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Effect of Manual Therapy on Tibiotarsal Joint Mobility in Diabetic Individuals

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04372810
Recruitment Status : Completed
First Posted : May 4, 2020
Last Update Posted : May 4, 2020
Sponsor:
Information provided by (Responsible Party):
Elaine Caldeira de Oliveira Guirro, University of Sao Paulo

Brief Summary:
The study aimed to evaluate the acute effect of manual therapy on ankle joint mobility in diabetic patients. Forty volunteers, with a mean age of 59.35±7.85, with type 2 DM and neurological symptoms of Diabetic Distal Polyneuropathy according to a Diabetic Polyneuropathy Diagnostic Scale (EDPNDD) protocol with the amplitude were performed. Were divided into two groups: Sham group (GS), and intervention group (GI), which underwent manual manipulation intervention and seven-day follow-up. Joint range of motion analysis was performed using digital goniometry and static discharge of weights assessed by computerized baropodometry with open and closed eyes, and the Shapiro-Wilk normality test evaluated data distribution and relative, Tukey post hoc set ANOVA tests were used for non-normal variables. The Kruskal- Wallis test followed by Dunn's post-hoc test. SAS statistical software was used and the significance level of 5%. Results: The results showed an increased joint range of motion, plantar flexion, and dorsiflexion, between the moments and moments after manipulation and follow-up. It was still possible to make a significant difference between GI when it was with GS at poster and follow-up. No intragroup analysis was performed by GS, for analysis over time. Regarding intragroup comparisons over time (pre, post-intervention, and follow-up), a significant difference was made for Front and back displacement amplitude (PAD) with open eyes of the GI, with an increase after intervention and reduction without follow up. Conclusion: Based on the results obtained, the work performed with manual therapy increased the ankle joint amplitude in diabetic individuals.

Condition or disease Intervention/treatment Phase
Diabetes Complications Procedure: High Velocity Low Amplitude manipulation (HVLA) Procedure: Care assessment and guidance Not Applicable

Detailed Description:
Diabetes Melittus (DM) is a disease of great incidence, and one of the main public health problems worldwide, having as complications the deficit in the functional performance of the lower limbs, which can interfere in the maintenance of the balance, besides being a Strong predictor of functional limitations. Individuals affected by diabetes are predisposed to reduce the mobility of the tibial-tarsal joint. Manual therapy is often used for the purpose of improving range of motion. The objective of this study is to evaluate the acute effect of manual therapy on ankle joint mobility in diabetic patients. 40 volunteers, aged 59,35±7,85 years, DM type 2 and tibial-tarsal joint amplitude limitation, of both genders were recruited, divided into two groups: group 1 (Sham: submitted to evaluations and follow up of seven days), and group 2 (intervention: submitted to the evaluations, manipulative manual intervention, with follow up of seven days). The analysis of joint range of motion was acessed by digital goniometry and the static discharge of weight was evaluated by baropodometry computed with open and closed eyes. After tabulation of variables, the Shapiro-Wilk normality test was applied to analyze the distribution. Before a normal and related distribution, ANOVA followed by Tukey post-hoc tests were used. For the variables that presented a non-normal distribution, the Kruskal-Wallis test was used, followed by the Dunn post-hoc test. For the variables that presented a non-normal distribution, the Kruskal-Wallis test was used, followed by the Dunn post-hoc test. The SAS software was used and a significance level of 5% was considered. The results showed an increase in joint range of motion, in the right and left dorsiflexions of the GI between the initial moment and the post-manipulation moments, as well as after seven days of the follow-up. There was also a significant difference between GI when compared to GS in the post and follow-up moments. Regarding the clinical effect of the intervention over time, the intragroup analysis showed that in GS there was no difference between the amplitude of movement registers comparing the pre-intervention moment with the subsequent records (post and follow-up), even for plantar and dorsiflexion flexion movements on both sides. In relation to static plantar weight discharge, there was a change in recorded values for the peak of total foot pressure, on the right and left sides of the GI, between the moments after the immediate intervention and in the measurement 7 days after the manipulative intervention (follow -up), for registration with open eyes. Regarding intra-group comparisons over time (pre, post-intervention and follow-up), a significant difference was observed for the condition amplitude of anteroposterior displacement (DAP) with open eyes of the GI, observing an increase after intervention and reduction in the follow-up. In view of the obtained results, it can be inferred that the acute intervention with manual therapy produces an increase in the joint amplitude of the ankle of diabetic individuals.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The volunteers were randomized by means of sealed matte envelopes in the following groups: sham group (GS), evaluated on day 1 and day 7, and received preventive diabetes guidance at the end of the experiment (follow-up) and intervention group (GI), assessed on day 1, then underwent manual manipulation intervention and were reevaluated post-intervention. They were again evaluated on the 7th post-treatment day and received preventive guidance at the end of the experiment (follow-up).
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acute Effect of Manual Therapy on Tibiotarsal Joint Mobility of Lower Limbs in Diabetic Individuals
Actual Study Start Date : August 9, 2017
Actual Primary Completion Date : September 20, 2017
Actual Study Completion Date : December 14, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Group
Intervention group, assessed on day 1, then underwent manual manipulation intervention and were reevaluated post-intervention and again evaluated on the 7th post-treatment day and received preventive guidance at the end of the experiment (follow-up).
Procedure: High Velocity Low Amplitude manipulation (HVLA)
The thrust manipulation technique was used, which consists of high speed and small amplitude manipulation. The therapeutic intervention was performed through decompressive maneuvers for the tibiotarsal joints. The choice of the place of application of the manipulation technique was delimited by the identification of the area or areas with compressive compartmental impairment and joint restriction. The use of the method depended directly on the identification of one or more regions of joint restraint.

Procedure: Care assessment and guidance
Evaluation and care guidelines on glycemic control and diabetic foot care.

Sham Comparator: Sham Group
Sham group, evaluated on day 1 and day 7, and received preventive diabetes guidance at the end of the experiment (follow-up).
Procedure: Care assessment and guidance
Evaluation and care guidelines on glycemic control and diabetic foot care.




Primary Outcome Measures :
  1. Tibiotarsal joint range of motion [ Time Frame: 2 minutes ]
    degrees


Secondary Outcome Measures :
  1. Static balance [ Time Frame: 6 minute ]
    cm



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients of both sexes aged between 35 and 70 years, and with more than 5 years of Diagnosis of Diabetes Mellitus.

Exclusion Criteria:

Patients with skin lesions or lower limb fractures in the last six months, plantar malformations, severe postural changes and real difference in the length of the lower limbs.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04372810


Locations
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Brazil
Medical School of Ribeirão Preto
Ribeirão Preto, São Paulo, Brazil, 14049-900
University of São Paulo
Ribeirão Preto, São Paulo, Brazil, 14049-900
Sponsors and Collaborators
University of Sao Paulo
Investigators
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Study Director: Elaine CO Guirro, PhD University of Sao Paulo
Publications of Results:
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Responsible Party: Elaine Caldeira de Oliveira Guirro, PhD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT04372810    
Other Study ID Numbers: 63957816.7.0000.5440
First Posted: May 4, 2020    Key Record Dates
Last Update Posted: May 4, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: after the end of Research

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elaine Caldeira de Oliveira Guirro, University of Sao Paulo:
Physiotherapy
Diabetes Melittus
Manual Therapy
Ankle Joint
Additional relevant MeSH terms:
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Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases