Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
Journal of Orthopaedic Surgery and Research
Published in: Journal of Orthopaedic Surgery and Research 1/2024

Open Access 01-12-2024 | Shoulder Stiffness | Study Protocol

Comparative effectiveness of low-level laser therapy versus muscle energy technique among diabetic patients with frozen shoulder: a study protocol for a parallel group randomised controlled trial

Authors: Halima I. Hassan, Bashir Kaka, Fatima Bello, Francis Fatoye, Aminu A. Ibrahim

Published in: Journal of Orthopaedic Surgery and Research | Issue 1/2024

Login to get access

Abstract

Background

Diabetes mellitus is one of the fastest-growing health challenges of the twenty-first century with multifactorial impact including high rates of morbidity and mortality as well as increased healthcare costs. It is associated with musculoskeletal complications, with frozen shoulder being commonly reported. While low-level laser therapy (LLLT) and muscle energy technique (MET) are commonly used to manage  this condition, there remains a lack of agreement on the most effective approach, with limited research available on their comparative efficacy.

Objectives

To evaluate the comparative effectiveness of LLLT versus MET among diabetic patients with frozen shoulder.

Methods

This is a single-centre, prospective, single-blind, randomised controlled trial with three parallel groups to be conducted at Ahmadu Bello University Teaching Hospital, Zaria, Kaduna State, Nigeria. Sixty diabetic patients with frozen shoulder will be randomly assigned into LLLT group, MET group, or control group in a 1:1:1 ratio. All the groups will receive treatment three times weekly for 8 weeks. The primary outcome will be shoulder function and the secondary outcomes will include pain intensity, shoulder ROM, interleukin-6 (IL-6), depression, anxiety, and quality of life (QoL). All outcomes will be assessed at baseline, at post 8-week intervention, and at 3 months follow-up.

