Back to resultsThe Effect of Extracorporeal Shockwave Therapy on Adhesive Capsulitis Shoulder
Primary Purpose
Adhesive Capsulitis of Shoulder
Status
Recruiting
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
ESWT+ traditional physical therapy treatment
Placebo shockwave + traditional physical therapy treatment
Sponsored by
About this trial
This is an interventional treatment trial for Adhesive Capsulitis of Shoulder focused on measuring Frozen shoulder, Extracorporeal shockwave therapy
Eligibility Criteria
Inclusion Criteria: Having a relapsed or episode of pain score ≥5 at the assessment with a past history of pain for at least 2 weeks. phase 1 or 2 frozen shoulder confirmed by a physician ROM restriction (>75% ROM loss in ≥2 directions including abduction, flexion and external rotation) no treatment other than analgesics with unresponsive ROM restriction for the past 2 months unwilling or waiting and did not undergo joint injection Diagnosed with shoulder adhesive capsulitis, ≥18 years Diabetes mellitus Exclusion Criteria: bilateral shoulder involvement History of previous surgery on the shoulder Shoulder fracture Cancer Glenohumeral or Acromioclavicular arthritis Inflammatory disorders Bleeding disorders Presence of severe osteoporosis Pulmonary diseases Any neuromuscular disorders Pregnancy Implanted pacemaker
Sites / Locations
- Al-Thager General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ESWT+ traditional physical therapy treatment
Placebo shockwave + traditional physical therapy treatment
Arm Description
ESWT+ traditional physical therapy treatment
Placebo shockwave + traditional physical therapy treatment
Outcomes
Primary Outcome Measures
Visual analogue scale
Visual analogue scale for pain measurement
Range of Motion
Range of Motion is measured by goniometer
Secondary Outcome Measures
Quick DASH
Disabilities of the Arm, Shoulder, and Hand (DASH) score.
DASS
DASS, the Depression Anxiety Stress Scales, is made up of 42 self-report items
SF-36 (short version)
The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05771220
Brief Title
The Effect of Extracorporeal Shockwave Therapy on Adhesive Capsulitis Shoulder
Official Title
The Effect of Extracorporeal Shockwave Therapy on Adhesive Capsulitis Shoulder: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2023 (Actual)
Primary Completion Date
June 15, 2023 (Anticipated)
Study Completion Date
July 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taif University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Introduction: Adhesive capsulities or Frozen shoulder is one of the common causes of shoulder pain and disability in the upper extremity. It affects the functions of glenohumeral joint, limiting both active and passive movements of the shoulder. One way of non-surgical treatment method that has been receiving attention recently is extracorporeal shockwave therapy (ESWT). ESWT is a pulsed sound wave, characterized by short duration, high pressure amplitude, and relatively low tensile wave component. ESWT has beenrepotreatingtreat a variety of pain conditions effectively and safely.
Purpose: The purpose of the present study is to determine whether ESWT could be effective in thetreatment of adhesive capsulitis or frozen shoulder.
Detailed Description
Methods: Experiment Group patients were given shockwave therapy for 6 weeks as a one session per week follow up after 12 weeks. Control Group patients received shame shockwave therapy inaddition to traditional treatment the same period of the experiment group.Importance: Till date, only a few studies have reported the efficacy and clinical improvements obtained by extracorporeal shockwave therapy (ESWT) on frozen shoulder. Limited by asmall number of studies and insufficient outcomes, it is important and necessary to conduct a new randomized controlled trial
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Capsulitis of Shoulder
Keywords
Frozen shoulder, Extracorporeal shockwave therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized control trial, single blinded, placebo
Masking
Participant
Masking Description
Single blinded
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ESWT+ traditional physical therapy treatment
Arm Type
Experimental
Arm Description
ESWT+ traditional physical therapy treatment
Arm Title
Placebo shockwave + traditional physical therapy treatment
Arm Type
Placebo Comparator
Arm Description
Placebo shockwave + traditional physical therapy treatment
Intervention Type
Combination Product
Intervention Name(s)
ESWT+ traditional physical therapy treatment
Intervention Description
Participants will receive one session per week for 6 weeks on the affected tissue region which will be achieved by a sequence of 2000 shock wave pulses fired with a repetition frequency of 2 pulses per second. Energy level or intensity will be set at a tolerable level by patient (0.2mJ/mm2).
