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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05261763
Other study ID # REC-FSD-00238
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 15, 2021
Est. completion date March 1, 2022

Study information

Verified date April 2022
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 assessing the pain,functional disability and range of motion of the affected individuals.


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.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date March 1, 2022
Est. primary completion date March 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 40 Years
Eligibility 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

Study Design


Intervention

Other:
Dry Needling
abc
Sham Dry Needing
xyz

Locations

Country Name City State
Pakistan Riphah International University Faisalabad Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Visual Analogue Scale Visual Analogue Scale 8th week
Primary Kujala Questionnaire functional disability will be check by Kujala Questionnaire 8th week
Primary Goniometer range of motion will be checked by Goniometer 8th week
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