Patellofemoral Pain SyndromeNCT05261763
Effects of Trigger Point Dry Needling in Individuals With Patello Femoral Pain Syndrome : A Randomized Controlled Trial
A study testing Dry Needling in people with Patellofemoral Pain Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
A double blinded clinical controlled trial will be performed on individuals with patello femoral pain syndrome in which Trigger Point Dry Needling will be given to experimental group while Sham Needling will be given to the control group, targeting the trigger points present in the Quadriceps of affected individuals… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- Dry Needling
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Mar 2021to 1 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1. Both genders 2. Ages range from 18-40 years 3. They have clinical diagnosis of PFPS (the diagnosis was confirmed by a positive patellar grind test and tenderness of medial and lateral patellar facets) 4. Participants are also required to have a minimum pain score of 3 on Numeric Pain Scale 5. Kujala patellofemoral questionnaire score of 50 to 80 before the intervention.
- 6. Patients willing to participate
Who cannot join
- History of any following conditions
- Participants who have received any treatment for PFPS within the 3 months
- A history of lower extremities fracture or surgery
- Presence of MSK diseases such as Acute Herniated Disc or Spondylolisthesis
- History of any chronic disease e.g. Diabetes Mellitus
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University
Faisalabad, Punjab Province, 38000
About this study
Official title: Study on the Effects of Trigger Point Dry Needling on Patients With Patello-femoral Pain Syndrome: A Randomized Controlled Trial
A double blinded clinical controlled trial will be performed on individuals with patello femoral pain syndrome in which Trigger Point Dry Needling will be given to experimental group while Sham Needling will be given to the control group, targeting the trigger points present in the Quadriceps of affected individuals assessing the pain,functional disability and range of motion of the affected individuals.
Read the detailed description
A double blinded Randomized Controlled Trial of 6 months study after the approval of synopsis, will be conducted. Convenience sampling technique will be used to enroll the patients. Patients will be selected according to predefined inclusion and exclusion criteria. All patients who fulfill inclusion criteria will be allocated in two group through randomization by lottery method. Group A will receive TrP-DN and group B will receive Sham Needling. Both groups will be asked to perform stretching exercise of Quadriceps daily after needling. The patients' outcomes will be measured by VAS for pain intensity and Kujala Questionnaire for functional status. The comparison between pre-treatment and post-treatment data will be done after 3 months. Informed consents will be taken from each patient. Data entry and analysis will be done with SPSS 23.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- Dry Needling, Sham Dry Needing
- Keywords
- Patellofemoral Pain Syndrome, Dry Needling, Trigger Points
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry NeedlingOther
abc
Sham Dry NeedingOther
xyz
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Group A will receive trigger point dry needling in quadricep muscles Receives: Other: Dry Needling |
| Group B | Sham comparator | Group B will get Sham needling in quadriceps muscles Receives: Other: Sham Dry Needing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
Visual Analogue Scale
Measured: 8th week
Kujala Questionnaire
functional disability will be check by Kujala Questionnaire
Measured: 8th week
Goniometer
range of motion will be checked by Goniometer
Measured: 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start15 Mar 2021
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Patellofemoral Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Kashif, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05261763
- Sponsor's protocol ID
- REC-FSD-00238
- Status last verified
- Apr 2022
- First submitted
- 20 Feb 2022
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Neal BS, Lack SD, Lankhorst NE, Raye A, Morrissey D, van Middelkoop M. Risk factors for patellofemoral pain: a systematic review and meta-analysis. Br J Sports Med. 2019 Mar;53(5):270-281. doi: 10.1136/bjsports-2017-098890. Epub 2018 Sep 21.
PubMed 30242107Erratum: Effects of Trigger Point Dry Needling on Neuromuscular Performance and Pain of Individuals Affected by Patellofemoral Pain: A Randomized Controlled Trial [Corrigendum]. J Pain Res. 2020 Sep 7;13:2237. doi: 10.2147/JPR.S278493. eCollection 2020.
