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CTRI Number  CTRI/2023/02/049640 [Registered on: 10/02/2023] Trial Registered Prospectively
Last Modified On: 09/02/2023
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 effects of IASTM and dynamic cupping on neck pain  
Scientific Title of Study   Comparison of Dynamic Cupping and Instrument Assisted Soft Tissue Mobilization on myofascial trigger points in the posterior neck fascia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Simran Esther Thomas Kurisinkal 
Designation  Post Graduate Student 
Affiliation  Dr. Balabhai nanavati hospital 
Address  Department of Physiotherapy, Ground Floor, Nanavati Super Specialty Hospital SV Road, Vile Parle(w) Bhaktivedanta Road Mumbai (Suburban) MAHARASHTRA 400056 India
Department of Physiotherapy, Ground Floor, Nanavati Super Specialty Hospital SV Road, Vile Parle(w) Bhaktivedanta Road Mumbai (Suburban) MAHARASHTRA 400056 India
Mumbai (Suburban)
MAHARASHTRA
400056
India 
Phone  8655123906  
Fax    
Email  simran.esther1996@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mansi Bhartiya 
Designation  Associate professor 
Affiliation  SVKMs Narsee Monjee Institute of Management studies 
Address  Department of Physiotherapy, Ground Floor, Nanavati Super Specialty Hospital SV Road, Vile Parle(w) Bhaktivedanta Road Mumbai (Suburban) MAHARASHTRA 400056 India
Department of Physiotherapy, Ground Floor, Nanavati Super Specialty Hospital SV Road, Vile Parle(w) Bhaktivedanta Road Mumbai (Suburban) MAHARASHTRA 400056 India
Mumbai (Suburban)
MAHARASHTRA
400056
India 
Phone  9867512415  
Fax    
Email  Mansi.Bhartiya@nmims.edu  
 
Details of Contact Person
Public Query
 
Name  Simran Esther Thomas Kurisinkal  
Designation  Post Graduate 
Affiliation  SVKMs Narsee Monjee Institute of Management studies 
Address  Department of Physiotherapy, Ground Floor, Nanavati Super Specialty Hospital SV Road, Vile Parle(w) Bhaktivedanta Road Mumbai (Suburban) MAHARASHTRA 400056 India
Department of Physiotherapy, Ground Floor, Nanavati Super Specialty Hospital SV Road, Vile Parle(w) Bhaktivedanta Road Mumbai (Suburban) MAHARASHTRA 400056 India
Mumbai (Suburban)
MAHARASHTRA
400056
India 
Phone  8655123906  
Fax    
Email  simran.esther1996@gmail.com  
 
Source of Monetary or Material Support  
DEPARTMENT OF PHYSIOTHERAPY BALABHAI NANAVATI HOSPITAL LIC colony, Suresh colony, vile parle west, Mumbai 400056 
 
Primary Sponsor  
Name  nil 
Address  nil 
Type of Sponsor  Other [nil] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR MANSI BHARTIYA  Dr. Balabhai Nanavati Hospital  Department of Physiotherapy, Ground Floor, Nanavati Super Specialty Hospital SV Road, Vile Parle(w) Bhaktivedanta Road Mumbai (Suburban) MAHARASHTRA 400056 India
Mumbai (Suburban)
MAHARASHTRA 
9867512415

Mansi.Bhartiya@nmims.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee, Dr Balabhai nanavati Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  DYNAMIC CUPPING For 6 days.  Patient will be asked to lie in side lying position on the couch with their upper torso unclothed, covered with paraffin oil then place cup on skin and suction will be created by pump. Then drawn over skin along the spine from cervical to thoracic up to lateral border maintain the suction within skin throughout the procedure. The cup massage will be conducted for approximately 3–5 minutes. Patients will be informed that the treatment area may become patchy and there are chances of ecchymosis on the same area. This intervention will be given for 6 days. 
Intervention  IASTM For 6 days  For IASTM, the subject was seated in a comfortable position. The subject’s will be positioned in side lying with the posterior neck fascia exposed. A lubricant (paraffin oil) will be applied to the skin around the neck area prior to treatment and the rock blade was cleaned with an alcohol pad. First, the Rock blade was used to find the exact areas of restriction in the neck region. Then the Rock blade will be used, at an angle of 45 degree and apply slow strokes along the region, without causing any discomfort or pain (sweeping technique) for approximately 3 min. This intervention will be given for 6 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Both male and female.
Myofascial Trigger points in the posterior neck fascia.
Age above 18 years.
 
 
ExclusionCriteria 
Details  Presence of any irritable skin conditions.
History of surgery or any trauma around the cervical complex.
History of any pathological condition of spine or any neurological condition

 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
PRESSURE ALGOMETER will assess the pressure pain threshold or force eliciting a pressure pain threshold.
This machine is designed to quantify and document levels of tenderness via pressure pain threshold measurement and pain sensitivity.
Pre and post 6 sessions readings will be taken and will be compared. 
Baseline Pre and post 6th session. 
 
