Comparison of PFS and ART in Adhesive Capsulitis in Diabetic Patients

Adhesive Capsulitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04561310
• Other study ID #: REC/00241 Ummal Baneen
• Status: Completed
• Phase: N/A
• Start date: June 15, 2020
• Est. completion date: January 30, 2021

Study information

• Verified date: September 2020
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 30, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Adhesive Capsulitis
• Bursitis

Intervention

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 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

Locations

Country	Name	City	State
Pakistan	Asif Hospital Wah Cantt	Islamabad	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (15)

Anton HA. Frozen shoulder. Can Fam Physician. 1993 Aug;39:1773-8. Review. — View Citation

Donatelli R, Ruivo RM, Thurner M, Ibrahim MI. New concepts in restoring shoulder elevation in a stiff and painful shoulder patient. Phys Ther Sport. 2014 Feb;15(1):3-14. doi: 10.1016/j.ptsp.2013.11.001. Epub 2013 Nov 16. Review. — View Citation

Ewald A. Adhesive capsulitis: a review. Am Fam Physician. 2011 Feb 15;83(4):417-22. Review. — View Citation

Garcilazo C, Cavallasca JA, Musuruana JL. Shoulder manifestations of diabetes mellitus. Curr Diabetes Rev. 2010 Sep;6(5):334-40. Review. — View Citation

Gupta S, Jaiswal P, Chhabra D. A comparative study between postisometric relaxation and isometric exercises in non-specific neck pain. Journal of exercise science and physiotherapy. 2008;4(2):88.

Gutiérrez Espinoza HJ, Pavez F, Guajardo C, Acosta M. Glenohumeral posterior mobilization versus conventional physiotherapy for primary adhesive capsulitis: a randomized clinical trial. Medwave. 2015 Sep 22;15(8):e6267. doi: 10.5867/medwave.2015.08.6267. English, Spanish. — View Citation

Hsu CL, Sheu WH. Diabetes and shoulder disorders. J Diabetes Investig. 2016 Sep;7(5):649-51. doi: 10.1111/jdi.12491. Epub 2016 Mar 16. — View Citation

Hung CJ, Hsieh CL, Yang PL, Lin JJ. Relationships between posterior shoulder muscle stiffness and rotation in patients with stiff shoulder. J Rehabil Med. 2010 Mar;42(3):216-20. doi: 10.2340/16501977-0504. — View Citation

Kim JH, Lee HS, Park SW. Effects of the active release technique on pain and range of motion of patients with chronic neck pain. J Phys Ther Sci. 2015 Aug;27(8):2461-4. doi: 10.1589/jpts.27.2461. Epub 2015 Aug 21. — View Citation

Noten S, Meeus M, Stassijns G, Van Glabbeek F, Verborgt O, Struyf F. Efficacy of Different Types of Mobilization Techniques in Patients With Primary Adhesive Capsulitis of the Shoulder: A Systematic Review. Arch Phys Med Rehabil. 2016 May;97(5):815-25. doi: 10.1016/j.apmr.2015.07.025. Epub 2015 Aug 15. Review. — View Citation

Ravichandran H, Balamurugan J. Effect of proprioceptive neuromuscular facilitation stretch and muscle energy technique in the management of adhesive capsulitis of the shoulder. Saudi Journal of Sports Medicine. 2015 May 1;15(2):170.

Rose PG. Effective Reduction of Adhesive Capsulitis Pain with a Suprascapular Nerve Block Given in a Primary Care Clinic. InConference Highlights (p. 30).

Shih YF, Liao PW, Lee CS. The immediate effect of muscle release intervention on muscle activity and shoulder kinematics in patients with frozen shoulder: a cross-sectional, exploratory study. BMC Musculoskelet Disord. 2017 Nov 28;18(1):499. doi: 10.1186/s12891-017-1867-8. — View Citation

Tighe CB, Oakley WS Jr. The prevalence of a diabetic condition and adhesive capsulitis of the shoulder. South Med J. 2008 Jun;101(6):591-5. doi: 10.1097/SMJ.0b013e3181705d39. — View Citation

Vermeulen HM, Rozing PM, Obermann WR, le Cessie S, Vliet Vlieland TP. Comparison of high-grade and low-grade mobilization techniques in the management of adhesive capsulitis of the shoulder: randomized controlled trial. Phys Ther. 2006 Mar;86(3):355-68. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shoulder pain and disability Index (SPADI)	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
Primary	The oxford scale	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
Primary	Numeric Pain Rating Scale (NPRS)	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
Primary	ROM Shoulder Flexion	Goniometer is used to measure the range of the motion of the shoulder flexion	6th week
Primary	ROM Shoulder Extension	Goniometer is used to measure the range of the motion of the shoulder extension	6th week
Primary	ROM Shoulder Abduction	Goniometer is used to measure the range of the motion of the shoulder Abduction	6th week
Primary	ROM Shoulder External Rotation	Goniometer is used to measure the range of the motion of the shoulder External Rotation	6th week
Primary	ROM Shoulder Internal Rotation	Goniometer is used to measure the range of the motion of the shoulder Internal Rotation	6th week