Patellofemoral Pain SyndromeNCT03966937
Trigger Point Dry Needling In Patient With Patellofemoral Pain Syndrome
A study testing Dry needling in people with Patellofemoral Pain Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study intends to determine the effects of trigger point dry needling in patients with Patellofemoral pain Syndrome. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- Dry needling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePakistan
- Study dates
- 19 Mar 2019to 30 Jun 2019
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females with age limit 20 to 40 years,
- Active knee extension/90-90 test positive for Screening (With AKE range less than 160 degrees),
- No known history of hip joint or knee joint disease,
- No history of recent hamstring strain.
Who cannot join
- Patient with meniscal tears, patellar tendinopathy, and ligamentous injuries.
- Patient with knee osteoarthritis
- Patient with lumbosacral nerve root or peripheral nerve involvement
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
District Health Quarter Taunsa
Dera Ghazi Khan, Punjab Province, 32200
About this study
Official title: Effects of Trigger Point Dry Needling In Patient With Patellofemoral Pain Syndrome
This study intends to determine the effects of trigger point dry needling in patients with Patellofemoral pain Syndrome.
Read the detailed description
This is a single blinded randomized controlled trial, will be conducted at District Head Quarter (DHQ) hospital Taunsa Sharif.
Dry needling is a technique used to release myofascial trigger points. this study is planned to determine the effects of dry needling on quadriceps muscle in patients with Patellofemoral pain syndrome. The sample size was calculated to be n=92 through Open Epi tool version 3, with 95 % confidence interval (CI), and power 80%,
After the completion of therapeutic protocols, the participants will be assessed with the help of Numeric Pain Rating Scale (NPRS), Algometer and Anterior Knee Pain scale along with knee Range of Motion(ROM)
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- Dry needling, Control
- Keywords
- Anterior Knee Pain Syndrome, Patellofemoral Syndrome
- 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
Hot Pack will be applied on Quadriceps muscles before session for general relaxation for 7-10 minutes. Stretching of quadriceps femoris muscle with 4 repetitions and 15 second hold per session will be performed. Strengthening exercises of 3 sets of 10 RM with progressive loading per session will be performed.
Then after wearing gloves and appropriate personal protective measures, a thin filiform needle will be inserted which will penetrate into the skin and stimulate underlying myofascial trigger points.
ControlOther
Hot Pack will be applied on Quadriceps muscles before session for general relaxation for 7-10 minutes. Stretching of quadriceps femoris muscle with 4 repetitions and 15 second hold per session will be performed. Strengthening exercises of 3 sets of 10 RM with progressive loading per session will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Dry needling | Experimental | The experimental group will receive dry needling over trigger points of Quadriceps muscles along with therapeutic exercises. Receives: Other: Dry needling |
| Control | Active comparator | The control group will only receive standardized therapeutic exercises for Patellofemoral pain syndrome. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale (NPRS)
Numeric Pain Rating Scale (NPRS) is used to assess pain. It scores ranges from 0-10, 0 means No pain and 10 means Severe pain. Patient will be asked to verbally report the pain score.
Measured: Baseline
Numeric Pain Rating Scale (NPRS)
Numeric Pain Rating Scale (NPRS) is used to assess pain. It scores ranges from 0-10, 0 means No pain and 10 means Severe pain. Patient will be asked to verbally report the pain score.
Measured: Post 1st week
Algometer
Pressure threshold is the minimal pressure (force) which induces pain. The digital algometer is a force gauge with a rubber disc of 1 cm2 surface. It will be placed over trigger point in muscle and pressure pain sensitivity would be measured.
Measured: Baseline
Algometer
Pressure threshold is the minimal pressure (force) which induces pain. The digital algometer is a force gauge with a rubber disc of 1 cm2 surface. It will be placed over trigger point in muscle and pressure pain sensitivity would be measured.
Measured: Post 1st week
Anterior Knee Pain Scale (AKPS)
The Anterior Knee Pain Scale (AKPS) - sometimes called the Kujala Scale is a 13-item knee-specific self-report questionnaire. It documents response to six activities (walking, running, jumping, climbing stairs, squatting, and sitting for prolonged periods with knees bent), as well as symptoms such as limp.
The maximum score is 100 that indicate good results, if score is 70 then it is moderate, lower scores like 50 or below 50 indicates severity of the disease.
Measured: Baseline
Anterior Knee Pain Scale (AKPS)
The Anterior Knee Pain Scale (AKPS) - sometimes called the Kujala Scale is a 13-item knee-specific self-report questionnaire. It documents response to six activities (walking, running, jumping, climbing stairs, squatting, and sitting for prolonged periods with knees bent), as well as symptoms such as limp.
The maximum score is 100 that indicate good results, if score is 70 then it is moderate, lower scores like 50 or below 50 indicates severity of the disease.
