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Comparison of PFS and ART in Adhesive Capsulitis in Diabetic Patients

Primary Purpose

Adhesive Capsulitis

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Post facilitation stretch
Active release technique
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adhesive Capsulitis focused on measuring Shoulder, Pain, Fibrosis, Disability

Eligibility Criteria

35 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Controlled diabetic patients (random 200-250mg/dl /fasting 120-160mg/dl).
  • Grade 2 & 3 of adhesive capsulitis,
  • Pain (NPRS) ranging between 3-10
  • Reduced normal shoulder ROM's i.e

    • Flexion less than 160 degrees.
    • Extension less than 50 degrees.
    • Abduction less than 170 degrees.
    • External rotation less than 80 degrees.
    • Internal rotation less than 70 degrees

Exclusion Criteria:

  • Trauma history of shoulder/surgery.
  • Frozen shoulder accompanied with neurological involvement.
  • People with any injury or disability of elbow or hand

Sites / Locations

  • Asif Hospital Wah Cantt

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Post facilitation stretch

Active release technique

Arm Description

Post facilitation stretch with Maitland mobilization

Active release technique with Maitland mobilization

Outcomes

Primary Outcome Measures

Shoulder pain and disability Index (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. Each of the 13 items is to be rated with a number from 0 to 10: For the pain score (first 5 items): 0 means no pain and 10 means worst pain imaginable; For the disability score (last 8 items): 0 means no impairment and 10 means the patient requires help to perform that action
The oxford scale
The Oxford Scale is a 0-5 scale which is then recorded as 0/5 or 2/5, sometimes with a + or - sign to indicate more or less power but not sufficient to reduce or increase the number.
Numeric Pain Rating Scale (NPRS)
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. Similar to the VAS, the NPRS is anchored by terms describing pain severity extremes.
ROM Shoulder Flexion
Goniometer is used to measure the range of the motion of the shoulder flexion
ROM Shoulder Extension
Goniometer is used to measure the range of the motion of the shoulder extension
ROM Shoulder Abduction
Goniometer is used to measure the range of the motion of the shoulder Abduction
ROM Shoulder External Rotation
Goniometer is used to measure the range of the motion of the shoulder External Rotation
ROM Shoulder Internal Rotation
Goniometer is used to measure the range of the motion of the shoulder Internal Rotation

