Heavy Slow Resistance Training in Adults With Frozen Shoulder (HSRFSRCT)
Primary Purpose
Frozen Shoulder
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Heavy Slow Resistance
Control group
Sponsored by
About this trial
This is an interventional treatment trial for Frozen Shoulder focused on measuring Frozen shoulder, Heavy slow resistance, Isometrics, Eccentric exercise, Muscle guarding
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Heavy Slow Resistance group
Control group
Arm Description
Heavy slow resistance exercise will be given along with traditional physical therapy program
Traditional physical therapy program will be given to the control group
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05466435
Brief Title
Heavy Slow Resistance Training in Adults With Frozen Shoulder
Acronym
HSRFSRCT
Official Title
Efficacy of Heavy Slow Resistance Training in Adults With Frozen Shoulder- a Double Blind Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2022 (Anticipated)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ministry of Health, Kuwait
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frozen Shoulder
Keywords
Frozen shoulder, Heavy slow resistance, Isometrics, Eccentric exercise, Muscle guarding
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Heavy Slow Resistance group
Arm Type
Experimental
Arm Description
Heavy slow resistance exercise will be given along with traditional physical therapy program
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Traditional physical therapy program will be given to the control group
Intervention Type
Other
Intervention Name(s)
Heavy Slow Resistance
Intervention Description
Heavy slow resistance exercise will be given twice a week for 12 weeks along with traditional physical therapy program
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
Traditional physical therapy program only will be given twice a week for 12 weeks
Primary Outcome Measure Information:
Title
Range of motion measurement for external rotation and abduction using clinometer application at week 12
Description
The smart phone clinometer is a validated tool to measure range of motion
Time Frame
week 12 from baseline measurement
Secondary Outcome Measure Information:
Title
Quick DASH(Quick Disabilities of the of Arm Shoulder and Hand)
Description
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.
Time Frame
week 12 from baseline measurement
Title
12-Item Short Form Health Survey (SF-12)
Description
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.
Time Frame
week 12 from baseline measurement
Title
The Oxford Shoulder Score(OSS)
Description
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.
Time Frame
week 12 from baseline measurement
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rafi Ahmed, MPT
Phone
00965-67667808
Email
rafithepainpt@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Najla Alsiri, Ph.D
Email
Dr.alsiri@outllook.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rafi Ahmed, MPT
Organizational Affiliation
Ministry of Health, Kuwait
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be available on request.
IPD Sharing Time Frame
Five years after completing the study
Citations:
PubMed Identifier
15687748
Citation
Jurgel J, Rannama L, Gapeyeva H, Ereline J, Kolts I, Paasuke M. Shoulder function in patients with frozen shoulder before and after 4-week rehabilitation. Medicina (Kaunas). 2005;41(1):30-8.
Results Reference
background
PubMed Identifier
9344306
Citation
Mao CY, Jaw WC, Cheng HC. Frozen shoulder: correlation between the response to physical therapy and follow-up shoulder arthrography. Arch Phys Med Rehabil. 1997 Aug;78(8):857-9. doi: 10.1016/s0003-9993(97)90200-8.
Results Reference
background
PubMed Identifier
6742895
Citation
Bulgen DY, Binder AI, Hazleman BL, Dutton J, Roberts S. Frozen shoulder: prospective clinical study with an evaluation of three treatment regimens. Ann Rheum Dis. 1984 Jun;43(3):353-60. doi: 10.1136/ard.43.3.353.
Results Reference
background
PubMed Identifier
29489251
Citation
Mezian K, Coffey R, Chang KV. Frozen Shoulder. 2022 Aug 29. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482162/
Results Reference
background
PubMed Identifier
7001312
Citation
Neviaser JS. Adhesive capsulitis and the stiff and painful shoulder. Orthop Clin North Am. 1980 Apr;11(2):327-31.
Results Reference
background
PubMed Identifier
29242941
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.
Results Reference
background
PubMed Identifier
25157702
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.
Results Reference
background
PubMed Identifier
17416123
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. doi: 10.2519/jospt.2007.2307.
Results Reference
background
PubMed Identifier
15383804
Citation
Diercks RL, Stevens M. Gentle thawing of the frozen shoulder: a prospective study of supervised neglect versus intensive physical therapy in seventy-seven patients with frozen shoulder syndrome followed up for two years. J Shoulder Elbow Surg. 2004 Sep-Oct;13(5):499-502. doi: 10.1016/j.jse.2004.03.002.
