| CTRI Number |
CTRI/2023/03/050505 [Registered on: 09/03/2023] Trial Registered Prospectively |
| Last Modified On: |
05/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Ultrasound Therapy and Static Muscle Contraction with Stretching Exercises 0n Taut Band of Muscle Fibers Around Neck |
|
Scientific Title of Study
|
EFFECT OF HIGH POWER PAIN THRESHOLD STATIC ULTRASOUND
& MUSCLE ENERGY TECHNIQUE IN UPPER TRAPEZIUS MYOFASCIAL TRIGGER POINTS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANAND KUMAR SINGH |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
G D GOENKA UNIVERSITY |
| Address |
DEPARTMENT OF PHYSIOTHERAPY
SCHOOL OF MEDICAL AND ALLIED SCIENCES
G D GOENKA UNIVERSITY
SOHNA GURGAON
DEPARTMENT OF PHYSIOTHERAPY
SCHOOL OF MEDICAL AND ALLIED SCIENCES
G D GOENKA UNIVERSITY
SOHNA
Gurgaon
HARYANA
122103
India |
| Phone |
8607370746 |
| Fax |
|
| Email |
anandkumar.singh@gdgu.org |
|
Details of Contact Person
Scientific Query
|
| Name |
KAMRAN ALI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
G D GOENKA UNIVERSITY |
| Address |
DEPARTMENT OF PHYSIOTHERAPY
SCHOOL OF MEDICAL AND ALLIED SCIENCES
G D GOENKA UNIVERSITY
SOHNA GURGAON
DEPARTMENT OF PHYSIOTHERAPY
SCHOOL OF MEDICAL AND ALLIED SCIENCES
G D GOENKA UNIVERSITY
SOHNA
Gurgaon
HARYANA
122103
India |
| Phone |
8607370746 |
| Fax |
|
| Email |
KAMRAN.ALI@GDGU.ORG |
|
Details of Contact Person
Public Query
|
| Name |
ANAND KUMAR SINGH |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
G D GOENKA UNIVERSITY |
| Address |
DEPARTMENT OF PHYSIOTHERAPY
SCHOOL OF MEDICAL AND ALLIED SCIENCES
G D GOENKA UNIVERSITY
SOHNA GURGAON
DEPARTMENT OF PHYSIOTHERAPY
SCHOOL OF MEDICAL AND ALLIED SCIENCES
G D GOENKA UNIVERSITY
SOHNA
Gurgaon
HARYANA
122103
India |
| Phone |
8607370746 |
| Fax |
|
| Email |
anandkumar.singh@gdgu.org |
|
|
Source of Monetary or Material Support
|
| DR. ANJU PHYSIO & REHAB CENTRE
Commercial Shop Number 32 GLS Arawali Homes Sohna Sector 4 Gurgoan Haryana |
| G D Goenka University
Goenka educational city Sohna Gurgaon Road Sohna Haryana 122103 |
| THE PHYSIOS
Physiotherapy clinic 170/16 shivaji Nagar Gurgoan |
|
|
Primary Sponsor
|
| Name |
G D GOENKA UNIVERSITY |
| Address |
Goenka eductatinal city, Sohna - Gurgaon Rd, Sohna, Haryana 122103 |
| Type of Sponsor |
Other [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 |
| Anand Kumar Singh |
G D Goenka University |
PHYSIOTHERAPY DEPARTMENT
ROOM NO. 318
SOHNA GURGAON ROAD
Gurgaon
HARYANA |
8607370746
anand01physio@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| WAVES WOMEN EMPOWERMENT TRUST |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
HIGH POWER PAIN THRESHOLD STATIC ULTRASOUND TECHNIQUE –I, MUSCLE ENERGY TECHNIQUE. |
the transducer will be place on LTrPs and keep static, and the waveform during each session will be continuous. The intensity is gradually increase from 0.5 W/cm2 to the pain threshold level at which the patient verbally report the pain. The therapist keep the intensity at that level for 4–5 s, and then move the US transducer in a circle without the change of the intensity for 15 s. The area of the circular movement is approximately 40 cm2. The patients will be asked whether serious pain or any abnormal sensation is felt during HPPTUS. The intensity will vary from 0.5 to 1.5 W/cm2. The procedure will be repeated NINE times in the HPPTUS-9 group
The therapist positioned the cervical spine in the lateral flexion (in the opposite direction to the relaxed muscle) until a slight tension of the soft tissues will be felt. If the participant did not experience any pain, the therapist started the technique. It consisted of two stages. The first phase is to activate the upper trapezius for 10 s. This will be achieved by isometric contraction towards the elevation of the shoulder girdle. The therapist will apply resistance with his hand in the direction perpendicular to the upper side of the participant’s shoulder. During this phase, the participant could not experience any muscle vibrations that would indicate too much resistance. The participant then relax their muscles while breathing in and out deeply. This will be followed by a 10 s contraction of the antagonist muscle group (lowering of the shoulder girdle). Then, the therapist slightly position the subject’s shoulder girdle towards depression. The whole procedure will be performed gently and slowly so as not to cause discomfort. This is followed by the second stage (relaxation phase). It consist of passive lying on the back for 30 s. The therapist hold this new shoulder girdle position. Total duration of this intervention will be 15 Minutes |
| Intervention |
HIGH POWER PAIN THRESHOLD STATIC ULTRASOUND TECHNIQUE –II, MUSCLE ENERGY TECHNIQUE. |
the transducer will be placed directly on the MTrP and kept static, and the waveform during each session is continuous. The intensity is gradually increase from 0.5W/cm2 to the pain threshold level at which the patient wii report that the pain is no longer tolerable. The therapist will keep the intensity at that level for 4 to 5 seconds, after which the intensity will be reduce to half that level for a 15-second duration. This procedure will be repeated 3 times. The application time for the HPPTUS technique will be less than 5 minutes. The intensity will vary from 0.5 W/cm2 to 1.5 W/cm2. The patients will be asked to constantly report their pain level during the treatment.