PubMed 32982385Mason JS, Crowell M, Dolbeer J, Morris J, Terry A, Koppenhaver S, Goss DL. THE EFFECTIVENESS OF DRY NEEDLING AND STRETCHING VS. STRETCHING ALONE ON HAMSTRING FLEXIBILITY IN PATIENTS WITH KNEE PAIN: A RANDOMIZED CONTROLLED TRIAL. Int J Sports Phys Ther. 2016 Oct;11(5):672-683.
PubMed 27757280
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effects of Trigger Point Dry Needling on Patients With Patello-femoral Pain Syndrome: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05261763
- Acronym / sponsor ID
- REC-FSD-00238
- Conditions
- Patellofemoral Pain Syndrome
- Keywords
- Patellofemoral Pain Syndrome, Dry Needling, Trigger Points
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 2 Mar 2022 (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.
A double blinded clinical controlled trial will be performed on individuals with patello femoral pain syndrome in which Trigger Point Dry Needling will be given to experimental group while Sham Needling will be given to the control group, targeting the trigger points present in the Quadriceps of affected individuals assessing the pain,functional disability and range of motion of the affected individuals.
Detailed description
A double blinded Randomized Controlled Trial of 6 months study after the approval of synopsis, will be conducted. Convenience sampling technique will be used to enroll the patients. Patients will be selected according to predefined inclusion and exclusion criteria. All patients who fulfill inclusion criteria will be allocated in two group through randomization by lottery method. Group A will receive TrP-DN and group B will receive Sham Needling. Both groups will be asked to perform stretching exercise of Quadriceps daily after needling. The patients' outcomes will be measured by VAS for pain intensity and Kujala Questionnaire for functional status. The comparison between pre-treatment and post-treatment data will be done after 3 months. Informed consents will be taken from each patient. Data entry and analysis will be done with SPSS 23.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Other: Dry NeedlingGroup A will receive trigger point dry needling in quadricep muscles |
| Group B | Sham comparator | Other: Sham Dry NeedingGroup B will get Sham needling in quadriceps muscles |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 1. Both genders 2. Ages range from 18-40 years 3. They have clinical diagnosis of PFPS (the diagnosis was confirmed by a positive patellar grind test and tenderness of medial and lateral patellar facets) 4. Participants are also required to have a minimum pain score of 3 on Numeric Pain Scale 5. Kujala patellofemoral questionnaire score of 50 to 80 before the intervention.
- 6. Patients willing to participate
Key exclusion criteria (5 listed)
- History of any following conditions
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 |
|---|---|---|
| Dry Needlingabc | Other | Group A |
| Sham Dry Needingxyz | Other | Group B |
Primary outcome
Visual Analogue Scale
Time frame: 8th week
Visual Analogue Scale
Kujala Questionnaire
Time frame: 8th week
functional disability will be check by Kujala Questionnaire
Goniometer
Time frame: 8th week
range of motion will be checked by Goniometer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Background: PubMed 30242107Neal BS, Lack SD, Lankhorst NE, Raye A, Morrissey D, van Middelkoop M. Risk factors for patellofemoral pain: a systematic review and meta-analysis. Br J Sports Med. 2019 Mar;53(5):270-281. doi: 10.1136/bjsports-2017-098890. Epub 2018 Sep 21.
- Background: PubMed 32982385Erratum: Effects of Trigger Point Dry Needling on Neuromuscular Performance and Pain of Individuals Affected by Patellofemoral Pain: A Randomized Controlled Trial [Corrigendum]. J Pain Res. 2020 Sep 7;13:2237. doi: 10.2147/JPR.S278493. eCollection 2020.
- Background: PubMed 27757280Mason JS, Crowell M, Dolbeer J, Morris J, Terry A, Koppenhaver S, Goss DL. THE EFFECTIVENESS OF DRY NEEDLING AND STRETCHING VS. STRETCHING ALONE ON HAMSTRING FLEXIBILITY IN PATIENTS WITH KNEE PAIN: A RANDOMIZED CONTROLLED TRIAL. Int J Sports Phys Ther. 2016 Oct;11(5):672-683.
- 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.
Muhammad Kashif study chair
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry Needling in people with Patellofemoral Pain Syndrome, run by Riphah International 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 22 Apr 2022. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Analogue Scale (time frame: 8th week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05261763, which also lists 3 linked publications.
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 22 Apr 2022.