SpondylosisNCT05768438
Mulligan Mobilizations and McKenzie Exercises Along With Neural Mobilizations in Cervical Spondylosis
A study testing Mulligan with upper limb movement and McKenzie exercises with neural mobilizations in people with Spondylosis, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
Cervical pain is one of the common problem among general population. However, cervical spondylosis may cause unavoidable neck pain and range limitations due to wear and tear changes in the cervical spine. This condition can further lead to dysfunction and neuro musculoskeletal symptoms. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Spondylosis
- What is being tested?
- Mulligan with upper limb movement and McKenzie exercises with neural mobilizations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Dec 2022to 5 Jan 2024
- 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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 40 - 60 years old adults.
- Diagnosed and referred cases of cervical spondylosis and both males and females are included.
- Unilateral radiculopathy pain C5-C8 and T1.
- Individuals whose Spurling's and distraction test is positive.
- Patients with NPRS > 3/10 score.
- Patients with ipsilateral cervical rotation less than 60 degrees.
Who cannot join
- Individuals with history of;
- cervical or shoulder girdle trauma.
- any specific pathology or red flags (diplopia, dizziness, drop attacks, dysarthria, dysphagia)
- cervical myelopathy
- neoplastic lesions
- vertebral artery insufficiency
Show all 11Show fewer
- upper cervical ligamentous instability,
- spondylolisthesis
- hypermobile cervical spine
- cervical fracture inflammatory
- cardiac or severe psychiatric disease.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Hafsa Shehzadi
Karachi, Sindh, 74200
Hafsa Shehzadi, DPT, 03112497040, hafsashehzadi96@gmail.com
Saba A Ali, MSAPT, 0300-2886769, saba.aijaz@duhs.edu.pk
About this study
Official title: Effectiveness of Mulligan Mobilizations With Upper Limb Movement and McKenzie Exercises Along With Neural Mobilizations in Cervical Spondylosis - A Comparative Randomized Controlled Trial
Cervical pain is one of the common problem among general population. However, cervical spondylosis may cause unavoidable neck pain and range limitations due to wear and tear changes in the cervical spine. This condition can further lead to dysfunction and neuro musculoskeletal symptoms. Literature suggests the use of Mulligan therapy, McKenzie exercises and Neural mobilizations in spondylosis. According to author's knowledge there is limited evidence regarding effects of specific treatment approach.
Read the detailed description
A randomized control trial will be conducted among 80 patients with cervical spondylosis having age group 40 to 60 years. The non-probability purposive sampling technique will be used to recruit on the basis of study criteria. The study settings will be Dow University of health sciences, Karachi Pakistan. After taking informed consent all the patients will be randomized into two groups (A, B). Group A will receive mulligan with upper limb movement of involved side, group B will receive McKenzie exercises and neural mobilizations. Patients will be evaluated at baseline and after four weeks of treatment by using a goniometer, numerical pain rating scale (NPRS), and neck disability index (NDI) for cervical range of motions, pain intensity and neck disability respectively. There will be twelve sessions of treatment with thrice a week.
Duration of each session will be thirty minutes. All the data will be entered and analyzed through statistical package of social sciences version 24. Descriptive analysis will be performed for both continuous and categorical data. Inferential statistics will be performed to compare pain, disability index and range of motion between group and within group. The level of significance will be considered as 0.05.
- Conditions
- Spondylosis
- Being tested
- Mulligan with upper limb movement, McKenzie exercises with neural mobilizations
- Keywords
- Cervical spondylosis, McKenzie, NPRS, NDI, Mulligan with mobilization, Universal goniometer
- Medical subject headings
- Spondylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mulligan with upper limb movementOther
Group A subjects will receive mulligan mobilizations with upper limb movement of the involved side. The patient will be in a sitting position and the therapist will stand beside the patient. The therapist will place one thumb overlapped by the other on one of the selected cervical and then the therapist will push down the spinous process of that specific vertebrae, the pressure will be sustained and the patient will actively abduct his/her arm, assistance will be provided if needed. Initially it will start from 10 repetitions and 1 set which will further progress up to 2 or 3 sets as per patient's tolerance with 60 seconds rest in between each set.
