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Addition of Transcranial Direct Current Stimulation and Transcutaneous Electrical Nerve Stimulation to an Education and Exercise Program in Subjects With Chronic Pain Due to Knee Osteoarthritis

Primary Purpose

Osteo Arthritis Knee, Chronic Pain

Status

Recruiting

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

transcranial direct current stimulation (tDCS)

TENS

Exercise and General Education

About this trial

This is an interventional treatment trial for Osteo Arthritis Knee focused on measuring tDCS, transcranial direct current stimulation, knee osteoarthritis, TENS, chronic knee pain

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adults over fifty years of age with a diagnosis of knee osteoarthritis by radiography.
Chronic pain of more than six months, compliance with the diagnostic criteria for knee osteoarthritis according to the Osteoarthritis Research Society International (OARSI) guideline:
Pain in Analog Visual Scale more than 4/10
Matutinal less than 30 minutes
Absence of hyperthermia upon palpation in the joint
Alteration of the bone image
Crepitus

Exclusion Criteria:

Patients who can provide low-quality or biased information discriminated by the Mini-Mental State Examination (Score less than 24).
Severe hearing, visual or sensory impairment or comorbidities that prevent the correct completion of the questionnaires and mobility activities.
Patients who have undergone knee replacement surgery on the contralateral knee.
Patients who have received intervention (infiltration, blockages, etc...) in the last 6 weeks.
Pain due to tendinopathy, knee fracture, low back pain radiating to the knee, or fibromyalgia.
Patients who decline to participate out of fear or denial of therapy.
Severe heart disease that prevent exercise.
Body Mass Index above 45.
Patients with neuropsychiatric disorders (schizophrenia, epilepsy or bipolar disorders) or taking medication for these conditions (antiepileptic drugs).
Patients with metallic implants in the area (skull or knee).

Sites / Locations

University of MurciaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

tDCS Active vs TENS Active

tDCS Active vs TENS Placebo

tDCS Placebo vs TENS Placebo

Arm Description

Outcomes

Primary Outcome Measures

Chronic Knee Pain

The Visual Analogic Scale will be used to assess the impact on chronic knee pain. The values range from 0 to 10 (0 = No pain, 10 = the worst pain).

Secondary Outcome Measures

Function and Quality of Life

The Western Ontario and McMaster (WOMAC) scale will be used to assess pain, function, and quality of life in knee osteoarthritis and range from 0 to 96 (higher score, worst outcome).

Force

Using a dynamometer for quadriceps muscle (measurement in Kg, higher score means better outcome).

Balance

A short physical performance battery (SPPB) will be used to measure balance. SPPB ranges from 0 (worst) to 12 (best).

Gait properties.

6 Minutes Walk Test (meters) measure exercise tolerance, less than 350 meters is high risk of death in some patients. More meters, more score.

Coordination and Balance

Timed Up and Go Test (TUG), less than 10 seconds (low risk of falls) more than 20 seconds (high risk of falls).

Uncertainly

Mishel's Uncertainly Scale (MUIS) range from 55 to 121 (more score, greater uncertainly, worst outcome).

Catastrophizing

The Pain Catastrophizing Scale (PCS) range from 0 to 52 (more score, greater catastrophizing, worst outcome).

Kinesiophobia

The Tampa Scale of Kinesiophobia (TSK) range from 11 to 44 (higher values are worst outcome).

Central Sensitization

8Central Sensitization Inventory (CSI) range from 0 to 100 (higher values are worst outcome)

Full Information

NCT ID

NCT05138471

First Posted

October 4, 2021

Last Updated

July 11, 2023

Sponsor

Universidad de Murcia

1. Study Identification

Unique Protocol Identification Number

NCT05138471

Brief Title

Addition of Transcranial Direct Current Stimulation and Transcutaneous Electrical Nerve Stimulation to an Education and Exercise Program in Subjects With Chronic Pain Due to Knee Osteoarthritis

Official Title

Addition of Transcranial Direct Current Stimulation and Transcutaneous Electrical Nerve Stimulation to an Education and Exercise Program in Subjects With Chronic Pain Due to Knee Osteoarthritis.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

November 17, 2021 (Actual)

Primary Completion Date

December 1, 2023 (Anticipated)

Study Completion Date

December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Universidad de Murcia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Knee osteoarthritis has a very high prevalence in the population over 50 years of age. Patients with osteoarthritis often suffer from chronic pain that becomes disabling, affecting both quality of life and mental and physical health. This pathology has also been linked to maladaptive plasticity in the brain, which can contribute to chronic pain. Therapies with neuromodulatory approaches, such as transcranial direct current stimulation (tDCS) and peripheral electrical stimulation (TENS), have been used therapeutically to counteract the maladaptive plasticity of the brain. Transcranial therapy and TENS can be a possible effective treatment in the rehabilitation services of the health system for the improvement of chronic pain and quality of life in different pathologies, such as chronic low back pain, fibromyalgia or knee and hip osteoarthritis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteo Arthritis Knee, Chronic Pain

Keywords

tDCS, transcranial direct current stimulation, knee osteoarthritis, TENS, chronic knee pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

tDCS Active vs TENS Active

Arm Type

Experimental

Arm Title

tDCS Active vs TENS Placebo

Arm Type

Experimental

Arm Title

tDCS Placebo vs TENS Placebo

Arm Type

Placebo Comparator

Intervention Type

Device

Intervention Name(s)

transcranial direct current stimulation (tDCS)

Intervention Description

tDCS intervention will consist in placing two electrodes, the cathode on the supraorbital surface on the same side as the painful knee, and the anode on the parietal area, corresponding to the area of the primary motor cortex, on the opposite side. The intensity will be 2 milli amperes (mA) and stimulation will be 20 minutes. The placebo will generate an initial sensation, and then descend until the stimulation is turned off.

