IRCT | Comparison of the effect of lumbopelvic manipulation,with lumbopelvic manipulation and dry needling of quadratus lumbarom and Gluteus Medius muscles on pain and function of athletes knee with patellofemoral pain syndrome (PFPS)

Protocol summary

Study aim: Comparison of the effect of lumbopelvic manipulation,with lumbopelvic manipulation and dry needling of quadratus lumbarom and Gluteus Medius muscles on pain and function of athletes knee with patellofemoral pain syndrome (PFPS)
Design: Clinical trial with two comparison groups, with parallel groups, one-way blind, randomized, sample size of 30 people, blocked randomization
Settings and conduct: The two groups of lumboplevic manipulation and lumboplevic manipulation and dry needle of the quadratus lumbarm and gluteus medius muscles are performed in Shiraz Rehabilitation School.And evaluation in the first and last session of treatment by the evaluator who is blind to the patients
Participants/Inclusion and exclusion criteria: Entry requirements : ،Athletes 18 to 45 years of age with unilateral patellar pain syndrome who exercise regularly (at least 3 sessions per week). ،Complaints of anterior knee pain in at least 2 of the following daily activities: sitting for long periods of time, going up and down stairs, squatting, kneeling, jumping and running. ،Report of pain when touching the internal and external patellar procedures , Kajala score score less than 40 out of 80 ،Having at least 3 out of 10 pain levels on a numerical pain scale over the past week No entry conditions: ،Existence of other pathologies of the knee joint such as rupture of meniscus or knee ligaments, wear and tear of the knee joint, tendon problems, dislocation or partial dislocation of the patella ،Hip pathologies ،Radicular pain in the lumbar region and neurological symptoms ،Previous knee surgery ،Contraindications to the use of dry needles
Intervention groups: lumbopelvic manipulation lumbopelvic manipulation and dry needling of quadratus lumbarom and Gluteus Medius muscles on pain and function of athletes knee with patellofemoral pain syndrome (PFPS)
Main outcome variables: Intensity of pain ; Functional ability

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20210315050709N1

Registration date: 2021-09-14, 1400/06/23

Registration timing: prospective

Last update: 2021-09-14, 1400/06/23

Update count: 0
Registration date: 2021-09-14, 1400/06/23

Registrant information: Name

Amin Shakouri

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 34 3282 1128

Email address

aminshakouri@sums.ac.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2021-09-23, 1400/07/01
Expected recruitment end date: 2021-11-22, 1400/09/01
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Comparison of the effect of lumbopelvic manipulation,with lumbopelvic manipulation and dry needling of quadratus lumbarom and Gluteus Medius muscles on pain and function of athletes knee with patellofemoral pain syndrome (PFPS)

Public title: Comparison of the effect of lumbopelvic manipulation,with lumbopelvic manipulation and dry needling of quadratus lumbarom and Gluteus Medius muscles on pain and function of athletes knee with patellofemoral pain syndrome (PFPS)
Purpose: Supportive
Inclusion/Exclusion criteria: Inclusion criteria:

Athlete 18 to 45 years old with patellofemoral pain syndrome who exercise regularly (at least three times per week) Complain of anterior knee pain at least in 2 of the following activity: sitting for long periods of time, going up and down stairs, squatting, kneeling, jumping and running Pain report when touching internal and external of patella surface and positive clarke test in knee extended and sitting At least be positive result of one of the three following tests:Positive vastus medialis co-ordination test Positive 20 cm going down stair test Positive Patellar apprehension test Gradual start of symptoms without history of trauma or injury for at least past 3 months kujala score level 40 to 70 At least 3 out of 10 score level of NPRS in past tree weeks

Exclusion criteria:

Existence of other pathologies of knee joint such as rupture of meniscus or knee ligaments, knee joint wear, tendon problems, patellar dislocation or partial dislocation, Sinding-Larsen disease, Osgood-Schlatter disease and Plica syndrome, ankle and knee injuries. Pathologies of the hip such as rupture of the ligaments of the thigh, joint wear and tear, tendon problems, dislocation or partial dislocation and injury of the thigh. Structural and biomechanical problems such as: valgus and varus in the knee or femoral anterior Radicular pain in the lumbar region and neurological symptoms (diagnosis with the help of history and lower limb percussion test, dural stretch test) Previous knee surgery Neurological disorders affecting balance Contraindications to using dry needles such as: Existence of metabolic diseases including diabetes, rheumatic diseases To. Pregnancy. Respiratory and cardiovascular problems (Peripheral vascular disease), cancer and any malignancy. Immune system defects. Menstruation. Needle phobia. Bleeding disorders and taking anticoagulants. Liver and kidney diseases
Age: From 18 years old to 45 years old
Gender: Both

Phase

N/A

Groups that have been masked

Outcome assessor

Sample size

Target sample size: 30

Randomization (investigator's opinion)

Randomized

Randomization description

blocked randomization In this way, we placed 30 cases in blocks and 4-person cases Each block is randomly assigned to the control and intervention group

Blinding (investigator's opinion)

Single blinded

Blinding description

At the beginning of the treatment and at the end of the treatment, she is kept blind. At the beginning, the evaluation is done and at the end, the final evaluation and data recording is done. Initially, the case is studied in an intervention or control group and the therapist performs treatment for each case depending on whether it is control or intervention, but the evaluator is blind at the beginning of the pre-treatment and post-treatment evaluation and not know about the treatment is performed. And the case of treatment

Placebo

Not used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics committee of Shiraz University of Medical Sciences

Street address

School of Rehabilitation, Abiverdi 1 St، Chamran Blvd.

