CTRI Number |
CTRI/2018/07/015144 [Registered on: 31/07/2018] Trial Registered Prospectively |
Last Modified On: |
31/07/2018 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Physiotherapy (Not Including YOGA) |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
comparison between the effectiveness of Mulligans Spinal Mobilization with Arm Movements and Sustained mobilization without arm movements in reducing pain and functional disabilities in patients with Cervical Radiculopathy |
Scientific Title of Study
|
Effectiveness of Mulligans Spinal Monilization with Arm Movements and Sustained Natural Apophyseal Glides in reducing pain and functional disabilities in patients with Cervical Radiculopathy:A comparative study |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Sanika Shahade |
Designation |
PG Student |
Affiliation |
Sancheti Institute College of Physiotherapy |
Address |
Musculoskeletal Physiotherapy department
Sancheti healthcare Academy
Thube Park
Near Nexa showroom
Shivajinagar
Pune-411005 Musculoskeletal Physiotherapy department
Sancheti healthcare Academy
Thube Park
Near Nexa showroom
Shivajinagar
Pune-411005 Pune MAHARASHTRA 411005 India |
Phone |
7303286224 |
Fax |
|
Email |
shahadesanika@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Venu Mohan |
Designation |
PG Student |
Affiliation |
Sancheti Institute College of Physiotherapy |
Address |
Sancheti healthcare Academy
Thube Park
Near Nexa showroom
Shivajinagar
Pune-411005 Sancheti healthcare Academy
Thube Park
Near Nexa showroom
Shivajinagar
Pune-411005 Pune MAHARASHTRA 411005 India |
Phone |
9440690707 |
Fax |
|
Email |
venumohan@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Sanika Shahade |
Designation |
PG Student |
Affiliation |
Sancheti Institute College of Physiotherapy |
Address |
Musculoskeletal Physiotherapy department
Sancheti healthcare Academy
Thube Park
Near Nexa showroom
Shivajinagar
Pune-411005 Musculoskeletal Physiotherapy department
Sancheti healthcare Academy
Thube Park
Near Nexa showroom
Shivajinagar
Pune-411005 Pune MAHARASHTRA 411005 India |
Phone |
7303286224 |
Fax |
|
Email |
shahadesanika@gmail.com |
|
Source of Monetary or Material Support
|
Sancheti Healthcare Academy,Sancheti Institute College of Physiotherapy, 11/12 Thube park, shivajinagar |
|
Primary Sponsor
|
Name |
sancheti institute college of physiotherapy |
Address |
Sancheti Healthcare Academy,Sancheti Institute College of Physiotherapy, 11/12 Thube park, shivajinagar |
Type of Sponsor |
Research institution and hospital |
|
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 |
Sanika Shahade |
Sancheti Institute of Orthopaedics and Rehabilitation (outpatient Department) |
Sancheti Institute of Orthopaedics and Rehabilitation
Shivajinagar, Pune-411005
Department- Physiotherapy
Division- Musculoskeletal
Pune MAHARASHTRA |
7303286224
shahadesanika@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Review Board |
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 |
Group 1: SMWAM group |
Patient sits upright on a chair. Therapist stands behind the patient.
Therapist approaches the desired level of the spinous process from medial
aspect of the thumb of one hand which is reinforced by the index finger of the
other hand. Pure sustained transverse glide is performed from affected to
unaffected side. While the glide is sustained , patient performs the desired
neurodynamic movement for median nerve.(External rotation, abduction at the
shoulder ,elbow extension, forearm supination ,wrist and finger extension)
• Dosage: 3 sets of ten repetitions
• Duration: once a day, 3 sessions for 1 week
EXERCISES:
1. Neck Isometrics exercises
2. Neck range of motion exercises
3. Scapular Strengthening
4. deep neck flexor
activation exs |
Comparator Agent |
Group 2- SNAGS group |
Procedure: Patient position: sitting upright on a chair.
• Therapist position: standing behind the patient in stride stance.
• Hand placement: Therapist places medial border of distal phalanx of thumb
obliquely, under the spinous process of the desired level of vertebra.
Therapist places pulp of the thumb of other hand reinforcing the lateral side of
the thumb places earlier. The other fingers are placed comfortably on the
mandible. For unilateral snags: if SNAGS are given on right side, right thumb
is placed on the facet joint, which is reinforced by the left thumb. The glide is
given under the spinous process/facet joint by pushing it towards the eyeball.
15
Patient is asked to perform the painful/restricted/offending movement.
Therapist moves his hand along the movement of the spine to sustain the
glide along.
• Dosage: 3 sets of 10 repetitions.
• Duration : once a day,3 sessions for 1 week
EXERCISES:
1. Neck Isometrics exercises
2. Neck range of motion exercises
3. Scapular Strengthening
4. deep neck flexor
activation exs |
|
Inclusion Criteria
|
Age From |
30.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
NRS score 4 to 7. (Moderate pain).
ï‚· Diagnosed cases of unilateral cervical radiculopathy.
 Subjects with Spurling‘s test positive.
