| CTRI Number |
CTRI/2025/03/082259 [Registered on: 13/03/2025] Trial Registered Prospectively |
| Last Modified On: |
12/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the Impact of Neck Stabilization Exercises and Muscle Energy Techniques on Pain, Anxiety, Posture, and Breathing in Chronic Neck Pain |
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Scientific Title of Study
|
Evaluating the Comparative Effects of Cervical Stabilization Exercises and Muscle Energy Techniques on Pain, Anxiety, Forward Head Posture, and Respiratory Status in Chronic Neck Pain |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nikita Saini |
| Designation |
MPT Student |
| Affiliation |
Shree Guru Gobind Singh Tricentenary University |
| Address |
Department of Faculty of Physiotherapy, SGT University, Chandu-Budhera, Gurgaon, Haryana 122505
Department of Faculty of Physiotherapy, SGT University, Chandu-Budhera, Gurgaon, Haryana 122505
Gurgaon
HARYANA
122101
India |
| Phone |
08826047941 |
| Fax |
|
| Email |
nikitasaini5553@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Snigdha Tiwari |
| Designation |
Assistant Professor |
| Affiliation |
Shree Guru Gobind Singh Tricentenary University |
| Address |
Department of Faculty of Physiotherapy, SGT University, Chandu-Budhera, Gurgaon, Haryana 122505
Department of Faculty of Physiotherapy, SGT University, Chandu-Budhera, Gurgaon, Haryana 122505
Gurgaon
HARYANA
122505
India |
| Phone |
08826047941 |
| Fax |
|
| Email |
snigdha_FPHY@sgtuniversity.org |
|
Details of Contact Person
Public Query
|
| Name |
Nikita Saini |
| Designation |
MPT Student |
| Affiliation |
Shree Guru Gobind Singh Tricentenary University |
| Address |
Department of Faculty of Physiotherapy, SGT University, Chandu-Budhera, Gurgaon, Haryana 122505
Department of Faculty of Physiotherapy, SGT University, Chandu-Budhera, Gurgaon, Haryana 122505
Gurgaon
HARYANA
122101
India |
| Phone |
08826047941 |
| Fax |
|
| Email |
nikitasaini5553@gmail.com |
|
|
Source of Monetary or Material Support
|
| Faculty of physiotherapy, SGT University, Chandu-Budhera, 122505 |
|
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Primary Sponsor
|
| Name |
Nikita |
| Address |
Faculty of physiotherapy, SGT University, Chandu-Budhera, 122505 |
| Type of Sponsor |
Other [self] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Nikita Saini |
SGT Medical college and Hospital |
Department of Faculty of Physiotherapy, SGT University, Chandu-Budhera, Gurgaon, Haryana 122505
Gurgaon
HARYANA |
08826047941
nikitasaini5553@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental Ethical Committee, Faculty of Physiotherapy, SGT University |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Chronic Neck Pain |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cervical Stabilization exercises |
Progressive Cervical Stabilization exercises will be carried out. Each exercise session will comprise 10-minute warm-up exercises, 30-minute stabilization exercises, and 10-minute cool-down and stretching exercises. The whole program will be carried out 3 days per week for 4 weeks.
For the cervical stabilization exercise, the cervical bracing technique with the activation of deep neck flexors will be performed. The participants will be asked to maintain the positions and contractions during the exercises and throughout the day as much as possible.
The exercises include workouts using the bracing technique in neurodevelopment stages (supine, prone, quadrupedal, bipedal) for the cervical spine. Participants should hold the contraction for 10 seconds at each position, with 10 repetitions. Extremity ROM exercises will be conducted while maintaining a stable spine at the specific positions. All exercise repetitions will be increased progressively from 8 to 12. Then, cervical isometric exercises will be performed directly forward, obliquely, toward right and left, and directly backward by maintaining a stable spine with elastic resistive bands, with 10 repetitions and a holding time of 6 to 10 seconds each. The exercises also include functional training with elastic resistance and exercise balls on unstable surfaces, with 10 repetitions and a holding time of 10 to 15 seconds each.
these exercises will be given 3 days a week for 4 weeks |
| Comparator Agent |
Muscle Energy Technique |
The second group will receive MET on upper trapezius, levator scapulae and scalene muscles for 5 repetitions using 20% of maximal isometric contraction keeping the stretch beyond resistance barrier for 20 seconds. the patient will be asked to apply approximately 20% of his strength to do the desired movements. This isometric contraction will be maintained for a period of 7 seconds while holding the breath and then the patient was asked to relax and exhale. During the period of relaxation, the therapist will stretch the muscle to its new length and the stretch force was maintained for a period of 10 seconds. this will be given for 3 days a week for 4 weeks |
|
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Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
neck pain on Numeric Pain Rating Scale between 3 to 8 (moderate cases)
chronic neck pain (duration of pain more than 3 months).
CVA 50 degrees or lower
Participants who are willing to participate in the study |
|
| ExclusionCriteria |
| Details |
1. signs of serious pathology (e.g. malignancy, inflammatory disorders, infectious diseases etc.)
2. history of cervical spine surgery in previous 12 months
3. history of trauma and fractures in cervical spine and shoulder
4. signs of cervical radiculopathy or myelopathy
5. history of significant cardiovascular or respiratory diseases that may interfere with exercise or respiratory function testing.
6. mental or cognitive problems
7. patient on any type of painkiller medicines
8. Current participation in other physical therapy or rehabilitation programs for neck pain.
|
|
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Method of Generating Random Sequence
|
Other |
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Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Pain will be assessed using Numerical Pain Rating Scale |
baseline and last day of 4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Respiratory function (FEV1, FVC, FEV1/FVC Ratio) |
Day 1 Assessment
4th week Assessment |
| Forward head posture using CV angle |
Day 1 Assessment
4th week Assessment |
| Anxiety using PASS-20 scale |
Day 1 Assessment
4th week Assessment |
|
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Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Neck pain (NP) is a widespread issue, often resulting from poor posture, muscle imbalance, and lack of exercise. Chronic NP (CNP), lasting over three months, is commonly associated with forward head posture (FHP), which increases cervical lordosis, weakens muscles, and compromises respiratory function due to altered biomechanics. Muscle Energy Technique (MET) is an effective manual therapy that enhances joint mobility, reduces pain, and improves muscle flexibility through isometric and isotonic contractions. It also promotes neuromuscular relaxation and circulation. Similarly, cervical stabilization exercises strengthen deep cervical muscles, improving coordination, mobility, and reducing NP-related disability. Spinal stabilization exercises activate deep muscles while decreasing surface muscle overactivity, enhancing posture and spinal alignment. Given the strong link between posture and NP, targeted exercises remain a key rehabilitative approach for restoring function and preventing recurrence. Hypothesis Alternate Hypothesis(H11): There will be a significant difference in the effects of cervical stabilization exercises and muscle energy technique on pain reduction. H12: There will be a significant difference in the effects of cervical stabilization exercises and muscle energy technique on quality-of-life improvement. H13: There will be a significant difference in the effects of cervical stabilization exercises and muscle energy technique on forward head posture correction. H14: There will be a significant difference in the effects of cervical stabilization exercises and muscle energy technique on respiratory status enhancement in individuals with chronic neck pain. Null Hypothesis(H01): There will be no significant difference in the effects of cervical stabilization exercises and muscle energy technique on pain reduction. H02: There will be no significant difference in the effects of cervical stabilization exercises and muscle energy technique on quality-of-life improvement. H03: There will be no significant difference in the effects of cervical stabilization exercises and muscle energy technique on forward head posture correction. H04: There will be no significant difference in the effects of cervical stabilization exercises and muscle energy technique on respiratory status enhancement in individuals with chronic neck pain.
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