| CTRI Number |
CTRI/2021/02/031202 [Registered on: 10/02/2021] Trial Registered Prospectively |
| Last Modified On: |
10/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of spinal mobilizations on postural sway and posture in low back pain patients |
|
Scientific Title of Study
|
Immediate effect of Spinal Mobilizations on Postural sway and posture in individuals with Mechanical Back Pain |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Savani Gokhale |
| Designation |
PG scholar |
| Affiliation |
Dr. D. Y. Patil College of Physiotherapy |
| Address |
Physiotherapy Department, 3rd floor, Dr. D. Y. Patil College of Physiotherapy,Sant Tukaram Nagar, Plot no BGP, 190, Pimpri colony, Pimpri Chinchwad, Maharashtra 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
8554865382 |
| Fax |
|
| Email |
savani.25go@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gaurang Baxi |
| Designation |
Associate Professor |
| Affiliation |
Dr. D. Y. Patil College of Physiotherapy |
| Address |
Physiotherapy Department, 3rd floor, Dr. D. Y. Patil College of Physiotherapy,Sant Tukaram Nagar, Plot no BGP, 190, Pimpri colony, Pimpri Chinchwad, Maharashtra 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9371007824 |
| Fax |
|
| Email |
gaurang.baxi@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Savani Gokhale |
| Designation |
PG scholar |
| Affiliation |
Dr. D. Y. Patil College of Physiotherapy |
| Address |
Physiotherapy Department, 3rd floor, Dr. D. Y. Patil College of Physiotherapy,Sant Tukaram Nagar, Plot no BGP, 190, Pimpri colony, Pimpri Chinchwad, Maharashtra 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
08554865382 |
| Fax |
|
| Email |
savani.25go@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D. Y. Patil College of Physiotherapy |
|
|
Primary Sponsor
|
| Name |
Savani Gokhale |
| Address |
Dr. D. Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Plot no BGP, 190, Pimpri colony, Pimpri Chinchwad, Maharashtra 411018 |
| 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 |
| Savani Gokhale |
Dr. D. Y. Patil College of Physiotherapy |
Physiotherapy Department, 3rd floor, Sant Tukaram Nagar, Plot No. BGP, Pimpri colony, Pimpri-Chinchwad, Maharashtra 411018
Pune
MAHARASHTRA |
8554865382
savani.25go@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Dr. D. Y. Patil College of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M545||Low back pain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Spinal Mobilizations |
Spinal Mobilizations (Maitland Grade 1 and 2) to all spinal segments from C2 to L5 level.
Frequency - 8 to 10 oscillations to each spinal segment. One time intervention.
Duration - approximately 6-8 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Young and middle aged adults between age group 18-55 years
2.Patients with mechanical back pain (Cervical, Thoracic or Lumbar region)
|
|
| ExclusionCriteria |
| Details |
1. Contraindications to spinal mobilizations such as recent fractures, infections, metastasis, Spinal deformities, Cervical or thoracic pathology producing neurological symptoms in lower limbs.
2. Individuals with severe disc prolapse causing neurological deficits.
3. Individuals with vertebrao-basilar insufficiency/ cervicogenic dizziness/vertigo/deafness
4. Individuals undergone joint replacement surgeries (hip/knee)
5. Individuals with grade 3,4 osteoarthritis of hip/knee
6. Individuals with compromised higher mental functions.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Postural Sway (degrees/second- measured on Neurocom Balance Master)
2. Posture (measured in cm by posture screen mobile app) |
at baseline and immediately after intervention (after giving spinal mobilizations) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pain (NPRS)
|
at baseline and immediately after intervention (after giving spinal mobilizations) |
| Posture Assessment (on Posture screen mobile App) |
at baseline and immediately after intervention (after giving spinal mobilizations) |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/02/2021 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Immediate effect of Spinal Mobilizations on Postural Sway and Posture in individuals with mechanical back pain
Aim: To study immediate effects of Spinal Mobilizations to Cervical, Thoracic, and Lumbar spine on postural sway and posture in patients with mechanical back pain. Objectives: 1. To find out immediate effect of spinal mobilization technique on postural sway posture in individuals with mechanical back pain. 2. To find out immediate effect of spinal mobilization technique on posture in individuals with mechanical back pain. 3. To find out immediate effect of spinal mobilization technique on postural sway on pain in individuals with mechanical back pain. Need of study: Individuals with nonspecific back pain are susceptible to have impaired posture and balance due to disturbed alignment of spine and as a result of pain. Postural control is not specific to any one region; but it’s a combination of proprioceptive inputs from cervical, thoracic and lumbar region all together. Therefore realignment of the entire spine by mobilizations might be more effective and necessary than giving the mobilization to the affected area alone. This study will help generate evidence whether spinal mobilizations are effective in improving postural sway and posture, and whether this technique can be integrated in routine practice to treat patients with neck pain and back pain.
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