Secondary Outcome Measures

Full Information

First Posted
September 17, 2020
Last Updated
March 22, 2021
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04561310
Brief Title
Comparison of PFS and ART in Adhesive Capsulitis in Diabetic Patients
Official Title
Comparison of Post Facilitation Stretch and Active Release Technique in Adhesive Capsulitis in Diabetic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
June 15, 2020 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
January 30, 2021 (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
To determine the technique that will have better effects in realigning the muscle kinematics and to normalize the muscle activity along with reducing muscle stiffness with mobilizations techniques
Detailed Description
There is a very limited literature available Active release technique (ART) and Post Facilitation Stretch (PFS) in frozen shoulder. Additionally there is a very limited literature on the evaluation of ART in comparison with PFS in adhesive capsulitis of diabetic patient. Disease such as rheumatoid arthritis (RA), osteoarthritis (OA) etc that cause stiffness of the shoulder joint also present with altered muscle activity, that in long run becomes one of the main causes of reduces joint range of motion. With this study, we will be able to determine the technique that will have better effects in realigning the muscle kinematics and to normalize the muscle activity along with reducing muscle stiffness with mobilizations techniques. This study will also fulfill that research gap and will provide clinicians with an alternative approach in treatment of adhesive capsulitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Capsulitis
Keywords
Shoulder, Pain, Fibrosis, Disability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Post facilitation stretch
Arm Type
Experimental
Arm Description
Post facilitation stretch with Maitland mobilization
Arm Title
Active release technique
Arm Type
Active Comparator
Arm Description
Active release technique with Maitland mobilization
Intervention Type
Other
Intervention Name(s)
Post facilitation stretch
Intervention Description
Post facilitation stretch with maitland mobilization Grade I & II Maitland mobilization of shoulder joint in 1st and 2nd week progressing to Grade III oscillatory mobilization of shoulder joint in 3rd week. It will further progress to Grade IV Maitland oscillatory mobilizations in the 4th or 5th week. Treatment will be provided 3 session/week for 6 weeks with 40 minutes/session
Intervention Type
Other
Intervention Name(s)
Active release technique
Intervention Description
Active release technique with maitland mobilization Grade I & II Maitland mobilization of shoulder joint in 1st and 2nd week progressing to Grade III oscillatory mobilization of shoulder joint in 3rd week. It will further progress to Grade IV Maitland oscillatory mobilizations in the 4th or 5th week. Treatment will be provided 3 session/week for 6 weeks with 40 minutes/session
Primary Outcome Measure Information:
Title
Shoulder pain and disability Index (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. Each of the 13 items is to be rated with a number from 0 to 10: For the pain score (first 5 items): 0 means no pain and 10 means worst pain imaginable; For the disability score (last 8 items): 0 means no impairment and 10 means the patient requires help to perform that action
Time Frame
6th week
Title
The oxford scale
Description
The Oxford Scale is a 0-5 scale which is then recorded as 0/5 or 2/5, sometimes with a + or - sign to indicate more or less power but not sufficient to reduce or increase the number.
Time Frame
6th week
Title
Numeric Pain Rating Scale (NPRS)
Description
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. Similar to the VAS, the NPRS is anchored by terms describing pain severity extremes.
Time Frame
6th week
Title
ROM Shoulder Flexion
Description
Goniometer is used to measure the range of the motion of the shoulder flexion
Time Frame
6th week
Title
ROM Shoulder Extension
Description
Goniometer is used to measure the range of the motion of the shoulder extension
Time Frame
6th week
Title
ROM Shoulder Abduction
Description
Goniometer is used to measure the range of the motion of the shoulder Abduction
Time Frame
6th week
Title
ROM Shoulder External Rotation
Description
Goniometer is used to measure the range of the motion of the shoulder External Rotation
Time Frame
6th week
Title
ROM Shoulder Internal Rotation
Description
Goniometer is used to measure the range of the motion of the shoulder Internal Rotation
Time Frame
6th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Controlled diabetic patients (random 200-250mg/dl /fasting 120-160mg/dl). Grade 2 & 3 of adhesive capsulitis, Pain (NPRS) ranging between 3-10 Reduced normal shoulder ROM's i.e Flexion less than 160 degrees. Extension less than 50 degrees. Abduction less than 170 degrees. External rotation less than 80 degrees. Internal rotation less than 70 degrees Exclusion Criteria: Trauma history of shoulder/surgery. Frozen shoulder accompanied with neurological involvement. People with any injury or disability of elbow or hand
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nazish Rafique, MSPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asif Hospital Wah Cantt
City
Islamabad
State/Province
Punjab
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Rose PG. Effective Reduction of Adhesive Capsulitis Pain with a Suprascapular Nerve Block Given in a Primary Care Clinic. InConference Highlights (p. 30).
Results Reference
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Citation
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18475240
Citation
Tighe CB, Oakley WS Jr. The prevalence of a diabetic condition and adhesive capsulitis of the shoulder. South Med J. 2008 Jun;101(6):591-5. doi: 10.1097/SMJ.0b013e3181705d39.
Results Reference
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PubMed Identifier
20701586
Citation
Garcilazo C, Cavallasca JA, Musuruana JL. Shoulder manifestations of diabetes mellitus. Curr Diabetes Rev. 2010 Sep;6(5):334-40. doi: 10.2174/157339910793360824.
Results Reference
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PubMed Identifier
27182002
Citation
Hsu CL, Sheu WH. Diabetes and shoulder disorders. J Diabetes Investig. 2016 Sep;7(5):649-51. doi: 10.1111/jdi.12491. Epub 2016 Mar 16. No abstract available.
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26485477
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Gutierrez Espinoza HJ, Pavez F, Guajardo C, Acosta M. Glenohumeral posterior mobilization versus conventional physiotherapy for primary adhesive capsulitis: a randomized clinical trial. Medwave. 2015 Sep 22;15(8):e6267. doi: 10.5867/medwave.2015.08.6267. English, Spanish.
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Kim JH, Lee HS, Park SW. Effects of the active release technique on pain and range of motion of patients with chronic neck pain. J Phys Ther Sci. 2015 Aug;27(8):2461-4. doi: 10.1589/jpts.27.2461. Epub 2015 Aug 21.
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Comparison of PFS and ART in Adhesive Capsulitis in Diabetic Patients

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