NCT06130969

Brief Summary

This study aims to determine the effect of combining diaphragmatic exercises with cervical retraction exercise on pain, disability, active range of motions of cervical spine and craniovertebral angle in individuals 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
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 10, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 14, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2024

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2024

Completed
Last Updated

December 27, 2023

Status Verified

December 1, 2023

Enrollment Period

8 months

First QC Date

November 9, 2023

Last Update Submit

December 26, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • Photogrammetry for Craniovertebral Angle (CVA) by image j software

    CVA, can be measured using the lateral photos exposing C7 and the ear. The participants will maintain the natural head posture through the measurement method of self-balance posture. It is the angle made by the line that connects the seventh cervical spine with the tragus and the horizontal line of the seventh cervical spine in the sitting and standing positions. A CVA of \<49° is characterized as FHP (3). Image J is an image processing and analysis program that can read both image file formats and raw formats. It can display, edit, analyze, process, store, and print images, as well as measure distances and angles.

    6 weeks

  • 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.

    6 weeks

  • Neck disability index (NDI):

    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.

    6 weeks

  • Goniometer for Cervical Range of motion (CROM)

    Universal goniometer has fair inter-tester reliability ranging from 0.79-0.92. Validity of this tool is good i.e. 0.97-0.98 This tool is most commonly used in the clinical settings for evaluating joint ROM.

    6 weeks

Secondary Outcomes (1)

  • Global rating of change (GRC)

    6 weeks

Study Arms (2)

Group A

EXPERIMENTAL

Cervical Retraction exercise without diaphragmatic breathing along with baseline treatment

Other: Cervical Retraction ExerciseOther: Baseline Treatment

Group B

EXPERIMENTAL

Cervical Retraction exercise with diaphragmatic breathing along with baseline treatment

Other: Cervical Retraction ExerciseOther: Diaphragmatic BreathingOther: Baseline Treatment

Interventions

Participants will hold cervical retraction for 10 s up to 10 times. A break of 5 s will be provided per one movement and 30 s per one set. A total of three sets will be conducted. Therefore, the total exercise time will be \<10 mints.

Group AGroup B

The diaphragmatic exercise will be performed in a supine position with 40° trunk flexion while holding 2.5 kg on the abdomen in the first 5 sessions and then 5 kg in the second 5 sessions. Participants will perform 3 sets with 10 repetitions at a ratio of one second of inspiration to two seconds of expiration, three sets of 15 repetitions at a ratio of two seconds of inspiration to four seconds of expiration, and three sets of 20 repetitions at a ratio of three seconds of inspiration to six seconds of expiration. The rest between rests will be 60 s.

Group B

Hot fomentation will be given by applying cervical hot pack over the area in prone lying position for 10 mints and Isometric neck strengthening exercises (10 repetitions, each 5-second hold, 1 set) (20). • Nerve Stimulation (TENS) on the painful regions around the neck for 15 minutes with a TENS device. TENS parameters will be 150 μs square pulses with a frequency of 80 Hz. The intensity of the current will be adjusted to produce no contraction. • Posture education to keep upright posture during sitting.

Group AGroup B

Eligibility Criteria

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

You may qualify if:

  • Primary complaint of neck pain (pain on the posterior part of the cervical spine to the beginning of the thoracic area with or without pain in the shoulder girdle)
  • Age from 20 to 35 years
  • Both gender
  • CVA \<49° (16)

You may not qualify if:

  • Any serious pathology such as tumor
  • Had history of whiplash injury within 3 months of the examination,
  • Underwent prior surgery to the cervical spine
  • Currently using muscle relaxation medication.
  • Degenerative conditions
  • Exhibited positive neurologic signs consistent with nerve root compression.
  • Patients with a history of respiratory disease, such as repeated bronchitis, pneumonia, asthma, pulmonary lymph nodes, pleurisy, cured tuberculosis and others

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chiropractor & Physio Pain Relief Center

Lahore, Punjab Province, 54782, Pakistan

RECRUITING

Study Officials

  • Ali Raza

    Riphah International University

    PRINCIPAL INVESTIGATOR
  • Aneeqa Manzoor

    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 9, 2023

First Posted

November 14, 2023

Study Start

May 10, 2023

Primary Completion

January 15, 2024

Study Completion

February 10, 2024

Last Updated

December 27, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations