AzTrials
AzTrials

Osteoarthritis, KneeNCT05159986

Diadynamic and Exercises in Knee Osteoarthritis

A study testing Group that received aplication of Diadynamic currents associated to Exercise during eight weeks with three sessions a week and Group that received exercise during eight weeks with three sessions a week in people with Osteoarthritis, Knee, run by University of Sao Paulo General Hospital at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Osteoarthritis represents failed repair of joint damage resulting from stresses initiated by any joint or periarticular tissue abnormality. The rate of progression varies among persons and within a knee over time. Read more about this study

Who is it for?
Ages 50 to 75 years
Conditions the study is for
Osteoarthritis, Knee
What is being tested?
Group that received aplication of Diadynamic currents associated to Exercise during eight weeks with three sessions a week and Group that received exercise during eight weeks with three sessions a week
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteBrazil
Study dates
1 Jan 2021to 1 Aug 2021
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 50 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • aged from 50 and 75;
  • symptomatic knee osteoarthritis for at least three months;
  • visual analogue scale12 score above 3 and
  • radiographic knee osteoarthritis (uni or bilateral) compatible with Kellgren-Lawrence13 grade two or higher.

Who cannot join

  • contraindication to laser application (e.g. cancer and insulin-dependent diabetes);
  • inability to perform the assessment or treatment;
  • continuous use of anti-inflammatory drugs,
  • symptomatic hip osteoarthritis
  • physiotherapeutic knee treatment within the last 3 months.

Trial locations and contacts

1 site in 1 country.

Brazil1 site
  • Raquel Aparecida Casarotto

    São Paulo

Other trials in Brazil

About this study

Official title: Eefficacy of Diadynamic Currents Associated Exercise in Patients With Knee Osteoarthritis

Osteoarthritis represents failed repair of joint damage resulting from stresses initiated by any joint or periarticular tissue abnormality. The rate of progression varies among persons and within a knee over time.

The symptoms and signs of knee osteoarthritis include pain, stiffness, reduced joint motion, and muscle weakness. Long-term consequences can include reduced physical activity, deconditioning, impaired sleep, fatigue, depression, and disability.This reduction in activity to avoid pain (kinesiophobia) to evade the onset of pain, especially in the acute phase, limiting their compliance with effective rehabilitation strategies such as regular exercises.

Read more

Physical medicine has a wide range of analgesic anti-inflammatory and muscle stimulating treatment methods. Both diadynamic and TENS currents have become the most frequently implemented electrotherapeutic methods. The impact of diadynamic currents consists of analgesic effects and specific dynamics during the formation of physiological processes in tissues.

They occur during the administration of the current and lasts up to a few hours after the treatment has been terminated. One of the theories explaining the analgesic effect of diadynamic currents is the gate control theory of pain by Wall and Melzack. Recently, another theory has become very popular. It explains the analgesic effect provoked by bodies characterized as polypeptides called endorphins. Electric stimulation using diadynamic currents generates an increase in the amount of endorphins in a system.

Although the analgesic impact of TENS therapy is well known, Diadynamic currents therapies have not been studied in knee osteoarthritis pain conditions. Therefore, the aim of the present study was to investigate the medium-term effects of Diadynamic currents combined with exercise on pain and disability in patients with osteoarthritis of the knee.

Read the detailed description

The study included patients who attended the Special Rehabilitation Services in Taboão da Serra-SP, with knee osteoarthritis diagnosed by an independent rehabilitation specialist, and fulfilled the following inclusion criteria: (1) aged from 50 and 75; (2) symptomatic knee osteoarthritis for at least three months; (3) visual analogue scale12 score above 3 and (4) radiographic knee osteoarthritis (uni or bilateral) compatible with Kellgren-Lawrence grade two or higher.

The exclusion criteria were as follows: contraindication to laser application (e.g. cancer and insulin-dependent diabetes); inability to perform the assessment or treatment; continuous use of anti-inflammatory drugs, symptomatic hip osteoarthritis and physiotherapeutic knee treatment within the last 3 months.

All potentially eligible participants were contacted by telephone and those interested in participating were invited to attend a physical examination for inclusion and exclusion criterion. All participants were informed about the study and provided informed consent before participating. They were assigned by block randomization, stratified according to treatment group. An independent researcher not involved in outcome assessment was responsible for group allocation, using a computer-generated random number table. Immediately after baseline assessment by the blinded assessor, the treating physiotherapist accessed the allocation schedule from a centrally located locked cabinet. Patients and the physiotherapist responsible for the evaluation and physiotherapist responsible for the treatment were all unaware of the randomization results as allocation to groups was concealed.