Discussion

This will be the first randomised controlled trial to evaluate the comparative effectiveness of LLLT versus MET on both clinical and psychological parameters among diabetic patients with frozen shoulder. The findings of the study may provide evidence on the efficacy of these interventions and most likely, the optimal treatment approach for frozen shoulder related to diabetes, which may guide clinical practice.
Trial Registration: Pan African Clinical Trials Registry (PACTR202208562111554). Registered on August 10, 2022.
Appendix
Available only for authorised users
Literature
1.
2.
Sun H, Saeedi P, Karuranga S, Pinkepank M, Ogurtsova K, Duncan BB, et al. IDF Diabetes Atlas: global, regional and country-level diabetes prevalence estimates for 2021 and projections for 2045. Diabetes Res Clin Pract. 2022;183: 109119.PubMedCrossRef
3.
Ogurtsova K, da Rocha Fernandes JD, Huang Y, Linnenkamp U, Guariguata L, Cho NH, et al. IDF Diabetes Atlas: global estimates for the prevalence of diabetes for 2015 and 2040. Diabetes Res Clin Pract. 2017;128:40–50.PubMedCrossRef
4.
Wolde HF, Derso T, Biks GA, Yitayal M, Ayele TA, Gelaye KA, et al. High hidden burden of diabetes mellitus among adults aged 18 years and above in urban Northwest Ethiopia. 2020;2020:9240398.
5.
6.
Merashli M, Chowdhury TA, Jawad AS. Musculoskeletal manifestations of diabetes mellitus. QJM. 2015;108(11):853–7.PubMedCrossRef
7.
Ghosal S, Ghosal A. Diabetes and musculoskeletal disorders-a review. J Diabetes Metab Disord Control. 2020;7:63–71.CrossRef
8.
Hassan HI, Kaka B, Sharaye KO, Abdulaziz U, Sada A, Fatoye F, et al. Musculoskeletal disorders and their associated factors among individuals with diabetes mellitus in northwest Nigeria. Reumatol. 2023;61(6):439–47.CrossRef
9.
Molsted S, Tribler J, Snorgaard O. Musculoskeletal pain in patients with type 2 diabetes. Diabetes Res Clin Pract. 2012;96(2):135–40.PubMedCrossRef
10.
Kaka B, Maharaj SS, Fatoye F. Prevalence of musculoskeletal disorders in patients with diabetes mellitus: a systematic review and meta-analysis. J Back Musculoskelet Rehabil. 2019;32(2):223–35.PubMedCrossRef
11.
12.
13.
14.
Majjad A, Errahali Y, Toufik H, Djossou J, Ghassem MA, Kasouati J, et al. Musculoskeletal disorders in patients with diabetes mellitus: a cross-sectional study. Int J Rheumato. 2018;2018:3839872.
15.
Inayat F, Ali NS, Shahid H, Younus F. Prevalence and determinants of frozen shoulder in patients with diabetes: a single center experience from Pakistan. Cureus. 2017;9(8): e1544.PubMedPubMedCentral
16.
Silva MB, Skare TL. Musculoskeletal disorders in diabetes mellitus. Rev Bras Reumatol. 2012;52(4):601–359.PubMedCrossRef
17.
Brett Paul D, Trishna R-M, Claire B, van der Danielle W, Milica B. Diabetes as a risk factor for the onset of frozen shoulder: a systematic review and meta-analysis. BMJ Open. 2023;13(1): e062377.CrossRef
18.
Zreik NH, Malik RA, Charalambous CP. Adhesive capsulitis of the shoulder and diabetes: a meta-analysis of prevalence. Muscles Ligaments Tendons J. 2016;6(1):26–34.PubMedPubMedCentralCrossRef
19.
Cole A, Gill TK, Shanahan EM, Phillips P, Taylor AW, Hill CL. Is diabetes associated with shoulder pain or stiffness? Results from a population based study. J Rheumatol. 2009;36(2):371–7.PubMedCrossRef
20.
21.
Ebrahimzadeh MH, Moradi A, Bidgoli HF, Zarei B. The Relationship between depression or anxiety symptoms and objective and subjective symptoms of patients with frozen shoulder. Int J Prev Med. 2019;10:38.PubMedPubMedCentralCrossRef
22.
Laslett LL, Burnet SP, Jones JA, Redmond CL, McNeil JD. Musculoskeletal morbidity: the growing burden of shoulder pain and disability and poor quality of life in diabetic outpatients. Clin Exp Rheumatol. 2007;25(3):422–9.PubMed
23.
Dyer BP, Burton C, Rathod-Mistry T, Blagojevic-Bucknall M, van der Windt DA. Diabetes as a prognostic factor in frozen shoulder: a systematic review. Arch Rehabil Res Clin Transl. 2021;3(3): 100141.PubMedPubMedCentral
24.
Arkkila PE, Kantola IM, Viikari JS, Rönnemaa T. Shoulder capsulitis in type I and II diabetic patients: association with diabetic complications and related diseases. Ann Rheum Dis. 1996;55(12):907–14.PubMedPubMedCentralCrossRef
25.
Boyle-Walker KL, Gabard DL, Bietsch E, Masek-VanArsdale DM, Robinson BL. A profile of patients with adhesive capsulitis. J Hand Ther. 1997;10(3):222–8.PubMedCrossRef
26.
