Effect of Manual Therapy on Tibiotarsal Joint Mobility in Diabetic Individuals

NCT04372810 | Completed DMC

• 1 other identifier: 63957816.7.0000.5440
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes Complications

Keywords

Physiotherapy; Diabetes Melittus; Manual Therapy; Ankle Joint

Outcome Measures

Primary Outcomes (1)

• Tibiotarsal joint range of motion

  degrees

  2 minutes

Secondary Outcomes (1)

• Static balance

  6 minute

Study Arms (2)

Intervention Group

EXPERIMENTAL

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); Procedure: Care assessment and guidance

Sham Group

SHAM COMPARATOR

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

Interventions

High Velocity Low Amplitude manipulation (HVLA) PROCEDURE

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 Group

Care assessment and guidance PROCEDURE

Evaluation and care guidelines on glycemic control and diabetic foot care.

Intervention Group; Sham Group

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (2)

Medical School of Ribeirão Preto

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

University of São Paulo

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

Related Publications (1)

• 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.

  PMID: 24679362 RESULT

MeSH Terms

Conditions

Diabetes Complications

Interventions

Counseling

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Elaine CO Guirro, PhD

  University of Sao Paulo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: 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).

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 4, 2020
• Study Start: August 9, 2017
• Primary Completion: September 20, 2017
• Study Completion: December 14, 2017
• Last Updated: May 4, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)