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Effects of Trigger Point Dry Needling in Individuals With Patello Femoral Pain Syndrome : A Randomized Controlled Trial

Primary Purpose

Patellofemoral Pain Syndrome

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

About this trial

This is an interventional treatment trial for Patellofemoral Pain Syndrome focused on measuring Patellofemoral Pain Syndrome, Dry Needling, Trigger Points

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- 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

Exclusion Criteria:

  • History of any following conditions

    1. Participants who have received any treatment for PFPS within the 3 months
    2. A history of lower extremities fracture or surgery
    3. Presence of MSK diseases such as Acute Herniated Disc or Spondylolisthesis
    4. History of any chronic disease e.g. Diabetes Mellitus

Sites / Locations

  • Riphah International University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Group A

Group B

Arm Description

Group A will receive trigger point dry needling in quadricep muscles

Group B will get Sham needling in quadriceps muscles

Outcomes

Primary Outcome Measures

Visual Analogue Scale
Visual Analogue Scale
Kujala Questionnaire
functional disability will be check by Kujala Questionnaire
Goniometer
range of motion will be checked by Goniometer

Secondary Outcome Measures

Full Information

First Posted
February 20, 2022
Last Updated
April 21, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05261763
Brief Title
Effects of Trigger Point Dry Needling in Individuals With Patello Femoral Pain Syndrome : A Randomized Controlled Trial
Official Title
Study on the Effects of Trigger Point Dry Needling on Patients With Patello-femoral Pain Syndrome: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
March 1, 2022 (Actual)
Study Completion Date
March 1, 2022 (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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Pain Syndrome
Keywords
Patellofemoral Pain Syndrome, Dry Needling, Trigger Points

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Group A will receive trigger point dry needling in quadricep muscles
Arm Title
Group B
Arm Type
Sham Comparator
Arm Description
Group B will get Sham needling in quadriceps muscles
Intervention Type
Other
Intervention Name(s)
Dry Needling
Intervention Description
abc
Intervention Type
Other
Intervention Name(s)
Sham Dry Needing
Intervention Description
xyz
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
Visual Analogue Scale
Time Frame
8th week
Title
Kujala Questionnaire
Description
functional disability will be check by Kujala Questionnaire
Time Frame
8th week
Title
Goniometer
Description
range of motion will be checked by Goniometer
Time Frame
8th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Kashif
Organizational Affiliation
Riphah International University
Official's Role
Study Chair
Facility Information:
Facility Name
Riphah International University
City
Faisalabad
State/Province
Punjab
ZIP/Postal Code
38000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30242107
Citation
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.
Results Reference
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PubMed Identifier
32982385
Citation
Erratum: 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.
Results Reference
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PubMed Identifier
27757280
Citation
Mason 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.
Results Reference
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Effects of Trigger Point Dry Needling in Individuals With Patello Femoral Pain Syndrome : A Randomized Controlled Trial

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