Sheridan MA, Hannafin JA. Upper extremity: emphasis on frozen shoulder. Orthop Clin North Am. 2006;37(4):531–9.PubMedCrossRef
27.
28.
29.
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.PubMedCrossRef
30.
Page MJ, Green S, Kramer S, Johnston RV, McBain B, Buchbinder R. Electrotherapy modalities for adhesive capsulitis (frozen shoulder). Cochrane Database Syst Rev. 2014;1:Cd011324.
31.
Page MJ, Green S, Kramer S, Johnston RV, McBain B, Chau M, et al. Manual therapy and exercise for adhesive capsulitis (frozen shoulder). Cochrane Database Syst Rev. 2014;8:Cd011275.
32.
Mallick DK, Paul S, Ghosh T. Effects of muscle energy technique on improving the range of motion and pain in patients with frozen shoulder. Biomedicine. 2023;43(1):26–9.CrossRef
33.
Dundar U, Toktas H, Cakir T, Evcik D, Kavuncu V. Continuous passive motion provides good pain control in patients with adhesive capsulitis. Int J Rehabil Res. 2009;32(3):193–8.PubMedCrossRef
34.
Farivar S, Malekshahabi T, Shiari R. Biological effects of low level laser therapy. J Lasers Med Sci. 2014;5(2):58–62.PubMedPubMedCentral
35.
Baxter GD, Bell AJ, Allen JM, Ravey J. Low level laser therapy: current clinical practice in Northern Ireland. Physiotherapy. 1991;77(3):171–8.CrossRef
36.
Awotidebe AW, Inglis-Jassiem G, Young T. Does low-level laser therapy provide additional benefits to exercise in patients with shoulder musculoskeletal disorders? A meta-analysis of randomised controlled trials. Ortop Traumatol Rehabil. 2019;21(6):407–16.PubMedCrossRef
37.
Orrock PJ. Profile of members of the Australian osteopathic association: part 2–the patients. Int J Osteopathic Med. 2009;12(4):128–39.CrossRef
38.
Chaitow L, Franke H, Chaitow L. Muscle energy techniques: Churchill Livingstone. London: Elsevier; 2006.
39.
Fryer G, Ruszkowski W. The influence of contraction duration in muscle energy technique applied to the atlanto-axial joint. J Osteopath Med. 2004;7(2):79–84.CrossRef
40.
Greenman P. Principles of manual medicine. 2nd ed. Baltimore (MD): Williams and Wilkins; 1996.
41.
Faqih AI, Bedekar N, Shyam A, Sancheti P. Effects of muscle energy technique on pain, range of motion and function in patients with post-surgical elbow stiffness: a randomized controlled trial. Hong Kong Physiother J. 2019;39(1):25–33.PubMedCrossRef
42.
Thomas E, Cavallaro AR, Mani D, Bianco A, Palma A. The efficacy of muscle energy techniques in symptomatic and asymptomatic subjects: a systematic review. Chiropr Man Therap. 2019;27:35.PubMedPubMedCentralCrossRef
43.
Suri SA, Anand M. Comparative study on the effectiveness of Maitland mobilization technique versus muscle energy technique in treatment of shoulder adhesive capsulitis. Indian J Physiother Occup Ther. 2013;7(4):1.CrossRef
44.
Khalil R, Tanveer F, Hanif A, Ahmad A. Comparison of Mulligan technique versus muscle energy technique in patients with adhesive capsulitis. J Pak Med Assoc. 2022;72(2):211–5.PubMedCrossRef
45.
Iqbal M, Riaz H, Ghous M, Masood K. Comparison of Spencer muscle energy technique and Passive stretching in adhesive capsulitis: a single blind randomized control trial. J Pak Med Assoc. 2020;70(12(a)):2113–8.
46.
Jaiswal N, Saketa J, Rajsekhar H. Efficacy of muscle energy techniques as an adjunct with mulligans mobilization in adhesive capsulitis of shoulder. Int J Physiother. 2019:52–7.
47.
Leclaire R, Bourgouin J. Electromagnetic treatment of shoulder periarthritis: a randomized controlled trial of the efficiency and tolerance of magnetotherapy. Arch Phys Med Rehabil. 1991;72(5):284–7.PubMed
48.
Stergioulas A. Low-power laser treatment in patients with frozen shoulder: preliminary results. Photomed Laser Surg. 2008;26(2):99–105.PubMedCrossRef
49.
Breckenridge JD, McAuley JH. Shoulder Pain and Disability Index (SPADI). J Physiother. 2011;57(3):197.PubMedCrossRef
50.
Venturin D, Giannotta G, Pellicciari L, Rossi A, Pennella D, Goffredo M, et al. Reliability and validity of the Shoulder Pain and Disability Index in a sample of patients with frozen shoulder. BMC Musculoskel Disord. 2023;24(1):212.CrossRef
51.
Roy JS, MacDermid JC, Woodhouse LJ. Measuring shoulder function: a systematic review of four questionnaires. Arthritis Rheum. 2009;61(5):623–32.PubMedCrossRef
52.
Hill CL, Lester S, Taylor AW, Shanahan ME, Gill TK. Factor structure and validity of the shoulder pain and disability index in a population-based study of people with shoulder symptoms. BMC Musculoskel Disord. 2011;12(1):8.CrossRef
