| CTRI Number |
CTRI/2024/09/074496 [Registered on: 27/09/2024] Trial Registered Prospectively |
| Last Modified On: |
24/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of effectiveness of mulligan technique versus mckenzie mobilization in cervical radiculopathy patients using neck disability index |
|
Scientific Title of Study
|
A comparative study to find out the effectiveness of mulligan versus mckenzie mobilization in cervical radiculopathy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manish Kumar Sah |
| Designation |
Master of Physiotherapy Student |
| Affiliation |
Burdwan Institute of Medical and Life Sciences |
| Address |
Exercise therapy lab, Department of Physiotherapy, Burdwan Institute of Medical and Life Sciences, University Campus, Golapbag, University Road Bardhaman
Barddhaman WEST BENGAL 713104 India |
| Phone |
7003786769 |
| Fax |
|
| Email |
sahmanishkumar7@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr MS Anwar |
| Designation |
Principal |
| Affiliation |
Burdwan Institute of Medical and Life Sciences |
| Address |
Exercise therapy lab, Department of Physiotherapy, Burdwan Institute of Medical and Life Sciences, University Campus, Golapbag, University Road Bardhaman
Barddhaman WEST BENGAL 713104 India |
| Phone |
9732445289 |
| Fax |
|
| Email |
anwarshahzada@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Rajnee Mishra |
| Designation |
Assistant Professor |
| Affiliation |
Burdwan Institute of Medical and Life Sciences |
| Address |
Exercise therapy lab, Department of Physiotherapy, Burdwan Institute of Medical and Life Sciences, University Campus, Golapbag, University Road Bardhaman
Barddhaman WEST BENGAL 713104 India |
| Phone |
8697568628 |
| Fax |
|
| Email |
rajnee08mishra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room number 2,Exercise therapy lab, Department of Physiotherapy, Burdwan Institute of Medical and Life Sciences, University Campus, Golapbag, University Road, Bardhaman, West Bengal,PIN Code 713104, India |
|
|
Primary Sponsor
|
| Name |
Manish Kumar Sah |
| Address |
Exercise therapy lab, Department of Physiotherapy, Burdwan Institute of Medical and Life Sciences, University Campus, Golapbag, University Road Bardhaman |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manish Kumar Sah |
Burdwan Institute of Medical and Life Sciences |
Exercise therapy lab, Department of Physiotherapy, Burdwan Institute of Medical and Life Sciences, University Campus, Golapbag, University Road Bardhaman Barddhaman WEST BENGAL |
7003786769
sahmanishkumar7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of Burdwan Institute of Medical and Life Sciences, Bardhaman, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M501||Cervical disc disorder with radiculopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mulligan Mobilization technique |
Exercise in this
group consists of functional SNAG/cervical MWMs, Natural apophyseal glides (NAGs),
Sustained natural apophyseal glide (SNAGs) with help of mulligan belt. These exercises will
be done 4 days in a week up to 4 weeks. |
| Comparator Agent |
McKenzie mobilization technique. |
Exercise in this
group consists of Retraction mobilization, Retraction extension with bilateral movement, and
rotation mobilization. These exercises will be done 4 days in a week up to 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patient having primary complain of radicular neck pain.
Pain intensity greater than 2 and less than 10 on NPRS.
Duration of illness two weeks including pain and stiffness.
Pain aggravated by movement. |
|
| ExclusionCriteria |
| Details |
Infective condition of spine.
Autoimmune disorders.
Malignancy.
Any history of spine surgery.
Spinal deformity.
Osteoporosis.
