Clinical trial NCT06816940: Dry Needling and Exercise Program in Osteoarthritis
Official title: Analysis of Dry Needling Combined With an Exercise Program in the Treatment of Osteoarthritis Knee: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Musculoskeletal
Physical Medicine/Rehabilitation
Physiotherapy
Dry needling
Therapeutic exercise
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be divided into two groups, randomly selected (experimental group and control group), of 30 subjects each. Allocation was concealed and it was done by central randomisation by computer (EPIDARcomputer program).The main objective of the study is to observe the resulting data on pain, function, strength and range of motion, in subjects with knee OA, after being treated with a specific exercise program and dry needling technique in the popliteal muscle. All participants will be assessed before carrying out any intervention and after it has been carried out. This assessment will consist of measuring pain, strength, range of motion, and functionality. As for the intervention, both will be treated with a specific exercise program specific for knee osteoarthritis, and only one group will be additionally operated on by the dry needling technique of the popliteal muscle, following the safety criteria of the same.
Primary purpose: TREATMENT

Brief summary: Osteoarthrosis (OA) is a chronic degenerative disease that affects the joints, knee OA is the most prevalent type, affecting 265 million people worldwide, more than 40% of adults over 45 years of age, being one of the greatest causes of disability, which leads to a decrease in the quality of life of those who suffer from it, and increased medical care and costs.

Currently, clinical guidelines recommend physical exercise as the first line of treatment for knee OA.

Reviews conducted in 2020 observe a low level of evidence regarding dry needling in subjects with OA, suggesting the need for future publications focused on this research problem.

Popliteal muscle involvement is often underestimated in knee pain, however, some authors also suggest that the presence of trigger points in this muscle may represent a cause of diffuse knee pain. Active trigger points in the popliteus have been observed in 17% of people with symptomatic knee OA.

This study aims to evaluate data resulting from pain, function, strength and range of motion, in subjects with OA, after being treated with a specific exercise program and dry needling technique in the popliteal muscle. The subjects will be recruited at a health centre in the city of Seville, and at the Physiotherapy department of the University of Seville.

As this is research with people, the researcherse wanted to be especially attentive to the following ethical aspects: all participants will be informed of the objective of the project and will be asked for written informed consent, their wish not to participate or abandon the project will be respected and they will be guaranteed that the information obtained will be completely anonymous and for use exclusively for the purposes of the research. The informed consent to be given is based on the ethical principles set out in the World Medical Association's 1964 Declaration of Helsinki for medical research involving human subjects. Compliance with the rules of the General Health Law of 1986 and the Basic Law 41/2002 Regulating Patient Autonomy.

1. General Objective To evaluate and compare the resulting data on pain, function, strength, and range of motion in subjects with knee OA after being treated with a specific exercise program; and treated with the same exercise program combined with dry needling technique in the popliteal muscle.

Detailed description: This study will constitute a comparative Randomized Clinical Study (RCT) of two groups with different treatments in subjects diagnosed with knee OA. The control group (CG) will be treated with a specific exercise protocol for knee OA, while the experimental group (EG) will be operated on with the dry needling technique in the popliteal muscle, in addition to performing the same exercise protocol as the CG.

The development of the study will take place over a period of 6 months, starting in March 2024.

A study conducted on cadavers in 2021, shows a safe and effective way to carry out the dry needling technique of the popliteal muscle. With the knee bent at approximately 90°, the needle is inserted from medial to lateral direction into the upper third of the tibia closest to the knee and at an anterior angle toward the posterior aspect of the tibia, remaining as close as possible to the posterior aspect of the tibia bone to a depth that was clinically considered more likely in the popliteal muscle, thus being isolated from the vasculonervous bundle.

Population to be studied The study is designed to be conducted on people of legal age. The target population will be patients diagnosed with knee OA uni or bilaterally, while the eligible population will be all those patients diagnosed with knee OA who attend the Physiotherapy of the "El Cachorro" Health Center in Seville and who can and wish to be part of the study and who meet the inclusion and exclusion criteria.

Subjects diagnosed with uni or bilateral knee OA will be included. Those who do not give their consent to participate, minors and those subjects with knee prostheses, surgical intervention in the area, or treatment in less than 6 months in the study area will be excluded.

Initially, a meeting will be held (in the aforementioned centres) with the patients under study, where they will be informed and any doubts that may arise in relation to the research will be resolved. In addition, the correct adequacy of these to the inclusion and exclusion criteria of our study will be checked. Subsequently, they will be individually given the informed consent prepared expressly for this study, any doubts that may arise regarding it will be resolved and they will be signed. At that time, and individually again, the researchers will proceed to the preparation of the Physiotherapy clinical history where only and exclusively the information necessary for our study will be collected.

The sample will consist of 60 subjects, divided between both groups, diagnosed with knee OA uni or bilaterally, who have given their written consent to participate.

