| 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
|
|
|
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
|
|
|
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. |