Intervention Type

Device

Intervention Name(s)

TENS

Intervention Description

TENS intervention will consist in placing two electrodes on the sides of the patella of the affected knee. The frequency will be 10Herzts and the intensity will remain at a sensitive threshold level, without reaching the motor. The placebo will generate a sensation of current to descend to the minimum value that the equipment allows. Stimulation will last for 20 minutes.

Intervention Type

Behavioral

Intervention Name(s)

Exercise and General Education

Intervention Description

The General Education Intervention consisting in an educational program will be applied to all groups using audiovisual material to increase the subject's knowledge about his/her pathology, about chronic pain and recommendations for supervised exercise based on the NEMEX protocol for osteoarthritis (Ageberg et al.)18: the participants will be taught analytical strengthening exercises (quadriceps and hamstrings) and neuromuscular functional exercises (getting up from the chair or going up a step), with their detailed dosage (2 to 3 series with 10 to 15 repetitions) and a home follow-up model where the participant must record compliance with exercise as well as pain during activity.

Primary Outcome Measure Information:

Title

Chronic Knee Pain

Description

The Visual Analogic Scale will be used to assess the impact on chronic knee pain. The values range from 0 to 10 (0 = No pain, 10 = the worst pain).

Time Frame

Through study completion, an average of 1 year.

Secondary Outcome Measure Information:

Title

Function and Quality of Life

Description

The Western Ontario and McMaster (WOMAC) scale will be used to assess pain, function, and quality of life in knee osteoarthritis and range from 0 to 96 (higher score, worst outcome).

Time Frame

Through study completion, an average of 1 year.

Title

Force

Description

Using a dynamometer for quadriceps muscle (measurement in Kg, higher score means better outcome).

Time Frame

Through study completion, an average of 1 year.

Title

Balance

Description

A short physical performance battery (SPPB) will be used to measure balance. SPPB ranges from 0 (worst) to 12 (best).

Time Frame

Through study completion, an average of 1 year.

Title

Gait properties.

Description

6 Minutes Walk Test (meters) measure exercise tolerance, less than 350 meters is high risk of death in some patients. More meters, more score.

Time Frame

Through study completion, an average of 1 year.

Title

Coordination and Balance

Description

Timed Up and Go Test (TUG), less than 10 seconds (low risk of falls) more than 20 seconds (high risk of falls).

Time Frame

Through study completion, an average of 1 year.

Title

Uncertainly

Description

Mishel's Uncertainly Scale (MUIS) range from 55 to 121 (more score, greater uncertainly, worst outcome).

Time Frame

Through study completion, an average of 1 year.

Title

Catastrophizing

Description

The Pain Catastrophizing Scale (PCS) range from 0 to 52 (more score, greater catastrophizing, worst outcome).

Time Frame

Through study completion, an average of 1 year.

Title

Kinesiophobia

Description

The Tampa Scale of Kinesiophobia (TSK) range from 11 to 44 (higher values are worst outcome).

Time Frame

Through study completion, an average of 1 year.

Title

Central Sensitization

Description

8Central Sensitization Inventory (CSI) range from 0 to 100 (higher values are worst outcome)

Time Frame

Through study completion, an average of 1 year.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adults over fifty years of age with a diagnosis of knee osteoarthritis by radiography. Chronic pain of more than six months, compliance with the diagnostic criteria for knee osteoarthritis according to the Osteoarthritis Research Society International (OARSI) guideline: Pain in Analog Visual Scale more than 4/10 Matutinal less than 30 minutes Absence of hyperthermia upon palpation in the joint Alteration of the bone image Crepitus Exclusion Criteria: Patients who can provide low-quality or biased information discriminated by the Mini-Mental State Examination (Score less than 24). Severe hearing, visual or sensory impairment or comorbidities that prevent the correct completion of the questionnaires and mobility activities. Patients who have undergone knee replacement surgery on the contralateral knee. Patients who have received intervention (infiltration, blockages, etc...) in the last 6 weeks. Pain due to tendinopathy, knee fracture, low back pain radiating to the knee, or fibromyalgia. Patients who decline to participate out of fear or denial of therapy. Severe heart disease that prevent exercise. Body Mass Index above 45. Patients with neuropsychiatric disorders (schizophrenia, epilepsy or bipolar disorders) or taking medication for these conditions (antiepileptic drugs). Patients with metallic implants in the area (skull or knee).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jose Antonio JL Lozano, PT

Phone

868887283

Ext

+34

joseantonio.lozano@um.es

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joaquina JM Montilla, PhD, PT

Organizational Affiliation

Director

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Mariano MG Gacto, PhD, PT

Organizational Affiliation

Co-Director

Official's Role

Study Director

Facility Information:

Facility Name

University of Murcia

City

Murcia

ZIP/Postal Code

30100

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jose Antonio JL Lozano, PT

Phone

868887283

Ext

+34

joseantonio.lozano@um.es

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Addition of Transcranial Direct Current Stimulation and Transcutaneous Electrical Nerve Stimulation to an Education and Exercise Program in Subjects With Chronic Pain Due to Knee Osteoarthritis

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