Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06130969
Other study ID # REC/RCR & AHS/23/0155
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 10, 2023
Est. completion date February 10, 2024

Study information

Verified date December 2023
Source Riphah International University
Contact Imran Amjad, PhD
Phone +923324390125
Email imran.amjad@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Forward head posture altering breathing pattern is one of the most common musculoskeletal deformity. Diaphragmatic exercises can reduce pain and disability levels, and correct forward head posture (FHP) in patients with neck discomfort. In this randomized clinical trial, fifty two participants displaying forward head posture (FHP) will be randomly assigned to one of the two intervention groups: the Diaphragmatic Exercises and Cervical Retraction Exercise Combined Group or the Cervical Retraction Exercise Alone Group. Randomization will be performed using a convenient random sampling method via sealed opaque envelopes. Each participant will receive a total of twelve treatment sessions over a four-week period. The efficacy of the interventions will be assessed at the beginning (first session), conclusion (twelfth session), and two weeks after completing the sessions. Outcome measures, including pain intensity, disability levels, cervical range of motion, and craniovertebral angle (CVA), will be evaluated using the Numeric Pain Rating Scale (NPRS), Neck Disability Index (NDI), universal goniometer and Image J software, respectively. Data will be analyzed using Statistical Package for the Social Sciences (SPSS) software version 26. Normality of data will be assessed using the Kolmogorov-Smirnov test. For within-group comparisons, either repeated measures ANOVA or the Friedman test will be used. To compare changes between the groups, the independent t-test or Mann-Whitney U test will be applied, depending on the data distribution. The analysis of these outcome measures will provide valuable insights into the impact of the interventions on participants' symptoms and postural alignment.


Recruitment information / eligibility

Status Recruiting
Enrollment 52
Est. completion date February 10, 2024
Est. primary completion date January 15, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 35 Years
Eligibility Inclusion Criteria: - 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) Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Cervical Retraction Exercise
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.
Diaphragmatic Breathing
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.
Baseline Treatment
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.

Locations

Country Name City State
Pakistan Chiropractor & Physio Pain Relief Center Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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 Global rating of change (GRC) GRC scale is used as an objective means to test the improvement of patient symptoms, to identify the intervention effect after treatment completion in clinical practice 6 weeks
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05642130 - Effect of Muscle Energy Technique on Craniovertebral and Shoulder Angles in Forward Head Posture N/A
Completed NCT01806519 - Motor_Control_Neck_SSED N/A
Not yet recruiting NCT05533853 - Different Methods of Forward Head Posture Correction N/A
Completed NCT04216862 - Strengthening and Stretching Exercise to Improve Forward Head Posture and Rounded Shoulders N/A
Completed NCT06131164 - Breathing Exercises Effects on Forward Head Posture N/A
Not yet recruiting NCT06123351 - Forward Head Posture Correction Impact on Temporomandibular Dysfunction N/A
Recruiting NCT06086834 - McKenzie Retraction and Bruegger's Exercises Effects on Forward Head Posture N/A
Completed NCT06270563 - High Intensity Laser Therapy Versus Scapular Stabilization Exercises on Ventilatory Function in Forward Head Posture N/A
Completed NCT05619094 - Effects of Exercise on Alignment and Muscle Parameters in Forward Head Posture N/A
Completed NCT05338814 - Conventional Neck Exercise With and Without Scapular Corrective Exercises in Patients With Forward Head Posture N/A
Not yet recruiting NCT03778034 - Effect of Forward Head Posture(FHP)on Temopromandibular Joint (TMJ) Proprioception in Post-pubertal Females
Enrolling by invitation NCT03038139 - Postural Correction Exercises for Forward Head Posture N/A
Completed NCT05878600 - Cervical Spine Strengthening Exercises Versus Kendall Exercises in Patients With Forward Head Posture. N/A
Not yet recruiting NCT05103111 - Effect of FHP on TMJ Proprioception in Postmenopausal Women
Recruiting NCT06108752 - Comparative Effect of Scapular Stabilization vs Thoracic Extension Exercises in Young Adults With Text Neck Syndrome. N/A
Recruiting NCT06407089 - Effectiveness of a Telerehabilitation Program Based on Specific Neck Exercises in Patients With Forward Head Posture. N/A
Recruiting NCT06131697 - Effects Of McKenzie Exercises With And Without Mulligan Mobilization In Text Neck Syndrome. N/A
Recruiting NCT06151951 - Comparative Effects of Visual and Pressure Biofeedback in Symptomatic Forward Head Posture. N/A
Recruiting NCT06197919 - Effect of Posture and Breathing Exercises in Forward Head Posture N/A
Recruiting NCT04723511 - Effects of Global Postural Reeducation on Forward Head Posture N/A