Secondary Outcome  
Outcome  TimePoints 
RANGE OF MOTION WITH GONIOMETER
VISUAL ANALOGUE SCALE
NECK DISABILITY INDEX 
BASELINE POST 6TH SESSION  
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/02/2023 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

International association of pain define neck pain as a pain arising from anywhere from superiorly through nuchal line to inferiorly by first thoracic vertebra and laterally up to shoulder. Its prevalence in general population is up to 50%.1 Most patients suffer from simple or non-specific neck pain, which is mainly caused by mechanical factors such as sprain and strains. They do not only include poor posture and high physical load, but also poor psychological health, stress, low socioeconomic status, and smoking, usually mechanical pain resolves within three to six months; but 14% of the patients will suffer from recurrent or persistent pain.7

Myofascial pain syndrome is defined as sensory, motor, and autonomic symptoms resulting from painful spots in the fascia surrounding skeletal muscle known as myofascial trigger points (MTrPs). MTrPs are associated with palpable nodules in taut bands of muscle fibers. Compression of these points may elicit a) motor dysfunction, b) local and referred tenderness, b) pain perceived at a different spot than the site of the painful stimulus (referred pain), c) transient contraction of the muscle (local twitch response) and d) autonomic phenomena. Diagnostic findings of MTrPs include severe ROM limitation, a palpable taut band with exquisitely tender nodule and familiar to patient pain elicited from pressure on painful Spots (jump sign).4 There are many therapies available to treat the neck pain like Myofascial Release, Muscle Energy Technique, massage, dry needling, Cupping, Instrument Assisted Soft Tissue Mobilization (IASTM), mobilization etc.1

IASTM techniques use special stainless-steel instruments that enable clinicians to locate efficiently and treat soft tissue dysfunctions, such as fibrosis, adhesions, chronic inflammation, or degeneration. Benefits from IASTM use include increased fibroblast proliferation, reduction in scar tissue and adhesions, increased vascular response, and remodeling of disorganized collagen fiber matrix. IASTM technique also has been found that it results in clinical benefits such as improvements in range of motion, strength and pain perception following treatment. Despite extensive use of IASTM techniques research regarding its effect on myofascial pain reduction, is limited.4 There is converging evidence that cupping can induce comfort and relaxation on a systemic level and the resulting increase in endogenous opioid production in the brain leads to improved pain control. Other researchers proposed that the main action of cupping therapy is to enhance the circulation of blood and to remove toxins and waste from the body.1,3In Ayurveda also mentioned use of cupping therapy by Acharaya Sushruta named as a raktmoshana in ‘Pradhanakarma’, it implies on blood refine from blood stream. The main aim of this therapy is elimination of vitiated blood from the body. Thought of act of cupping is mainly to increase blood circulation and relive painful muscle tension.1

From last few years there is growing evidences of dynamic cupping and IASTM in neck pain. IASTM and cupping therapy techniques are procedures rapidly growing in popularity due to their effectiveness and efficiency in treating soft tissue restrictions while remaining non-invasive.

Aim:To compare Dynamic Cupping and Instrument Assisted Soft Tissue Mobilization on myofascial trigger points in the posterior neck fascia 

OBJECTIVES:

  • To check the effect of the treatment on Pressure algometer, visual analogue scale, cervical range of motion, neck disability index comparing subjects treated with dynamic cupping and IASTM.
  • To check which treatment gives faster and better effects.

PROCEDURE

 

Ethical committee approval will be taken. CTRI registration will be done. Participants would be selected based on inclusion and exclusion criteria. Participants will be informed about the study. Written Consent will be taken. The participants would be divided into 2 groups. 

Group A Dynamic cupping:Patient will be asked to lie in side lying position on the couch with their upper torso unclothed, covered with paraffin oil then place cup on skin and suction will be created by pump. Then drawn over skin along the spine from cervical to thoracic up to lateral border maintain the suction within skin throughout the procedure. The cup massage will be conducted for approximately 3–5 minutes. Patients will be informed that the treatment area may become patchy and there are chances of ecchymosis on the same area.

Group B IASTM: For IASTM, the subject was seated in a comfortable position. The subject’s will be positioned in side lying with the posterior neck fascia exposed. A lubricant (paraffin oil) will be applied to the skin around the neck area prior to treatment and the rock blade was cleaned with an alcohol pad. First, the Rock blade was used to find the exact areas of restriction in the neck region. Then the Rock blade will be used, at an angle of 45 degree and apply slow strokes along the region, without causing any discomfort or pain (sweeping technique) for approximately 3 min.

OUTCOME MEASURES:

GONIOMETER

PRESSURE ALGOMETER

VAS

NECK DISABILITY INDEX

For IASTM, the subject was seated in a comfortable position. The subject’s will be positioned in side lying with the posterior neck fascia exposed. A lubricant (paraffin oil) will be applied to the skin around the neck area prior to treatment and the rock blade was cleaned with an alcohol pad. First, the Rock blade was used to find the exact areas of restriction in the neck region. Then the Rock blade will be used, at an angle of 45 degree and apply slow strokes along the region, without causing any discomfort or pain (sweeping technique) for approximately 3 min.

 
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