The usual physical therapy care consists of hot pack (10min), stretching, pendulum exercises, isometrics exercises of shoulder one per week, and for 12 weeks. home exercises program (HEP)
Intervention Type
Combination Product
Intervention Name(s)
Placebo shockwave + traditional physical therapy treatment
Intervention Description
Participants will be treated one time a week over a six-week period. Placebo shockwave treatment (apply low intensity with low dose and frequency: intensity 0.1, freq 1, dose 200 shocks).
The usual physical therapy care consists of hot pack (10min), stretching, pendulum exercises, isometrics exercises of shoulder one per week, and for 12 weeks. home exercises program (HEP)
Primary Outcome Measure Information:
Title
Visual analogue scale
Description
Visual analogue scale for pain measurement
Time Frame
2 months
Title
Range of Motion
Description
Range of Motion is measured by goniometer
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Quick DASH
Description
Disabilities of the Arm, Shoulder, and Hand (DASH) score.
Time Frame
2 months
Title
DASS
Description
DASS, the Depression Anxiety Stress Scales, is made up of 42 self-report items
Time Frame
2 months
Title
SF-36 (short version)
Description
The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life.
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Having a relapsed or episode of pain score ≥5 at the assessment with a past history of pain for at least 2 weeks.
phase 1 or 2 frozen shoulder confirmed by a physician
ROM restriction (>75% ROM loss in ≥2 directions including abduction, flexion and external rotation)
no treatment other than analgesics with unresponsive ROM restriction for the past 2 months
unwilling or waiting and did not undergo joint injection
Diagnosed with shoulder adhesive capsulitis,
≥18 years
Diabetes mellitus
Exclusion Criteria:
bilateral shoulder involvement
History of previous surgery on the shoulder
Shoulder fracture
Cancer
Glenohumeral or Acromioclavicular arthritis
Inflammatory disorders
Bleeding disorders
Presence of severe osteoporosis
Pulmonary diseases
Any neuromuscular disorders
Pregnancy
Implanted pacemaker
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Turki Sharahili, Bachelor
Phone
+966505358057
Email
pt.turkii@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hosam Alzahrani, PhD
Phone
+966 55 066 8282
Email
halzahrani@tu.edu.sa
Facility Information:
Facility Name
Al-Thager General Hospital
City
Jeddah
State/Province
Mecca
ZIP/Postal Code
21477
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marwah Afeef
Phone
6202333
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29200621
Citation
Lee S, Lee S, Jeong M, Oh H, Lee K. The effects of extracorporeal shock wave therapy on pain and range of motion in patients with adhesive capsulitis. J Phys Ther Sci. 2017 Nov;29(11):1907-1909. doi: 10.1589/jpts.29.1907. Epub 2017 Nov 24.
Results Reference
result
PubMed Identifier
31417208
Citation
Muthukrishnan R, Rashid AA, Al-Alkharji F. The effectiveness of extracorporeal shockwave therapy for frozen shoulder in patients with diabetes: randomized control trial. J Phys Ther Sci. 2019 Jul;31(7):493-497. doi: 10.1589/jpts.31.493. Epub 2019 Jul 2.
Results Reference
result
PubMed Identifier
19194024
Citation
Kelley MJ, McClure PW, Leggin BG. Frozen shoulder: evidence and a proposed model guiding rehabilitation. J Orthop Sports Phys Ther. 2009 Feb;39(2):135-48. doi: 10.2519/jospt.2009.2916.
Results Reference
result
PubMed Identifier
25104999
Citation
Vahdatpour B, Taheri P, Zade AZ, Moradian S. Efficacy of extracorporeal shockwave therapy in frozen shoulder. Int J Prev Med. 2014 Jul;5(7):875-81.
Results Reference
result
PubMed Identifier
28405218
Citation
Le HV, Lee SJ, Nazarian A, Rodriguez EK. Adhesive capsulitis of the shoulder: review of pathophysiology and current clinical treatments. Shoulder Elbow. 2017 Apr;9(2):75-84. doi: 10.1177/1758573216676786. Epub 2016 Nov 7.
Results Reference
result
PubMed Identifier
30762780
Citation
Cao DZ, Wang CL, Qing Z, Liu LD. Effectiveness of extracorporeal shock-wave therapy for frozen shoulder: A protocol for a systematic review of randomized controlled trial. Medicine (Baltimore). 2019 Feb;98(7):e14506. doi: 10.1097/MD.0000000000014506.
Results Reference
result
PubMed Identifier
33185587
Citation
Nakandala P, Nanayakkara I, Wadugodapitiya S, Gawarammana I. The efficacy of physiotherapy interventions in the treatment of adhesive capsulitis: A systematic review. J Back Musculoskelet Rehabil. 2021;34(2):195-205. doi: 10.3233/BMR-200186.
Results Reference
result
PubMed Identifier
28174448
Citation
Agarwal S, Raza S, Moiz JA, Anwer S, Alghadir AH. Effects of two different mobilization techniques on pain, range of motion and functional disability in patients with adhesive capsulitis: a comparative study. J Phys Ther Sci. 2016 Dec;28(12):3342-3349. doi: 10.1589/jpts.28.3342. Epub 2016 Dec 27.
Results Reference
result
PubMed Identifier
24284277
Citation
Jain TK, Sharma NK. The effectiveness of physiotherapeutic interventions in treatment of frozen shoulder/adhesive capsulitis: a systematic review. J Back Musculoskelet Rehabil. 2014;27(3):247-73. doi: 10.3233/BMR-130443.
Results Reference
result
PubMed Identifier
29581969
Citation
Yuan X, Zhou F, Zhang L, Zhang Z, Li J. Analgesic Effect of Extracorporeal Shock Wave Treatment Combined with Fascial Manipulation Theory for Adhesive Capsulitis of the Shoulder: A Retrospective Study. Biomed Res Int. 2018 Jan 18;2018:3450940. doi: 10.1155/2018/3450940. eCollection 2018.
Results Reference
result
PubMed Identifier
26834326
Citation
Park C, Lee S, Yi CW, Lee K. The effects of extracorporeal shock wave therapy on frozen shoulder patients' pain and functions. J Phys Ther Sci. 2015 Dec;27(12):3659-61. doi: 10.1589/jpts.27.3659. Epub 2015 Dec 28.
Results Reference
result
PubMed Identifier
24374758
Citation
Struyf F, Meeus M. Current evidence on physical therapy in patients with adhesive capsulitis: what are we missing? Clin Rheumatol. 2014 May;33(5):593-600. doi: 10.1007/s10067-013-2464-3. Epub 2013 Dec 28.
Results Reference
result
PubMed Identifier
35141337
Citation
Zhang R, Wang Z, Liu R, Zhang N, Guo J, Huang Y. Extracorporeal Shockwave Therapy as an Adjunctive Therapy for Frozen Shoulder: A Systematic Review and Meta-analysis. Orthop J Sports Med. 2022 Feb 4;10(2):23259671211062222. doi: 10.1177/23259671211062222. eCollection 2022 Feb.
Results Reference
result
PubMed Identifier
32756135
Citation
Qiao HY, Xin L, Wu SL. Analgesic effect of extracorporeal shock-wave therapy for frozen shoulder: A randomized controlled trial protocol. Medicine (Baltimore). 2020 Jul 31;99(31):e21399. doi: 10.1097/MD.0000000000021399.
Results Reference
result
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The Effect of Extracorporeal Shockwave Therapy on Adhesive Capsulitis Shoulder
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