Demographic and anthropometric data, the use of pain relief medications, the duration of knee pain, the knee range of motion, and a range of patient-reported outcomes were collected at baseline (before randomization) and 8 weeks from baseline by the same blinded evaluator.

The primary outcomes were pain intensity measured by the numeric pain rating scale (0-10) with a minimal clinically important change set at two points and disability measured using the Lequesne questionnaire, which consists of 11 questions about pain, discomfort, and function. Scores range from 0 to 24 (from 'no' to 'extremely severe' dysfunction).

Secondary outcomes included medication intake (Paracetamol) for knee pain relief, mobility and balance, range of motion, muscular strength, and activity. Mobility and balance were evaluated by the Timed Up and Go test. The Timed Up and Go test, a measure of functional mobility, quantifies in seconds the time that the individual needs to stand up from a chair, walk 3m, turn back toward the chair and sit down again. Range of motion of the knees was measured with a universal goniometer (AESCULAP). Muscular strength was estimated at maximal isometric force for the quadriceps, using a portable dynamometer (Lafayette, USA). Under stabilized conditions, patients, sitting with knees flexed at 60 (measured by a goniometer), were asked to extend the legs as far as they could. Three attempts were conducted, and the mean value was obtained. Muscular strength was estimated at maximal isometric force for the quadriceps, using a portable dynamometer. Under stabilized conditions, patients, sitting with knees flexed at 10, 60 and 90 degrees (measured by a goniometer), were asked to extend the legs as far as they could. Three attempts were conducted and the mean value was obtained. Physical activity was measured using the Western Ontario and McMaster Universities Osteoarthritis questionnaire, which is self-administered and measures pain, stiff joints, and physical activity. Increased scores suggest decreased activity.

In this study, all patients had osteoarthritis of both knees, and in every patient both knees were treated with the allocated treatment.

Participants in the Group I received Diadynamic currents associated to Exercise while the Group II received only exercises three times a week for 8 weeks following initial assessment.

The group I, Diadynamic currents was performed with the following parameters: application of the two-phase current and then the long-term one. Each current was applied for 4 minutes on the medial and lateral sides of the knee.

All patients followed the same training program (Table 1). The intervention was divided into Phase-1, Phase-2 and Phase-3 during eight weeks with three sessions a week. Each session lasted 45 minutes:

  • 10 minutes warming-up (treadmill, ergometer bike or rowing machine);
  • 30 minutes 2-3 sets with Phase-1, Phase-2 and Phase-3;
  • 5 minutes stretching (hamstrings, quadriceps, adductors, and gastrocmenius). Participants were instructed not to use analgesic medications other than paracetamol (500 mg/day) or anti-inflammatory drugs during the study, and not to perform any other type of physical exercise in addition to the exercise performed during the study.

After describing the data, the hypothesis of normality of continuous variables was tested using the Shapiro-Wilk test. The age, weight, height and BMI of volunteers between groups were compared using Student's t-test for independent samples. To investigate the effect of the treatment on the pre and post evaluation, as well as the interaction of this effect between the groups, the General Linear Models with mixed design (evaluations x groups) were applied. To analyze the effects of the interactions, Tukey's Post Hoc tests were performed considering an alpha error of 5%. All analyzes were performed using the statistical program R version 3.1.3 using the R Commander graphical interface.

Being tested
Group that received aplication of Diadynamic currents associated to Exercise during eight weeks with three sessions a week, Group that received exercise during eight weeks with three sessions a week
Keywords
PAIN, Electric Stimulation Therapy, Exercise Therapy
Medical subject headings
Osteoarthritis, Knee, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group that received aplication of Diadynamic currents associated to Exercise during eight weeks with three sessions a weekProcedure or surgery

    Diadynamic currents was performed followed by exercises (divided into Phase-1, Phase-2 and Phase-3 during eight weeks with three sessions a week).

  • Group that received exercise during eight weeks with three sessions a weekOther

    The intervention was divided into Phase-1, Phase-2 and Phase-3 during eight weeks with three sessions a week. Each session lasted 45 minutes.

