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

Frozen Shoulder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05391984
• Other study ID #: REC/RCR & AHS/22/0118
• Status: Recruiting
• Phase: N/A
• Start date: June 7, 2022
• Est. completion date: January 1, 2023

Study information

• Verified date: October 2022
• Source: Riphah International University
• Contact: Imran Amjad, PhD
• Phone: 03324390125
• Email: imran.amjad[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Bursitis
• Frozen Shoulder

Intervention

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.
• 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.

Locations

Country	Name	City	State
Pakistan	Social security hospital, Kot Lakhpat	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (10)

Abrassart S, Kolo F, Piotton S, Chih-Hao Chiu J, Stirling P, Hoffmeyer P, Lädermann 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. Review. — View 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.

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. Review. — View 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. — View 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. — View 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. — View 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. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	4th week
Primary	Goniometer for range of motion	It will be used to measure flexion, extension, abduction, adduction, and internal and external rotation of shoulder.	4th week
Primary	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.	4th week