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Effect of Manual Therapy on Tibiotarsal Joint Mobility in Diabetic Individuals

Primary Purpose

Diabetes Complications

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
High Velocity Low Amplitude manipulation (HVLA)
Care assessment and guidance
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Complications focused on measuring Physiotherapy, Diabetes Melittus, Manual Therapy, Ankle Joint

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Medical School of Ribeirão Preto
  • University of São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Intervention Group

Sham Group

Arm Description

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).

Sham group, evaluated on day 1 and day 7, and received preventive diabetes guidance at the end of the experiment (follow-up).

Outcomes

Primary Outcome Measures

Tibiotarsal joint range of motion
degrees

Secondary Outcome Measures

Static balance
cm

Full Information

First Posted
April 29, 2020
Last Updated
April 29, 2020
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT04372810
Brief Title
Effect of Manual Therapy on Tibiotarsal Joint Mobility in Diabetic Individuals
Official Title
Acute Effect of Manual Therapy on Tibiotarsal Joint Mobility of Lower Limbs in Diabetic Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
August 9, 2017 (Actual)
Primary Completion Date
September 20, 2017 (Actual)
Study Completion Date
December 14, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Complications
Keywords
Physiotherapy, Diabetes Melittus, Manual Therapy, Ankle Joint

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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).
Arm Title
Sham Group
Arm Type
Sham Comparator
Arm Description
Sham group, evaluated on day 1 and day 7, and received preventive diabetes guidance at the end of the experiment (follow-up).
Intervention Type
Procedure
Intervention Name(s)
High Velocity Low Amplitude manipulation (HVLA)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Care assessment and guidance
Intervention Description
Evaluation and care guidelines on glycemic control and diabetic foot care.
Primary Outcome Measure Information:
Title
Tibiotarsal joint range of motion
Description
degrees
Time Frame
2 minutes
Secondary Outcome Measure Information:
Title
Static balance
Description
cm
Time Frame
6 minute

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elaine CO Guirro, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Study Director
Facility Information:
Facility Name
Medical School of Ribeirão Preto
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14049-900
Country
Brazil
Facility Name
University of São Paulo
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14049-900
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
after the end of Research
Citations:
PubMed Identifier
24679362
Citation
Marron-Gomez D, Rodriguez-Fernandez AL, Martin-Urrialde JA. The effect of two mobilization techniques on dorsiflexion in people with chronic ankle instability. Phys Ther Sport. 2015 Feb;16(1):10-5. doi: 10.1016/j.ptsp.2014.02.001. Epub 2014 Feb 14.
Results Reference
result

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Effect of Manual Therapy on Tibiotarsal Joint Mobility in Diabetic Individuals

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