Study groups in NCT05159986
Study groupRoleWhat they receive
Group Diadynamic and ExercisesExperimentalGroup Diadynamic and Exercises received Diadynamic currents associated to Exercise three times a week for 8 weeks following initial assessment (n=30, 60 knees) Diadynamic currents was performed with the following parameters: application of the two-phase current and then the long-term one. Each current was applied for 4 minutes on the medial and lateral sides of the knee.
Receives: Procedure: Group that received aplication of Diadynamic currents associated to Exercise during eight weeks with three sessions a week; Other: Group that received exercise during eight weeks with three sessions a week
Group ExercisesExperimentalGroup Exercises received only exercises three times a week for 8 weeks following initial assessment (n=30, 60 knees).
Receives: Other: Group that received exercise during eight weeks with three sessions a week

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in pain intensity

    Pain intensity measured by the numeric pain rating scale (0-10) with a minimal clinically important change set at two points

    Measured: outcomes were collected at baseline (before randomization) and 8 weeks from baseline by the same blinded evaluator.

  2. Change in Disability

    Disability measured using the Lequesne questionnaire,14 which consists of 11 questions about pain, discomfort, and function. Scores range from 0 to 24 (from 'no' to 'extremely severe' dysfunction).

    Measured: outcomes were collected at baseline (before randomization) and 8 weeks from baseline by the same blinded evaluator.

Secondary outcomes (5)
  1. Change in Medication intake (Paracetamol) for knee pain relief

    Control of the use of pain medications before, during and after treatment.

    Measured: outcomes were collected at baseline (before randomization) and 8 weeks from baseline by the same blinded evaluator.

  2. Change in Mobility and balance

    Mobility and balance were evaluated by the Timed Up and Go test. The Timed Up and Go test, a measure of functional mobility, quantifies in seconds the time that the individual needs to stand up from a chair, walk 3m, turn back toward the chair and sit down again.

    Measured: outcomes were collected at baseline (before randomization) and 8 weeks from baseline by the same blinded evaluator.

  3. Change in Range of motion

    Range of motion of the knees was measured with a universal goniometer (AESCULAP).

    Measured: outcomes were collected at baseline (before randomization) and 8 weeks from baseline by the same blinded evaluator.

  4. Change in Muscular strength

    Muscular strength was estimated at maximal isometric force for the quadriceps, using a portable dynamometer (Lafayette, USA). Under stabilized conditions, patients, sitting with knees flexed at 60 (measured by a goniometer),17 were asked to extend the legs as far as they could. Three attempts were conducted, and the mean value was obtained. Muscular strength was estimated at maximal isometric force for the quadriceps, using a portable dynamometer. Under stabilized conditions, patients, sitting with knees flexed at 10, 60 and 90 degrees (measured by a goniometer),17 were asked to extend the legs as far as they could. Three attempts were conducted and the mean value was obtained.

    Measured: outcomes were collected at baseline (before randomization) and 8 weeks from baseline by the same blinded evaluator.

  5. Change in Physical activity

    Physical activity was measured using the Western Ontario and McMaster Universities Osteoarthritis questionnaire,18 which is self-administered and measures pain, stiff joints, and physical activity. Increased scores suggest decreased activity.

    Measured: outcomes were collected at baseline (before randomization) and 8 weeks from baseline by the same blinded evaluator.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2021
  2. Study start1 Jan 2021
  3. Primary completion1 Apr 2021
  4. Study completion1 Aug 2021

Resources

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
Participants were randomly allocated to a Group I (diadynamic currents associated to Exercise; n=30, 60 knees) and Group II (exercises group; n=30, 60 knees) were treated 3 times a week for 8 weeks.
Masking
Single blind
Who is masked
Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05159986
Sponsor's protocol ID
CT01306435
Status last verified
Nov 2021
First submitted
10 Nov 2021
Last updated
16 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Group that received aplication of Diadynamic currents associated to Exercise during eight weeks with three sessions a week and Group that received exercise during eight weeks with three sessions a week in people with Osteoarthritis, Knee, run by University of Sao Paulo General Hospital at 1 site 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 4 inclusion and 5 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 16 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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?

Change in pain intensity (time frame: outcomes were collected at baseline (before randomization) and 8 weeks from baseline by the same blinded evaluator.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 16 Dec 2021.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in