Measured: Post 1st week
Knee Range of Motion (ROM)
To assess Knee range of motion (ROM), Goniometer will be use to measure knee range of motion in flexion \& extension. Participants will be seated upright and asked to actively move their knee in each direction.
Measured: Baseline
Knee Range of Motion (ROM)
To assess Knee range of motion (ROM), Goniometer will be use to measure knee range of motion in flexion \& extension. Participants will be seated upright and asked to actively move their knee in each direction.
Measured: Post 1st week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start19 Mar 2019
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There will be two treatment groups of participants, One group will receive Dry Needling for releasing trigger points in Quadriceps along with therapeutic exercises whereas other will receive only therapeutic exercises
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huma Riaz, PHD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03966937
- Sponsor's protocol ID
- RiphahIU Nadia Ishtiaq
- Status last verified
- Aug 2019
- First submitted
- 16 May 2019
- Last updated
- 9 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boling M, Padua D, Marshall S, Guskiewicz K, Pyne S, Beutler A. Gender differences in the incidence and prevalence of patellofemoral pain syndrome. Scand J Med Sci Sports. 2010 Oct;20(5):725-30. doi: 10.1111/j.1600-0838.2009.00996.x.
PubMed 19765240Collado H, Fredericson M. Patellofemoral pain syndrome. Clin Sports Med. 2010 Jul;29(3):379-98. doi: 10.1016/j.csm.2010.03.012.
PubMed 20610028Saltychev M, Dutton RA, Laimi K, Beaupre GS, Virolainen P, Fredericson M. Effectiveness of conservative treatment for patellofemoral pain syndrome: A systematic review and meta-analysis. J Rehabil Med. 2018 May 8;50(5):393-401. doi: 10.2340/16501977-2295.
PubMed 29392329Starkweather A. The Evidence on Dry Needling for Pain Management.Topics in Pain Management. 2018 Nov 1;34(4):1-9
Sutlive TG, Golden A, King K, Morris WB, Morrison JE, Moore JH, Koppenhaver S. SHORT-TERM EFFECTS OF TRIGGER POINT DRY NEEDLING ON PAIN AND DISABILITY IN SUBJECTS WITH PATELLOFEMORAL PAIN SYNDROME. Int J Sports Phys Ther. 2018 Jun;13(3):462-473.
PubMed 30038832
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Trigger Point Dry Needling In Patient With Patellofemoral Pain Syndrome
- ClinicalTrials.gov ID
- NCT03966937
- Acronym / sponsor ID
- RiphahIU Nadia Ishtiaq
- Conditions
- Patellofemoral Pain Syndrome
- Keywords
- Anterior Knee Pain Syndrome, Patellofemoral Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 19 Mar 2019 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 29 May 2019 (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.
This study intends to determine the effects of trigger point dry needling in patients with Patellofemoral pain Syndrome.
Detailed description
This is a single blinded randomized controlled trial, will be conducted at District Head Quarter (DHQ) hospital Taunsa Sharif.
Dry needling is a technique used to release myofascial trigger points. this study is planned to determine the effects of dry needling on quadriceps muscle in patients with Patellofemoral pain syndrome. The sample size was calculated to be n=92 through Open Epi tool version 3, with 95 % confidence interval (CI), and power 80%,
After the completion of therapeutic protocols, the participants will be assessed with the help of Numeric Pain Rating Scale (NPRS), Algometer and Anterior Knee Pain scale along with knee Range of Motion(ROM)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- There will be two treatment groups of participants, One group will receive Dry Needling for releasing trigger points in Quadriceps along with therapeutic exercises whereas other will receive only therapeutic exercises
| Arm | Type | Receives |
|---|---|---|
| Dry needling | Experimental | Other: Dry needlingThe experimental group will receive dry needling over trigger points of Quadriceps muscles along with therapeutic exercises. |
| Control | Active comparator | Other: ControlThe control group will only receive standardized therapeutic exercises for Patellofemoral pain syndrome. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Males and females with age limit 20 to 40 years,
- Active knee extension/90-90 test positive for Screening (With AKE range less than 160 degrees),
- No known history of hip joint or knee joint disease,
- No history of recent hamstring strain.
Key exclusion criteria (3 listed)
- Patient with meniscal tears, patellar tendinopathy, and ligamentous injuries.
