Neck PainNCT05865223
Comparison Of Mackenzie Exercise Program Versus Routine Physical Therapy Management in Chronic Mechanical Neck Pain
A study testing Mckenzie exercise program and Conventional Physical therapy in people with Neck Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
Study will be a Randomized clinical trial to check comparison of mckenzie exercise program versus routine physical therapy management on pain, range of motion and function in patients with chronic neck pain so that we can devise a treatment protocol.Total fifty subjects will be included in this study .Out of total 25… Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Mckenzie exercise program and Conventional Physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Apr 2023to 30 Aug 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 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both Gender
- Neck pain for at least 3 months
- Age 25-55 years old
Who cannot join
- • History of trauma
- Vertebral Fracture
- Congenital disorder
- Ankylosing spondylitis
- Tumour
- Pott's Spine
- Any bony or soft tissue systemic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Title Comparison Of Mackenzie Exercise Program Versus Routine Physical Therapy Management On Pain , Range Of Motion And Function in Patient With Chronic Mechanical Neck Pain
Study will be a Randomized clinical trial to check comparison of mckenzie exercise program versus routine physical therapy management on pain, range of motion and function in patients with chronic neck pain so that we can devise a treatment protocol.Total fifty subjects will be included in this study .Out of total 25 will be randomly allocated via lottery method in group 1 and 25 will be allocated in group 2. Group 1 will receive mckenzie exercise program and routine physical therapy(Joint mobilization, hot pack for 15 minutes and home exercise program) while Group 2 will receive only routine physical therapy (Joint mobilization , hot pack for 15 min and home exercise program). All patients will be treated for 12 sessions, two sessions per week for 6 weeks. Neck pain and disability index consist of two parts, part one which assesses pain severity and part two which assesses functional disability. Study setting will be services hospital. Assesment will be done at 0 week, 4week, 8week and 12weeks. Data was analysed by using SPSS version 26.
Read the detailed description
Neck pain is a key public health issue that affects the human beings with reduction productivity and quality of life and produced significant socioeconomic burden on society.The purpose of this study to determine the effectiveness of Mckenzie exercise program and routine physical therapy management on pain range of motion and function in patient with chronic mechanical neck pain. Patients of both gender, neck pain for at least 3 months and age 25-55 years will be included. Patients having history of trauma, vertebral fracture, congenital disorder, ankylosing spondylitis, tumour, pott's disease and any bony or soft tissue systematic disease will be excluded. The main objective of this study is to evaluate pain level and effect of Mackenzie protocol for individuals suffering from chronic neck pain.
The tools used will be Neck disability index score (NDI), Numeric Pain Rating Scale (NPRS) and Goniometer for outcome measure pain, range of motion and function. Study will be conducted into 2 groups, each group will have 12 patients and comparisons of two groups will be evaluated. One group will receive Mckenzie exercise program and Routine physical therapy (Joint Mobilization, Hot pack and home exercise program) for 12 weeks and 2 days a week for 40 min each session and other group will receive Routine physical therapy (Joint mobilization, Hot pack and home exercise plan) for 12 weeks and 2 days a week for 30 min each session. Assessment will be done at 0 weeks, 4 week, 8 week and 12 week.Both groups received hot packs for 15 minutes for warming up.
- Conditions
- Neck Pain
- Being tested
- Mckenzie exercise program, Conventional Physical therapy
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mckenzie exercise programOther
MacKenzie extension exercise program for cervical spine
Conventional Physical therapyOther
hot pack for 15 minutes will be given followed by joint mobilization,and home exercise program.
| Study group | Role | What they receive |
|---|---|---|
| Mckenzie exercise program | Experimental | Group A Week 0 : Hot pack for 15 minutes, mackenzie extension exercise program for cervical regions and mobilization with movement at cervical regions for improving flexion, extension, side flexion and rotation. 3 sets of painless glides of 10 repetitions were given, with 1 minute rest between sets.
* Week 2 \& 4: Hot pack for 15 minutes, mckenzie exercise program at cervical region with the progression in repetition and MWM at cervical regions and then we will add progression.5 sets of painless glides of 10 repetitions were given, with 3 minute rest between sets.
* Week 3 \& 6: Hot pack for 15 minutes, mckenzie exercise program for cervical region and MWM at cervical region . 5 sets of painless glides for 10 repetitions were given. Progression can be introduced by increasing number of repetitions performed exercises for 3 weeks. Receives: Other: Mckenzie exercise program |
| conventional physical therapy | Active comparator | A routine physical therapy(joint mobilization,hot pack and home exercise program) treatment and hot pack for 15 minutes. Receives: Other: Conventional Physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale (NRS)
Patients are asked to circle the number on a Numerical Rating Scale (NRS) that best describes their level of discomfort between 0 and 10, 0 and 20, or 0 and 100. The lower limit often denotes "the least amount of suffering ," whereas zero typically denotes "no pain at all."
