Efficacy Analysis in Long Term of Radiofrecuency Combined vs. T.E. in the Treatment of Patellofemoral Pain Syndrome.

NCT04462718 | Completed

• 1 other identifier: RvsTE6MFU
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

The present study aims to promote research in the field of Physiotherapy, focusing on a health problem of maximum relevance, such as patellofemoral pain syndrome. Although these treatments seem to be based on theoretical reasoning, the evidence for the efficacy of these interventions is not well established. Therefore, we select from among all the therapeutic tools available in physiotherapy, a procedure of therapeutic physical exercise. Main objectives: To know the efficacy of a therapeutic physical exercise protocol in the reduction of pain and the improvement of functional disability in patients with patellofemoral pain syndrome (PFPS). Secondary objectives:

• Quantify the reduction of pain in the anterior aspect of the knee in patients with patellofemoral pain syndrome (PFPS), after treatment with monopolar capacitive diathermy by radiofrequency.
• To evaluate the improvement of functional disability in patients with patellofemoral pain syndrome (PFPS), after treatment with monopolar capacitive diathermy by radiofrequency. Study hypothesis: The treatment of patellofemoral pain syndrome (PFPS) with a therapeutic physical exercise protocol produces statistically significant changes in the reduction of pain and functional disability and the normalization of the anthropometric values of the joint balance of the knee

Conditions

Patellofemoral Pain Syndrome

Keywords

Musculoskeletal; Physical Medicine / Rehabilitation; Physiotherapy; Knee Pain

Outcome Measures

Primary Outcomes (6)

• The perception of pain through the Visual Analogue Scale (EVA).

  The perception of pain through the Visual Analogue Scale (EVA). This variable has been obtained through a validated scale of 10 centimeters (0-10), where the subject self-positioned from absence of pain to the worst bearable pain.

  Time point 1: before the intervention

• The perception of pain through the Visual Analogue Scale (EVA).

  The perception of pain through the Visual Analogue Scale (EVA). This variable has been obtained through a validated scale of 10 centimeters (0-10), where the subject self-positioned from absence of pain to the worst bearable pain.

  Time point 2: when the intervention was finished (after 10 sesions : 2 weeks)

• The perception of pain through the Visual Analogue Scale (EVA).

  The perception of pain through the Visual Analogue Scale (EVA). This variable has been obtained through a validated scale of 10 centimeters (0-10), where the subject self-positioned from absence of pain to the worst bearable pain.

  Time point 3: six months later the initial evaluation.

• Kujala Score.

  The functional disability, quantified by means of the tests: Kujala Score.

  Time point 1: before the intervention

• Kujala Score.

  The functional disability, quantified by means of the tests: Kujala Score.

  Time point 2: when the intervention was finished (after 10 sesions : 2 weeks)

• Kujala Score.

  The functional disability, quantified by means of the tests: Kujala Score.

  Time point 3: six months later the initial evaluation.

Secondary Outcomes (3)

• Active and Pasive Knee's Range of Movement

  Time point 1: before the intervention.

• Active and Pasive Knee's Range of Movement

  Time point 2: when the intervention was finished (after 10 sesions : 2 weeks)

• Active and Pasive Knee's Range of Movement

  Time point 3: six months later the initial evaluation.

Study Arms (2)

CONTROL GROUP:

ACTIVE COMPARATOR

You will be provided exclusively therapeutic exercises protocol to develop in the home setting that you must perform following a daily activity for three weeks.

Other: Therapeutic Exercise

EXPERIMENTAL GROUP

EXPERIMENTAL

After the initial evaluation, the first 10 treatment sessions will be developed at the rate of five daily sessions in the first week, three sessions on alternate days in the second week and two sessions on alternate days in the third week (3 weeks in total), applying the monopolar capacitive diathermy with radiofrequency in the anterior aspect of the knee, in dynamic application in one of the members: affect or randomized (uni or bilateral pathology, respectively). This diathermy will be combined with a therapeutic exercise program supervised by a Physiotherapist. The treatment is administered with a pulsatile short-wave equipment and inductive electrodes of 100 W peak power, with a frequency of application of twice daily with a dose submitis (grade I), for 10 min, with a frequency of repetition of the impulses of 46 Hz and a pulse duration of 0.2 ms.

Other: Radiofrecuency

Interventions

Radiofrecuency OTHER

EXPERIMENTAL GROUP: After the initial evaluation, the first 10 treatment sessions will be developed at the rate of five daily sessions in the first week, three sessions on alternate days in the second week and two sessions on alternate days in the third week (3 weeks in total), applying the monopolar capacitive diathermy with radiofrequency in the anterior aspect of the knee, in dynamic application in one of the members: affect or randomized (uni or bilateral pathology, respectively). This diathermy will be combined with a therapeutic exercise program supervised by a Physiotherapist.

EXPERIMENTAL GROUP

Therapeutic Exercise OTHER

CONTROL GROUP: will be provided exclusively therapeutic exercises protocol to develop in the home setting that you must perform following a daily activity for three weeks. They will be evaluated at the end of that period and six moths later in order to have at least three timepoints to evaluate.

CONTROL GROUP:

Eligibility Criteria

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

You may not qualify if:

• Any contraindication for the use of MDR.
• Present cognitive alterations.
• Have undergone conservative or surgical treatment of the knee in less than 6 months.
• Having received injections of corticosteroids or hyaluronic acid; impaired cognition or communication; and be involved in an ongoing medical-legal dispute.

Sponsors & Collaborators

• University of Seville: lead

Study Sites (1)

Cristo Jesús Barrios Quinta

Seville, 41008, Spain

Location

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Patients diagnosed with unilateral or bilateral PFPS will be divided into two groups, randomly selected (experimental group and control group), of 45 subjects each. Allocation was concealed and it was done by central randomisation by computer (EPIDARcomputer program). The subjects of the experimental group will undergo a program of supervised physical therapeutic exercise. And the subjects of the control group will follow the medical-pharmacological treatment and the ergonomic recommendations according to the established protocol. The target population will be all patients diagnosed with patellofemoral pain syndrome (PFPS) unilaterally or bilaterally, from the health area of La Rinconada while the eligible population will be composed of all those patients residing in or around Seville who can and wish to be part of it. of the study and that they meet the inclusion and exclusion criteria

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: July 8, 2020
• Study Start: October 1, 2019
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2020
• Last Updated: August 17, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)