Neck pain due to trauma.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Neck disability index (NDI) |
1st day of Assessment and after 4 weeks of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NUMERICAL PAIN RATING SCALE |
1st day of treatment and after 4 weeks of treatment |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="7" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Cervical radiculopathy is a condition of neck pain disorder. Neck pain is most common issue
that can cause significant pain and disability. (1) The main cause of pain in cervical
radiculopathy is inflammation. (2)
It is estimated that 30-50% of the population affected in every
year. Almost two of every three persons will experience neck pain at a certain time during
their life time. Male and female are affected from cervical radiculopathy. Annual incidence
has been reported to be 107.3 per 100,000 for men and 63.5 per 100,000 for women affected
with cervical radiculopathy. (3)
Cervical radiculopathy is a dysfunction of a nerve root in the
cervical spine resulting in producing radicular symptom such as pain, paraesthesia, weakness,
numb-ness in the upper extremity. Radiculopathy is differentiated from radicular pain, where
radiculopathy is a neurological state in which conduction is limited or blocked along a spinal
nerve or its. Cervical radiculopathy is believed to result from various mechanisms causing
cervical nerve root irritation and a wide variety of symptoms distal to the irritation site. The
causes of cervical radiculopathy include cervical stenosis, spinal degenerative changes, and
cervical disc herniation, which can cause nerve root compression and/or irritation. (4)
Commonly in cervical radiculopathy 70 to 75 percent of cases is foramina encroachment of the
spinal nerve due to a combination of factors, including decreased disc height and degenerative
changes of the intervertebral joints anteriorly and zygapophyseal joints posteriorly seen. RATIONALE OF STUDY
Cervical radiculopathy is a clinical condition which is present with pain from neck to whole
upper limb or both upper limb. (9) Cervical radiculopathy is a specific lesion affecting the
cervical nerve roots in which neck pain is accompanied by upper limb pain and possibly
neurological symptoms and signs. (10) The nerve root is either irritated by bony osteophytes at
the zygapophyseal or uncovertebral joints that are acquired secondary to cervical spondylosis
or by a cervical disc herniation. Cervical radiculopathy will mostly classified as derangement.
The postural correction and correction of derangement of cervical spine will be more helpful
during treating the patients. Correction of derangement done by different types of mobilization
and manipulation techniques. Mulligan mobilization have been found effective in reducing pain, disability and improving
range of motion in patients with cervical radiculopathy. Working concept of Mulligan
mobilization is ‘positional fault theory’. It helps to correct any micro-malalignment present in
the joint surfaces so, pain can be decreased. It helps to increase the affected ranges. (11)
McKenzie mobilization widely used as a classification system for the diagnosis and treatment
of a variety of musculoskeletal conditions, including lower back, neck, and extremity pain. (12)
McKenzie originally defined centralization as “a situation in which pain arising from the spine
and felt laterally from the midline or distally is reduced and transferred to a more central or
near midline position when certain movements are performed.†McKenzie mobilization have
ability to centralize or decrease the patient’s referred or radicular symptoms through a series of
repeated movements. The concept of repeated motions and centralization have been shown to
be effective in treating radicular symptoms associated with the cervical spine, evidence is
inconclusive for the use of specific, repeated motions for treating cervical radiculopathy.(13)
This self-management aspect is very crucial for enabling individuals to apply techniques as
needed in their daily lives to reduce dependency on healthcare professionals.
Mulligan mobilization and McKenzie mobilization these two mobilization will take for treating
patients with cervical radiculopathy. There are few evidences documented in the literature
regarding the effectiveness of Mulligan mobilization McKenzie mobilization. The present
study will be conducted to find out the efficacy of both the techniques over each other.
OBJECTIVE OF RESEARCH
1. To evaluate the effectiveness of Mulligan Mobilization technique to reduce pain and
disability in patients with cervical radiculopathy.
2. To evaluate the effectiveness of McKenzie Mobilization technique to reduce pain and
disability in Patients with cervical radiculopathy.
3. To compare the effectiveness between Mulligan Mobilization and McKenzie
Mobilization technique to reducing pain and disability in patients with cervical
radiculopathy. RESEARCH HYPOTHESIS
NULL HYPOTHESIS (H0):
There will be no significant difference between the effectiveness of Mulligan Mobilization and
McKenzie Mobilization in reducing pain and disability in patients with cervical radiculopathy.
ALTERNATIVE HYPOTHESIS (H1):
There will be significant difference between the effectiveness of Mulligan Mobilization and
McKenzie Mobilization in reducing pain and disability in patients with cervical radiculopathy. STUDY TECHNIQUE
30 patients will be made as part of the study after selection based on inclusion and exclusion
criteria, following signing of the informed consent will be conveniently selected for this study
and they will be randomly allocated into two groups i.e. GROUP A and GROUP B, each group
will be having 15 patients.
GROUP A:
In this group patients will be treated with Mulligan Mobilization technique. Exercise in this
group consists of functional SNAG/cervical MWMs, Natural apophyseal glides (NAGs),
Sustained natural apophyseal glide (SNAGs) with help of mulligan belt. These exercises will
be done 4 days in a week up to 4 weeks.
GROUP B:
In this group patients will be treated with McKenzie mobilization technique. Exercise in this
group consists of Retraction mobilization, Retraction extension with bilateral movement, and
rotation mobilization. These exercises will be done 4 days in a week up to 4 weeks.
|