Dry Needling and Exercise Program in Osteoarthritis

NCT06816940 | Completed

• 1 other identifier: 0808-N-22
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Keywords

Musculoskeletal; Physical Medicine/Rehabilitation; Physiotherapy; Dry needling; Therapeutic exercise

Outcome Measures

Primary Outcomes (16)

• WOMAC (Western Ontario and McMaster Universities Osteoarthritis Questionnaire)

  It is a self-rated questionnaire specifically for patients with osteoarthritis of the hip and knee, which is made up of 24 items divided into 3 scales; pain (5 items), function (17 items), and stiffness (2 items). The answers are coded, being 0 "no difficulty" and 4 "extreme difficulty" to perform the activity (intermediate answers are 1: mild, 2: moderate, 3: severe). The final score is determined by adding the points for pain and function separately, and standardizing them over a range of values from 0 to 100, where 0 represents the best possible state of health and 100 the worst.

  Time point 1: They will be assessed before any intervention is carried out

• WOMAC (Western Ontario and McMaster Universities Osteoarthritis Questionnaire)

  It is a self-rated questionnaire specifically for patients with osteoarthritis of the hip and knee, which is made up of 24 items divided into 3 scales; pain (5 items), function (17 items), and stiffness (2 items). The answers are coded, being 0 "no difficulty" and 4 "extreme difficulty" to perform the activity (intermediate answers are 1: mild, 2: moderate, 3: severe). The final score is determined by adding the points for pain and function separately, and standardizing them over a range of values from 0 to 100, where 0 represents the best possible state of health and 100 the worst.

  Time point 2: It is assessed when the intervention is completed (3 and 6 months after the last session)..

• EVA (VISUAL ANALOGUE SCALE)

  A scale used to measure pain that is very similar to a numerical scale. The EVA consists of a 10 cm line with one end with the 0 meaning "no pain" and another end with the 10 indicating "the worst pain imaginable". The patient makes a mark on the line indicating the point that best describes the intensity of their pain. It establishes: * Mild pain if the score is less than 3. * Moderate pain if it is between 4 and 7. * Severe pain if the rating is greater than or equal to 8.

  Time point 1:They will be assessed before any intervention is carried out

• EVA (VISUAL ANALOGUE SCALE)

  A scale used to measure pain that is very similar to a numerical scale. The EVA consists of a 10 cm line with one end with the 0 meaning "no pain" and another end with the 10 indicating "the worst pain imaginable". The patient makes a mark on the line indicating the point that best describes the intensity of their pain. It establishes: * Mild pain if the score is less than 3. * Moderate pain if it is between 4 and 7. * Severe pain if the rating is greater than or equal to 8.

  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)

• Douleur Neurophatique 4 (DN4)

  It is a questionnaire consisting of 4 questions with a total of 10 items, which tries to describe symptoms and signs of pain that are evaluated with 1 (yes) or 0 (no) to identify patients who may have neuropathic pain. The lowest total value is 0 and means there is no neuropathic pain. The highest value is 10 for those people who have all the characteristics of neuropathic pain. A cut-off point of 4 is set.

  Time point 1: They will be assessed before any intervention is carried out

• Douleur Neurophatique 4 (DN4)

  It is a questionnaire consisting of 4 questions with a total of 10 items, which tries to describe symptoms and signs of pain that are evaluated with 1 (yes) or 0 (no) to identify patients who may have neuropathic pain. The lowest total value is 0 and means there is no neuropathic pain. The highest value is 10 for those people who have all the characteristics of neuropathic pain. A cut-off point of 4 is set.

  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).

• Anterior Knee Pain Scale (KUJALA SCORE)

  The functional disability, quantified by means of the test: Kujala Score. The 13 items on the scale are used to assess subjective symptoms and functional restrictions. A score can have a minimum of 0 points or a maximum of 100 points. Subjects would receive a score of 100 if they showed no signs of previous knee pain.

  Time point 1: They will be assessed before any intervention is carried out

• Anterior Knee Pain Scale (KUJALA SCORE)

  The functional disability, quantified by means of the test: Kujala Score. The 13 items on the scale are used to assess subjective symptoms and functional restrictions. A score can have a minimum of 0 points or a maximum of 100 points. Subjects would receive a score of 100 if they showed no signs of previous knee pain.

  Time point 2: It is assessed when the intervention is completed (3 and 6 months after the last session)

• LEFS (Lower Extremity Functional Scale)

  It is a self-administered 20-item questionnaire that serves to assess the functional capacity of the lower limb. It is a 5-point Likert scale ranging from 0 (extreme difficulty) to 4 (no difficulty). From the scale, a total score is obtained that shows the functionality of the subject's lower limbs. It has a minimum value of 0 points, which indicates that the subject does not have any problems in the functionality of the lower limbs, and a maximum value of 80 points, which indicates severe problems in the functionality of the lower limbs.

