Knee OsteoarthritisNCT06739954
Effectiveness of DN With or Without Mulligan Two Leg Rotation Technique on Pain ROM and Joint Dysfunction in KO
A study testing Mulligan's Two Leg Rotation technique and Dry Needling in people with Knee Osteoarthritis, run by Superior University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Mulligan's Two Leg Rotation technique and Dry Needling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2024to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Mulligan's Two Leg Rotation technique, Dry Needling
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mulligan's Two Leg Rotation techniqueCombination product
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.
Dry NeedlingDiagnostic test
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 .
| Study group | Role | What they receive |
|---|---|---|
| Interventional group I | Experimental | Not described Receives: Combination Product: Mulligan's Two Leg Rotation technique |
| Interventional group II | Active comparator | Not described Receives: Diagnostic Test: Dry Needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start1 Mar 2024
- Primary completion1 Aug 2024
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06739954
- Sponsor's protocol ID
- MSRSW/Batch-Fall22/773
- Status last verified
- Dec 2024
- First submitted
- 13 Dec 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06739954
- Acronym / sponsor ID
- MSRSW/Batch-Fall22/773
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional group I | Experimental | Combination Product: Mulligan's Two Leg Rotation technique |
| Interventional group II | Active comparator | Diagnostic Test: Dry Needling |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mulligan's Two Leg Rotation techniqueThe 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. | Combination product | Interventional group I |
| Dry NeedlingThe 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 . | Diagnostic test | Interventional group II |
Primary outcome
Visual Analog Scale (VAS)
Time frame: 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
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mulligan's Two Leg Rotation technique and Dry Needling in people with Knee Osteoarthritis, run by Superior University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.