53.
Roach KE, Budiman-Mak E, Songsiridej N, Lertratanakul Y. Development of a shoulder pain and disability index. Arthritis Care Res. 1991;4(4):143–9.PubMedCrossRef
54.
Williamson A, Hoggart B. Pain: a review of three commonly used pain rating scales. J Clin Nurs. 2005;14(7):798–804.PubMedCrossRef
55.
Abbott JH, Schmitt J. Minimum important differences for the patient-specific functional scale, 4 region-specific outcome measures, and the numeric pain rating scale. J Orthop Sports Phys Ther. 2014;44(8):560–4.PubMedCrossRef
56.
Jensen MP, McFarland CA. Increasing the reliability and validity of pain intensity measurement in chronic pain patients. Pain. 1993;55(2):195–203.PubMedCrossRef
57.
Ibrahim AA, Akindele MO, Bello B, Kaka B. Translation, cross-cultural adaptation, and psychometric properties of the Hausa versions of the numerical pain rating scale and global rating of change scale in a low-literate population with chronic low back pain. Spine (Phila Pa 1976). 2020;45(8):E439–e47.
58.
Norkin CC, White DJ. Measurement of joint motion: a guide to goniometry: FA Davis; 2016.
59.
Sabari JS, Maltzev I, Lubarsky D, Liszkay E, Homel P. Goniometric assessment of shoulder range of motion: comparison of testing in supine and sitting positions. Arch Phys Med Rehabil. 1998;79(6):647–51.PubMedCrossRef
60.
Mullaney MJ, McHugh MP, Johnson CP, Tyler TF. Reliability of shoulder range of motion comparing a goniometer to a digital level. Physiother Theory Pract. 2010;26(5):327–33.PubMedCrossRef
61.
Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67(6):361–70.PubMedCrossRef
62.
Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002;52(2):69–77.
63.
Ware JE Jr, Gandek B. Overview of the SF-36 Health Survey and the International Quality of Life Assessment (IQOLA) Project. J Clin Epidemiol. 1998;51(11):903–12.PubMedCrossRef
64.
Ware JE, Jr., Sherbourne CD. The MOS 36-item Short-Form Health Survey (SF-36): I. Conceptual Framework and Item Selection. Medical Care. 1992;30(6).
65.
Ware JE Jr, Snow KK, Kosinski M, Gandek B. SF-36 manual and interpretation guide. Boston: The Health Institute, New England Medical Center; 1993.
66.
Smith KL, Harryman DT 2nd, Antoniou J, Campbell B, Sidles JA, Matsen FA 3rd. A prospective, multipractice study of shoulder function and health status in patients with documented rotator cuff tears. J Shoulder Elbow Surg. 2000;9(5):395–402.PubMedCrossRef
67.
Paul A, Lewis M, Shadforth MF, Croft PR, Van Der Windt DA, Hay EM. A comparison of four shoulder-specific questionnaires in primary care. Ann Rheum Dis. 2004;63(10):1293–9.PubMedPubMedCentralCrossRef
68.
Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007;39(2):175–91.PubMedCrossRef
69.
Azur MJ, Stuart EA, Frangakis C, Leaf PJ. Multiple imputation by chained equations: what is it and how does it work? Int J Methods Psychiatr Res. 2011;20(1):40–9.PubMedPubMedCentralCrossRef
Metadata
Title
Comparative effectiveness of low-level laser therapy versus muscle energy technique among diabetic patients with frozen shoulder: a study protocol for a parallel group randomised controlled trial
Authors
Halima I. Hassan
Bashir Kaka
Fatima Bello
Francis Fatoye
Aminu A. Ibrahim
Publication date
01-12-2024
Publisher
BioMed Central
Published in
Journal of Orthopaedic Surgery and Research / Issue 1/2024
Electronic ISSN: 1749-799X
DOI
https://doi.org/10.1186/s13018-024-04735-7

Other articles of this Issue 1/2024

Journal of Orthopaedic Surgery and Research 1/2024 Go to the issue

Research article

Landet: an efficient physics-informed deep learning approach for automatic detection of anatomical landmarks and measurement of spinopelvic alignment

Research article

Gentiopicroside ameliorates the lipopolysaccharide-induced inflammatory response and hypertrophy in chondrocytes

Research article

Biofilm on total joint replacement materials can be reduced through electromagnetic induction heating using a portable device

Research article

Preoperative handgrip strength can predict early postoperative shoulder function in patients undergoing arthroscopic rotator cuff repair

Research article

Bidirectional two-sample Mendelian randomization analysis identifies causal associations between cardiovascular diseases and frozen shoulder

Research article

Optimal analgesic regimen for total shoulder arthroplasty: a randomized controlled trial and network meta-analysis