CTRI Number |
CTRI/2024/03/063878 [Registered on: 08/03/2024] Trial Registered Prospectively |
Last Modified On: |
06/03/2024 |
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
|
Manual therapy treatments for patients with neck and arm pain. |
Scientific Title of Study
|
Effectiveness of Mulligan Mobilization with Neural Glides Versus Conventional Therapy in C5 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 |
Sweta Verma |
Designation |
Student |
Affiliation |
Lovely Professional University |
Address |
Department of Physiotherapy, school of allied medical sciences
Kapurthala PUNJAB 144411 India |
Phone |
09041691502 |
Fax |
|
Email |
Vermasweta907@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Naina Joshi |
Designation |
Assistant Professor |
Affiliation |
Lovely Professional University |
Address |
Department of Physiotherapy, School of allied medical science, room no. 4-213
Kapurthala PUNJAB 144411 India |
Phone |
9888855000 |
Fax |
|
Email |
nainajijoshi@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Sweta Verma |
Designation |
Student |
Affiliation |
Lovely Professional University |
Address |
Department of physiotherapy, school of allied medical sciences
Kapurthala PUNJAB 144411 India |
Phone |
09041691502 |
Fax |
|
Email |
Vermasweta907@gmail.com |
|
Source of Monetary or Material Support
|
Department of physiotherapy, School of allied medical science, Lovely Professional University, Jalandhar- Delhi GT road, Phagwara, Punjab, India- 144411 |
|
Primary Sponsor
|
Name |
Sweta Verma |
Address |
Lovely Professional University
Jalandhar-G.T. road |
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 |
Sweta Verma |
Uni hospital, Lovely professional University |
Physiotherapy OPD, Department of Physiotherapy, school of allied medical sciences, room no. 3- 105 Kapurthala PUNJAB |
9041691502
vermasweta907@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
INSTITUTIONAL ETHICS COMMITTEE, LOVELY PROFESSIONAL UNIVERSITY (ICE- LPU) |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Cervical Radiculopathy |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Conventional therapy |
Patient will be given neural mobilization in supine lying with shoulder abduction external rotation to 110˚ and flex the elbow to 90˚. When therapist will move patient’s wrist in extension, patient will take his neck in side flexion towards other hand. Neck stretching will be given for sternocleidomastoid, upper trapezius, suboccipital, scalene muscles (3 repetitions with 30 second hold). Post treatment neck isometric exercises will be advised to the patients 10 repetition each. |
Intervention |
Mulligan mobilization with neural glides. |
The patient is sitting on a chair while the therapist stood behind them. The therapist uses the medial aspect of right thumb and left thumb reinforcing it, apply pressure to the spinous process of the C5 vertebrae, SNAG(Sustained natural appophyseal glide) technique is applied- patient is encouraged to perform neck flexion, and the therapist maintained the pressure with their thumb during this movement. As the patient reached the end of their pain-free range of motion in the neck, they were encouraged to give overpressure with their other hand, which will facilitate a deeper joint glide. This position will be held for 6 seconds. The patient then returned their neck to the starting position and this treatment is repeated for a total of 3 sets, with 6 repetitions in each set.
The therapist uses the medial aspect of right thumb and left thumb reinforcing it, apply pressure to the facet joint of the C5 vertebrae, second therapists one hand will be over the upper scapula of the patient to prevent elevation other hand will take patients affected upper limb in shoulder abduction external rotation to 110Ëš and flex the elbow to 90Ëš. SNAG (Sustained natural appophyseal glide) technique is applied- patient is encouraged to perform neck side flexion, and the therapist maintained the pressure with their thumb during this movement. As the patient reached the end of their pain-free range of motion in the neck, they are encouraged to give overpressure with their other hand, which will facilitate a deeper joint glide, simultaneously neural mobilization is applied patient is asked to extend wrist to 10Ëš. This position will be held for 6 seconds. The patient then returned their neck and elbow to the starting position and this treatment is repeated for a total of 3 sets, with 6 repetitions in each set. Post treatment neck isometric exercises will be advised to the patients 10 repetition each. |
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
50.00 Year(s) |
Gender |
Both |
Details |
Age group 20-50 years;
Unilateral cervical radiculopathy along with motor and/or sensory symptoms;
Both male and female;
Positive for ULTT, spurling test, cervical distraction test, ipsilateral cervical rotation less than 60 degree;
Not taking any medication for pain;
Voluntary participation. |
|
ExclusionCriteria |
Details |
Bilateral cervical radiculopathy;
Musculoskeletal disease (torticollis, trapizitis, severe muscle spasm, muscular dystrophy, scoliosis, osteoarthritis, benign paroxysmal positional vertigo), Cardiovascular and respiratory disease;
Patients who are undergoing treatment for neck pain with other means of physiotherapy or medication at the time of the study;
Cervical spine fracture, surgery or other pathologies;
Central Nervous System (CNS) involvement (stroke, traumatic brain injury, cerebral palsy);
Medical red flags (tumour, rheumatoid arthritis (RA), osteoporosis, thyroid etc.). |
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Alternation |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
1. Visual Analog Scale,
2. Neck Disability Index |
1. 12 times
2. 4 times |
|
Secondary Outcome
|
Outcome |
TimePoints |
1. Range of Motion |
1. 4 times |
|
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
|
Phase 3 |
Date of First Enrollment (India)
|
16/03/2024 |
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="6" 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 which involves nerve roots which gets inflamed or damaged, results in
numbness or tingling sensation, weakness, pain radiating towards upper limbs
either on one side or both sides and sometimes it may radiate towards upper
back or chest. Most common causes of cervical radiculopathy are osteophyte
formation or herniated cervical intervertebral disc. The average annual
incidence of cervical radiculopathy is about 83 per 100,000 people in the
entire population. Sixth and seventh cervical nerve roots are most commonly
involved in cervical radiculopathy due to increased mobility at C5-C6 and C6-C7
cervical vertebral levels. A person
having neck pain 213radiating towards upper limb suffers more level of
disability than people suffering with neck pain alone.
This RCT will help us know
the effects of neural glides applied with Mulligan mobilization. The added
benefits of neural glides can also be tested through statistical calculations
which can be an effective intervention to alleviate pain in population with C5 cervical
radiculopathy. The purpose of the study is to determine the effect of Mulligan
mobilization with neural glides compared to conventional therapy in patients
with C5. |