Clinical trial NCT06739954: Effectiveness of DN With or Without Mulligan Two Leg Rotation Technique on Pain ROM and Joint Dysfunction in KO
Official title: Effectiveness of Dry Needling With or Without Mulligan Two Leg Rotation Technique on Pain, Range of Motion and Joint Dysfunction in Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 44
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: 12 Months
measure: Western Ontario and McMaster universities osteoarthritis (WOMAC) index
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Ghurki trust and teaching hospital
state: Punjab
Study officials:
References: