Comparison of PFS and ART in Adhesive Capsulitis in Diabetic Patients

NCT04561310 | Completed

• 1 other identifier: REC/00241 Ummal Baneen
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Adhesive Capsulitis

Keywords

Shoulder; Pain; Fibrosis; Disability

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• ROM Shoulder Flexion

  Goniometer is used to measure the range of the motion of the shoulder flexion

  6th week

• ROM Shoulder Extension

  Goniometer is used to measure the range of the motion of the shoulder extension

  6th week

• ROM Shoulder Abduction

  Goniometer is used to measure the range of the motion of the shoulder Abduction

  6th week

• ROM Shoulder External Rotation

  Goniometer is used to measure the range of the motion of the shoulder External Rotation

  6th week

• ROM Shoulder Internal Rotation

  Goniometer is used to measure the range of the motion of the shoulder Internal Rotation

  6th week

Study Arms (2)

Post facilitation stretch

EXPERIMENTAL

Post facilitation stretch with Maitland mobilization

Other: Post facilitation stretch

Active release technique

ACTIVE COMPARATOR

Active release technique with Maitland mobilization

Other: Active release technique

Interventions

Post facilitation stretch OTHER

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

Post facilitation stretch

Active release technique OTHER

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

Active release technique

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Trauma history of shoulder/surgery.
• Frozen shoulder accompanied with neurological involvement.
• People with any injury or disability of elbow or hand

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Asif Hospital Wah Cantt

Islamabad, Punjab Province, Pakistan

Location

Related Publications (15)

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

  BACKGROUND

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

  PMID: 21322517 BACKGROUND

• 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.

  PMID: 18475240 BACKGROUND

• Garcilazo C, Cavallasca JA, Musuruana JL. Shoulder manifestations of diabetes mellitus. Curr Diabetes Rev. 2010 Sep;6(5):334-40. doi: 10.2174/157339910793360824.

  PMID: 20701586 BACKGROUND

• 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. No abstract available.

  PMID: 27182002 BACKGROUND

• 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.

  PMID: 24315683 BACKGROUND

• Anton HA. Frozen shoulder. Can Fam Physician. 1993 Aug;39:1773-8.

  PMID: 8374364 BACKGROUND

• Gutierrez 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.

  PMID: 26485477 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 16506872 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 26357426 BACKGROUND

• 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.

  PMID: 29183307 BACKGROUND

• 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.

  PMID: 26284892 BACKGROUND

• 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.

  PMID: 20411215 BACKGROUND

MeSH Terms

Conditions

Bursitis; Pain; Fibrosis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Nazish Rafique, MSPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: September 23, 2020
• Study Start: June 15, 2020
• Primary Completion: January 1, 2021
• Study Completion: January 30, 2021
• Last Updated: March 24, 2021

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)