ï‚· Subjects with ULTT-1, 2 positive. |
|
ExclusionCriteria |
Details |
Spondylolisthesis
ï‚· Cervical spine fracture
ï‚· Bilateral Radiculopathy
ï‚· Any Spinal Surgery |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
1. Numerical rating Scale
2. Cervical ROM using Universal Goniometer.
3. Neck Disability Index |
Outcome measures will be assessed pre-treatment first session and post treatment third session |
|
Secondary Outcome
|
Outcome |
TimePoints |
1. Numerical rating Scale
2. Cervical ROM using Universal Goniometer.
3. Neck Disability Index |
Outcome measures will be assessed pre-treatment first session and post treatment third session |
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
01/08/2018 |
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="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
NOt yet published |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
INTRODUCTION: Cervical radiculopathy is a disease process marked by nerve compression from herniated disk material or arthritic bone spurs. Those can be compression, irritation, traction, and a lesion on the nerve root caused by a herniated disc, foraminal narrowing or degenerative spondylotic change leading to stenosis of the intervertebral foramen. [1, 2] Typical symptoms of cervical radiculopathy are: irradiating arm pain corresponding a dermatomal pattern, neck pain, paraesthesia, muscle weakness in a myotomal pattern, headaches, scapular pain, sensory and motor dysfunction in upper extremities and neck. [1, 2] Physical therapy interventions often used for the management of cervical radiculopathy include cervical traction, postural education, exercise, electrical modalities like IFT and TENS, and manual therapy applied to the cervical spine and thoracic spine. [3] 3 The Mulligan concept has its foundation built on Kaltenborn’s principles of restoring the accessory component of physiological joint movement. Mulligan proposed that injuries or sprains might result in a minor positional fault to a joint, thus altering the biomechanics at the joint, causing restrictions in physiological movement. Mobilization of the spine maybe done in the functional, weight bearing position by applying the force parallel to the spinal facet planes. It maybe oscillatory (Natural Apophyseal Glides- NAGs) or a sustained glide maintained coupled with the patient performing the offending spinal movement (Sustained NAGs- SNAGs). [1] In 1990, Brian Mulligan introduced a technique known as: spinal mobilisations with limb movements (SMWLMs). Here, a sustained transverse glide is applied to the spinous process of a vertebra while the restricted peripheral upper or lower limb movement is performed, actively or passively. The foremost emphasis remains that the mobilization must result in symptom-free movement. Mulligan proposed that utilization of these mobilization techniques was indicated when peripheral joint limitation of movement is spinal in origin. [1] SMWAM amalgamates the concept of neurodynamics with Mulligan’s concept that minor positional faults of joints can occur following injuries and strains, whereby joints are no longer aligned in their natural, congruent position, but are subtly maligned. IN the case of radiating pain, neural tissues may be adhered to surrounding structures, resulting in lack of sliding and gliding, and hence giving 4 additional stretch to the nerve. Due to transverse glide, the vertebral body rotates towards the same side, resulting in opening of foramina on the affected side. Adding arm movement with opened foramina will result in mobilization of neural tissues. [4, 5, 6] 5 NEED FOR THE STUDY: The Mulligan concept is now an integral component of many manual physiotherapists clinical practice. Studies have been conducted measuring the efficacy of SNAGS, showing the beneficial effects. Spinal mobilisation with arm movements (SMWAMs) can be used for restricted upper limb movements that could be as a result of a spinal joint dysfunction or abnormal neural dynamics. However, data regarding the effects of SMWAM is scarce. This study aims to gain data regarding the effectiveness of Mulligan SMWAM and to obtain a comparison between the effects of the both techniques, thereby providing clinical therapists an evidence-based better choice of treatment. 6 AIM: To compare the effects of SMWAM and SNAGS on pain, ROM and function in patients with cervical radiculopathy. OBJECTIVES: 1. To find the effect of SMWAM on pain, cervical ROM and functional outcome in patients with cervical radiculopathy. 2. To find the effect of SNAGS on pain, cervical ROM and functional outcome in patients with cervical radiculopathy. 3. To compare the effects of SMWAM and SNAGS in patients with cervical radiculopathy. 7 RESEARCH QUESTION: Which of the two techniques is better in relieving pain, improving ROM and function, in patients with cervical radiculopathy- SMWAM or SNAGS? HYPOTHESIS: There is significant difference between SMWAM and SNAGS in relieving pain, improving ROM and function in patients with cervical radiculopathy. NULL HYPOTHESIS: There is no significant difference between SMWAM and SNAGS in relieving pain, improving ROM and function in patients with cervical radiculopathy. METHODOLGY: STUDY DESIGN: Experimental study METHOD OF SAMPLING: Simple Randomisation using computer generated random table SAMPLE SIZE: 40 (20 in each group) MATERIALS USED: Universal Goniometer INCLUSION CRITERIA:  Age group from 30 to 60 years.  Males and females both included.  NRS score 4 to 7. (Moderate pain).  Diagnosed cases of unilateral cervical radiculopathy.  Subjects with Spurling‘s test positive.  Subjects with ULTT-1, 2 positive. EXCLUSION CRITERIA:  Spondylolisthesis  Cervical spine fracture  Bilateral Radiculopathy  Any Spinal Surgery 13 PROCEDURE: •Post approval by the institutional ethical committee, patients will be assessed for eligibility and informed consent will be obtained from the subjects who fulfil the inclusion criteria. •Patients will be assigned into two groups by computerised random sampling. •Group A will be given SMWAM and exercise therapy. •Group B will be given SNAGS and exercise therapy. •A pre-treatment NRS, Cervical range of motion using universal goniometer and Neck Disability Index will be performed and documented. •Patients will receive treatment for 3 sessions for 1 week. •A post treatment NRS, Cervical range of motion and Neck Disability Index will be performed in both the groups. OUTCOME MEASURES: 1. Numerical rating Scale 2. Cervical ROM using Universal Goniometer. 3. Neck Disability Index. |