Measured: up to 12 weeks
Universal Goniometer for range of motion measurement
The most popular and reliable approach for determining shoulder range of motion (ROM) is by utilizing a goniometer. A goniometer is a straightforward instrument that has two arms joined at a hinge. The goniometer's second arm would be used to measure the joint angle while the physiotherapist placed one arm of the patient against the patient's body
Measured: up to 12 weeks
Neck disability index (NDI)
The Neck Disability Index (modification of the oswestry low back pain disability index) scale scores range from 0 to 5 and the total score is the sum of the item scores possible range 0 no pain to 100 maximal pain
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start15 Apr 2023
- Primary completion20 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zanam Nasir, MS*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05865223
- Sponsor's protocol ID
- REC/RCR&AHS/23/0018
- Status last verified
- Sep 2023
- First submitted
- 18 Apr 2023
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abdel-Aziem AA, Mohamed RR, Draz AH, Azab AR, Hegazy FA, Diab RH. The effect of McKenzie protocol vs. deep neck flexor and scapulothoracic exercises in subjects with chronic neck pain - a randomized controlled study. Eur Rev Med Pharmacol Sci. 2022 May;26(9):3138-3150. doi: 10.26355/eurrev_202205_28731.
PubMed 35587064Guez M, Hildingsson C, Nilsson M, Toolanen G. The prevalence of neck pain: a population-based study from northern Sweden. Acta Orthop Scand. 2002 Aug;73(4):455-9. doi: 10.1080/00016470216329.
PubMed 12358121Farooq MN, Mohseni-Bandpei MA, Gilani SA, Ashfaq M, Mahmood Q. The effects of neck mobilization in patients with chronic neck pain: A randomized controlled trial. J Bodyw Mov Ther. 2018 Jan;22(1):24-31. doi: 10.1016/j.jbmt.2017.03.007. Epub 2017 Mar 4.
PubMed 29332752Letafatkar A, Rabiei P, Alamooti G, Bertozzi L, Farivar N, Afshari M. Effect of therapeutic exercise routine on pain, disability, posture, and health status in dentists with chronic neck pain: a randomized controlled trial. Int Arch Occup Environ Health. 2020 Apr;93(3):281-290. doi: 10.1007/s00420-019-01480-x. Epub 2019 Oct 25.
PubMed 31654125Swenson RS. Therapeutic modalities in the management of nonspecific neck pain. Phys Med Rehabil Clin N Am. 2003 Aug;14(3):605-27. doi: 10.1016/s1047-9651(03)00038-x.
PubMed 12948344Kjellman G, Oberg B. A randomized clinical trial comparing general exercise, McKenzie treatment and a control group in patients with neck pain. J Rehabil Med. 2002 Jul;34(4):183-90. doi: 10.1080/16501970213233.
PubMed 12201614
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Title Comparison Of Mackenzie Exercise Program Versus Routine Physical Therapy Management On Pain , Range Of Motion And Function in Patient With Chronic Mechanical Neck Pain
- ClinicalTrials.gov ID
- NCT05865223
- Acronym / sponsor ID
- REC/RCR&AHS/23/0018
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 20 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 18 May 2023 (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.
Study will be a Randomized clinical trial to check comparison of mckenzie exercise program versus routine physical therapy management on pain, range of motion and function in patients with chronic neck pain so that we can devise a treatment protocol.Total fifty subjects will be included in this study .Out of total 25 will be randomly allocated via lottery method in group 1 and 25 will be allocated in group 2. Group 1 will receive mckenzie exercise program and routine physical therapy(Joint mobilization, hot pack for 15 minutes and home exercise program) while Group 2 will receive only routine physical therapy (Joint mobilization , hot pack for 15 min and home exercise program). All patients will be treated for 12 sessions, two sessions per week for 6 weeks. Neck pain and disability index consist of two parts, part one which assesses pain severity and part two which assesses functional disability. Study setting will be services hospital. Assesment will be done at 0 week, 4week, 8week and 12weeks. Data was analysed by using SPSS version 26.
Detailed description
Neck pain is a key public health issue that affects the human beings with reduction productivity and quality of life and produced significant socioeconomic burden on society.The purpose of this study to determine the effectiveness of Mckenzie exercise program and routine physical therapy management on pain range of motion and function in patient with chronic mechanical neck pain. Patients of both gender, neck pain for at least 3 months and age 25-55 years will be included. Patients having history of trauma, vertebral fracture, congenital disorder, ankylosing spondylitis, tumour, pott's disease and any bony or soft tissue systematic disease will be excluded. The main objective of this study is to evaluate pain level and effect of Mackenzie protocol for individuals suffering from chronic neck pain.
