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Comparison of Theraband, Co-contraction and Isometric Exercises in Frozen Shoulder

Primary Purpose

Frozen Shoulder

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Theraband exercises
Co-contraction exercises
Isometric exercises
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frozen Shoulder focused on measuring Theraband, Co-contraction Isometric, Frozen Shoulder

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Idiopathic with 6 month chronicity.
  • Patients with AROM/PROM less than or equal to 90 degrees.
  • Affected shoulder has not more than 90 degrees of abduction & 50% decreased external rotation as compared to normal side/normal ROM values.

Exclusion Criteria:

  • Traumatic & diabetic.
  • Patient with any cervical or thoracic problem.
  • Patients with any intra-articular injection in glenohumeral joint.
  • Patients with rotator cuff complete tear.
  • Patients with any other serious pathology/red flags

Sites / Locations

  • DHQ hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Theraband exercises

Co-contraction exercises

isometric exercises

Arm Description

Group A: baseline physical therapy treatment along with theraband exercises

Group B: baseline physical therapy treatment along with co-contraction exercises

Group C: baseline physical therapy treatment along with isometric exercises

Outcomes

Primary Outcome Measures

Numeric Pain rating scale (NPRS)
Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. where 0 indicate no pain and 10 indicate severe pain

Secondary Outcome Measures

SPADI
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. The SPADI takes 5 to 10 minutes for a patient to complete and is the only reliable and valid region-specific measure for the shoulder.

Full Information

First Posted
October 19, 2020
Last Updated
October 26, 2020
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04603768
Brief Title
Comparison of Theraband, Co-contraction and Isometric Exercises in Frozen Shoulder
Official Title
Comparison of Theraband, Co-contraction and Isometric Exercises in Patients With Chronic Frozen Shoulder
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
December 30, 2019 (Actual)
Primary Completion Date
August 30, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

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

5. Study Description

Brief Summary
This project was a Randomized control trial conducted to check the effects of in patients with chronic frozen shoulder theraband, isometric and co-contraction exercises so that we can have best treatment option for patients with chronic frozen shoulder. upper cross syndrome, duration was of 6months,convenient sampling was done, subject following eligibility criteria from DHQ hospital Sheikhupura, were randomly allocated in three groups via lottery method, baseline assessment was done, Group A participants were given baseline treatment along with theraband exercises , Group B participants were given baseline treatment along with co-contraction exercises and Group C were given baseline treatment along with isometric exercises on 3rd and 6th week, post intervention assessment was done via, Numeric pain rating scale(NPRS),Shoulder Pain And Disability Index (SPADI) and goniometric measurements of shoulder ranges ,3 sessions per week were given, data was analyzed by using SPSS version 26.
Detailed Description
Frozen shoulder is among the most commonly reported problems to physicians, orthopedics and physical therapists. Even before reporting to clinics there is long history of using over the counter pain killers. Pain avoidance behaviors let the joint stiff so much that a clinician help is sought. Most times the cause of frozen shoulder is not known, therefore is termed as 'idiopathic frozen shoulder'.There is huge literature regarding the management of frozen shoulder and yet after the decades of research there are gaps in treatment options. In modern age of health care, it is common goal of every health care to make patient self-sufficient as early as possible. The self-care models have tremendous advantages. The current study has compared the use of theraband, co-contraction and isometric exercises. The current study was novel in a way that there is limited literature about treating shoulder hypomobility with physical strengthening exercises. All three methods were employed to see if they improve ranges along with accompanying pain and disability.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frozen Shoulder
Keywords
Theraband, Co-contraction Isometric, Frozen Shoulder

