Additional Effects of Surface Electromyographic Biofeedback on Post Facilitation Stretching and Strengthening in Lower Crossed Syndrome;A Randomized Control Trial

December 16, 2025 updated by: Foundation University Islamabad

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
46

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Pakistan
    • Punjab Province
      • Punjāb Chak, Punjab Province, Pakistan, 46000
        • Foundation University College of Physical Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

  1. Warm up phase:
  2. Strengthening phase:
  3. Cool down phase:
Other: 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.
Experimental: Visual and auditory biofeeback
Group B will receive surface EMG biofeedback(visual and auditary) in addition to standard treatment.
Other: 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.

Other: Visual and auditory feedback on SEMG biofeedback unit
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
Other: 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.

Other: Visual and auditory feedback on SEMG biofeedback unit
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.
Other: Electrical muscle stimulation
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
4 weeks
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
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.
4 weeks
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.
4 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Foundation University Islamabad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 18, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 2, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 20, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 23, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 26, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FUI/CTR/2024/33

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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