Results Reference
background
PubMed Identifier
23507791
Citation
Yoon SH, Lee HY, Lee HJ, Kwack KS. Optimal dose of intra-articular corticosteroids for adhesive capsulitis: a randomized, triple-blind, placebo-controlled trial. Am J Sports Med. 2013 May;41(5):1133-9. doi: 10.1177/0363546513480475. Epub 2013 Mar 18.
Results Reference
background
PubMed Identifier
26229109
Citation
Celik 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.
Results Reference
background
PubMed Identifier
22405512
Citation
Maund E, Craig D, Suekarran S, Neilson A, Wright K, Brealey S, Dennis L, Goodchild L, Hanchard N, Rangan A, Richardson G, Robertson J, McDaid C. Management of frozen shoulder: a systematic review and cost-effectiveness analysis. Health Technol Assess. 2012;16(11):1-264. doi: 10.3310/hta16110.
Results Reference
background
PubMed Identifier
33010843
Citation
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.
Results Reference
background
PubMed Identifier
17071012
Citation
Pruimboom L, van Dam AC. Chronic pain: a non-use disease. Med Hypotheses. 2007;68(3):506-11. doi: 10.1016/j.mehy.2006.08.036. Epub 2006 Oct 30.
Results Reference
background
PubMed Identifier
24315683
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.
Results Reference
background
PubMed Identifier
22581193
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.
Results Reference
background
PubMed Identifier
27351548
Citation
Dejaco B, Habets B, van Loon C, van Grinsven S, van Cingel R. Eccentric versus conventional exercise therapy in patients with rotator cuff tendinopathy: a randomized, single blinded, clinical trial. Knee Surg Sports Traumatol Arthrosc. 2017 Jul;25(7):2051-2059. doi: 10.1007/s00167-016-4223-x. Epub 2016 Jun 28.
Results Reference
background
PubMed Identifier
31610787
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.
Results Reference
background
PubMed Identifier
22522590
Citation
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.
Results Reference
background
PubMed Identifier
27956820
Citation
Talbott And NR, Witt DW. In vivo measurements of humeral movement during posterior glenohumeral mobilizations. J Man Manip Ther. 2016 Dec;24(5):269-276. doi: 10.1179/2042618615Y.0000000007.
Results Reference
background
PubMed Identifier
21252605
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.
Results Reference
background
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
Results Reference
background
PubMed Identifier
1516300
Citation
Ekelund AL, Rydell N. Combination treatment for adhesive capsulitis of the shoulder. Clin Orthop Relat Res. 1992 Sep;(282):105-9.
Results Reference
background
PubMed Identifier
34066777
Citation
Aldon-Villegas R, Ridao-Fernandez 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):845. doi: 10.3390/diagnostics11050845.
Results Reference
background
PubMed Identifier
29986193
Citation
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.
Results Reference
result
PubMed Identifier
19004045
Citation
Raven EE, Haverkamp D, Sierevelt IN, van Montfoort DO, Poll 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 Dec;35(12):2334-8. doi: 10.3899/jrheum.080067. Epub 2008 Nov 1.
Results Reference
result
PubMed Identifier
18234099
Citation
Wee CC, Davis RB, Hamel MB. Comparing the SF-12 and SF-36 health status questionnaires in patients with and without obesity. Health Qual Life Outcomes. 2008 Jan 30;6:11. doi: 10.1186/1477-7525-6-11.
Results Reference
result
PubMed Identifier
16776489
Citation
Millar AL, Lasheway PA, Eaton W, Christensen F. A retrospective, descriptive study of shoulder outcomes in outpatient physical therapy. J Orthop Sports Phys Ther. 2006 Jun;36(6):403-14. doi: 10.2519/jospt.2006.2101.
Results Reference
result
PubMed Identifier
24925699
Citation
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: 10.1016/j.jse.2014.02.030. Epub 2014 Jun 9.
Results Reference
result
Citation
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
Results Reference
result
Learn more about this trial
Heavy Slow Resistance Training in Adults With Frozen Shoulder
We'll reach out to this number within 24 hrs