| CTRI Number |
CTRI/2024/05/067842 [Registered on: 24/05/2024] Trial Registered Prospectively |
| Last Modified On: |
18/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Physiotherapy including yoga] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The effect of yoga as a complementary therapy to physical therapy for forward head position in young adults studying in college |
|
Scientific Title of Study
|
Effectiveness of Yoga as an adjunct to physiotherapy on Forward Head Posture among Young Collegiate Adults: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Harshit Verma |
| Designation |
Post Graduate Student |
| Affiliation |
Nitte Institute of Physiotherapy |
| Address |
Department of Physiotherapy, room number 20, second base division, Nitte Institute of Physiotherapy, Nitte Deemed to be University, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8114463679 |
| Fax |
|
| Email |
harshitverma175@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhanesh Kumar K U |
| Designation |
Professor |
| Affiliation |
Nitte Institute of Physiotherapy |
| Address |
Department of Physiotherapy, room number 20, second base division, Nitte Institute of Physiotherapy, Nitte Deemed to be University, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9019431417 |
| Fax |
|
| Email |
principal.nipt@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhanesh Kumar K U |
| Designation |
Professor |
| Affiliation |
Nitte Institute of Physiotherapy |
| Address |
Department of Physiotherapy, room number 20, second base division, Nitte Institute of Physiotherapy, Nitte Deemed to be University, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9019431417 |
| Fax |
|
| Email |
principal.nipt@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, room number 20, second base division, Nitte Institute of Physiotherapy, Nitte Deemed to be University, Deralakatte, Mangaluru, Karnataka 575018, India |
|
|
Primary Sponsor
|
| Name |
Nitte Deemed to be University |
| Address |
Nitte Institute of Physiotherapy, Nitte Deemed to be University,
Nithyananda Nagar, Deralakatte, Mangaluru, Dakshina Kannada |
| Type of Sponsor |
Other [Constituent Physiotherapy Institute of Nitte Deemed to be University] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Harshit Verma |
Justice K.S Hegde charitable Hospital |
Department of Physiotherapy, room number 20, second base division, Justice K.S Hegde charitable Hospital, Medical science complex, University road, Deralakatte, Mangaluru 575018
Dakshina Kannada
KARNATAKA |
8114463679
harshitverma175@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Nitte Institute of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Forward Head Posture |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional therapy for Forward Head Posture |
This program consists of flexibility and strengthening exercises, with each session lasting 30 minutes. The exercises will be conducted three times a week, alternately, over 4 weeks. The stretching exercises will involve 10 repetitions with a 5-second hold, while the strengthening exercises will include 10-15 repetitions. This has to be done as a home based treatment, exercises which involve is-
Strengthening exercises -
1. Y to W - Arms flexed and abducted to 120°, thumbs pointed up, arms 4–5 in. raised while keeping the retraction of scapula. Then elbows flexed and shoulders moved into a position of extension
2. L to Y - Arms abducted to 90° and elbows flexed to 90° with retracted scapula and arms externally rotated. Arms raised above the head and fully extended the elbows so that formed the letter Y
3. Scapular protraction - Prone hip bridge, shoulder retracted with forearms and toes supporting the body on the floor or table. Then 1–2 cm pushed up while protracting the scapula, and preventing the scapula from winging.
