Effects of Activity Versus Structural Oriented Treatment Approach in Patients With Frozen Shoulder.

October 17, 2022 updated by: Riphah International University

Effects of Activity Versus Structural Oriented Treatment Approach on Pain, Range of Motion, and Function in Patients With Frozen Shoulder.

The aim of this study is to compare the effects of activity versus structural oriented treatment approach on pain, range of motion, and function in diabetic patients with frozen shoulder.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Frozen shoulder, also known as adhesive capsulitis, is a condition of uncertain etiology, characterized by shoulder stiffness, severe pain, significant restriction of range of motions, and limitation in participation in socio-economical life. According to a concept, pain causes changes in the brain making it learn the non-use, and therefore, even after healing of peripheral structures has occurred, the brain may not be able to organize voluntary actions owing to the induced central changes. Physical therapy plays an important role to bring pain relief and return of functional motion in frozen shoulder and there are many approaches available that can be used but literature on treatments based on neuroplasticity is comparatively less.

According to the research available, neuroplasticity has been effective in treating frozen shoulder. Similarly, PNF, home exercises, and joint mobilizations have also proven to be effective. The effects of the activity related and structural-oriented treatment on the frozen shoulder has not been addressed in diabetic patients yet. More RCTs are required to determine the best treatment for managing adhesive capsulitis in diabetics. Therefore, this research will be conducted which will compare the activity-based approach and the conventional approach to treating frozen shoulder in diabetics. The results may open new aspects of treating frozen shoulder in diabetics which can be cost-effective as well.

Study Type

Interventional

Enrollment (Anticipated)

30

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
      • Lahore, Punjab, Pakistan, 54000
        • Recruiting
        • Social security hospital, Kot Lakhpat
        • Contact:
        • Principal Investigator:
          • Komal Nasir, MSPT-OM

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

40 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosed with frozen shoulder, limited ROM, and pain in the shoulder region
  • Patients with diabetes from 10+ years

Exclusion Criteria:

  • History of headaches and dizziness
  • Pain and limited ROM in the cervical spine
  • Pain and limited ROM in temporomandibular joint

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Activity oriented
Activity-oriented therapy will be given to 15 patients which will train the structures around the shoulder in different activities of daily life.
Other: Activity oriented treatment
15 patients will be treated with activity oriented therapy. All subjects will receive 20 therapeutic sessions, 5 times a week over the time span of 4 weeks.
Experimental: Structural oriented
Structural-oriented therapy will be given to 15 patients including a fixed sequence of physiotherapy techniques.
Other: Structural oriented treatment
15 patients will be treated with structural oriented therapy. All subjects will receive 20 therapeutic sessions, 5 times a week over the time span of 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NPRS for pain
Time Frame: 4th week
The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
4th week
Goniometer for range of motion
Time Frame: 4th week
It will be used to measure flexion, extension, abduction, adduction, and internal and external rotation of shoulder.
4th week
SPADI for pain and disability
Time Frame: 4th week
Shoulder pain and disability index include thirteen questions measuring pain and disability on an eleven-point scale. O being no pain, difficulty and 10 being worst pain and difficulty.
4th week

Collaborators and Investigators

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

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Muhammad Salman Bashir, PhD, 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 7, 2022

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

May 23, 2022

First Submitted That Met QC Criteria

May 23, 2022

First Posted (Actual)

May 26, 2022

Study Record Updates

Last Update Posted (Actual)

October 19, 2022

Last Update Submitted That Met QC Criteria

October 17, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR & AHS/22/0118

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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