NCT06613620

Brief Summary

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. .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 18, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 26, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2025

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2025

Completed
Last Updated

December 22, 2025

Status Verified

December 1, 2025

Enrollment Period

11 months

First QC Date

September 23, 2024

Last Update Submit

December 16, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Lumber lordotic angle

    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

    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

    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

    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

Study Arms (3)

Post Facilitation Stretching and Strengthening

EXPERIMENTAL

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

Visual and auditory biofeeback

EXPERIMENTAL

Group B will receive surface EMG biofeedback(visual and auditary) in addition to standard treatment.

Other: Standard TreatmentOther: Visual and auditory feedback on SEMG biofeedback unit

Electrical stimulation along with visual and auditory feedback

EXPERIMENTAL

Group C will receive 3 types of feedbacks (electrical, visual and auditory) in addition to standard treatment

Other: Standard TreatmentOther: Visual and auditory feedback on SEMG biofeedback unitOther: Electrical muscle stimulation

Interventions

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.

Electrical stimulation along with visual and auditory feedbackPost Facilitation Stretching and StrengtheningVisual and auditory biofeeback

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 stimulation along with visual and auditory feedbackVisual and auditory biofeeback

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.

Electrical stimulation along with visual and auditory feedback

Eligibility Criteria

Age19 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy

Punjāb Chak, Punjab Province, 46000, Pakistan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Control Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2024

First Posted

September 26, 2024

Study Start

July 18, 2024

Primary Completion

June 2, 2025

Study Completion

June 20, 2025

Last Updated

December 22, 2025

Record last verified: 2025-12

Locations