| CTRI Number |
CTRI/2021/04/032618 [Registered on: 07/04/2021] Trial Registered Prospectively |
| Last Modified On: |
01/04/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Physiotherapy (Not Including YOGA)
Other (Specify) [Physiotherapy with yoga] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study of Effect of two techniques Manual Therapy (MT) and Mindfulness-Based Stress Reduction (MBSR) Therapy in Patients with Diabetic Frozen Shoulder. |
|
Scientific Title of Study
|
Study of Effect of Manual Therapy (MT) and Mindfulness-Based Stress Reduction (MBSR) Therapy in Patients with Diabetic Frozen Shoulder |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NIRAJ KUMAR |
| Designation |
Ph.D Scholar Physiotherapy (Orthopaedics) |
| Affiliation |
SHRI GURU RAM RAI UNIVERSITY |
| Address |
SHRI GURU RAM RAI UNIVERSITY
PATEL NAGAR, DEHRADUN UTTARAKHAND
PATEL NAGAR, DEHRADUN UTTARAKHAND
Dehradun
UTTARANCHAL
248001
India |
| Phone |
7037957755 |
| Fax |
|
| Email |
drnirajkumar25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Niraj Kumar |
| Designation |
Ph.D Scholar Physiotherapy (Orthopaedics) |
| Affiliation |
SHRI GURU RAM RAI UNIVERSITY |
| Address |
SHRI GURU RAM RAI UNIVERSITY
SHRI GURU RAM RAI Institute of Medical & Health Sciences
PATEL NAGAR, DEHRADUN UTTARAKHAND
PATEL NAGAR, DEHRADUN UTTARAKHAND
Dehradun
UTTARANCHAL
248001
India |
| Phone |
7037957755 |
| Fax |
|
| Email |
drnirajkumar25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Navneet Badoni |
| Designation |
Professor Department of Orthopaedics |
| Affiliation |
SHRI GURU RAM RAI UNIVERSITY |
| Address |
SHRI GURU RAM RAI UNIVERSITY
SHRI GURU RAM RAI Institute of Medical & Health Sciences
PATEL NAGAR, DEHRADUN UTTARAKHAND
PATEL NAGAR, DEHRADUN UTTARAKHAND
Dehradun
UTTARANCHAL
248001
India |
| Phone |
09897069972 |
| Fax |
|
| Email |
badoninavneet@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Shri Guru Ram Rai University
Patel Nagar, Dehradun, Uttarakhand |
|
|
Primary Sponsor
|
| Name |
SHRI GURU RAM RAI UNIVERSITY |
| Address |
Shri Guru Ram Rai University
Patel Nagar, Dehradun, Uttarakhand
|
| Type of Sponsor |
Private medical college |
|
|
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 |
| NIRAJ KUMAR |
Shri Mahant Indiresh Hospital |
Department of Physiotherapy and Orthopedic units OPD & IPD SMIH Patel Nagar, Dehradun (Uttrakhand).
Dehradun
UTTARANCHAL |
7037957755
drnirajkumar25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutinal Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Manual Therapy |
Manual Therapy with Mindfulness-Based Stress Reduction Therapy is a new intervention techniques used to improve ROM of shoulder joint and decrease pain. In Mulligan Techniques the frequency will be performed 3 sets of 10 repetitions, with 1 minute rest between sets. Maitland Mobilization Techniques the frequency 10-15 repetitions will be made of grade 3 and 4 for 3 sets with 1 minute rest in between sets. Muscle Energy Techniques (MET) For Rotatar Cuff Muscle the frequency will be given for 5 repetitions per set for 3 sets and the treatment procedure performed 3 sessions. Shoulder Stabilization Exercise the frequency will be 8 to 15 repetitions for 3 sets only 5 times / week for 8 weeks. |
| Comparator Agent |
Mindfulness-Based Stress Reduction Therapy (MBSR) |
MBSR would be 8-week programs with weekly 2 to 2.5 hour sessions and an additional 6-hour session in the 6th week.. Daily home work of 45 minutes meditation will be recommended 6 days a week. |
|
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Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with limited Range of motion of shoulder abduction, external rotation and flexion.
All the patients (both males and females) between ages 40 to 70 years.
Diabetic patients
All the subjects must have frozen shoulder for at least last 15 days.
Affected shoulder must have not more than 90 degrees of abduction and 50% decreased external rotation as compared to normal side/normal ROM values.
|
|
| ExclusionCriteria |
| Details |
Subjects with Rotator cuff tears and other shoulder ligament injuries.
History of any arthritis related to shoulder.
RA shoulder secondary to fracture, dislocation, Reflex sympathetic dystrophy, neurological disorder
Malignancy.
All the patients having any cervical or thoracic problem. If present must be treated first before including in the study.
All the objects having any intra articular injection in the glenohumeral joint during last three months.
Patients with fractured scapula.
Any history of surgery on that shoulder and patients with tendon calcification.
Patients with cervical rib.
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
PAIN
DISABILITY
RANGE OF MOTION
ANXITY AND DEPRESSION
SOMATIC SYMPTOMS
QUALITY OF LIFE (QOL)
|
0 Week, 2 Week, 4 Week, 6 Week And 8 Week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="155"
Sample Size from India="155"
Final Enrollment numbers achieved (Total)= "155"
Final Enrollment numbers achieved (India)="155" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/04/2021 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="5" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Attached |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Niraj Kumar, Siddhartha Sen,
Navneet Badoni, Anirban Patra, Sobhit Garg (2022). Effectiveness of Movement
with Mobilization (MWM) on Pain, Proprioception and Muscle Strength in Diabetic
Frozen Shoulder Conditions. International Journal of Health Sciences, 6 (S1),
2630–2645. https://doi.org/10.53730/ijhs.v6nS1.5338.
Niraj Kumar, Navneet Badoni,
Siddhartha Sen, Anirban Patra, Shobit Garg, Kanchan Joshi (2022). Effectiveness
of Mindfulness-Based Stress Reduction Therapy (MBSRT) on Anxiety and
depression, Quality of Life and Mindfulness in Diabetic Frozen Shoulder
Conditions. Journal of Positive School Psychology. 6 (2). 2291 – 2308 https://journalppw.com/index.php/jpsp/article/view/1810/1025
|