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Trigger Point Dry Needling In Patient With Patellofemoral Pain Syndrome

Primary Purpose

Patellofemoral Pain Syndrome

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Dry needling
Control
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Patellofemoral Pain Syndrome focused on measuring Anterior Knee Pain Syndrome, Patellofemoral Syndrome

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patient with meniscal tears, patellar tendinopathy, and ligamentous injuries.
  • Patient with knee osteoarthritis
  • Patient with lumbosacral nerve root or peripheral nerve involvement

Sites / Locations

  • District Health Quarter Taunsa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dry needling

Control

Arm Description

The experimental group will receive dry needling over trigger points of Quadriceps muscles along with therapeutic exercises.

The control group will only receive standardized therapeutic exercises for Patellofemoral pain syndrome.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
May 16, 2019
Last Updated
August 8, 2019
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT03966937
Brief Title
Trigger Point Dry Needling In Patient With Patellofemoral Pain Syndrome
Official Title
Effects of Trigger Point Dry Needling In Patient With Patellofemoral Pain Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
March 19, 2019 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Pain Syndrome
Keywords
Anterior Knee Pain Syndrome, Patellofemoral Syndrome

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
This is a single blinded randomized controlled trial in which patients will be randomized into groups by sealed envelope method.
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dry needling
Arm Type
Experimental
Arm Description
The experimental group will receive dry needling over trigger points of Quadriceps muscles along with therapeutic exercises.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
The control group will only receive standardized therapeutic exercises for Patellofemoral pain syndrome.
Intervention Type
Other
Intervention Name(s)
Dry needling
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale (NPRS)
Description
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.
Time Frame
Baseline
Title
Numeric Pain Rating Scale (NPRS)
Description
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.
Time Frame
Post 1st week
Title
Algometer
Description
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.
Time Frame
Baseline
Title
Algometer
Description
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.
Time Frame
Post 1st week
Title
Anterior Knee Pain Scale (AKPS)
Description
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.
Time Frame
Baseline
Title
Anterior Knee Pain Scale (AKPS)
Description
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.
Time Frame
Post 1st week
Title
Knee Range of Motion (ROM)
Description
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.
Time Frame
Baseline
Title
Knee Range of Motion (ROM)
Description
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.
Time Frame
Post 1st week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Patient with meniscal tears, patellar tendinopathy, and ligamentous injuries. Patient with knee osteoarthritis Patient with lumbosacral nerve root or peripheral nerve involvement
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huma Riaz, PHD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
District Health Quarter Taunsa
City
Dera Ghazi Khan
State/Province
Punjab
ZIP/Postal Code
32200
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19765240
Citation
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.
Results Reference
background
PubMed Identifier
20610028
Citation
Collado H, Fredericson M. Patellofemoral pain syndrome. Clin Sports Med. 2010 Jul;29(3):379-98. doi: 10.1016/j.csm.2010.03.012.
Results Reference
background
PubMed Identifier
29392329
Citation
Saltychev 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.
Results Reference
background
Citation
Starkweather A. The Evidence on Dry Needling for Pain Management.Topics in Pain Management. 2018 Nov 1;34(4):1-9
Results Reference
background
PubMed Identifier
30038832
Citation
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.
Results Reference
background

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Trigger Point Dry Needling In Patient With Patellofemoral Pain Syndrome

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