The tools used will be Neck disability index score (NDI), Numeric Pain Rating Scale (NPRS) and Goniometer for outcome measure pain, range of motion and function. Study will be conducted into 2 groups, each group will have 12 patients and comparisons of two groups will be evaluated. One group will receive Mckenzie exercise program and Routine physical therapy (Joint Mobilization, Hot pack and home exercise program) for 12 weeks and 2 days a week for 40 min each session and other group will receive Routine physical therapy (Joint mobilization, Hot pack and home exercise plan) for 12 weeks and 2 days a week for 30 min each session. Assessment will be done at 0 weeks, 4 week, 8 week and 12 week.Both groups received hot packs for 15 minutes for warming up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mckenzie exercise program | Experimental | Other: Mckenzie exercise programGroup A Week 0 : Hot pack for 15 minutes, mackenzie extension exercise program for cervical regions and mobilization with movement at cervical regions for improving flexion, extension, side flexion and rotation. 3 sets of painless glides of 10 repetitions were given, with 1 minute rest between sets. * Week 2 \& 4: Hot pack for 15 minutes, mckenzie exercise program at cervical region with the progression in repetition and MWM at cervical regions and then we will add progression.5 sets of painless glides of 10 repetitions were given, with 3 minute rest between sets. * Week 3 \& 6: Hot pack for 15 minutes, mckenzie exercise program for cervical region and MWM at cervical region . 5 sets of painless glides for 10 repetitions were given. Progression can be introduced by increasing number of repetitions performed exercises for 3 weeks. |
| conventional physical therapy | Active comparator | Other: Conventional Physical therapyA routine physical therapy(joint mobilization,hot pack and home exercise program) treatment and hot pack for 15 minutes. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Both Gender
- Neck pain for at least 3 months
- Age 25-55 years old
Key exclusion criteria (7 listed)
- • History of trauma
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 |
|---|---|---|
| Mckenzie exercise programMacKenzie extension exercise program for cervical spine | Other | Mckenzie exercise program |
| Conventional Physical therapyhot pack for 15 minutes will be given followed by joint mobilization,and home exercise program. | Other | conventional physical therapy |
Primary outcome
Numerical Rating Scale (NRS)
Time frame: up to 12 weeks
Patients are asked to circle the number on a Numerical Rating Scale (NRS) that best describes their level of discomfort between 0 and 10, 0 and 20, or 0 and 100. The lower limit often denotes "the least amount of suffering ," whereas zero typically denotes "no pain at all."
Universal Goniometer for range of motion measurement
Time frame: up to 12 weeks
The most popular and reliable approach for determining shoulder range of motion (ROM) is by utilizing a goniometer. A goniometer is a straightforward instrument that has two arms joined at a hinge. The goniometer's second arm would be used to measure the joint angle while the physiotherapist placed one arm of the patient against the patient's body
Neck disability index (NDI)
Time frame: up to 12 weeks
The Neck Disability Index (modification of the oswestry low back pain disability index) scale scores range from 0 to 5 and the total score is the sum of the item scores possible range 0 no pain to 100 maximal pain
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 18 Sep 2023.
- Background: PubMed 35587064Abdel-Aziem AA, Mohamed RR, Draz AH, Azab AR, Hegazy FA, Diab RH. The effect of McKenzie protocol vs. deep neck flexor and scapulothoracic exercises in subjects with chronic neck pain - a randomized controlled study. Eur Rev Med Pharmacol Sci. 2022 May;26(9):3138-3150. doi: 10.26355/eurrev_202205_28731.
- Background: PubMed 12358121Guez M, Hildingsson C, Nilsson M, Toolanen G. The prevalence of neck pain: a population-based study from northern Sweden. Acta Orthop Scand. 2002 Aug;73(4):455-9. doi: 10.1080/00016470216329.
- Background: PubMed 29332752Farooq MN, Mohseni-Bandpei MA, Gilani SA, Ashfaq M, Mahmood Q. The effects of neck mobilization in patients with chronic neck pain: A randomized controlled trial. J Bodyw Mov Ther. 2018 Jan;22(1):24-31. doi: 10.1016/j.jbmt.2017.03.007. Epub 2017 Mar 4.
- Background: PubMed 31654125Letafatkar A, Rabiei P, Alamooti G, Bertozzi L, Farivar N, Afshari M. Effect of therapeutic exercise routine on pain, disability, posture, and health status in dentists with chronic neck pain: a randomized controlled trial. Int Arch Occup Environ Health. 2020 Apr;93(3):281-290. doi: 10.1007/s00420-019-01480-x. Epub 2019 Oct 25.
- Background: PubMed 12948344Swenson RS. Therapeutic modalities in the management of nonspecific neck pain. Phys Med Rehabil Clin N Am. 2003 Aug;14(3):605-27. doi: 10.1016/s1047-9651(03)00038-x.
- Background: PubMed 12201614Kjellman G, Oberg B. A randomized clinical trial comparing general exercise, McKenzie treatment and a control group in patients with neck pain. J Rehabil Med. 2002 Jul;34(4):183-90. doi: 10.1080/16501970213233.
- 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.
Zanam Nasir, MS* 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 Mckenzie exercise program and Conventional Physical 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 7 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 18 Sep 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?
Numerical Rating Scale (NRS) (time frame: up to 12 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 NCT05865223, which also lists 6 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 18 Sep 2023.