Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-25 @ 8:12 PM
Study NCT ID:
NCT05466435
Status:
UNKNOWN
Last Update Posted:
2022-07-20
First Post:
2022-07-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Heavy Slow Resistance Training in Adults With Frozen Shoulder
Sponsor:
Organization:
Raw JSON
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The higher the score from 0 to 100 scale the higher the disability.'}, {'measure': '12-Item Short Form Health Survey (SF-12)', 'timeFrame': 'week 12 from baseline measurement', 'description': 'SF-12 is a 12 item ,self-reported outcome measure for assessing quality of life.\n\nScores range from 0 to 100, with higher scores indicating better physical and mental health functioning.'}, {'measure': 'The Oxford Shoulder Score(OSS)', 'timeFrame': 'week 12 from baseline measurement', '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Frozen shoulder', 'Heavy slow resistance', 'Isometrics', 'Eccentric exercise', 'Muscle guarding'], 'conditions': ['Frozen Shoulder']}, 'referencesModule': {'references': [{'pmid': '15687748', 'type': 'BACKGROUND', '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.'}, {'pmid': '9344306', 'type': 'BACKGROUND', '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.'}, {'pmid': '6742895', 'type': 'BACKGROUND', '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.'}, {'pmid': '29489251', 'type': 'BACKGROUND', 'citation': 'Mezian K, Coffey R, Chang KV. Frozen Shoulder(Archived). 2023 Aug 28. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482162/'}, {'pmid': '7001312', 'type': 'BACKGROUND', 'citation': 'Neviaser JS. Adhesive capsulitis and the stiff and painful shoulder. Orthop Clin North Am. 1980 Apr;11(2):327-31.'}, {'pmid': '29242941', 'type': 'BACKGROUND', '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.'}, {'pmid': '25157702', 'type': 'BACKGROUND', '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;2014(8):CD011275. doi: 10.1002/14651858.CD011275.'}, {'pmid': '17416123', 'type': 'BACKGROUND', '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.'}, {'pmid': '15383804', 'type': 'BACKGROUND', '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.'}, {'pmid': '23507791', 'type': 'BACKGROUND', '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.'}, {'pmid': '26229109', 'type': 'BACKGROUND', '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.'}, {'pmid': '22405512', 'type': 'BACKGROUND', '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.'}, {'pmid': '33010843', 'type': 'BACKGROUND', '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.'}, {'pmid': '17071012', 'type': 'BACKGROUND', '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.'}, {'pmid': '24315683', 'type': 'BACKGROUND', '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.'}, {'pmid': '22581193', 'type': 'BACKGROUND', '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.'}, {'pmid': '27351548', 'type': 'BACKGROUND', '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.'}, {'pmid': '31610787', 'type': 'BACKGROUND', '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.'}, {'pmid': '22522590', 'type': 'BACKGROUND', '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."}, {'pmid': '27956820', 'type': 'BACKGROUND', '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.'}, {'pmid': '21252605', 'type': 'BACKGROUND', '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.'}, {'type': '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'}, {'pmid': '1516300', 'type': 'BACKGROUND', 'citation': 'Ekelund AL, Rydell N. Combination treatment for adhesive capsulitis of the shoulder. Clin Orthop Relat Res. 1992 Sep;(282):105-9.'}, {'pmid': '34066777', 'type': 'BACKGROUND', '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.'}, {'pmid': '29986193', 'type': 'RESULT', '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.'}, {'pmid': '19004045', 'type': 'RESULT', '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.'}, {'pmid': '18234099', 'type': 'RESULT', '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.'}, {'pmid': '16776489', 'type': 'RESULT', '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.'}, {'pmid': '24925699', 'type': 'RESULT', '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.'}, {'type': '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'}]}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n* Symptoms present for at least 3 months\n* Normal x-rays on anteroposterior, axillary and lateral views\n\nExclusion Criteria:\n\n* Severe degeneration, or trauma involving the shoulder\n* Inflammatory joint disease affecting the shoulder.\n* Pain or disorders of the cervical spine, elbow, wrist, or hand\n* Stroke or peripheral nerve neuropathy Injection with corticosteroids in the affected shoulder in the preceding 4 weeks.'}, 'identificationModule': {'nctId': 'NCT05466435', 'acronym': 'HSRFSRCT', 'briefTitle': 'Heavy Slow Resistance Training in Adults With Frozen Shoulder', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ministry of Health, Kuwait'}, 'officialTitle': 'Efficacy of Heavy Slow Resistance Training in Adults With Frozen Shoulder- a Double Blind Randomised Controlled Trial', 'orgStudyIdInfo': {'id': '121'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Heavy Slow Resistance group', 'description': 'Heavy slow resistance exercise will be given along with traditional physical therapy program', 'interventionNames': ['Other: Heavy Slow Resistance', 'Other: Control group']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Traditional physical therapy program will be given to the control group', 'interventionNames': ['Other: Control group']}], 'interventions': [{'name': 'Heavy Slow Resistance', 'type': 'OTHER', 'description': 'Heavy slow resistance exercise will be given twice a week for 12 weeks along with traditional physical therapy program', 'armGroupLabels': ['Heavy Slow Resistance group']}, {'name': 'Control group', 'type': 'OTHER', 'description': 'Traditional physical therapy program only will be given twice a week for 12 weeks', 'armGroupLabels': ['Control group', 'Heavy Slow Resistance group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Rafi Ahmed, MPT', 'role': 'CONTACT', 'email': 'rafithepainpt@gmail.com', 'phone': '00965-67667808'}, {'name': 'Najla Alsiri, Ph.D', 'role': 'CONTACT', 'email': 'Dr.alsiri@outllook.com'}], 'overallOfficials': [{'name': 'Rafi Ahmed, MPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ministry of Health, Kuwait'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Five years after completing the study', 'ipdSharing': 'YES', 'description': 'Data will be available on request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ministry of Health, Kuwait', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'N.A.RAFI AHMED', 'investigatorAffiliation': 'Ministry of Health, Kuwait'}}}}