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Effect of Yoga@Work Program

Primary Purpose

Musculoskeletal Pain, Neck Pain, Shoulder Pain

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Yoga@work
Sponsored by
NMP Medical Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Musculoskeletal Pain

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • IT companies employee
  • Full time employment
  • Neck and Shoulder Pain
  • pain of at least 3 months duration
  • able to comply with intervention schedule

Exclusion Criteria:

  • Pregnancy
  • Refuse to give informed consent
  • spinal fracture
  • recent cervical spine or shoulder surgery
  • recent (3 months) chemotherapy/radiotherapy/ intervention

Sites / Locations

  • NMP Medical Reserach Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Yoga Group

Wait-list Group

Arm Description

Participants in the intervention group engaged in a 8-week yoga program delivered at their place of work (IT companies). Sessions were group-based, prescribed three sessions per week during break time (30-mins).

Participants in Wait-List control were not given any intervention. 8-weeks, group followed usual break time.

Outcomes

Primary Outcome Measures

Visual analogue scale for pain
100-mm visual analog scale (VAS), horizontal line ranging from 0mm (no pain) to 100mm (worst imaginable pain).

Secondary Outcome Measures

Neck disability index (NDI)
The NDI is a standard instrument for measuring self-rated disability due to neck pain.10-item, 50-point index; each of the 10 items is scored from 0 - 5. Higher points represent worse pain
Shoulder pain disability index
The SPADI is a 13-item patient completed instrument. Its categories include pain (5 items) and disability (8 items), overall total scores range from 0 to 130. Higher score represent worse disability

Full Information

First Posted
February 9, 2019
Last Updated
February 20, 2019
Sponsor
NMP Medical Research Institute
Collaborators
Warwick Research Services, Yog-Kulam
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1. Study Identification

Unique Protocol Identification Number
NCT03840304
Brief Title
Effect of Yoga@Work Program
Official Title
Effectiveness of Yoga@Work Program on Neck and Shoulder Pain in Information Technology (IT) Employees
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
July 12, 2018 (Actual)
Primary Completion Date
December 12, 2018 (Actual)
Study Completion Date
January 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NMP Medical Research Institute
Collaborators
Warwick Research Services, Yog-Kulam

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Employees working in IT industry are prone to develop musculoskeletal pain,specifically back, neck and shoulder pain. This study evaluates the effectiveness of work-site yoga intervention, Yoga@work on neck and shoulder pain in IT employees.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Pain, Neck Pain, Shoulder Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yoga Group
Arm Type
Experimental
Arm Description
Participants in the intervention group engaged in a 8-week yoga program delivered at their place of work (IT companies). Sessions were group-based, prescribed three sessions per week during break time (30-mins).
Arm Title
Wait-list Group
Arm Type
No Intervention
Arm Description
Participants in Wait-List control were not given any intervention. 8-weeks, group followed usual break time.
Intervention Type
Other
Intervention Name(s)
Yoga@work
Other Intervention Name(s)
Yoga
Intervention Description
Each session included warm-up practices(for the large joints, spine, and extremities), Physical postures (Asana), breathing exercises (pranayama) and supine meditation/relaxation (savasana).
Primary Outcome Measure Information:
Title
Visual analogue scale for pain
Description
100-mm visual analog scale (VAS), horizontal line ranging from 0mm (no pain) to 100mm (worst imaginable pain).
Time Frame
change from baseline to 8 weeks
Secondary Outcome Measure Information:
Title
Neck disability index (NDI)
Description
The NDI is a standard instrument for measuring self-rated disability due to neck pain.10-item, 50-point index; each of the 10 items is scored from 0 - 5. Higher points represent worse pain
Time Frame
Change from baseline to 8-weeks
Title
Shoulder pain disability index
Description
The SPADI is a 13-item patient completed instrument. Its categories include pain (5 items) and disability (8 items), overall total scores range from 0 to 130. Higher score represent worse disability
Time Frame
Change from baseline to 8-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: IT companies employee Full time employment Neck and Shoulder Pain pain of at least 3 months duration able to comply with intervention schedule Exclusion Criteria: Pregnancy Refuse to give informed consent spinal fracture recent cervical spine or shoulder surgery recent (3 months) chemotherapy/radiotherapy/ intervention
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neha Sharma
Organizational Affiliation
Yog-Kulam
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Durga Prasad Sharma
Organizational Affiliation
International Labour Organization, UN
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Divya Gaur
Organizational Affiliation
NMP Medical Research Institute, India
Official's Role
Principal Investigator
Facility Information:
Facility Name
NMP Medical Reserach Institute
City
Jaipur
State/Province
Rajasthan
Country
India

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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