"Shoulder Musculoskeletal Disorders in Type 2 Diabetes Mellitus: Contributing Factors and Rehabilitation Protocol"

NCT04817514 | Unknown

• 1 other identifier: 11200574
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

Goals: to compare the effects of two distinct rehabilitation protocols (conventional shoulder musculoskeletal rehabilitation combined with aerobic exercises versus solely conventional shoulder musculoskeletal rehabilitation) on shoulder pain, function, strength, kinematics and tendon thickness in patients with type 2 DM after 12 weeks of intervention and a subsequent follow up of 8 weeks. The secondary objective of this study will be to evaluate the association between AGEs accumulation and shoulder pain, function, strength, kinematics and tendon thickness in individuals with type 2 DM. Methodology: is a single-blinded randomized controlled trial, in which all subjects with a clinical diagnosis of type 2 DM (with at least 1 year of diagnosis), of both sexes, between 40 and 70 years, presenting shoulder pain (uni or bilateral) for at least 3 months with a pain intensity score from 3 points on a numerical rating scale for pain intensity, will be invited to participate. The main outcomes of this study will include the AGEs accumulation through skin autofluorescence measurement; shoulder pain through NRS scales; shoulder function through SPADI questionnaire and range of motion measurement; isometric shoulder muscles strength through manual muscle dynamometer measurement; shoulder kinematics through three dimensional inertial units measurements; supraspinatus tendon thickness through ultrasound measurement. All these outcomes will be measured before and after the rehabilitation protocols. Participants will be randomly assigned to one of the two rehabilitation groups: specific shoulder rehabilitation protocol group (SRG); or 2) specific protocol of shoulder rehabilitation plus aerobic exercise group (ARG). All individuals will be evaluated before starting the rehabilitation protocol (baseline) and at the end of rehabilitation (post 12 weeks) and 8 weeks after the end of the rehabilitation (follow up). For the statistical analysis, to verify the effectiveness of protocols over time, a variance analysis (ANOVA) of mixed model with Bonferroni adjustment will be performed for pairwise comparisons. Variables that do not meet the ANOVA assumptions will be analyzed by the Mann-Whitney and Wilcoxon tests with Bonferroni correction a priori. In order to assess the secondary objective of the study, correlation tests depending on data distribution will be performed (Pearson or Spearman correlation tests). A simple linear regression analysis will also be performed in order to analyze how much the AGEs accumulation can explain the alterations in the musculoskeletal and biomechanical variables. The significance level will be set at 5%.

Conditions

Diabetes Mellitus, Type 2; Musculoskeletal Pain; Shoulder Pain

Keywords

Diabetes mellitus; Shoulder function

Outcome Measures

Primary Outcomes (10)

• HbA1c - Glycated hemoglobin

  HbA1c (mmol/mol) will be evaluated through blood tests that will be performed in the clinical laboratory of the University, at the beginning (before starting the treatment protocol), after the 12-week intervention (3-7 days after the last session) and after the 8-week follow-up.

  12-weeks

• lipid profile

  lipid profile (mmol/L) will be evaluated through blood tests that will be performed in the clinical laboratory of the University, at the beginning (before starting the treatment protocol), after the 12-week intervention (3-7 days after the last session) and after the 8-week follow-up.

  12-weeks

• fasting glucose

  fasting glucose (mmol/L) will be evaluated through blood tests that will be performed in the clinical laboratory of the University, at the beginning (before starting the treatment protocol), after the 12-week intervention (3-7 days after the last session) and after the 8-week follow-up.

  12-weeks

• AGEs accumulation measurement

  Skin autofluorescence (nm wavelength) is considered as a substitute variable of AGEs accumulation. To perform this measurement, the AGE Reader (DiagnOptics, Groningen, the Netherlands) will be used, which non-invasively assesses skin autofluorescence.

  12-weeks

• Shoulder pain measurement

  Shoulder pain will be evaluated through the numerical pain scale (Numerical Rating Scale 0 to 10, the higher the score, higher the pain).

  12-weeks

• Shoulder function measurement SPADI

  The participant must respond to the SPADI questionnaire (Shoulder Pain and Disability Index - Spanish validated version).The SPADI score can range from 0 % indicating no pain or disability, to 100 % indicating severe pain and total disability

  12-weeks

• Shoulder function measurement Range of motion

  the range of motion will be measured (in degrees) for all shoulder complex movements using a digital inclinometer (Acumar™, Lafayette Intrument Company, Lafayette, IN).

  12-weeks

• Isometric shoulder muscles strength measurement

  Isometric muscle strength of the shoulder muscles will be assessed (in Newton) using a hand held dynamometer (HHD) (Lafayette Instrument, Lafayette, IN).

  12-weeks

• Shoulder three dimensional kinematics

  Shoulder three-dimensional kinematics (in degrees) will be recorded (80 Hz) during arm elevation in the scapular plane and during a reaching over 90° functional task, using an inertial movement units system (IMU system) (MTW Awinda Xsens, Nexgen Ergonomics, Canada).

  12-weeks

• Supraspinatus tendon thickness measurement

  Ultrasonographic measurement for each participant's supraspinatus tendon thickness (millimeters) will be scanned by using a Lumify Ultrasound in conjunction with a 4-12 MHz linear transducer (Philips Medical System).

  12-weeks

Study Arms (2)

specific shoulder rehabilitation protocol group (SRG);

EXPERIMENTAL

Other: Shoulder rehabilitation exercises and aerobic exercises

specific protocol of shoulder rehabilitation plus aerobic exercise group (ARG)

EXPERIMENTAL

Other: Shoulder rehabilitation exercises and aerobic exercises

Interventions

Shoulder rehabilitation exercises and aerobic exercises OTHER

SRG group: the group will only perform mobility and strengthening exercises involving the shoulder complex. ARG group: The ARG group will perform the shoulder rehabilitation protocol presented above combined with the aerobic exercise program that will last 20 minutes per session at 40% of the reserve heart rate (HRC), progressing up to 40 minutes with a maximum of 60% of the HRC in the last two weeks, according to the recommendations for patients with type 2 DM proposed in the American College of Sports Medicine Guidelines.

specific protocol of shoulder rehabilitation plus aerobic exercise group (ARG); specific shoulder rehabilitation protocol group (SRG);

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• It will be excluded participants with a history of stabilization or surgical shoulder repair; recent history of fracture of the upper limb; cognitive deficits that make it difficult to understand verbal commands; who have undergone shoulder rehabilitation in the past 6 months; neuromuscular diseases; central nervous system diseases and rheumatological arthropathies.

Sponsors & Collaborators

• Universidad Católica del Maule: lead
• Fondo Nacional de Desarrollo Científico y Tecnológico, Chile: collaborator

Related Publications (1)

• Habechian FAP, Flores Quezada ME, Cools AM, Kjaer BH, Cuevas Cid RI, Zanca GG. Shoulder-specific rehabilitation combined with aerobic exercises versus solely shoulder-specific rehabilitation in patients with type 2 diabetes mellitus: study protocol for a randomized controlled superiority trial. Trials. 2022 Aug 17;23(1):678. doi: 10.1186/s13063-022-06647-5.

  PMID: 35978380 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Musculoskeletal Pain; Shoulder Pain; Diabetes Mellitus

Interventions

Exercise

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthralgia; Joint Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor will be blinded to what kind of protocol the participant is going through
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 26, 2021
• Study Start: November 1, 2021
• Primary Completion: May 30, 2022
• Study Completion: October 30, 2023
• Last Updated: March 26, 2021

Record last verified: 2021-03