Mechanical Neck PainNCT05404659
Comparative Effects of Oscillatory Mobilizations and Mckenzie Retraction Exercises on Mechanical Neck Pain
A study testing Oscillatory Mobilization and Mckenzie Retraction Exercises in people with Mechanical Neck Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
The neck pain is a public health problem and a common source of disability in the general population. Its exact pathology remains obscure, but the source of symptoms has been asserted to involve mechanical dysfunction of the cervical spine, particularly the zygoapophysial joints. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Mechanical Neck Pain
- What is being tested?
- Oscillatory Mobilization and Mckenzie Retraction Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 25 May 2022to 25 Jan 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
- Patient with primary complaint of non specific neck pain. Pain of sufficient intensity (greater than 2 out of 10 on numerical pain scale) · Pain and stiffness for at least 2 weeks Pain aggravated by neck movement ·
Who cannot join
- History of orthopedic surgery to the neck and shoulder and Temporo-mandibular Joint neurological symptoms due to cervical dysfunction History of Carcinoma Progressive neurological deficits
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Arif Memorial Teaching Hospital
Lahore, Punjab Province, 54000
Saba Rafique, Phd*, +923034045433, saba.rafique@riphah.edu.pk
Hafiza Nida Rasheed, MsPT (OMPT)
About this study
Official title: Comparative Effects of Oscillatory Mobilizations and Mckenzie Retraction Exercises on Pain, Range of Motion and Disability in Patients With Mechanical Neck Pain
The neck pain is a public health problem and a common source of disability in the general population. Its exact pathology remains obscure, but the source of symptoms has been asserted to involve mechanical dysfunction of the cervical spine, particularly the zygoapophysial joints. Among the diversity of neck pain, mechanical neck pain is the most common type, with the pain primarily confined in the area on the posterior aspect of the neck that can be exacerbated by neck movements or by sustained neck postures. The usual clinical presentation of this mechanical neck pain is a reduction in mobility of either a single segment or multiple segments of the cervical spine in association with pain. This study will be a randomized control trial and will be conducted at Arif Memorial Teaching Hospital Lahore. The study will be completed within the time duration of six months. Convenience sampling technique will be used to collect data. A sample size of 30 patients(15 in each group) which will fulfill inclusion criteria will be taken in the study. Participants will be divided into two groups. Both Groups will be given conventional physical therapy and postural correction education. Group A will be provide oscillatory mobilizations. The following grades will be use: grades I and II for pain and grades III and IV to increase joint range of motion. This oscillatory mobilization will perform at a rate of 2-3 oscillations per second. and a frequency of 3-4 mobilization of the joint lasting approximately 30 sec each.
The rest time between each mobilization will be one minute for 5 days a week for four weeks , while group B will be treat withmckenzie retraction exercises in which foursets of 10-15 repetitions with 1-2 minutes rest between each set for 5 days a week during four weeks. Data will collect by using tools like numeric pain rating scale to measure pain, universal goniometer will be use for range of motion and disability level will be record pre and post treatment by using neck disability index. Then data will analyzed by using SPSS.
- Conditions
- Mechanical Neck Pain
- Being tested
- Oscillatory Mobilization, Mckenzie Retraction Exercises
- Keywords
- Cervical spine, exercise therapy, pain, Manual therapy
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oscillatory MobilizationOther
conventional physical therapy treatment, postural correction and maitland's oscillatory mobilizitions.
Mckenzie Retraction ExercisesOther
conventional physical therapy treatment, postural correction and Mckenzie retraction exercises.
| Study group | Role | What they receive |
|---|---|---|
| Oscillatory Mobilizations | Active comparator | Not described Receives: Other: Oscillatory Mobilization |
| Mckenzie Retraction Exercises | Experimental | Not described Receives: Other: Mckenzie Retraction Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck pain
Numeric pain rating scale is valid and reliable tool to measure pain
Measured: 5 week
Range of motion
Goniometre is used to measure ROM. It measurement has been found to have greater intra-tester reliability in both clinical and research settings
Measured: 5 week
Disability
The Neck Disability Index is the most widely used instrument for assessing self-rated disability in patients with neck pain
Measured: 5 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start25 May 2022 (estimated)
- Primary completion25 Oct 2022 (estimated)
- Study completion25 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saba Rafique, Phd*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05404659
- Sponsor's protocol ID
- REC/RCR&AHS/22/0124
- Status last verified
- May 2022
- First submitted
- 31 May 2022
- Last updated
- 3 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Osama M, Shakil Ur Rehman S. Effects of static stretching as compared to autogenic inhibition and reciprocal inhibition muscle energy techniques in the management of mechanical neck pain: a randomized controlled trial. J Pak Med Assoc. 2020 May;70(5):786-790. doi: 10.5455/JPMA.9596.
