| CTRI Number |
CTRI/2023/04/051560 [Registered on: 12/04/2023] Trial Registered Prospectively |
| Last Modified On: |
01/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare muscle energy technique versus scapular neuromuscular facilitation in improving pain and range of motion in patients with adhesive capsulitis |
|
Scientific Title of Study
|
A study to compare the effectiveness of muscle energy technique versus scapular neuromuscular facilitation technique in improving pain and range of motion in patients with adhesive capsulitis of age group 40 to 60 years: A Randomized Control Trail |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chandana N |
| Designation |
Master of physiotherapy in musculoskeletal science |
| Affiliation |
Narayana hrudayalaya institute of physiotherapy |
| Address |
Narayana Hrudayalaya Foundations
258/A,Health City,Bommasandra industrial area,Anekal Taluk,Bangalore
Bangalore
KARNATAKA
560099
India |
| Phone |
7904493141 |
| Fax |
|
| Email |
chandana31n@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Chandana N |
| Designation |
Master of physiotherapy in musculoskeletal science |
| Affiliation |
Narayana hrudayalaya institute of physiotherapy |
| Address |
Narayana Hrudayalaya Foundations
258/A,Health City,Bommasandra industrial area,Anekal Taluk,Bangalore
Bangalore
KARNATAKA
560099
India |
| Phone |
7904493141 |
| Fax |
|
| Email |
chandana31n@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Smruti Swagatika Dash |
| Designation |
Professor |
| Affiliation |
Narayana hrudayalaya institute of physiotherapy |
| Address |
Narayana Hrudayalaya Foundations
258/A,Health City,Bommasandra industrial area,Anekal Taluk,Bangalore
Bangalore
KARNATAKA
560099
India |
| Phone |
9448552026 |
| Fax |
|
| Email |
smruti.dash@hrudayalayafoundation.org |
|
|
Source of Monetary or Material Support
|
| Narayana Hrudayalaya Institute of Physiotherapy |
|
|
Primary Sponsor
|
| Name |
Chandana N |
| Address |
Narayana Hrudayalaya Foundations
258/A, Health city, Bommasandra industrial Area, Anekal Taluk, Bangalore |
| 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 |
| Chandana N |
Narayana Health City |
Physiotherapy out patient rehabilitation department, basement
Bangalore
KARNATAKA |
7904493141
chandana31n@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Narayana Health Academic Ethics committe |
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 |
| Intervention |
1.Muscle Energy Technique
|
Muscle energy technique will be given to group A,
Muscle energy technique will be given as 5 repetitions/set, 3 sets/session, 3session/week for 4 weeks duration for shoulder flexion, shoulder abduction, shoulder internal rotation and shoulder external rotation along with conventional physiotherapy
|
| Intervention |
2. Scapular proprioceptive neuromuscular facilitation |
Scapular proprioceptive neuromuscular facilitation will be given to group B, scapular Proprioceptive neuromuscular facilitation will be applied by in two diagonals, anterior elevation and posterior depression and posterior elevation and anterior depression.
Subjects will be applied with scapular proprioceptive neuromuscular facilitation for 20 repetitions/set, 3session/week for 4 weeks duration along with conventional physiotherapy
|
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age group between 40-60 years.
2. Both males and females.
3. Unilateral limb involvement.
4. Subject having stiff painful shoulder for at least 3 month duration.
5. Subjects with limited Range of motion of shoulder abduction and external rotation.
|
|
| ExclusionCriteria |
| Details |
1. Acute inflammation,
2. Subjects with systemic disorders,
3. Subject with neurological disorders/ musculoskeletal disorder,
4. Recent fracture in and around the shoulder,
5. Recent shoulder dislocation,
6. Rheumatoid arthritis,
7. Any cardiac pacemakers,
8. Skin problem,
9. Past surgery around shoulder joint
|
|
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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 |
| visual analog scale, Range of motion, SPADI |
Baseline-0th week
Post intervention-4th weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SPADI |
Baseline-0th week
Post intervention-4th weeks |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
15/04/2023 |
| 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="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
purpose: The study aims to find
effectiveness of muscle energy technique along with conventional physiotherapy
which is compared with scapular proprioceptive neuromuscular technique in
improving range of motion and pain among adhesive capsulitis of age group group
40 to 60.
The hypotheses and
objectives of the study can be outlined as:
Hypothesis:
Null
Hypothesis [H0]:
§ There
will be no significant effect of muscle energy technique in improving range of
motion and pain on adhesive capsulitis patients
§ There
will be no significant effect of scapular proprioceptive neuromuscular
facilitations in improving range of motion and pain on adhesive capsulitis
patients
§ There
will be no significant difference of muscle energy techniques compared to
scapular proprioceptive neuromuscular facilitation in improving range of motion
and pain on adhesive capsulitis patients
Alternate Hypothesis [H1]:
§ There
will be significant effect of muscle energy technique in improving range of
motion and pain on adhesive capsulitis patients
§ There
will be significant effect of scapular proprioceptive neuromuscular
facilitations in improving range of motion and pain on adhesive capsulitis
patients
§ There
will be significant difference of muscle energy techniques compared to scapular
proprioceptive neuromuscular facilitation in improving range of motion and pain
on adhesive capsulitis patients
|