  Time point 1: They will be assessed before any intervention is carried out

• LEFS (Lower Extremity Functional Scale)

  It is a self-administered 20-item questionnaire that serves to assess the functional capacity of the lower limb. It is a 5-point Likert scale ranging from 0 (extreme difficulty) to 4 (no difficulty). From the scale, a total score is obtained that shows the functionality of the subject's lower limbs. It has a minimum value of 0 points, which indicates that the subject does not have any problems in the functionality of the lower limbs, and a maximum value of 80 points, which indicates severe problems in the functionality of the lower limbs.

  Time point 2: It is assessed when the intervention is completed (3 and 6 months after the last session)

• Active and Pasive Knee's Range of Movement

  In addition an anthropometric study of knee joint range of movement will be performed. Evaluating the Active and Pasive Knee's Range of Movement using universal goniometer measurement. we pay special attention to the possible restrictions in the normal range of motion

  Time point 1: They will be assessed before any intervention is carried out

• Active and Pasive Knee's Range of Movement

  In addition an anthropometric study of knee joint range of movement will be performed. Evaluating the Active and Pasive Knee's Range of Movement using universal goniometer measurement. we pay special attention to the possible restrictions in the normal range of motion

  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)

• DANIELS SCALE

  The grades in the manual muscle assessment are obtained in the form of a numerical score ranging from zero (0), which represents the absence of activity, to five (5), which represents a normal response to the test, or as normal as it can be assessed in a manual test. Because this test is performed on the applied movements and not on the muscle individually, so the activity of all the muscles in that movement is evaluated. This scale from 0 to 5 is the most commonly accepted. Each numerical score is accompanied by a word that gives it a qualitative score 5 → normal (N) 4→ good (B) 3 → Regular (R) 2→ Bad (M) 1→ Low activity (E) 0→ Null (No Activity) (0)

  Time point 1: They will be assessed before any intervention is carried out

• DANIELS SCALE

  The grades in the manual muscle assessment are obtained in the form of a numerical score ranging from zero (0), which represents the absence of activity, to five (5), which represents a normal response to the test, or as normal as it can be assessed in a manual test. Because this test is performed on the applied movements and not on the muscle individually, so the activity of all the muscles in that movement is evaluated. This scale from 0 to 5 is the most commonly accepted. Each numerical score is accompanied by a word that gives it a qualitative score 5 → normal (N) 4→ good (B) 3 → Regular (R) 2→ Bad (M) 1→ Low activity (E) 0→ Null (No Activity) (0)

  Time point 2: It is assessed when the intervention is completed (3 and 6 months after the last session)

• TAMPA Scale of Kinesiophobia (TSK-11SV)

  It is an 11-item questionnaire that is used to assess the patient's fear of suffering the injury again due to movement, i.e., it measures kinesiophobia. The TSK-11 is scored on a 4-point Likert scale, with responses ranging from 1 (strongly disagree) to 4 (strongly agree). The lowest possible score, 11, denotes insignificant or no kinesiophobia. The highest possible score, 44, denotes a severe fear of experiencing pain when moving.

  Time point 1: They will be assessed before any intervention is carried out

• TAMPA Scale of Kinesiophobia (TSK-11SV)

  It is an 11-item questionnaire that is used to assess the patient's fear of suffering the injury again due to movement, i.e., it measures kinesiophobia. The TSK-11 is scored on a 4-point Likert scale, with responses ranging from 1 (strongly disagree) to 4 (strongly agree). The lowest possible score, 11, denotes insignificant or no kinesiophobia. The highest possible score, 44, denotes a severe fear of experiencing pain when moving.

  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)

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: CONTROL GROUP:

EXPERIMENTAL GROUP

EXPERIMENTAL

EXPERIMENTAL GROUP: will be provided therapeutic exercises protocol to develop in the home setting that you must perform following a daily activity for three weeks, and rurgery was also performed using the dry needling technique of the popliteal muscle, following its safety criteria.

Other: EXPERIMENTAL GROUP

Interventions

CONTROL GROUP: OTHER

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 before any intervention is carried out

CONTROL GROUP

EXPERIMENTAL GROUP OTHER

will be provided therapeutic exercises protocol to develop in the home setting that you must perform following a daily activity for three weeks, and rurgery was also performed using the dry needlig

EXPERIMENTAL GROUP

Eligibility Criteria

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

Sponsors & Collaborators

• Manuel Albornoz Cabello: lead

Study Sites (1)

Isabel Escobio Prieto

Lebrija, Sevilla, 41740, Spain

Location

Related Publications (1)

• Agost-Gonzalez A, Escobio-Prieto I, de Los Angeles Cardero-Duran M, Yanez-Alvarez AR, Fernandez-Morales C, Albornoz-Cabello M. Effects of dry needling combined with exercise on knee osteoarthritis at 6 month follow up a randomized clinical trial. Sci Rep. 2025 Dec 18;15(1):44117. doi: 10.1038/s41598-025-27821-0.

  PMID: 41413069 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: February 10, 2025
• Study Start: March 20, 2024
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: April 3, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)