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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03966937
Other study ID # RiphahIU Nadia Ishtiaq
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 19, 2019
Est. completion date June 30, 2019

Study information

Verified date August 2019
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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)


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date June 30, 2019
Est. primary completion date June 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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

Study Design


Intervention

Other:
Dry needling
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.
Control
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.

Locations

Country Name City State
Pakistan District Health Quarter Taunsa Dera Ghazi Khan Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & 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. — View 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. Review. — View Citation

Saltychev M, Dutton RA, Laimi K, Beaupré 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. Review. — View Citation

Starkweather 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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