- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06613620
Additional Effects of Surface Electromyographic Biofeedback on Post Facilitation Stretching and Strengthening in Lower Crossed Syndrome;A Randomized Control Trial
This study is a randomised control trial and the purpose of this study is to determine the additional effects of surface electromyographic biofeedback on post facilitation stretching and strengthening in lower crossed syndrome.
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Study Overview
Status
Conditions
Detailed Description
Participants will be recruited into their respective groups using a sealed envelope method. Lower crossed syndrome will be assessed using the following tests:
Prone hip extension test Trunk flexion strength test Tightness in erector spinae Modified Thomas test
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab Province
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Punjāb Chak, Punjab Province, Pakistan, 46000
- Foundation University College of Physical Therapy
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 19-35 years
- Both genders
- Positive modified Thomas test
- Positive prone hip extension strength test
- Positive trunk flexion strength test
- Tight erector spinae
- BMI normal (18.5-24.9 Kg/m2)
- Local intermittent lumbar pain
- moderate pain (NPRS 3-7)
- Painless movement and activity
- Pain only produced by sustained loading in relevant position, which is then relieved on moving from that pos
Exclusion criteria:
- Acute flare of LBP
- Centralization and peripheralization of pain
- Signs of stenosis(leg symptoms when walking that are eased upon flexion)
- Pain due to repetitive movements
- Paresthesia/Numbness
- Structual deformity(Kyphosis, spondylosis, spondylolisthesis,scoliosis and joint contractures)
- Curve reversal
- Pregnancy
- Post surgery
- Degenerative and inflammatory spine diseases
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Post Facilitation Stretching and Strengthening
Group A will recieve standard treatment of post facilitation stretching and strengthening. Strengthening will be divided into following phases
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All participants will receive 4 weeks of intervention with a frequency of 3 times/week i.e. 10minutes of hot pack followed by post facilitation stretching and strengthening protocol. The exercise protocol will be taught to the patient by an experienced physiotherapist and supervised on the subsequent sessions. The protocol will be gradually progressed as per the patient's tolerance. |
|
Experimental: Visual and auditory biofeeback
Group B will receive surface EMG biofeedback(visual and auditary) in addition to standard treatment.
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All participants will receive 4 weeks of intervention with a frequency of 3 times/week i.e. 10minutes of hot pack followed by post facilitation stretching and strengthening protocol. The exercise protocol will be taught to the patient by an experienced physiotherapist and supervised on the subsequent sessions. The protocol will be gradually progressed as per the patient's tolerance.
Patients will receive SEMG biofeedback assisted post facilitation stretching and strengthening.
Patients will receive 50-80%of their maximum voluntary contraction as per the biofeedback and gradually the contraction time will be increased.
|
|
Experimental: Electrical stimulation along with visual and auditory feedback
Group C will receive 3 types of feedbacks (electrical, visual and auditory) in addition to standard treatment
|
All participants will receive 4 weeks of intervention with a frequency of 3 times/week i.e. 10minutes of hot pack followed by post facilitation stretching and strengthening protocol. The exercise protocol will be taught to the patient by an experienced physiotherapist and supervised on the subsequent sessions. The protocol will be gradually progressed as per the patient's tolerance.
Patients will receive SEMG biofeedback assisted post facilitation stretching and strengthening.
Patients will receive 50-80%of their maximum voluntary contraction as per the biofeedback and gradually the contraction time will be increased.
Electrical muscle stimulation will be provided in addition to visual and auditory feedback by the SEMG biofeedback unit to the weak muscles until the patients achieve the desired level of contractions.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lumber lordotic angle
Time Frame: 4 weeks
|
It will be measured using a mobile application.
One sensor will be placed at the T12-L1 and other at L5-S1 spinous processes.
The two angles will be recorded and their sum will be considered as the lumber lordotic angle.
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4 weeks
|
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Joint position sense
Time Frame: 4 weeks
|
One sensor will be placed at T12-L1 and the other placed at L5-S1 simultaneously.
Patient will be asked to flex and then extend maximally; his end ranges will be recorded.
Within the middle range, therapist will decide the targeted angle for individualized patient.
Patient will be asked to memorize the target position for 5seconds.
The absolute error will measure by subtracting the actual angle and the target angle.
|
4 weeks
|
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pain intensity
Time Frame: 4 weeks
|
It will be measured on a numeric pain rating scale in which the subjects select a number ranging from 0-10 according to their intensity of pain.
'0' score indicates no pain while '10' indicates worst pain experienced.
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4 weeks
|
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Functional disability
Time Frame: 4 Weeks
|
It will be measured using a Modified Oswestry lower back Disability Index.
It is a 10item based questionnaire and each item is further divided into 6statements.
The score of '0-4' indicated no disability while 35-50 indicate complete disability.
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4 Weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FUI/CTR/2024/33
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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