City

shiraz

Province

Fars

Postal code

۱۷۳۳-۷۱۳۴۵
Approval date: 2021-02-24, 1399/12/06
Ethics committee reference number: IR.SUMS.REHAB.REC.1400.001

Health conditions studied

1

Description of health condition studied: patella femoral pain syndrom(pfps)
ICD-10 code: M22.2
ICD-10 code description: Patellofemoral disorders

Primary outcomes

1

Description: pain score
Timepoint: At the beginning of the study (before the intervention) and sessions 4 and 1 month later
Method of measurement: Numeric Pain Rating Scale

Secondary outcomes

1

Description: Functional ability
Timepoint: At the beginning of the study (before the intervention) and sessions 4 and 1 month later
Method of measurement: Kojala Questionnaire

2

Description: Functional ability
Timepoint: At the beginning of the study (before the intervention) and sessions 4 and 1 month later
Method of measurement: Lateral plank duration

Intervention groups

1

Description: Control group: lumbopelvic manipulation(In this group, only lumbar-pelvic placment is performed, in which the person is placed in a special position and the technique is performed)
Category: Rehabilitation

2

Description: Intervention group: lumbopelvic manipulation and dry needling of quadratus lumbarom and Gluteus Medius muscles.(In this group, in addition to pelvic lumbar placement in the said muscles, the dry needle technique is also applied)
Category: Rehabilitation

Recruitment centers

1

Recruitment center: Name of recruitment center

Shiraz Faculty of Rehabilitation Sciences

Full name of responsible person

Amin shakouri

Street address

School of Rehabilitation, Abiverdi 1 St, Chamran Blvd.

City

shiraz

Province

Fars

Postal code

۱۷۳۳-۷۱۳۴۵

Phone

+98 71 3627 1552

Email

Hd136767@gmail.com

Web page address

http://amintherapy.com/

1

Sponsor: Name of organization / entity

Shiraz University of Medical Sciences

Full name of responsible person

Abbas Rezaieanzadeh

Street address

School of Rehabilitation, Abiverdi 1 St, Chamran Blvd.

City

shiraz

Province

Fars

Postal code

۳۳۶۶۹-۷۱۹۴۷

Phone

+98 71 3627 1552

Fax

Email

hd136767@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Shiraz University of Medical Sciences
Proportion provided by this source: 100
Public or private sector: Public
Domestic or foreign origin: Domestic
Category of foreign source of funding: empty
Country of origin
Type of organization providing the funding: Academic

Person responsible for general inquiries

Contact: Name of organization / entity

Shiraz University of Medical Sciences

Full name of responsible person

Amin Shakouri

Position

Master student shiraz university

Latest degree

Bachelor

Other areas of specialty/work

Physiotherapy

Street address

No 8, jahad Blvd Amin clinic physiotherapy

City

Kerman

Province

Kerman

Postal code

7619738513

Phone

+98 34 3282 1128

Fax

Email

hd136767@gmail.com

Web page address

http://amintherapy.com/

Person responsible for scientific inquiries

Contact: Name of organization / entity

Shiraz University of Medical Sciences

Full name of responsible person

Amin Shakouri

Position

Master student shiraz university

Latest degree

Bachelor

Other areas of specialty/work

Physiotherapy

Street address

No 8, jahad Blvd Amin clinic physiotherapy

City

Kerman

Province

Kerman

Postal code

7619738513

Phone

+98 34 3282 1128

Fax

Email

hd136767@gmail.com

Web page address

http://amintherapy.com/

Person responsible for updating data

Contact: Name of organization / entity

Shiraz University of Medical Sciences

Full name of responsible person

Amin Shakouri

Position

Master student shiraz university

Latest degree

Bachelor

Other areas of specialty/work

Physiotherapy

Street address

No 8, jahad Blvd Amin clinic physiotherapy

City

Kerman

Province

Kerman

Postal code

7619738513

Phone

+98 34 3282 1128

Fax

Email

hd136767@gmail.com

Web page address

http://amintherapy.com/

Sharing plan

Deidentified Individual Participant Data Set (IPD): No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD: There is no more information
Study Protocol: No - There is not a plan to make this available
Statistical Analysis Plan: Not applicable
Informed Consent Form: No - There is not a plan to make this available
Clinical Study Report: No - There is not a plan to make this available
Analytic Code: Not applicable
Data Dictionary: Not applicable

Comparison of the effect of lumbopelvic manipulation,with lumbopelvic manipulation and dry needling of quadratus lumbarom and Gluteus Medius muscles on pain and function of athletes knee with patellofemoral pain syndrome (PFPS)