Heavy Slow Resistance Training in Adults With Frozen Shoulder

Frozen Shoulder Clinical Trial

— HSRFSRCT  

Official title:

Efficacy of Heavy Slow Resistance Training in Adults With Frozen Shoulder- a Double Blind Randomised Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05466435
• Other study ID #: 121
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2022
• Est. completion date: August 2025

Study information

• Verified date: July 2022
• Source: Ministry of Health, Kuwait
• Contact: Rafi Ahmed, MPT
• Phone: 00965-67667808
• Email: rafithepainpt[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to evaluate the efficacy of Heavy Slow Resistance exercise in patients diagnosed with frozen shoulder using randomized controlled trial design

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: August 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• Unilateral painful, restricted active and passive range of motion of the shoulder, with loss of passive external rotation of at least 50% compared to opposite side at 0 deg of abduction

• Symptoms present for at least 3 months

• Normal x-rays on anteroposterior, axillary and lateral views

Exclusion Criteria:

• Severe degeneration, or trauma involving the shoulder

• Inflammatory joint disease affecting the shoulder.

• Pain or disorders of the cervical spine, elbow, wrist, or hand

• Stroke or peripheral nerve neuropathy Injection with corticosteroids in the affected shoulder in the preceding 4 weeks.

Related Conditions & MeSH terms

• Bursitis
• Frozen Shoulder

Intervention

Other:
• Heavy Slow Resistance
Heavy slow resistance exercise will be given twice a week for 12 weeks along with traditional physical therapy program
• Control group
Traditional physical therapy program only will be given twice a week for 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ministry of Health, Kuwait

References & Publications (30)

Aldon-Villegas R, Ridao-Fernández C, Torres-Enamorado D, Chamorro-Moriana G. How to Assess Shoulder Functionality: A Systematic Review of Existing Validated Outcome Measures. Diagnostics (Basel). 2021 May 8;11(5). pii: 845. doi: 10.3390/diagnostics11050845. Review. — View Citation

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Çelik D, Kaya Mutlu E. Does adding mobilization to stretching improve outcomes for people with frozen shoulder? A randomized controlled clinical trial. Clin Rehabil. 2016 Aug;30(8):786-94. doi: 10.1177/0269215515597294. Epub 2015 Jul 30. — View Citation

Celik D. Comparison of the outcomes of two different exercise programs on frozen shoulder. Acta Orthop Traumatol Turc. 2010;44(4):285-92. doi: 10.3944/AOTT.2010.2367. — View Citation

Chan HBY, Pua PY, How CH. Physical therapy in the management of frozen shoulder. Singapore Med J. 2017 Dec;58(12):685-689. doi: 10.11622/smedj.2017107. — View Citation

Current management of shoulder adhesive capsulitis: a randomized, triple-blind placebo-controlled trial Riyadh a. Almashni1*, abdullah w. Calacattawi2, meshal a. Almeshal3, elaf j. Alsharif4, mohamad w. Hijazi5, shahd a. Abdulwahab5, anfal j. Alsharif6, nasser o. Altufayl7, anwar a. Alghamdi1, hisham a. Almuzayyen

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Hollmann L, Halaki M, Kamper SJ, Haber M, Ginn KA. Does muscle guarding play a role in range of motion loss in patients with frozen shoulder? Musculoskelet Sci Pract. 2018 Oct;37:64-68. doi: 10.1016/j.msksp.2018.07.001. Epub 2018 Jul 6. — View Citation

Johnson AJ, Godges JJ, Zimmerman GJ, Ounanian LL. The effect of anterior versus posterior glide joint mobilization on external rotation range of motion in patients with shoulder adhesive capsulitis. J Orthop Sports Phys Ther. 2007 Mar;37(3):88-99. — View Citation

Jürgel J, Rannama L, Gapeyeva H, Ereline J, Kolts I, Pääsuke M. Shoulder function in patients with frozen shoulder before and after 4-week rehabilitation. Medicina (Kaunas). 2005;41(1):30-8. — View Citation

