Comparison of PFS and ART in Adhesive Capsulitis in Diabetic Patients

March 22, 2021 updated by: Riphah International University

Comparison of Post Facilitation Stretch and Active Release Technique in Adhesive Capsulitis in Diabetic Patients

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Islamabad, Punjab, Pakistan
        • Asif Hospital Wah Cantt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Post facilitation stretch
Post facilitation stretch with Maitland mobilization
Other: Post facilitation stretch

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
Active Comparator: Active release technique
Active release technique with Maitland mobilization
Other: Active release technique

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shoulder pain and disability Index (SPADI)
Time Frame: 6th week

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
6th week
The oxford scale
Time Frame: 6th week
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.
6th week
Numeric Pain Rating Scale (NPRS)
Time Frame: 6th week
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.
6th week
ROM Shoulder Flexion
Time Frame: 6th week
Goniometer is used to measure the range of the motion of the shoulder flexion
6th week
ROM Shoulder Extension
Time Frame: 6th week
Goniometer is used to measure the range of the motion of the shoulder extension
6th week
ROM Shoulder Abduction
Time Frame: 6th week
Goniometer is used to measure the range of the motion of the shoulder Abduction
6th week
ROM Shoulder External Rotation
Time Frame: 6th week
Goniometer is used to measure the range of the motion of the shoulder External Rotation
6th week
ROM Shoulder Internal Rotation
Time Frame: 6th week
Goniometer is used to measure the range of the motion of the shoulder Internal Rotation
6th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2020

Primary Completion (Actual)

January 1, 2021

Study Completion (Actual)

January 30, 2021

Study Registration Dates

First Submitted

September 17, 2020

First Submitted That Met QC Criteria

September 22, 2020

First Posted (Actual)

September 23, 2020

Study Record Updates

Last Update Posted (Actual)

March 24, 2021

Last Update Submitted That Met QC Criteria

March 22, 2021

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/00241 Ummal Baneen

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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