Effectiveness of DN With or Without Mulligan Two Leg Rotation Technique on Pain ROM and Joint Dysfunction in KO

Not Applicable

Active, not recruiting

• Conditions: Knee Osteoarthritis

• Registration Number: NCT06739954
• Lead Sponsor: Superior University

Brief Summary

The objective of study is to determine the effectiveness of dry needling with or without mulligan two leg rotation technique on pain, range of motion and joint dysfunction in knee osteoarthritis. The study will be a single blinded randomized controlled trial conducted at the Physical Therapy Department of Hussain Memorial Hospital, focusing on the treatment of knee osteoarthritis in adults aged 40 to 80 years.

Detailed Description

The selection criteria will include patients with a confirmed diagnosis of knee osteoarthritis according to the Kellgren and Lawrence classification system, persistent symptoms for at least 6 months, and willingness to participate in the study. Exclusion criteria will include patients with other joint pathologies, severe psychiatric disorders, unstable medical conditions, or currently enrolled in another clinical trial. The sample size will be 40 patients, and divided into two groups, with Group A receiving dry needling combined with Mulligan two-leg rotation technique and Group B receiving only dry needling.

Study Timeline

• Study Start: 2024-03-01
• Primary Completion: 2024-08-01
• Status Verified: 2024-12
• Study First Submitted: 2024-12-13
• Study First Submitted QC: 2024-12-13
• Last Update Submitted: 2024-12-13
• Study First Posted: 2024-12-18
• Last Update Posted: 2024-12-18
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Adult patients with age 18-65 diagnosed with chronic coccydynia for at least 3 months were recruited.
• Participants who will be willing & able to adhere to the study protocol.
• Including participants who will be attending follow-up appointments & completing outcome measures.
• Participants who will be able to understand & provide written informed consent.
• Participants with a complete screening of other medical conditions and previous medical records.

Exclusion Criteria

• Participants with previous surgery on the coccyx or lumbosacral spine, pregnancy or breastfeeding, history of bleeding disorders or anticoagulant use, active infection, or significant medical condition that could pose a safety risk during the procedures (GIB or CESI) was omitted.
• Patients above the age of 65 were eliminated to reduce confounding by age-related health concerns and to provide a more homogenous study population for more accurate treatment outcomes.
• Participants with neurological conditions affecting pain perception or sensation were excluded.
• Participants with known allergies to medications used in the study (local anesthetic, steroid for injections) were not part of the study.
• Participation in another interventional clinical trial within the past 3 months was not included.
• Participants who were unable to safely undergo fluoroscopy were also excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS)	12 Months	It is a tool used to measure pain intensity. It consists of a 10cm line with two endpoints representing 0, indicating 'no pain,' and 10, indicating 'pain as bad as it could possibly be.' Patients are asked to rate their current level of pain by marking the line accordingly. The distance in centimeters from the 'no pain marker' or zero to the marked point is measured using a ruler. This measurement provides a pain intensity score on a scale of 0 to 10. For example, a score of 6 out of 10 (or 6/10) indicates a pain level of 6.
Western Ontario and McMaster universities osteoarthritis (WOMAC) index	12 Months	This self-administered questionnaire was presented using a five-point ordinal scale with five categorical responses (numerical value of 0-4). WOMAC was designed to measure perceived pain, stiffness and dysfunction. High WOMAC scores reflect greater severity across the three measured domains. WOMAC has moderate-to-excellent reliability and validity to test pain, stiffness and function, especially in patients with hip or knee OA

Trial Locations

Locations (1)

Ghurki trust and teaching hospital; 🇵🇰 Lahore, Punjab, Pakistan