NCT06151951

Brief Summary

This study aims to determined the comparative effect of visual and pressure biofeedback on Pain,Disability and Range of Motion in young and middle aged adults diagnosed with forward head posture.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

May 10, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 30, 2023

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2024

Completed
Last Updated

November 30, 2023

Status Verified

November 1, 2023

Enrollment Period

7 months

First QC Date

November 22, 2023

Last Update Submit

November 22, 2023

Conditions

Keywords

FHP

Outcome Measures

Primary Outcomes (3)

  • Numeric Pain Rating Scale (NPRS)

    The NPRS is a subjective pain rating scale using an 11-point scale from 0 to 10, where 0 means 'no pain' and 10 means 'intolerable pain'. Participants select the whole number that best represents their level of pain. The reliability is \>0.95 with ICC values 0.86- 0.95

    4 weeks

  • Neck Disability Index (NDI)

    NDI is a self-reported questionnaire which is formulated to assess pain that restricts the activities of daily living (ADL); it also helps to determine self-assessed disability. NDI has 10 domains covering pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation. Scores range from 0 to 50, with 50 being the greatest levels of dysfunction. It is a valid and reliable tool with ICC=0.98

    4 weeks

  • Pressure Biofeedback (Simple Sphygmomanometer)

    It is used to measure the neck muscle strength. It was consisting of 3 chamber air filled pressure bag, a catheter \& sphygmomanometer gauze. To measure the strength, cuff is placed under occipital in supine position for Neck flexor and under forehead in prone position for neck extensor muscle. After setting pressure with the baseline Pressure of 100 mmHg, patient was asked to put maximum effort on cuff by giving 6 seconds hold for 3 repetitions. After taking the mean value, it is compared with the normal extensor flexor.

    4 weeks

Secondary Outcomes (2)

  • Visual Biofeedback (LED Headband light)

    4 weeks

  • goniometry

    4 weeks

Study Arms (2)

Group A

EXPERIMENTAL

Movement control training of Neck flexor muscles with Pressure Biofeedback along with baseline treatment

Other: Cervical StabilizationDevice: Pressure Biofeedback

Group B

EXPERIMENTAL

Movement control training of Neck flexor muscles with Visual Biofeedback along with baseline treatment

Other: Cervical StabilizationDevice: Visual Biofeedback

Interventions

Isometric stretching and strengthening exercises of Neck flexor muscle including suboccipitalis, levator scapulae,scalnae anterior and upper trapezius. Each exercise hold for 6 second and then release and repeated 10 times respectively 3 times in a week for 4 weeks. Therefore, the total exercise time will be 5-10 mints.

Group AGroup B

In this method patients in supine position. Sphygmomanometer is used and 100 mmHg pressure will be maintained before the treatment start then cuff will be placed under the occiopit of spine and patient will be asked to press the cuff against the occiopit until gauze show target pressure then hold this position for 6 second and release. Repeated this pressure to 10 times, 3 times in a week for 4 weeks. Therefore, the total exercise time will be 5-10 mints. Baseline Treatment Before starting the session participants received moist heat pack and soft tissue massage on cervical for 10 to 15 mints followed by movement control training.

Group A

In this method Led Head Band light will be used as a visual feedback. Patients in sitting or standing position with neck straight with the alignment of front wall marking followed by control movement training. Patient will be asked to follow the marking through head band light while performing motion control training. Each exercise hold for 6 second and then release and repeated 10 times respectively 3 times in a week for 4 weeks. Therefore, the total exercise time will be 5-10 mints. Baseline Treatment Before starting the session participants received moist heat pack and soft tissue massage on cervical for 10 to 15 mints followed by movement control training.

Group B

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \. Participants would be complaining of neck pain as a primary complain and age of 20- 35 year was recruited in the study .
  • Male and female both gender are included in the study.
  • \. patient with Craniovertebral angle (CVA)\<53 degree were included in the study .
  • \. Score more than 3 on NPRS and more than 10 on NDI.

You may not qualify if:

  • Participant failing to fall in this category would be excluded of the study.
  • Neurogenic findings like cervical trauma, myopathy, vestibular pathology, dizziness, visual problem, spinal Fracture, dislocation and hypertension will not include in the study.
  • History of sever metabolic diseases.
  • History of recurrent surgery in upper thoracic and lumber vertebrae
  • History of recent fractures in shoulder and neck region.
  • History of tumor. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bahawal Victoria Hospital QAMC Bahawalpur

Bahawalpur, Punjab Province, 63100, Pakistan

RECRUITING

Bahawal Victoria Hospital QAMC Bahawalpur

Chak Four Hundred Fifty-four, Punjab Province, 63100, Pakistan

RECRUITING

Study Officials

  • Ali Raza

    Riphah International University

    PRINCIPAL INVESTIGATOR
  • Nusrat Prveen

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2023

First Posted

November 30, 2023

Study Start

May 10, 2023

Primary Completion

December 10, 2023

Study Completion

January 10, 2024

Last Updated

November 30, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations