Diadynamic and Exercises in Knee Osteoarthritis

NCT05159986 | Completed

• 1 other identifier: CT01306435
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Osteoarthritis, Knee

Keywords

PAIN; Electric Stimulation Therapy; Exercise Therapy

Outcome Measures

Primary Outcomes (2)

• 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

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

• 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).

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

Secondary Outcomes (5)

• Change in Medication intake (Paracetamol) for knee pain relief

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

• Change in Mobility and balance

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

• Change in Range of motion

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

• Change in Muscular strength

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

• Change in Physical activity

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

Study Arms (2)

Group Diadynamic and Exercises

EXPERIMENTAL

Group 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.

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 Exercises

EXPERIMENTAL

Group Exercises received only exercises three times a week for 8 weeks following initial assessment (n=30, 60 knees).

Other: Group that received exercise during eight weeks with three sessions a week

Interventions

Group that received aplication of Diadynamic currents associated to Exercise during eight weeks with three sessions a week PROCEDURE

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 Diadynamic and Exercises

Group that received exercise during eight weeks with three sessions a week OTHER

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.

Group Diadynamic and Exercises; Group Exercises

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Raquel Aparecida Casarotto

São Paulo, Brazil

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Raquel Ap Casarotto, PhD

  USP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: December 16, 2021
• Study Start: January 1, 2021
• Primary Completion: April 1, 2021
• Study Completion: August 1, 2021
• Last Updated: December 16, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)