It consist of two stages. The first phase is to activate the upper trapezius for 10 s. This will be achieved by isometric contraction towards the elevation of the shoulder girdle. The therapist will apply resistance with his hand in the direction perpendicular to the upper side of the participant’s shoulder. During this phase, the participant could not experience any muscle vibrations that would indicate too much resistance. The participant then relax their muscles while breathing in and out deeply. This is followed by a 10 s contraction of the antagonist muscle group (lowering of the shoulder
girdle). Then, the therapist slightly position the subject’s shoulder girdle towards depression. The whole procedure will be performed gently and slowly so as not to cause discomfort. This will be followed by the second stage (relaxation phase). It will consist of passive lying on the back for 30 s. The therapist hold this new shoulder girdle position. Total duration of this intervention will be 15 Minutes |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Experiencing neck pain for more than three months, and having at least one latent MTrP in the upper trapezius muscle.
2. Patients with neck pain that increases with movements against resistance and with negative history of fracture & dislocation.
3. Local twitch response provoked by the snapping palpation of the taut band.
4. Reproduction of the typically referred pain pattern of the MTrPs in response to compression. |
|
| ExclusionCriteria |
| Details |
1. Red flags are serious diseases (i.e. systemic, infectious, neoplastics, fractures, dislocation)
2. Specific shoulder pain indicates that symptoms could refer to a pathology that has a clear structural, patho-anatomic or patho-physiologic origin.
3. Younger than 18 years old, unable to understand English or Hindi and positive case history for traumatic shoulder pathology and for cognitive impairments.
4. Diagnosis of cervical radiculopathy or myelopathy determined by their primary care physician.
5. Having undergone myofascial pain therapy within the past month before the study. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Pain
2. Pressure Pain threshold
3. Range of motion of cervical spine
|
BASELINE
DAY 5
DAY 11
DAY 41 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
4. Neck Pain Disability Index
5. Sleep Quality
|
BASELINE
DAY 5
DAY 11
DAY 41 |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "134"
Final Enrollment numbers achieved (India)="134" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/03/2023 |
| Date of Study Completion (India) |
01/09/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
15/10/2024 |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
1. Kumar Singh, A., & Ali, K. (2023). Effectiveness of muscle energy technique and high-power pain threshold static ultrasound in myofascial trigger points: A systematic review. European Journal of Molecular & Clinical Medicine, 10(4), 368-390.
2. Kumar Singh, A., & Ali, K. (2024). Impact of two different high-power pain threshold static ultrasound techniques on myofascial trigger points: A pilot study. Journal of Clinical and Diagnostic Research, 18(1), YC04-YC09.
3. Kumar Singh, A., & Ali, K. (2024). Impact of advanced high-power pain threshold static ultrasound and muscle energy technique on pain thresholds and functional improvement in myofascial trigger points. Iranian Journal of Medical Council, 7(3).
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
OBJECTIVE OF THE STUDY ï‚´ To investigate the Effect of high power pain threshold static ultrasound & MET on Cervical range of motion, disability, pain & pressure pain sensitivity in the upper trapezius myofascial trigger points
ALTERNATE HYPOTHESIS (H0):- ï‚´ High power pain threshold static ultrasound & MET will increase Cervical range of motion ï‚´ High power pain threshold static ultrasound & MET will decrease disability. ï‚´ High power pain threshold static ultrasound & MET will decrease pressure pain sensitivity in the upper trapezius myofascial trigger points ï‚´ High power pain threshold static ultrasound & MET will decrease pain. Null HYPOTHESIS (H0):- ï‚´ High power pain threshold static ultrasound & MET will not increase Cervical range of motion ï‚´ High power pain threshold static ultrasound & MET will not decrease disability. ï‚´ High power pain threshold static ultrasound & MET will not decrease pressure pain sensitivity in the upper trapezius myofascial trigger points ï‚´ High power pain threshold static ultrasound & MET will not decrease pain.
Significance of the study ïµ This study will increase the knowledge of physiotherapists and contributes towards evidence based practice. ïµ This study will also help in determining the best and effective physiotherapy intervention used for the upper myofascial trigger point. ïµ Treatment protocol will save the time and resources both on the part of the therapist as well as patient. |