Needling Techniques for Knee Osteoarthritis

NCT05014542 | Completed Results

• 1 other identifier: 39603233785
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The thirty-nine-week open-label clinical study investigates the efficacy of acupuncture for Knee Osteoarthritis (KOA) as adjunctive therapy to analgesics compared to analgesics only and assesses the effects after 9 and 24 weeks, with safety assessment provided. The study seeks to find possible additional benefits of acupuncture on Kidney Deficiency (KD) while treating KOA with an acupuncture protocol designed to treat KOA following Traditional Chinese Medicine (TCM) theory, which connects KOA with KD as its root cause. The points prescription uses local and Kidney-related points to treat KOA. The chronic conditions require a higher number of acupuncture treatments. This study will provide acupuncture treatments in three cycles, each three weeks long, with frequency three times weekly. Twenty-seven acupuncture treatments of KOA during fifteen weeks tend to improve KOA and KDS; symptoms are assessed in 10 successive time points, and treatment effects and effect persistence are analysed. 64 patients with symptomatic KOA are randomly allocated into the Acupuncture (A) or Control (C) group according to their permanent, unique, and coincidental Personal Identification Number, which is randomly given to all citizens in Croatia. Before the experiment starts, demographics and disease parameters of all participants are compared. To objectify acupuncture effects, the enrolled physiatrist's measures included knee measures at 3 time points: baseline, at the end of acupuncture (Week 15), and nine weeks later (Week 24). Subjective evaluations of symptoms are assessed by Western Ontario and McMaster University Arthritis Index (WOMAC) total and subscales scores, Numeric Rating Scale (NRS), and Kidney Deficiency Syndrome Questionnaire (KDSQ) every 3 weeks till the 24th week (9 assessments). Analgesics taken by participants (DRUG) in the last three days before the assessments are recorded. Acupuncture treatment was promised to all participants. Therefore, at Week 25, the between-group analysis ended, and the C group crossed over to receive the identical acupuncture protocol. The 10th assessment in Week 39 was used to estimate, by within-group analysis, the immediate effects of the acupuncture in group C and the effect persistence in group A. The Lequesne index was introduced additionally at Week 24 as another measure of the knee's functional state.

Conditions

Knee Osteoarthritis; Kidney Yin Deficiency; Kidney Yang Deficiency

Keywords

Needling; Techniques; Randomized; Reinforcing; Reducing; Acupuncture

Outcome Measures

Primary Outcomes (1)

• WOMAC Total in Week 15

  The Western Ontario and McMaster University Osteoarthritis Index (WOMAC) total score is the sum of the three subscales: pain, stiffness, and functional disability. The minimum value is 0, and the maximum value is 96, where the lower score/value represents a better outcome, and the higher score/value represents a worse outcome.

  Week 15

Secondary Outcomes (29)

• WOMAC Pain in Week 15

  Week 15

• WOMAC Stiffness in Week 15

  Week 15

• WOMAC Functional Disability in Week 15

  Week 15

• VAS in Week 15

  Week 15

• KDSQ in Week 15

  Week 15

Study Arms (2)

Acupuncture Group

EXPERIMENTAL

Participants in Acupuncture group will get acupuncture treatments to their symptomatic knee/knees according to the study protocol. Acupuncture will be provided to participants in three cycles, each three weeks duration, with frequency three times weekly. Period between the cycles is three weeks long. Participants will get acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to participant symptoms intensity. Participants and investigator are not blinded for treatment type.

Procedure: Acupuncture; Drug: Conventional Medical Treatment

Control Group

ACTIVE COMPARATOR

Participants in Control group will get their standard conventional treatment (analgesics) which dose could vary according to participant symptoms intensity. Participants and investigator are not blinded for treatment type.

Drug: Conventional Medical Treatment

Interventions

Acupuncture PROCEDURE

Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment is 30 minutes. All treatments will be equal.

Acupuncture Group

Conventional Medical Treatment DRUG

Participants could take their standard conventional medical treatment or analgesics. Analgesics therapy is prescribed by their general practitioner. The dose of analgesics could be modified according to participants' symptoms intensity.

Also known as: Analgesics

Acupuncture Group; Control Group

Eligibility Criteria

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

You may qualify if:

• Clinical diagnosis of Knee Osteoarthritis
• Knee Osteoarthritis for at least 6 months
• painful knee in last month
• radiographic changes of the knee (Kellgren-Lawrence grade 2 or more)
• signed informed consent
• participant can move independently

You may not qualify if:

• if the participant got knee intra-articular injection 3 months before his entry into the study
• uncontrolled malignant disease
• unstable heart disease
• advanced organ failure disease (NYHA III or IV, or a more than the twofold increase of creatinin, or marked dyspnea)
• unstable psychiatrist's disease
• bleeding diathesis
• anticoagulant use

Sponsors & Collaborators

• Svijetlana Perculija Durdevic: lead
• Nanjing University of Chinese Medicine, Xueping Zhou, Li Ren: collaborator
• School of Medicine, University of Zagreb, Pero Hrabac: collaborator
• Health Center Zagreb East, Ljiljana Karadakic: collaborator

Study Sites (1)

Family Medicine Practice Svijetlana Perculija Durdevic, MD

Zagreb, 10000, Croatia

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Acupuncture Therapy; Analgesics

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses

Limitations and Caveats

The assessor who did the physiatrist measurement was sick during 3rd assessment and because of that 3rd measurement, which differs in both groups from the previous two, was done with another assessor.

Results Point of Contact

• Title: Svijetlana Perculija Durdevic, MD, family medicine specialist, acupuncturist
• Organization: Family Medicine Practice Svijetlana Perculija Durdevic, MD, Ninska 10, Sesvete

svijetlana.perculija.durdevic@outlook.com

00385913302507

Study Officials

• Svijetlana Perculija Durdevic, M.D.

  Family Medicine Practice Svijetlana Perculija Durdevic, MD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessor of the physiatrists' measures and the assessor in charge of helping fill in WOMAC, VAS, KDSQ, DRUG, and Lequesne index were blind to the fact to which group participants belonged.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Family Medicine Practice, Principal Investigator

Model Details: A randomized, controlled, interventional, prospective.

Study Record Dates

• First Submitted: August 8, 2021
• First Posted: August 20, 2021
• Study Start: January 2, 2021
• Primary Completion: December 18, 2021
• Study Completion: June 12, 2022
• Last Updated: July 29, 2025
• Results First Posted: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 3 months following publication, ending 3 years following article publication
• Access Criteria: Access to trial IPD can be requested by a qualified researcher engaging in independent scientific research. For more information or to submit a request please contact svijetlana.perculija.durdevic@outlook.com

Locations

CR (1)