Heavy Slow Resistance Training in Adults With Frozen Shoulder

NCT05466435 | Unknown

• 1 other identifier: 121
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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

Conditions

Frozen Shoulder

Keywords

Frozen shoulder; Heavy slow resistance; Isometrics; Eccentric exercise; Muscle guarding

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Quick DASH(Quick Disabilities of the of Arm Shoulder and Hand)

  week 12 from baseline measurement

• 12-Item Short Form Health Survey (SF-12)

  week 12 from baseline measurement

• The Oxford Shoulder Score(OSS)

  week 12 from baseline measurement

Study Arms (2)

Heavy Slow Resistance group

EXPERIMENTAL

Heavy slow resistance exercise will be given along with traditional physical therapy program

Other: Heavy Slow Resistance; Other: Control group

Control group

PLACEBO COMPARATOR

Traditional physical therapy program will be given to the control group

Other: Control group

Interventions

Heavy Slow Resistance OTHER

Heavy slow resistance exercise will be given twice a week for 12 weeks along with traditional physical therapy program

Heavy Slow Resistance group

Control group OTHER

Traditional physical therapy program only will be given twice a week for 12 weeks

Control group; Heavy Slow Resistance group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ministry of Health, Kuwait: lead

Related Publications (30)

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  PMID: 21252605 BACKGROUND

• 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

  BACKGROUND

• Ekelund AL, Rydell N. Combination treatment for adhesive capsulitis of the shoulder. Clin Orthop Relat Res. 1992 Sep;(282):105-9.

  PMID: 1516300 BACKGROUND

• 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.

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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.

  PMID: 29986193 RESULT

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• 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: 18234099 RESULT

• 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: 16776489 RESULT

• 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.

  PMID: 24925699 RESULT

• 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

  RESULT

MeSH Terms

Conditions

Bursitis

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Rafi Ahmed, MPT

  Ministry of Health, Kuwait

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rafi Ahmed, MPT

CONTACT

00965-67667808; rafithepainpt@gmail.com

Najla Alsiri, Ph.D

CONTACT

Dr.alsiri@outllook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 4, 2022
• First Posted: July 20, 2022
• Study Start: August 1, 2022
• Primary Completion: January 1, 2025
• Study Completion: August 1, 2025
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Five years after completing the study