CTRI Number |
CTRI/2017/04/008321 [Registered on: 10/04/2017] Trial Registered Prospectively |
Last Modified On: |
07/04/2017 |
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 Comparative study of two types of stretching techniques on range of motion and functional activities in frozen shoulder condition |
Scientific Title of Study
|
A Comparative study of proprioceptive neuromuscular facilitation stretching and capsular stretching on range of motion and functional activities in 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 |
Samuel dickson philip |
Designation |
Post graduate student (MPT) |
Affiliation |
Father muller medical college |
Address |
Department of physiotherapy
Father muller medical college
Mangalore Department of physiotherapy
Father muller medical college
Mangalore Dakshina Kannada KARNATAKA 575002 India |
Phone |
7406145972 |
Fax |
|
Email |
dcksnphilp@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Mr Sudeep MJ Pais |
Designation |
Associate professor |
Affiliation |
Father muller medical college |
Address |
Department of physiotherapy
Father muller medical college
Mangalore Department of physiotherapy
Father muller medical college
Mangalore Dakshina Kannada KARNATAKA 575002 India |
Phone |
09739867404 |
Fax |
|
Email |
sudeep_pais@hotmail.com |
|
Details of Contact Person Public Query
|
Name |
Samuel dickson philip |
Designation |
Post graduate student (MPT) |
Affiliation |
Father muller medical college |
Address |
Department of physiotherapy
Father muller medical college
Mangalore Department of physiotherapy
Father muller medical college
Mangalore
KARNATAKA 575002 India |
Phone |
7406145972 |
Fax |
|
Email |
dcksnphilp@gmail.com |
|
Source of Monetary or Material Support
|
Samuel dickson philip
Department of physiotherapy
father muller medical college,Mangalore-575002 |
|
Primary Sponsor
|
Name |
Samuel dickson philip |
Address |
Department of physiotherapy
Father Muller Medical college
Mangalore-575002 |
Type of Sponsor |
Other [self sponsored ] |
|
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 |
Samuel Dickson Philip |
Father Muller Medical College |
Department of Physiotherapy
Father Muller Medical College
Mangalore-575002 Dakshina Kannada KARNATAKA |
7406145972
dcksnphilp@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Father Muller Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Frozen Shoulder Subjects, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Capsular stretching |
capsular stretching in four different directions(Passive forward elevation,external rotation,Horizontal Adduction and Internal rotation for 10 to 15 seconds with in pain limits for 10-15 repitions for twice a day for ten days in two weeks |
Intervention |
Proprioceptive neuromuscular facilitation stretching |
D2 proprioceptive neuromuscular facilitation stretching will be given in flexion and extension pattern .The stretch will be given for 8 repitions per set consisting of 2 sets per session with one single session per dayfor 10 days in two weeks with each stretch maintained for almost 10-15 seconds |
|
Inclusion Criteria
|
Age From |
40.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Unilateral frozen shoulder ,Frozen shoulder individuals with limited range of motioncfor shoulder abduction, external rotation and flexion |
|
ExclusionCriteria |
Details |
Any recent shoulder surgery,Rheumatoid arthritis,Any recent history for fracture around shoulder complex,Subjects with rotator cuff tear |
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
universal goniometer,
Shoulder pain and disability index |
Difference in Range of motion and functional activities after two weeks of intervention |
|
Secondary Outcome
|
Outcome |
TimePoints |
Visual analogue scale
|
Difference in pain after two weeks of intervention |
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
12/04/2017 |
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 Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
None yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
TITLE OF THE
TOPIC :
COMPARITIVE EFFECT OF PROPRIOCEPTIVE NEUROMUSCULAR FACILITATION STRETCHING AND
CAPSULAR STRETCHING ON RANGE OF MOTION AND FUNCTIONAL ACTIVITES IN FROZEN
SHOULDER
Frozen shoulder, or
adhesive capsulitis, describes the common shoulder condition characterized by
painful and limited active and passive range of motion (ROM). Frozen shoulder
is reported to affect 2% to 5% of the general population increasing to 10% to
38% in patients with diabetes and thyroid disease. Individuals with primary
frozen shoulder are commonly between 40 and 65 years old, and the incidence
appears higher in females than males.The occurrence of frozen shoulder in 1
shoulder increases the risk of contralateral shoulder involvement by 5% to 34%,
and simultaneous bilateral shoulder involvement occurs as often as 14% of the
time. Based on the etiology adhesive capsulitis can be classified
as primary or secondary. Primary adhesive capsulitis is an idiopathic
condition, where the exact underlying cause is unknown. Adhesive capsulitis
associated with a known underlying disorder is considered to be secondary.
adhesive capsulitis is described in four
stages, Stage I: Preadhesive stage in which lining of the joint (synovium) is
inflamed depicts little or no restriction of glenohumeral motion, Stage II (Freezing
stage): Acute adhesive synovitis with proliferative synovitis and scar
formation of the underlying capsule, Stage III (Frozen stage): Marked stiffness
due to scar formation in the capsule with loss of axillary fold, Stage IV
(Thawing stage): Chronic stage presenting with fully mature adhesions with
notable restriction of ROM. In Stages II and III of frozen shoulder, ROM is
significantly restricted. Restriction of movement is in the capsular pattern, that is,
external rotation is most limited, followed by limitation in abduction and
internal rotation respectively.
Research question:
Is there a significant
difference in the effectiveness between proprioceptive neuromuscular
facilitation stretching and capsular stretching in improving the Range of
motion and functional activities in individulas with frozen shoulder?
Hypothesis:
Null
hypothesis:
There
is no significant difference in the effectiveness between proprioceptive
neuromuscular facilitation stretching and capsular stretching in improving the
Range of motion and functional activities in individuals with frozen shoulder.
Alternate hypothesis:
There
is significant difference in the effectiveness between proprioceptive
neuromuscular facilitation stretching and capsular stretching in improving the
Range of motion and functional activities in individuals with frozen shoulder.
OBJECTIVE OF THE
STUDY: To compare the effectiveness
between proprioceptive neuromuscular facilitation stretching and capsular stretching in
improving the Range of motion and functional activities in frozen shoulder.
PROCEDURE:
The
subjects falling within the inclusion criteria will be included in the study
and then they will be randomly assigned into two groups. Three outcome measures
will be taken for the individuals that is both pre and post treatment outcome
measures by using goniometry for range of motion, visual analogue scale for
pain and shoulder pain and disability index for functional limitation.
GROUP-A:- The individuals in Group –A will be receiving first moist
heat therapy for 10 to 20 minutess followed by proprioceptive
neuromuscular facilitation stretching in supine lying to improve
flexion, abduction and external rotation of the glenohumeral joint in D2
proprioceptive neuromuscular facilitation stretching in Flexion and Extension
pattern. The stretch will be given for 8 repetitions per set consisting of 2
sets per session with one single session per day for 10 days in two weeks with
each repetition or stretch maintained for
a duration of 5–10 seconds. This will be followed by Active assisted
range of motion exercises, Pendulum exercises and Finger ladder exercises.
GROUP-B:-
The individuals in GroupÂ-B will also be receiving
first the moist heat therapy for 10 to 20 minutes followed by capsular
stretching in four directions (Passive forward elevation, external rotation,
Horizontal adduction and internal rotation) the stretching will be maintained
for 10 seconds within pain limits, with 10–15 repetitions. The sets of
exercises should be performed twice a day for ten days in two weeks. This will
be followed by Active assisted range of motion exercises, Pendulum
exercises and Finger ladder exercises.
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