Neck pain, which is the most common in neck diseases, limits the range of motion of the neck and causes neck dysfunction by causing crepitation and stiffness of the neck. The structural arrangement of the cervical spine makes it susceptible to mechanical changes, often triggered by degenerative shifts and improper posture, resulting in prevalent neck discomfort, with a 54% prevalence rate over 6 months. There are many methods of diagnosis both radiological and manual testing. Radiological tests include X.RAY, MRI, and CT. while manual testing includes compression and traction tests to rule out neurological or joint dysfunction. Palpation to check tenderness and manual muscle testing for neck muscles strength. Physical therapy interventions for chronic neck pain include diverse treatment approaches including manual therapy, isometrics, heating modalities stretching etc. that not only reduces pain but also increases functional ability of patient. From physiotherapist point of view it's important to use an effective manual technique that provides us with highest pain relief, improve mobility and maximum functional restoration and NAGS and SNAGS by brain mulligan are an effective approach. Cervical retraction exercise is performed with patients either in sitting or standing in an upright position while pushing their chin backward and simultaneously raising their head within the pain-free range (3 seconds). In manual therapy, joints are assessed and treated relying on the current knowledge about their kinematics, however, only limited information is available about the upper cervical spine and how its kinematics are influenced by manual mobilization. In terms of preference of techniques for the management of neck pain, exercise therapy and manual therapy are mostly applied by physiotherapists. Manual therapy techniques include joint mobilization and soft tissue mobilization techniques. Restoration of joint arthrokinematics is achieved by joint mobilizations, whereas soft tissue techniques, such as muscle energy techniques (MET) and static stretching, focus on flexibility of soft tissues, like extensibility of muscle and connective tissues. Conventional static stretching is commonly applied in the management of neck pain and other mechanical disorders, but it directs effect only on the passive component of muscle, like connective tissues or perimysium, whereas METs focus on the active component of muscle tone in addition to the passive component.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervical retraction exercise | Experimental | Other: Cervical retraction exerciseCervical retraction exercise |
| Facet oscillatory mobilization | Experimental | Other: Facet oscillatory mobilizationFacet oscillatory mobilization |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Participants falling in this category would be recruited into the study.
Key exclusion criteria (6 listed)
- Participant failing to fall in this category would be excluded of the study.
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 retraction exerciseNeck retraction exercises are performed on patients either in sitting or standing in an upright position while pushing their chin backward and simultaneously raising their head within the pain-free range (3 seconds hold)of 10 repetitions in each session at sitting position. Conventional treatment (TENS (2 to 10 Hz),10 mints, Heating pad, stretching of tight muscles Trapezius and SCM)should be included. The patients will received 20-30-minute sessions on 3 alternate days for two consecutive weeks, making it a total of 6 sessions. Patients were advised to revisit after 4 weeks (1 month from the baseline) for follow-up. | Other | Cervical retraction exercise |
| Facet oscillatory mobilizationFacet joint oscillatory mobilization on the cervical spine C2-C7(6 to 10 repetitions in each session) in the sitting position. Conventional treatment (TENS (2 to 10 Hz) 10 mints, Heating pad, stretching of tight muscles Trapezius and SCM) should be included. The patients will received 20-30-minute sessions on 3 alternate days for two consecutive weeks, making it a total of 6 sessions. Patients were advised to revisit after 4 weeks (1 month from the baseline) for follow-up. | Other | Facet oscillatory mobilization |
Primary outcome
Neck disability index
Time frame: 6 weeks
This questionnaire has been designed to give us information as to how your neck pain has affected your ability to manage in everyday life. Score: /50 Transform to percentage score x 100 = %points. It has 7 items for daily living, 2 for pain and 1 for concentration. Each item is rated from 0 to 5. Total score is presented in percentage. Higher score tells greater disability while 0 means no disability. Total score is 50. In cervical radiculopathy patients it has moderate test retest reliability ICC= 0.68 .The NDI has a fair to moderate test-retest reliability in patients with mechanical neck pain but also for patients with cervical radiculopathy. The NDI has a good construct validity.
Numerical pain rating scale
Time frame: 6 weeks
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her 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") High test-retest reliability has been observed in both literate and illiterate patients with rheumatoid arthritis (r = 0.96 and 0.95, respectively) before and after medical consultation.
Inclinometer
Time frame: 6 weeks
An inclinometer is a device used to measure angles. It is commonly used in physiotherapy to measure the range of motion (ROM) of joints and very similar to a goniometer. The digital inclinometer demonstrated excellent reliability (ICC=0.75-0.86), except for the right lateral flexion (ICC=0.74) and left rotation (ICC=0.72).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Background: PubMed 33399175Alansari SM, Youssef EF, Shanb AA. Efficacy of manual therapy on psychological status and pain in patients with neck pain. A randomized clinical trial. Saudi Med J. 2021 Jan;42(1):82-90. doi: 10.15537/smj.2021.1.25589.
- Background: PubMed 30931028Phadke A, Bedekar N, Shyam A, Sancheti P. Effect of muscle energy technique and static stretching on pain and functional disability in patients with mechanical neck pain: A randomized controlled trial. Hong Kong Physiother J. 2016 Apr 14;35:5-11. doi: 10.1016/j.hkpj.2015.12.002. eCollection 2016 Dec.
- 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.
Faheem Ullah Jan, MS-OMPT 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 retraction exercise and Facet oscillatory mobilization in people with Chronic 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 10 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 27 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Aman Ullah Nazir, PhD* (03335330065, aman.nazir@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck disability index (time frame: 6 weeks). 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 NCT06707870, which also lists 2 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 27 Nov 2024.