The sample size was obtained for an intergroup interaction with an error α of 95% or less than 0.05, a statistical power Β or 0.95 for two study groups in four measurements with an effect size (F) of 0.20, obtaining a total of 56 participants, 28 in each group, but taking into account a possible loss of 3%. Therefore, the sample will consist of 60 subjects, divided between both groups, diagnosed with knee OA uni or bilaterally, who have given their consent.

The professionals who will perform the intervention of both therapeutic exercise and dry needling are Physiotherapists with more than 10 years of clinical experience and trained in these disciplines.

The variables to be studied will be the same for both groups:

* WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index questionnaire).
* Degree of pain, using the visual analogue scale (VAS).
* DN4 Questionnaire (Douleur Neurophathique 4); Annex V
* Functional disability with the Kujala Score test (Escala de dolor anterior de rodilla).
* Lower Extremity Functional Scale (LEFS).
* Knee flexion and extension joint balance.
* Force using the Daniels scale and dynamometer.
* Fear in relation to pain with TSK-11SV questionnaire (Escala TAMPA de Kinesiophobia)

Data Analysis Plan For data analysis, the SPSS statistical program will be used to obtain the mean, median, maximum, minimum and standard deviation data. The researchers will carry out an analysis of all the variables collected by the scales and the relationships that the different variables have based on Pearson's correlations.

The main objective of the study is to observe the resulting data on pain, function, strength and range of motion, in subjects with knee osteoarthritis, after being treated with a specific exercise program and dry needling technique in the popliteal muscle.

To carry it out, the participants will be divided into two groups, chosen randomly. All participants will be assessed before carrying out any intervention and after it has been carried out. This assessment will consist of measuring pain, strength, range of motion, and functionality.

As for the intervention, both will be treated with a specific exercise program specific for knee osteoarthritis, and only one group will be additionally operated on by the dry needling technique of the popliteal muscle, following the safety criteria of the same.

Eligibility criteria: Inclusion Criteria: Subjects diagnosed with uni or bilateral knee OA will be included -

Exclusion Criteria: people who do not give their consent to participate, minors and those subjects with knee replacements, surgical intervention in the area, or treatment in less than 6 months in the study area.

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Primary outcomes:
measure: WOMAC (Western Ontario and McMaster Universities Osteoarthritis Questionnaire)
timeFrame: Time point 1: They will be assessed before any intervention is carried out
measure: WOMAC (Western Ontario and McMaster Universities Osteoarthritis Questionnaire)
timeFrame: Time point 2: It is assessed when the intervention is completed (3 and 6 months after the last session)..
measure: EVA (VISUAL ANALOGUE SCALE)
timeFrame: Time point 1:They will be assessed before any intervention is carried out
measure: EVA (VISUAL ANALOGUE SCALE)
timeFrame: Time point 2: In GE the subjects will be messured Pre and Post PS Intervention. Both groups is assessed when the intervention is completed (3 and 6 months after the last session)
measure: Douleur Neurophatique 4 (DN4)
timeFrame: Time point 1: They will be assessed before any intervention is carried out
measure: Douleur Neurophatique 4 (DN4)
timeFrame: Time point 2: In GE the subjects will be messured Pre and Post PS Intervention. Both groups is assessed when the intervention is completed (3 and 6 months after the last session).
measure: Anterior Knee Pain Scale (KUJALA SCORE)
timeFrame: Time point 1: They will be assessed before any intervention is carried out
measure: Anterior Knee Pain Scale (KUJALA SCORE)
timeFrame: Time point 2: It is assessed when the intervention is completed (3 and 6 months after the last session)
measure: LEFS (Lower Extremity Functional Scale)
timeFrame: Time point 1: They will be assessed before any intervention is carried out
measure: LEFS (Lower Extremity Functional Scale)
timeFrame: Time point 2: It is assessed when the intervention is completed (3 and 6 months after the last session)
measure: Active and Pasive Knee's Range of Movement
timeFrame: Time point 1: They will be assessed before any intervention is carried out
measure: Active and Pasive Knee's Range of Movement
timeFrame: Time point 2: In GE the subjects will be messured Pre and Post PS Intervention. Both groups is assessed when the intervention is completed (3 and 6 months after the last session)
measure: DANIELS SCALE
timeFrame: Time point 1: They will be assessed before any intervention is carried out
measure: DANIELS SCALE
timeFrame: Time point 2: It is assessed when the intervention is completed (3 and 6 months after the last session)
measure: TAMPA Scale of Kinesiophobia (TSK-11SV)
timeFrame: Time point 1: They will be assessed before any intervention is carried out
measure: TAMPA Scale of Kinesiophobia (TSK-11SV)
timeFrame: Time point 2: In GE the subjects will be messured Pre and Post PS Intervention. Both groups is assessed when the intervention is completed (3 and 6 months after the last session)
Secondary outcomes:
Other outcomes:
Locations:
city: Lebrija
country: Spain
facility: Isabel Escobio Prieto
state: Sevilla
Study officials:
References: