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

Effectiveness of Dry Needling With or Without Mulligan Two Leg Rotation Technique on Pain, Range of Motion and Joint Dysfunction in Knee Osteoarthritis

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Combination product: Mulligan's Two Leg Rotation technique; Diagnostic test: Dry Needling

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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan
      • Ghurki Trust and Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional group I	Combination product: Mulligan's Two Leg Rotation technique; The participants will undergo Mulligan's Two Leg Rotation technique, performing 10 repetitions with a 30-second hold for each repeat. There will be a 1-minute rest period between each stretch. The therapist positions themselves on the affected side of the supine patient lying on the treatment table and holds onto the side of the table with their hand on the opposite side. Both legs will be bent so that the feet are raised from the plinth. Maintaining the subject's shoulders on the bed, he gradually moves the subject's legs to the side, considering the restricted flexibility of the hamstring muscles. Once the patient reaches their maximum, the therapist applies extra pressure to sustain the posture for 30 seconds. Then, the legs are lowered to the plinth. A 1-minute interval was provided between each stretch, and the stretches were performed for a total of 10 repetitions. The identical technique is performed on the opposite side to address insufficient flexibility in the hamstrings.
Active Comparator: Interventional group II	Diagnostic test: Dry Needling; The DN technique, based on previous research, involved slowly inserting and removing the needle in the muscle or tendon to elicit a specific response. This response could be a local twitch, a dull ache, a feeling of heaviness or distension, or the reproduction of the participant's symptoms. The needle is manipulated in and out of the targeted tissue five times every five minutes for a total of fifteen minutes. After the treatment, sterile gauze is applied and pressed on the DN site, and sterile non-stick pads are used to cover the treated areas. The number of needles used varied depending on the participant's condition. The knee muscles that will be included in the dry needling intervention are the Quadriceps and Hamstrings .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS)	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.	12 Months
Western Ontario and McMaster universities osteoarthritis (WOMAC) index	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	12 Months

Collaborators and Investigators

• Sponsor: Superior University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Actual): August 1, 2024
• Study Completion (Estimated): February 28, 2025

Study Registration Dates

• First Submitted: December 13, 2024
• First Submitted That Met QC Criteria: December 13, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Rheumatic Diseases; Joint Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: MSRSW/Batch-Fall22/773

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No