McKenzie exercises with neural mobilizationsOther
The subjects of Group B will receive McKenzie exercises. Initially, it will start with retraction exercises. The frequency of exercises will be 10 to 15 repetitions followed by three to four sets with one second hold. On the second or third day, the cervical extension will be added. While in the second week the same set of exercises will be administered with the patient in a sitting position combined with application of over pressure at the end range by therapist. In the third week, extension and retraction exercises will be performed along with traction which will be applied by the therapist. Finally, in the fourth week all retraction and lateral flexion then neck rotation and the last one retraction with neck flexion will be added. Neural mobilizations will be given to patients in group B in supine lying. From proximal to distal, 20 oscillations (1 oscillation/ 1 second)
| Study group | Role | What they receive |
|---|---|---|
| Mulligan with upper limb movement | Experimental | This study arm will receive following therapy
.) Mulligan with upper limb movement. Receives: Other: Mulligan with upper limb movement |
| Mckenzie exercises with neural mobilizations | Experimental | This study arm will receive following therapy
.) McKenzie exercises with neural mobilizations Receives: Other: McKenzie exercises with neural mobilizations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity on Numerical Pain Rating Scale after four weeks.
The Numerical Pain Rating Scale is a unidimensional measure of pain intensity, use to record patients' pain progression or compare pain severity between pains with similar condition. It is 0 to 10 number scale. Higher the score, severe will be the pain experienced.
Measured: Baseline and 4 weeks.
Secondary outcomes (2)
Change in functional disability assessed with Neck Disability Index after four weeks.
NDI is a condition specific or patient completed questionnaire comprising of 10 items to evaluate pain and functional status which is mostly used for reporting neck pain. Each item on scale is scored from 0-5, where all the scores are added to total points and interpreted as percentages i.e. 0 point or 0% means no activity limitation and 50 points or 100% means complete activity limitation.
Measured: Baseline and 4 weeks.
Change in range of motion assessed with universal goniometer after four weeks
The universal goniometer is an instrument for the precise measurement of range of movement angles in degrees, especially one used to measure the angles before and after range of motion. Increase in the degree of angle suggests increase in range of movement.
Measured: Baseline and 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start5 Dec 2022
- Primary completion5 Dec 2023 (estimated)
- Study completion5 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondylosisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hafsa Shehzadi, Dow University of Health Sciences
- Investigators
- Hafsa Shehzadi, DPT, Principal investigator, DOW university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05768438
- Sponsor's protocol ID
- 1136
- Status last verified
- Mar 2023
- First submitted
- 17 Feb 2023
- Last updated
- 14 Mar 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 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Mulligan Mobilizations With Upper Limb Movement and McKenzie Exercises Along With Neural Mobilizations in Cervical Spondylosis - A Comparative Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05768438
- Acronym / sponsor ID
- 1136
- Conditions
- Spondylosis
- Keywords
- Cervical spondylosis, McKenzie, NPRS, NDI, Mulligan with mobilization, Universal goniometer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- 5 Dec 2023 (estimated)
- Study completion
- 5 Jan 2024 (estimated)
- First posted
- 14 Mar 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.
Cervical pain is one of the common problem among general population. However, cervical spondylosis may cause unavoidable neck pain and range limitations due to wear and tear changes in the cervical spine. This condition can further lead to dysfunction and neuro musculoskeletal symptoms. Literature suggests the use of Mulligan therapy, McKenzie exercises and Neural mobilizations in spondylosis. According to author's knowledge there is limited evidence regarding effects of specific treatment approach.