Stretching exercises -
1. Pectoralis flexibility - Supine on a foam roller with their spine, contracting transverses abdominis and flattening the lumbar curve against the foam roller. Arms together with shoulders and elbows flexed to 90°, touching forearms and palms. Then shoulders are horizontally abducted and the scapula retracted, wrists and elbows aligned in the plane of the body. Hold for 5 s and repeat 10 times
2. Chin tucks - The chin pushed into the table in an entirely posterior motion. It was not an exercise of tucking the chin to the chest through neck flexion |
| Intervention |
Yoga and Conventional therapy in Forward Head Posture |
Group A, the experimental group, will receive 30 minutes of 8 Yoga Asanas
which should be performed for 10 repetitions 15-sec hold with 30-sec rest
between each Asanas, and 5 minutes of Nadi Suddhi Pranayama 3 times a
week for four weeks, under supervision. They will also receive 30 minutes of
home-based conventional physiotherapy exercise, consisting of
strengthening and flexibility exercises, three times a week for four weeks. The flexibility exercises will be performed for 10 repetitions with a 5-second hold, and the strengthening exercises will be performed for 10 to 15 repetitions. The Asanas which are incorporated in this study is GrivÄsana or Kantha Sanchalana (neck rolls with lateral
bending of the head), UtkatÄsana (neck and chest extension), Utthana/Sama Hasta Hanu Shishosana (standing puppy pose with hands on the chin), Utthana/Sama Uttana Shishosana (standing extended puppy pose), Upavistha Ardha PurvottanÄsana (seated half-upward plank pose), AnuvittÄsana (variation of standing backbend pose), Upavistha AnuvittÄsana (Seated backbend pose with palms pushing the sacrum), Urdhva DhanurÄsana (upward bow pose), Nadi Suddhi Pranayama (cleansing and purifying breathing technique) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. All participants were required to be aged between 18 and 25 years including both Genders
2. Craniovertebral angle (cervical angle) should be less than 50 degree |
|
| ExclusionCriteria |
| Details |
1. Participants with chronic and/or acute neck pain due to a known specific cause such as disc protrusion, whiplash-associated disorder, congenital deformity of the spine, spinal canal stenosis, neoplasm, inflammatory rheumatic disease, and active oncologic disease
2. If they are pregnant
3. If had undergone invasive treatment of the spine in the previous 12 months
4. If they were suffering from neurological symptoms determined by the presence of sensory abnormalities, weakness, or altered reflexes
5. If had symptoms related to a motor vehicle accident or significant trauma that had occurred in the last 6 months
6. If had been practicing yoga anytime in the 6 months before the study
7. They would also be excluded if they missed practice for two consecutive sessions or more |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Craniovertebral angle using Mb-Ruler application |
Baseline (1st day) and Post Intervention (4th week)
The intervention period is 4 weeks followed by follow-up after 6th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 36-item Short Form health survey (SF 36) questionnaire |
Baseline (1st day) and Post Intervention (4th week)
The intervention period is 4 weeks followed by follow-up after 6th month |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
Final Enrollment numbers achieved (Total)= "44"
Final Enrollment numbers achieved (India)="44" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/06/2024 |
| Date of Study Completion (India) |
12/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
As electronic device usage increases, many develop poor posture habits like Forward Head Posture (FHP), often linked to Upper Crossed Syndrome (UCS). FHP, characterized by lower cervical flexion and upper cervical hyperextension, leads to issues like temporomandibular disorders (TMD), migraines, and neck pain, especially prevalent in young adults and students due to prolonged computer use and poor posture. FHP-related neck problems extend to psychological effects, impacting daily life and work. Treatment includes drugs, surgery, acupuncture, and exercise, with yoga emerging as a complementary therapy. Various styles like Hatha and Iyengar yoga focus on postures, breathing, and meditation, offering pain relief, mobility improvement, and mood enhancement. Research showcases yoga’s efficacy in treating PTSD, dyslexia, insomnia, and depression, alongside stress management. Yoga is particularly effective for musculoskeletal issues. Despite low injury risks, advanced poses and unsupervised practice may lead to adverse effects. Yoga serves holistically, enhancing quality of life, notably in nursing professionals and chronic low back pain sufferers. Intensive yoga programs prove more beneficial than traditional therapy in improving life quality and spinal flexibility. This study aims to investigate the effectiveness of integrating yoga into the treatment of Forward Head Posture (FHP) among college students. It will compare two treatment approaches: supervised yoga sessions alongside conventional treatment versus a home-based yoga program. Additionally, the study seeks to assess the psychological and functional well-being of students with FHP by including yoga in their quality of life evaluation. Utilizing a structured research design with both quantitative and qualitative measures, the study will evaluate the physical effects of the treatment strategies on FHP, as well as explore the psychological impact, including quality of life. Through a mixed-methods approach, the study aims to provide comprehensive insights into the effectiveness of incorporating yoga into FHP treatment. The findings from this study have the potential to offer valuable insights into the benefits of yoga as a complementary intervention for FHP, elucidating whether supervised sessions or home-based practice yield better outcomes. |