PubMed 32400728Hassan F, Osama M, Ghafoor A, Yaqoob MF. Effects of oscillatory mobilization as compared to sustained stretch mobilization in the management of cervical radiculopathy: A randomized controlled trial. J Back Musculoskelet Rehabil. 2020;33(1):153-158. doi: 10.3233/BMR-170914.
PubMed 31127753Shabbir M, Arshad N, Naz A, Saleem N. Clinical outcomes of maitland mobilization in patients with Myofascial Chronic Neck Pain: A randomized controlled trial. Pak J Med Sci. 2021 Jul-Aug;37(4):1172-1178. doi: 10.12669/pjms.37.4.4220.
PubMed 34290803Raja G P, Bhat N S, Fernandez-de-Las-Penas C, Gangavelli R, Davis F, Shankar R, Prabhu A. Effectiveness of deep cervical fascial manipulation and yoga postures on pain, function, and oculomotor control in patients with mechanical neck pain: study protocol of a pragmatic, parallel-group, randomized, controlled trial. Trials. 2021 Aug 28;22(1):574. doi: 10.1186/s13063-021-05533-w.
PubMed 34454582Young IA PT, DSc, Dunning J PT, DPT, Butts R PT, PhD, Mourad F PT, DPT, Cleland JA PT, PhD. Reliability, construct validity, and responsiveness of the neck disability index and numeric pain rating scale in patients with mechanical neck pain without upper extremity symptoms. Physiother Theory Pract. 2019 Dec;35(12):1328-1335. doi: 10.1080/09593985.2018.1471763. Epub 2018 Jun 1.
PubMed 29856244Kanlayanaphotporn R, Chiradejnant A, Vachalathiti R. The immediate effects of mobilization technique on pain and range of motion in patients presenting with unilateral neck pain: a randomized controlled trial. Arch Phys Med Rehabil. 2009 Feb;90(2):187-92. doi: 10.1016/j.apmr.2008.07.017.
PubMed 19236972Osama M, Tassadaq N, Malik RJ. Effect of muscle energy techniques and facet joint mobilization on spinal curvature in patients with mechanical neck pain: A pilot study. J Pak Med Assoc. 2020 Feb;70(2):344-347. doi: 10.5455/JPMA.14189.
PubMed 32063632Buyukturan O, Buyukturan B, Sas S, Kararti C, Ceylan I. The Effect of Mulligan Mobilization Technique in Older Adults with Neck Pain: A Randomized Controlled, Double-Blind Study. Pain Res Manag. 2018 May 15;2018:2856375. doi: 10.1155/2018/2856375. eCollection 2018.
PubMed 29861800
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Oscillatory Mobilizations and Mckenzie Retraction Exercises on Pain, Range of Motion and Disability in Patients With Mechanical Neck Pain
- ClinicalTrials.gov ID
- NCT05404659
- Acronym / sponsor ID
- REC/RCR&AHS/22/0124
- Conditions
- Mechanical Neck Pain
- Keywords
- Cervical spine, exercise therapy, pain, Manual therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 25 May 2022 (estimated)
- Primary completion
- 25 Oct 2022 (estimated)
- Study completion
- 25 Jan 2023 (estimated)
- First posted
- 3 Jun 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.
The neck pain is a public health problem and a common source of disability in the general population. Its exact pathology remains obscure, but the source of symptoms has been asserted to involve mechanical dysfunction of the cervical spine, particularly the zygoapophysial joints. Among the diversity of neck pain, mechanical neck pain is the most common type, with the pain primarily confined in the area on the posterior aspect of the neck that can be exacerbated by neck movements or by sustained neck postures. The usual clinical presentation of this mechanical neck pain is a reduction in mobility of either a single segment or multiple segments of the cervical spine in association with pain. This study will be a randomized control trial and will be conducted at Arif Memorial Teaching Hospital Lahore. The study will be completed within the time duration of six months. Convenience sampling technique will be used to collect data. A sample size of 30 patients(15 in each group) which will fulfill inclusion criteria will be taken in the study. Participants will be divided into two groups. Both Groups will be given conventional physical therapy and postural correction education. Group A will be provide oscillatory mobilizations. The following grades will be use: grades I and II for pain and grades III and IV to increase joint range of motion. This oscillatory mobilization will perform at a rate of 2-3 oscillations per second. and a frequency of 3-4 mobilization of the joint lasting approximately 30 sec each.
The rest time between each mobilization will be one minute for 5 days a week for four weeks , while group B will be treat withmckenzie retraction exercises in which foursets of 10-15 repetitions with 1-2 minutes rest between each set for 5 days a week during four weeks. Data will collect by using tools like numeric pain rating scale to measure pain, universal goniometer will be use for range of motion and disability level will be record pre and post treatment by using neck disability index. Then data will analyzed by using SPSS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oscillatory Mobilizations | Active comparator | Other: Oscillatory Mobilization |
| Mckenzie Retraction Exercises | Experimental | Other: Mckenzie Retraction Exercises |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patient with primary complaint of non specific neck pain. Pain of sufficient intensity (greater than 2 out of 10 on numerical pain scale) · Pain and stiffness for at least 2 weeks Pain aggravated by neck movement ·
Key exclusion criteria (1 listed)
- History of orthopedic surgery to the neck and shoulder and Temporo-mandibular Joint neurological symptoms due to cervical dysfunction History of Carcinoma Progressive neurological deficits
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 |
|---|---|---|
| Oscillatory Mobilizationconventional physical therapy treatment, postural correction and maitland's oscillatory mobilizitions. | Other | Oscillatory Mobilizations |
| Mckenzie Retraction Exercisesconventional physical therapy treatment, postural correction and Mckenzie retraction exercises. | Other | Mckenzie Retraction Exercises |
Primary outcome
Neck pain
Time frame: 5 week
Numeric pain rating scale is valid and reliable tool to measure pain
Range of motion
Time frame: 5 week
Goniometre is used to measure ROM. It measurement has been found to have greater intra-tester reliability in both clinical and research settings
Disability
Time frame: 5 week
The Neck Disability Index is the most widely used instrument for assessing self-rated disability in patients with neck pain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
- Background: PubMed 32400728Osama M, Shakil Ur Rehman S. Effects of static stretching as compared to autogenic inhibition and reciprocal inhibition muscle energy techniques in the management of mechanical neck pain: a randomized controlled trial. J Pak Med Assoc. 2020 May;70(5):786-790. doi: 10.5455/JPMA.9596.
- Background: PubMed 31127753Hassan F, Osama M, Ghafoor A, Yaqoob MF. Effects of oscillatory mobilization as compared to sustained stretch mobilization in the management of cervical radiculopathy: A randomized controlled trial. J Back Musculoskelet Rehabil. 2020;33(1):153-158. doi: 10.3233/BMR-170914.
- Background: PubMed 34290803Shabbir M, Arshad N, Naz A, Saleem N. Clinical outcomes of maitland mobilization in patients with Myofascial Chronic Neck Pain: A randomized controlled trial. Pak J Med Sci. 2021 Jul-Aug;37(4):1172-1178. doi: 10.12669/pjms.37.4.4220.
- Background: PubMed 34454582Raja G P, Bhat N S, Fernandez-de-Las-Penas C, Gangavelli R, Davis F, Shankar R, Prabhu A. Effectiveness of deep cervical fascial manipulation and yoga postures on pain, function, and oculomotor control in patients with mechanical neck pain: study protocol of a pragmatic, parallel-group, randomized, controlled trial. Trials. 2021 Aug 28;22(1):574. doi: 10.1186/s13063-021-05533-w.
- Background: PubMed 29856244Young IA PT, DSc, Dunning J PT, DPT, Butts R PT, PhD, Mourad F PT, DPT, Cleland JA PT, PhD. Reliability, construct validity, and responsiveness of the neck disability index and numeric pain rating scale in patients with mechanical neck pain without upper extremity symptoms. Physiother Theory Pract. 2019 Dec;35(12):1328-1335. doi: 10.1080/09593985.2018.1471763. Epub 2018 Jun 1.
- Background: PubMed 19236972Kanlayanaphotporn R, Chiradejnant A, Vachalathiti R. The immediate effects of mobilization technique on pain and range of motion in patients presenting with unilateral neck pain: a randomized controlled trial. Arch Phys Med Rehabil. 2009 Feb;90(2):187-92. doi: 10.1016/j.apmr.2008.07.017.
- Background: PubMed 32063632Osama M, Tassadaq N, Malik RJ. Effect of muscle energy techniques and facet joint mobilization on spinal curvature in patients with mechanical neck pain: A pilot study. J Pak Med Assoc. 2020 Feb;70(2):344-347. doi: 10.5455/JPMA.14189.
- Background: PubMed 29861800Buyukturan O, Buyukturan B, Sas S, Kararti C, Ceylan I. The Effect of Mulligan Mobilization Technique in Older Adults with Neck Pain: A Randomized Controlled, Double-Blind Study. Pain Res Manag. 2018 May 15;2018:2856375. doi: 10.1155/2018/2856375. eCollection 2018.
- 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.
Saba Rafique, Phd* 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 Oscillatory Mobilization and Mckenzie Retraction 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 1 inclusion and 1 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 3 Jun 2022. 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 Imran Amjad, Phd (+923324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck pain (time frame: 5 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 NCT05404659, which also lists 8 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 3 Jun 2022.