- Patient with knee osteoarthritis
- Patient with lumbosacral nerve root or peripheral nerve involvement
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 needlingHot Pack will be applied on Quadriceps muscles before session for general relaxation for 7-10 minutes. Stretching of quadriceps femoris muscle with 4 repetitions and 15 second hold per session will be performed. Strengthening exercises of 3 sets of 10 RM with progressive loading per session will be performed. Then after wearing gloves and appropriate personal protective measures, a thin filiform needle will be inserted which will penetrate into the skin and stimulate underlying myofascial trigger points. | Other | Dry needling |
| ControlHot Pack will be applied on Quadriceps muscles before session for general relaxation for 7-10 minutes. Stretching of quadriceps femoris muscle with 4 repetitions and 15 second hold per session will be performed. Strengthening exercises of 3 sets of 10 RM with progressive loading per session will be performed. | Other | Control |
Primary outcome
Numeric Pain Rating Scale (NPRS)
Time frame: Baseline
Numeric Pain Rating Scale (NPRS) is used to assess pain. It scores ranges from 0-10, 0 means No pain and 10 means Severe pain. Patient will be asked to verbally report the pain score.
Numeric Pain Rating Scale (NPRS)
Time frame: Post 1st week
Numeric Pain Rating Scale (NPRS) is used to assess pain. It scores ranges from 0-10, 0 means No pain and 10 means Severe pain. Patient will be asked to verbally report the pain score.
Algometer
Time frame: Baseline
Pressure threshold is the minimal pressure (force) which induces pain. The digital algometer is a force gauge with a rubber disc of 1 cm2 surface. It will be placed over trigger point in muscle and pressure pain sensitivity would be measured.
Algometer
Time frame: Post 1st week
Pressure threshold is the minimal pressure (force) which induces pain. The digital algometer is a force gauge with a rubber disc of 1 cm2 surface. It will be placed over trigger point in muscle and pressure pain sensitivity would be measured.
Anterior Knee Pain Scale (AKPS)
Time frame: Baseline
The Anterior Knee Pain Scale (AKPS) - sometimes called the Kujala Scale is a 13-item knee-specific self-report questionnaire. It documents response to six activities (walking, running, jumping, climbing stairs, squatting, and sitting for prolonged periods with knees bent), as well as symptoms such as limp. The maximum score is 100 that indicate good results, if score is 70 then it is moderate, lower scores like 50 or below 50 indicates severity of the disease.
Anterior Knee Pain Scale (AKPS)
Time frame: Post 1st week
The Anterior Knee Pain Scale (AKPS) - sometimes called the Kujala Scale is a 13-item knee-specific self-report questionnaire. It documents response to six activities (walking, running, jumping, climbing stairs, squatting, and sitting for prolonged periods with knees bent), as well as symptoms such as limp. The maximum score is 100 that indicate good results, if score is 70 then it is moderate, lower scores like 50 or below 50 indicates severity of the disease.
Knee Range of Motion (ROM)
Time frame: Baseline
To assess Knee range of motion (ROM), Goniometer will be use to measure knee range of motion in flexion \& extension. Participants will be seated upright and asked to actively move their knee in each direction.
Knee Range of Motion (ROM)
Time frame: Post 1st week
To assess Knee range of motion (ROM), Goniometer will be use to measure knee range of motion in flexion \& extension. Participants will be seated upright and asked to actively move their knee in each direction.
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 9 Aug 2019.
- Background: PubMed 19765240Boling M, Padua D, Marshall S, Guskiewicz K, Pyne S, Beutler A. Gender differences in the incidence and prevalence of patellofemoral pain syndrome. Scand J Med Sci Sports. 2010 Oct;20(5):725-30. doi: 10.1111/j.1600-0838.2009.00996.x.
- Background: PubMed 20610028Collado H, Fredericson M. Patellofemoral pain syndrome. Clin Sports Med. 2010 Jul;29(3):379-98. doi: 10.1016/j.csm.2010.03.012.
- Background: PubMed 29392329Saltychev M, Dutton RA, Laimi K, Beaupre GS, Virolainen P, Fredericson M. Effectiveness of conservative treatment for patellofemoral pain syndrome: A systematic review and meta-analysis. J Rehabil Med. 2018 May 8;50(5):393-401. doi: 10.2340/16501977-2295.
- BackgroundStarkweather A. The Evidence on Dry Needling for Pain Management.Topics in Pain Management. 2018 Nov 1;34(4):1-9
- Background: PubMed 30038832Sutlive TG, Golden A, King K, Morris WB, Morrison JE, Moore JH, Koppenhaver S. SHORT-TERM EFFECTS OF TRIGGER POINT DRY NEEDLING ON PAIN AND DISABILITY IN SUBJECTS WITH PATELLOFEMORAL PAIN SYNDROME. Int J Sports Phys Ther. 2018 Jun;13(3):462-473.
- 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.
Huma Riaz, PHD* principal investigator
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 4 inclusion and 3 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 9 Aug 2019. 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?
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?
Numeric Pain Rating Scale (NPRS) (time frame: Baseline). The study lists 8 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 NCT03966937, which also lists 5 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 9 Aug 2019.