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Theraband exercises
Arm Type
Experimental
Arm Description
Group A: baseline physical therapy treatment along with theraband exercises
Arm Title
Co-contraction exercises
Arm Type
Experimental
Arm Description
Group B: baseline physical therapy treatment along with co-contraction exercises
Arm Title
isometric exercises
Arm Type
Experimental
Arm Description
Group C: baseline physical therapy treatment along with isometric exercises
Intervention Type
Other
Intervention Name(s)
Theraband exercises
Intervention Description
Group A performed theraband exercises for 6 weeks.In the first 2 weeks theraband with low resistance was used to perform exercises and then we proceeded gradually with higher resistance therabands.Theraband exercises was performed for Shoulder Flexion,Shoulder Extension Strengthening, Shoulder Internal Rotation Strengthening, Shoulder External Rotation Strengthening, Shoulder Abduction, Empty Can Exercise & Rowing Exercise with 8-10 reps, 3sec hold and 2-3 sets With each of these exercises
Intervention Type
Other
Intervention Name(s)
Co-contraction exercises
Intervention Description
Muscle co-contraction is the simultaneous contraction of the muscles acting around a joint. Subject stood upright & contracted both the groups (agonist and antagonist) simultaneously without bringing movement at shoulder joint with 6-8 reps , 3sets & 5- 15 seconds duration of sustained self-arm bracing or stiffening was maintained. On eligible participants baseline assessment was done,3 session were given 3days per week, post intervention assessment was taken at 3rd and 6th week
Intervention Type
Other
Intervention Name(s)
Isometric exercises
Intervention Description
Isometric exercises of shoulder were performed in subjects for 6 weeks which included isometric Shoulder flexion, shoulder abduction isometric exercise, isometric shoulder external rotation, isometric shoulder internal rotation & isometric shoulder extension with 8-10 reps, 5 sec hold and 2 sets. On eligible participants baseline assessment was done,3 session were given 3days per week, post intervention assessment was taken at 3rd and 6th week
Primary Outcome Measure Information:
Title
Numeric Pain rating scale (NPRS)
Description
Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. where 0 indicate no pain and 10 indicate severe pain
Time Frame
3rd day
Secondary Outcome Measure Information:
Title
SPADI
Description
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. The SPADI takes 5 to 10 minutes for a patient to complete and is the only reliable and valid region-specific measure for the shoulder.
Time Frame
3rd day
Other Pre-specified Outcome Measures:
Title
Goniometric measurement of Shoulder ROM
Description
A goniometer is an instrument which measures the available range of motion at a joint.Flexion, Extension,Adduction,Abduction, Internal Rotation,External Rotation
Time Frame
3rd day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Idiopathic with 6 month chronicity. Patients with AROM/PROM less than or equal to 90 degrees. Affected shoulder has not more than 90 degrees of abduction & 50% decreased external rotation as compared to normal side/normal ROM values. Exclusion Criteria: Traumatic & diabetic. Patient with any cervical or thoracic problem. Patients with any intra-articular injection in glenohumeral joint. Patients with rotator cuff complete tear. Patients with any other serious pathology/red flags
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Syed Shakil Ur-Rehman, PhD
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
DHQ hospital
City
Sheikhupura
State/Province
Punjab
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29242941
Citation
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Results Reference
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31475043
Citation
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Results Reference
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PubMed Identifier
32534582
Citation
Moradi M, Hadadnezhad M, Letafatkar A, Khosrokiani Z, Baker JS. Efficacy of throwing exercise with TheraBand in male volleyball players with shoulder internal rotation deficit: a randomized controlled trial. BMC Musculoskelet Disord. 2020 Jun 13;21(1):376. doi: 10.1186/s12891-020-03414-y.
Results Reference
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PubMed Identifier
25439717
Citation
Hanchard N. Exercise classes supervised by a physiotherapist may be better at restoring function after frozen shoulder than individual physiotherapy. J Physiother. 2014 Dec;60(4):236. doi: 10.1016/j.jphys.2014.08.011. Epub 2014 Oct 23. No abstract available.
Results Reference
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PubMed Identifier
19543668
Citation
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Results Reference
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Citation
Shishir M, Abraham MM, Kanagasabai R, Najimudeen S, Gnanadoss JJ. Home Based Exercise Program for Frozen Shoulder-Follow-up of 36 Idiopathic Frozen Shoulder Patients. Indian Journal of Physiotherapy and Occupational Therapy. 2013;7(3):221.
Results Reference
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PubMed Identifier
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Citation
Alptekin HK, Aydin T, Iflazoglu ES, Alkan M. Evaluating the effectiveness of frozen shoulder treatment on the right and left sides. J Phys Ther Sci. 2016 Jan;28(1):207-12. doi: 10.1589/jpts.28.207. Epub 2016 Jan 30.
Results Reference
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PubMed Identifier
11188601
Citation
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Results Reference
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Citation
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Results Reference
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Comparison of Theraband, Co-contraction and Isometric Exercises in Frozen Shoulder

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