NCT03966937

Brief Summary

This study intends to determine the effects of trigger point dry needling in patients with Patellofemoral pain Syndrome.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 19, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 29, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

August 9, 2019

Status Verified

August 1, 2019

Enrollment Period

3 months

First QC Date

May 16, 2019

Last Update Submit

August 8, 2019

Conditions

Keywords

Anterior Knee Pain SyndromePatellofemoral Syndrome

Outcome Measures

Primary Outcomes (8)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    Post 1st week

Study Arms (2)

Dry needling

EXPERIMENTAL

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

Other: Dry needling

Control

ACTIVE COMPARATOR

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

Other: Control

Interventions

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.

Dry needling
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.

Control

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

District Health Quarter Taunsa

Dera Ghazi Khan, Punjab Province, 32200, Pakistan

Location

Related Publications (5)

  • 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.

    PMID: 19765240BACKGROUND
  • Collado H, Fredericson M. Patellofemoral pain syndrome. Clin Sports Med. 2010 Jul;29(3):379-98. doi: 10.1016/j.csm.2010.03.012.

    PMID: 20610028BACKGROUND
  • 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.

    PMID: 29392329BACKGROUND
  • Starkweather A. The Evidence on Dry Needling for Pain Management.Topics in Pain Management. 2018 Nov 1;34(4):1-9

    BACKGROUND
  • 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.

    PMID: 30038832BACKGROUND

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Officials

  • Huma Riaz, PHD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
This is a single blinded randomized controlled trial in which patients will be randomized into groups by sealed envelope method.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2019

First Posted

May 29, 2019

Study Start

March 19, 2019

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

August 9, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations