| CTRI Number |
CTRI/2024/06/069003 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
19/03/2025 |
| 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
|
How Muscle Energy Technique and Stabilization Exercises Enhance Cervical Joint Position Sense in patients with chronic neck pain. |
|
Scientific Title of Study
|
Effect of Muscle Energy Technique and Stabilization Exercise on Cervical Joint Position Sense in patients with chronic neck pain |
| Trial Acronym |
RCT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Srujan P S Aradhya |
| Designation |
PG Student |
| Affiliation |
St Johns Medical College Hospital |
| Address |
Room No:30
St Johns Medical College Hospital
Department of Physiotherapy, Sarjapur Marathahalli Rd, beside Bank Of Baroda, John Nagar, Koramangala, Bengaluru, Karnataka 560034
Bangalore
KARNATAKA
560034
India |
| Phone |
9620359139 |
| Fax |
|
| Email |
srujanaradhya57@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sneha Vishwanath |
| Designation |
Professor |
| Affiliation |
St Johns Medical College Hospital |
| Address |
Room No:33
St Johns Medical College Hospital
Department of Physiotherapy, Sarjapur Marathahalli Rd, beside Bank Of Baroda, John Nagar, Koramangala, Bengaluru, Karnataka 560034
Bangalore
KARNATAKA
560034
India |
| Phone |
9739314175 |
| Fax |
|
| Email |
snehapt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Srujan P S Aradhya |
| Designation |
PG Student |
| Affiliation |
St Johns Medical College Hospital |
| Address |
Room No:33
St Johns Medical College Hospital
Department of Physiotherapy, Sarjapur Marathahalli Rd, beside Bank Of Baroda, John Nagar, Koramangala, Bengaluru, Karnataka 560034
Bangalore
KARNATAKA
560034
India |
| Phone |
9620359139 |
| Fax |
|
| Email |
srujanaradhya57@gmail.com |
|
|
Source of Monetary or Material Support
|
| St Johns Medical College Hospital, Sarjapur Marathahalli Rd, beside Bank Of Baroda, John Nagar, Koramangala, Bengaluru, Karnataka,India 560034 |
|
|
Primary Sponsor
|
| Name |
not applicable |
| Address |
not applicable |
| Type of Sponsor |
Other [not applicable ] |
|
|
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 |
| DrSneha Vishwanath |
St Johns Medical College Hospital |
Room No:30
St Johns Medical College Hospital
Department of Physiotherapy, Sarjapur Marathahalli Rd, beside Bank Of Baroda, John Nagar, Koramangala, Bengaluru, Karnataka 560034
Bangalore
KARNATAKA |
9739314175
snehapt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,St Johns Medical College Hospital,Bengaluru |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M542||Cervicalgia, (2) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cervical Stabilization Exercise |
In the first phase of training the physiotherapist will teach the subject to perform a slow and controlled Cranio-Cervical Flexion(C-CF) action in the supine position.
Once the correct C-CF motion was achieved, subjects begin the second phase of training in which they will be trained to hold progressively increasing ranges of C-CF using feedback from an air-filled pressure sensor placed behind the neck.
The feedback dial will display the amount of pressure change as the cervical lordosis progressively flattened during C-CF. The subject initially will perform C-CF to sequentially reach 5 pressure targets in 2 mmHg increments from a baseline of 20 mmHg to the final level of 30 mmHg.
Sequence of stabilization exercises designed for 6 sessions. |
| Intervention |
Muscle Energy Technique |
Post-isometric relaxation technique will be applied to upper trapezius, levator scapulae, sternocleidomastoid and scalene for three-five repetitions using maximal isometric contraction. Stretch will be held beyond resistance barrier for 7-10 seconds.
The muscle which is short will be assessed using goniometer and Muscle Energy Technique will be given only for the muscles which are required.
|
| Comparator Agent |
Proprioceptive Training |
Gaze Direction Recognition Exercise protocol: Small boxes numbered between 1 and 6 were ordered on a table (1800 mm × 400 mm) with the same interval to divide five equal parts for GDRE. A researcher sits toward the table at a distance of 75 cm. The patient sits behind the researcher at a distance of 75 cm and toward the table. The researcher looks at the boxes randomly with cervical rotations. The patient at the back should know which box the researcher looks at by saying the number of the box.This training will be carried out for the duration of 10 minutes in each session. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patients with neck pain for more than 3 months.
Neck pain with limitation of neck range of motion.
NPRS ≥3
|
|
| ExclusionCriteria |
| Details |
Any neurological disorder related to cervical spine.
Signs of serious pathology (e.g., malignancy, inflammatory disorder, infection)
History of cervical spine surgery in previous 12 months.
History of trauma or fractures in cervical spine.
Signs of cervical radiculopathy or myelopathy.
Vestibular dysfunction
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cervical Joint Position Error |
Baseline and Two Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Numerical Pain Rating Scale,Range of Motion,Functional Status of Neck |
Baseline & Two Weeks |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
Final Enrollment numbers achieved (Total)= "28"
Final Enrollment numbers achieved (India)="28" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/07/2024 |
| Date of Study Completion (India) |
28/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
28/02/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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
|
Chronic
neck pain is a complex condition characterized by discomfort that extends
widely across the neck and shoulders, often accompanied by heightened
sensitivity to pain even with a gentle touch.Individuals with this condition may struggle to accurately perceive the
position of their neck joints, leading to difficulties in coordinating
movements and maintaining proper posture. The
sensory input from mechanoreceptors plays a crucial role in maintaining joint
stability by providing feedback on changes in joint position. When there is
abnormal sensory input from the cervical region, it can lead to a disruption in
the perception of joint position, known as cervical joint position error (JPE).
Muscle
Energy Technique (MET) stands as a method employed to tackle issues related to
muscular tension, pain, and joint dysfunction, with the primary goal of
augmenting the range of motion (ROM). This approach involves initiating muscle
relaxation followed by stretching, thereby exerting an effect on both static
and dynamic posture. The mechanism through which MET operates involves the
activation of proprioceptive and interoceptive pathways.In a nutshell, Muscle
Energy Technique (MET) is a therapeutic approach designed to alleviate muscular
tension, pain, and joint dysfunction while simultaneously improving range of
motion. By targeting proprioceptive pathways and actively engaging muscles, MET
facilitates relaxation, stretching, and ultimately enhances joint motion and
position sense.
The
purpose of this research is to evaluate the effect of
Muscle Energy Technique and Stabilization Exercise on joint position sense in
chronic neck pain patients using digital inclinometer.
|