Detailed description
A randomized control trial will be conducted among 80 patients with cervical spondylosis having age group 40 to 60 years. The non-probability purposive sampling technique will be used to recruit on the basis of study criteria. The study settings will be Dow University of health sciences, Karachi Pakistan. After taking informed consent all the patients will be randomized into two groups (A, B). Group A will receive mulligan with upper limb movement of involved side, group B will receive McKenzie exercises and neural mobilizations. Patients will be evaluated at baseline and after four weeks of treatment by using a goniometer, numerical pain rating scale (NPRS), and neck disability index (NDI) for cervical range of motions, pain intensity and neck disability respectively. There will be twelve sessions of treatment with thrice a week.
Duration of each session will be thirty minutes. All the data will be entered and analyzed through statistical package of social sciences version 24. Descriptive analysis will be performed for both continuous and categorical data. Inferential statistics will be performed to compare pain, disability index and range of motion between group and within group. The level of significance will be considered as 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mulligan with upper limb movement | Experimental | Other: Mulligan with upper limb movementThis study arm will receive following therapy .) Mulligan with upper limb movement. |
| Mckenzie exercises with neural mobilizations | Experimental | Other: McKenzie exercises with neural mobilizationsThis study arm will receive following therapy .) McKenzie exercises with neural mobilizations |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 40 - 60 years old adults.
- Diagnosed and referred cases of cervical spondylosis and both males and females are included.
- Unilateral radiculopathy pain C5-C8 and T1.
- Individuals whose Spurling's and distraction test is positive.
- Patients with NPRS > 3/10 score.
Key exclusion criteria (11 listed)
- Individuals with history of;
- cervical or shoulder girdle trauma.
- any specific pathology or red flags (diplopia, dizziness, drop attacks, dysarthria, dysphagia)
- cervical myelopathy
- neoplastic lesions
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 |
|---|---|---|
| Mulligan with upper limb movementGroup A subjects will receive mulligan mobilizations with upper limb movement of the involved side. The patient will be in a sitting position and the therapist will stand beside the patient. The therapist will place one thumb overlapped by the other on one of the selected cervical and then the therapist will push down the spinous process of that specific vertebrae, the pressure will be sustained and the patient will actively abduct his/her arm, assistance will be provided if needed. Initially it will start from 10 repetitions and 1 set which will further progress up to 2 or 3 sets as per patient's tolerance with 60 seconds rest in between each set. | Other | Mulligan with upper limb movement |
| McKenzie exercises with neural mobilizationsThe subjects of Group B will receive McKenzie exercises. Initially, it will start with retraction exercises. The frequency of exercises will be 10 to 15 repetitions followed by three to four sets with one second hold. On the second or third day, the cervical extension will be added. While in the second week the same set of exercises will be administered with the patient in a sitting position combined with application of over pressure at the end range by therapist. In the third week, extension and retraction exercises will be performed along with traction which will be applied by the therapist. Finally, in the fourth week all retraction and lateral flexion then neck rotation and the last one retraction with neck flexion will be added. Neural mobilizations will be given to patients in group B in supine lying. From proximal to distal, 20 oscillations (1 oscillation/ 1 second) | Other | Mckenzie exercises with neural mobilizations |
Primary outcome
Change in pain intensity on Numerical Pain Rating Scale after four weeks.
Time frame: Baseline and 4 weeks.
The Numerical Pain Rating Scale is a unidimensional measure of pain intensity, use to record patients' pain progression or compare pain severity between pains with similar condition. It is 0 to 10 number scale. Higher the score, severe will be the pain experienced.
2 secondary outcomes
Change in functional disability assessed with Neck Disability Index after four weeks.
Time frame: Baseline and 4 weeks.
Change in range of motion assessed with universal goniometer after four weeks
Time frame: Baseline and 4 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- 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.
Hafsa Shehzadi, DPT principal investigator
DOW 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 Mulligan with upper limb movement and McKenzie exercises with neural mobilizations in people with Spondylosis, run by Dow University of Health Sciences 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 6 inclusion and 11 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 14 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hafsa Shehzadi, DPT (03112497040, hafsashehzadi96@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity on Numerical Pain Rating Scale after four weeks. (time frame: Baseline and 4 weeks.). 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 14 Mar 2023.