| CTRI Number |
CTRI/2024/05/067286 [Registered on: 14/05/2024] Trial Registered Prospectively |
| Last Modified On: |
10/05/2024 |
| 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
|
In our study we will be including patients of frozen shoulder. We will be giving Proprioceptive Neuromuscular Facilitation Technique along with conventional physiotherapy to see it’s effect on their activities of daily living, pain, range of motion, strength and scapular asymmetry. |
|
Scientific Title of Study
|
Effectiveness of different PNF techniques along with conventional physiotherapy on functional outcomes in patients with adhesive capsulitis: A Randomized controlled trial. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ketaki Mahesh Kurulkar |
| Designation |
Postgraduate student |
| Affiliation |
MGM Institute of Physiotherapy |
| Address |
Department of Musculoskeletal Physiotherapy, OPD-1, MGM Institute of Physiotherapy.
Aurangabad.
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
8888712907 |
| Fax |
|
| Email |
ketaki.kk09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Surendra Kiran Wani |
| Designation |
Professor and HOD |
| Affiliation |
MGM Institute of Physiotherapy |
| Address |
Department of Musculoskeletal Physiotherapy, OPD-1, MGM Institute of Physiotherapy.
Aurangabad.
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9960473324 |
| Fax |
|
| Email |
surendrawani@mgmiop.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ketaki Mahesh Kurulkar |
| Designation |
Post graduate student |
| Affiliation |
MGM Institute of Physiotherapy |
| Address |
Department of Musculoskeletal Physiotherapy, OPD-1, MGM Institute of Physiotherapy.
Aurangabad.
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
8888712907 |
| Fax |
|
| Email |
ketaki.kk09@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM Institute of Physiotherapy |
|
|
Primary Sponsor
|
| Name |
MGM Institute of Physiotherapy |
| Address |
N-6 Cidco, Aurangabad |
| 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 |
| Dr Ketaki Kurulkar |
MGM medical college and hospital |
Department of Musculoskeletal Physiotherapy, OPD-01, MGM Institute of Physiotherapy (C wing),N-6 Cidco, Aurangabad
Aurangabad
MAHARASHTRA |
8888712907
ketaki.kk09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Research on Human Subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M750||Adhesive capsulitis of shoulder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Physiotherapy |
Conventional Physiotherapy (Maitland mobilization grade 1,2,3,4, pendular exercises, wand exercises, self-stretching techniques, hot pack will be given in patients with adhesive capsulitis for 3 sessions/week for 4 weeks |
| Intervention |
Proprioceptive Neuromuscular Facilitation Techniques and Conventional Physiotherapy |
Proprioceptive Neuromuscular Facilitation Techniques for upper extremity (Rhythmic stabilization, repeated contraction, stabilizing reversal and combination of isotonic) and proprioceptive neuromuscular facilitation techniques for scapula (rhythmic initiation, repeated contraction) will be given along with conventional physiotherapy in patients with adhesive capsulitis for 3 sessions/week for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
-Patients of both genders.
-Age group 40 -60years of age.
-Clinical Diagnostic criteria for frozen stage of AC: -Duration of symptoms lasts 4 to 12months
-Pain begins to subside
-Marked restriction of shoulder ROM (External
rotation, abduction, flexion)
-Clinical diagnostic criteria for AC according to the guidelines of the American Physical Therapy Association: - A loss of ROM greater than 25% in
two planes of motion
-loss of passive external rotation
greater than 50% compared to the
uninvolved shoulder or an external
rotation of less than 30°. |
|
| ExclusionCriteria |
| Details |
-Patients associated with instability or dislocation of the affected shoulder joint.
-Patients with non-healed fracture of shoulder complex.
-Degenerative, chronic inflammatory Diseases of shoulder joint, ( OA,RA)
-Patients associated with shoulder pain of cervical origin.
-Patients associated with neurovascular injuries. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Functional disability
|
pre and post intervention (4 weeks)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain |
pre and post intervention (4 weeks) |
| Range of motion |
pre and post intervention (4 weeks) |
| Muscle strength |
pre and post intervention (4 weeks) |
| Lateral scapular slide test |
pre and post intervention (4 weeks) |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
22/05/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Patients of frozen shoulder will be included in the study trial if they meet the inclusion criteria. The written and oral consent will be taken, and procedure will be explained. Demographic data will be noted. Baseline data which include functional disability, pain, range of motion, strength and lateral scapular slide test will be assessed. The patients will be randomly divided into two study groups-intervention group and control group. The patients will receive intervention as per the group allocation for 3 days. The intervention group will receive Proprioceptive Neuromuscular Facilitation Technique for upper extremity and scapula in addition to conventional physiotherapy whereas the control group will receive conventional physiotherapy only. The Proprioceptive Neuromuscular Facilitation Techniques for upper extremity and scapula involves rhythmic stabilization, repeated contraction, stabilizing reversals, combination of isotonic and repeated contraction, rhythmic initiation for scapula respectively for 3sessions/week for 4 weeks. Conventional physiotherapy includes (Maitland mobilization grade 1,2,3,4, pendular exercises, wand exercises, self-stretching techniques, hot pack will be given in patients with adhesive capsulitis for 3sessions/week for 4 weeks. All participants will be receiving one session of 45-50 minutes per day. Outcome measures will be assessed pre and post intervention. Statistical analysis of the collected data will be done. Conclusion will be established based on the obtained result of the study. |