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

NCT ID: NCT05391984

Last Updated: 2022-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-07

Study Completion Date

2023-01-01

Brief Summary

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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

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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.

Conditions

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Frozen Shoulder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Activity oriented treatment

Intervention Type OTHER

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.

Structural oriented

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

Group Type EXPERIMENTAL

Structural oriented treatment

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Muhammad Salman Bashir, PhD

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Social security hospital, Kot Lakhpat

Lahore, Punjab Province, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Imran Amjad, PhD

Role: CONTACT

03324390125

Facility Contacts

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Muhammad Salman Bashir, PhD

Role: primary

+923334497959

References

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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.

Reference Type BACKGROUND
PMID: 22999851 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32117540 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31475043 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32509332 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20924589 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19638329 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28081633 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22763295 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31789299 (View on PubMed)

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.

Reference Type BACKGROUND

Other Identifiers

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REC/RCR & AHS/22/0118

Identifier Type: -

Identifier Source: org_study_id

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