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

Primary Purpose

Frozen Shoulder

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Activity oriented treatment
Structural oriented treatment
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 frozen shoulder, manual therapy, proprioceptive neuromuscular facilitation, neuroplasticity, diabetes

Eligibility Criteria

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

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

Sites / Locations

  • Social security hospital, Kot LakhpatRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Activity oriented

Structural oriented

Arm Description

Activity-oriented therapy will be given to 15 patients which will train the structures around the shoulder in different activities of daily life.

Structural-oriented therapy will be given to 15 patients including a fixed sequence of physiotherapy techniques.

Outcomes

Primary Outcome Measures

NPRS for pain
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).
Goniometer for range of motion
It will be used to measure flexion, extension, abduction, adduction, and internal and external rotation of shoulder.
SPADI for pain and disability
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.

Secondary Outcome Measures

Full Information

First Posted
May 23, 2022
Last Updated
October 17, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05391984
Brief Title
Effects of Activity Versus Structural Oriented Treatment Approach in Patients With Frozen Shoulder.
Official Title
Effects of Activity Versus Structural Oriented Treatment Approach on Pain, Range of Motion, and Function in Patients With Frozen Shoulder.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 7, 2022 (Actual)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
January 1, 2023 (Anticipated)

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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frozen Shoulder
Keywords
frozen shoulder, manual therapy, proprioceptive neuromuscular facilitation, neuroplasticity, diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Activity oriented
Arm Type
Experimental
Arm Description
Activity-oriented therapy will be given to 15 patients which will train the structures around the shoulder in different activities of daily life.
Arm Title
Structural oriented
Arm Type
Experimental
Arm Description
Structural-oriented therapy will be given to 15 patients including a fixed sequence of physiotherapy techniques.
Intervention Type
Other
Intervention Name(s)
Activity oriented treatment
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Structural oriented treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
NPRS for pain
Description
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).
Time Frame
4th week
Title
Goniometer for range of motion
Description
It will be used to measure flexion, extension, abduction, adduction, and internal and external rotation of shoulder.
Time Frame
4th week
Title
SPADI for pain and disability
Description
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.
Time Frame
4th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, PhD
Phone
03324390125
Email
imran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Salman Bashir, PhD
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Social security hospital, Kot Lakhpat
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhammad Salman Bashir, PhD
Phone
+923334497959
Email
salman.bashir@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Komal Nasir, MSPT-OM

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22999851
Citation
Lho YM, Ha E, Cho CH, Song KS, Min BW, Bae KC, Lee KJ, Hwang I, Park HB. Inflammatory cytokines are overexpressed in the subacromial bursa of frozen shoulder. J Shoulder Elbow Surg. 2013 May;22(5):666-72. doi: 10.1016/j.jse.2012.06.014. Epub 2012 Sep 21.
Results Reference
background
PubMed Identifier
32117540
Citation
Cho CH, Lee YH, Kim DH, Lim YJ, Baek CS, Kim DH. Definition, Diagnosis, Treatment, and Prognosis of Frozen Shoulder: A Consensus Survey of Shoulder Specialists. Clin Orthop Surg. 2020 Mar;12(1):60-67. doi: 10.4055/cios.2020.12.1.60. Epub 2020 Feb 13.
Results Reference
background
PubMed Identifier
31475043
Citation
Cho CH, Bae KC, Kim DH. Treatment Strategy for Frozen Shoulder. Clin Orthop Surg. 2019 Sep;11(3):249-257. doi: 10.4055/cios.2019.11.3.249. Epub 2019 Aug 12.
Results Reference
background
PubMed Identifier
32509332
Citation
Abrassart S, Kolo F, Piotton S, Chih-Hao Chiu J, Stirling P, Hoffmeyer P, Ladermann A. 'Frozen shoulder' is ill-defined. How can it be described better? EFORT Open Rev. 2020 May 1;5(5):273-279. doi: 10.1302/2058-5241.5.190032. eCollection 2020 May.
Results Reference
background
PubMed Identifier
20924589
Citation
Klug S, Anderer P, Saletu-Zyhlarz G, Freidl M, Saletu B, Prause W, Aigner M. Dysfunctional pain modulation in somatoform pain disorder patients. Eur Arch Psychiatry Clin Neurosci. 2011 Jun;261(4):267-75. doi: 10.1007/s00406-010-0148-4. Epub 2010 Oct 6. Erratum In: Eur Arch Psychiatry Clin Neurosci. 2011 Jun;261(4):309. Stefanie, Klug [corrected to Klug, Stefanie]; Peter, Anderer [corrected to Anderer, Peter];Gerda, Saletu-Zyhlarz [corrected to Saletu-Zyhlarz, Gerda]; Marion, Freidl [corrected to Freidl, Marion]; Bernd, Saletu [corrected to Saletu, Bernd]; Wolfgang, Praus.
Results Reference
background
PubMed Identifier
19638329
Citation
Vartiainen N, Kirveskari E, Kallio-Laine K, Kalso E, Forss N. Cortical reorganization in primary somatosensory cortex in patients with unilateral chronic pain. J Pain. 2009 Aug;10(8):854-9. doi: 10.1016/j.jpain.2009.02.006.
Results Reference
background
PubMed Identifier
28081633
Citation
Horst R, Maicki T, Trabka R, Albrecht S, Schmidt K, Metel S, von Piekartz H. Activity- vs. structural-oriented treatment approach for frozen shoulder: a randomized controlled trial. Clin Rehabil. 2017 May;31(5):686-695. doi: 10.1177/0269215516687613. Epub 2017 Jan 13.
Results Reference
background
PubMed Identifier
22763295
Citation
Saab CY. Pain-related changes in the brain: diagnostic and therapeutic potentials. Trends Neurosci. 2012 Oct;35(10):629-37. doi: 10.1016/j.tins.2012.06.002. Epub 2012 Jul 3.
Results Reference
background
PubMed Identifier
31789299
Citation
Tedla JS, Sangadala DR. Proprioceptive neuromuscular facilitation techniques in adhesive capsulitis: a systematic review and meta-analysis. J Musculoskelet Neuronal Interact. 2019 Dec 1;19(4):482-491.
Results Reference
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Citation
AN Y, PARK C. EFFECTS OF A DEEP LEARNING-BASED SMARTPHONE APPLICATION ON SHOULDER ABDUCTION KINEMATICS AND BRAIN ACTIVATION IN ADHESIVE CAPSULITIS: A RANDOMIZED CONTROLLED TRIAL. Journal of Mechanics in Medicine and Biology. 2021:2140076.
Results Reference
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Effects of Activity Versus Structural Oriented Treatment Approach in Patients With Frozen Shoulder.

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