Diabetes ComplicationsNCT04372810
Effect of Manual Therapy on Tibiotarsal Joint Mobility in Diabetic Individuals
A study testing High Velocity Low Amplitude manipulation (HVLA) and Care assessment and guidance in people with Diabetes Complications, run by University of Sao Paulo at 2 sites in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Diabetes Complications
- What is being tested?
- High Velocity Low Amplitude manipulation (HVLA) and Care assessment and guidance
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesBrazil
- Study dates
- 9 Aug 2017to 14 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both sexes aged between 35 and 70 years, and with more than 5 years of Diagnosis of Diabetes Mellitus.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Medical School of Ribeirão Preto
Ribeirão Preto, São Paulo, 14049-900
University of São Paulo
Ribeirão Preto, São Paulo, 14049-900
About this study
Official title: Acute Effect of Manual Therapy on Tibiotarsal Joint Mobility of Lower Limbs in Diabetic Individuals
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.
Read the 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.
- Conditions
- Diabetes Complications
- Being tested
- High Velocity Low Amplitude manipulation (HVLA), Care assessment and guidance
- Keywords
- Physiotherapy, Diabetes Melittus, Manual Therapy, Ankle Joint
- Medical subject headings
- Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Velocity Low Amplitude manipulation (HVLA)Procedure or surgery
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.
Care assessment and guidanceProcedure or surgery
Evaluation and care guidelines on glycemic control and diabetic foot care.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Procedure: Care assessment and guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tibiotarsal joint range of motion
degrees
Measured: 2 minutes
Secondary outcomes (1)
Static balance
cm
Measured: 6 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start9 Aug 2017
- Primary completion20 Sep 2017
- Study completion14 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes ComplicationsStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elaine Caldeira de Oliveira Guirro, University of Sao Paulo
- Investigators
- Elaine CO Guirro, PhD, Study director, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04372810
- Sponsor's protocol ID
- 63957816.7.0000.5440
- Status last verified
- Apr 2020
- First submitted
- 29 Apr 2020
- Last updated
- 4 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: after the end of Research
Publications
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.
PubMed 24679362
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Manual Therapy on Tibiotarsal Joint Mobility of Lower Limbs in Diabetic Individuals
- ClinicalTrials.gov ID
- NCT04372810
- Acronym / sponsor ID
- 63957816.7.0000.5440
- Conditions
- Diabetes Complications
- Keywords
- Physiotherapy, Diabetes Melittus, Manual Therapy, Ankle Joint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 9 Aug 2017 (actual)
- Primary completion
- 20 Sep 2017 (actual)
- Study completion
- 14 Dec 2017 (actual)
- First posted
- 4 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Procedure: High Velocity Low Amplitude manipulation (HVLA), Procedure: Care assessment and guidanceIntervention 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 | Sham comparator | Procedure: Care assessment and guidanceSham group, evaluated on day 1 and day 7, and received preventive diabetes guidance at the end of the experiment (follow-up). |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients of both sexes aged between 35 and 70 years, and with more than 5 years of Diagnosis of Diabetes Mellitus.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | Intervention Group |
| Care assessment and guidanceEvaluation and care guidelines on glycemic control and diabetic foot care. | Procedure or surgery | Intervention Group, Sham Group |
Primary outcome
Tibiotarsal joint range of motion
Time frame: 2 minutes
degrees
1 secondary outcome
Static balance
Time frame: 6 minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2020.
- Results publication: PubMed 24679362Marron-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.
- Individual participant dataSharing planned: No. after the end of Research
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elaine CO Guirro, PhD study director
University of Sao Paulo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Velocity Low Amplitude manipulation (HVLA) and Care assessment and guidance in people with Diabetes Complications, run by University of Sao Paulo at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tibiotarsal joint range of motion (time frame: 2 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04372810, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2020.