Larsson R, Bernhardsson S, Nordeman L. Effects of eccentric exercise in patients with subacromial impingement syndrome: a systematic review and meta-analysis. BMC Musculoskelet Disord. 2019 Oct 14;20(1):446. doi: 10.1186/s12891-019-2796-5. — View Citation

Maenhout AG, Mahieu NN, De Muynck M, De Wilde LF, Cools AM. Does adding heavy load eccentric training to rehabilitation of patients with unilateral subacromial impingement result in better outcome? A randomized, clinical trial. Knee Surg Sports Traumatol Arthrosc. 2013 May;21(5):1158-67. doi: 10.1007/s00167-012-2012-8. Epub 2012 May 12. — View Citation

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Mezian K, Coffey R, Chang KV. Frozen Shoulder. 2022 May 12. StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482162/ — View Citation

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O'Sullivan K, McAuliffe S, Deburca N. The effects of eccentric training on lower limb flexibility: a systematic review. Br J Sports Med. 2012 Sep;46(12):838-45. doi: 10.1136/bjsports-2011-090835. Epub 2012 Apr 20. Review. — View Citation

Page MJ, Green S, Kramer S, Johnston RV, McBain B, Chau M, Buchbinder R. Manual therapy and exercise for adhesive capsulitis (frozen shoulder). Cochrane Database Syst Rev. 2014 Aug 26;(8):CD011275. doi: 10.1002/14651858.CD011275. Review. — View Citation

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Rangan A, Brealey SD, Keding A, Corbacho B, Northgraves M, Kottam L, Goodchild L, Srikesavan C, Rex S, Charalambous CP, Hanchard N, Armstrong A, Brooksbank A, Carr A, Cooper C, Dias JJ, Donnelly I, Hewitt C, Lamb SE, McDaid C, Richardson G, Rodgers S, Sharp E, Spencer S, Torgerson D, Toye F; UK FROST Study Group. Management of adults with primary frozen shoulder in secondary care (UK FROST): a multicentre, pragmatic, three-arm, superiority randomised clinical trial. Lancet. 2020 Oct 3;396(10256):977-989. doi: 10.1016/S0140-6736(20)31965-6. Erratum in: Lancet. 2021 Jan 9;397(10269):98. — View Citation

Raven EE, Haverkamp D, Sierevelt IN, van Montfoort DO, Pöll RG, Blankevoort L, Tak PP. Construct validity and reliability of the disability of arm, shoulder and hand questionnaire for upper extremity complaints in rheumatoid arthritis. J Rheumatol. 2008 D — View Citation

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Use of smart phone for measuring shoulder rotational range of motion in patients with frozen shoulder: A comparative study Kartik Shah, Mangala Deshpande Priyesha Ramteke Jyoti Singh Anjali Sondawle

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Werner BC, Holzgrefe RE, Griffin JW, Lyons ML, Cosgrove CT, Hart JM, Brockmeier SF. Validation of an innovative method of shoulder range-of-motion measurement using a smartphone clinometer application. J Shoulder Elbow Surg. 2014 Nov;23(11):e275-82. doi: — View Citation

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Range of motion measurement for external rotation and abduction using clinometer application at week 12	The smart phone clinometer is a validated tool to measure range of motion	week 12 from baseline measurement
Secondary	Quick DASH(Quick Disabilities of the of Arm Shoulder and Hand)	Quick DASH is an 11 item questionnaire to measure physical function and symptoms in people presenting with one or more disabilities of the arm, shoulder, and hand. The higher the score from 0 to 100 scale the higher the disability.	week 12 from baseline measurement
Secondary	12-Item Short Form Health Survey (SF-12)	SF-12 is a 12 item ,self-reported outcome measure for assessing quality of life.; Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.	week 12 from baseline measurement
Secondary	The Oxford Shoulder Score(OSS)	The Oxford Shoulder Score is validated tool for measuring pain and disability caused by shoulder pathology. It has 12 items with a score ranging from 0 to 48 with 48 being the best outcome.	week 12 from baseline measurement