| CTRI Number |
CTRI/2025/09/094929 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
08/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Dry cupping therapy in the management of Shoulder Tendinopathies. |
|
Scientific Title of Study
|
Efficacy of Dry Cupping Therapy in Avabahuka: A Randomised Control Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gaurav Prakash Londhe |
| Designation |
Associate Professor, PhD Scholar |
| Affiliation |
RA Podar Medical College. |
| Address |
Department of Shalya Tantra,
Bhargava Ayurveda College, R. H. Patel Technical Campus At. Vidhyagram,At. & Po. Dahemi, Ta, Borsad, Gujarat 388560
Anand
GUJARAT
388560
India |
| Phone |
7977071549 |
| Fax |
|
| Email |
hightide12345@ymail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradnya Rajesh Kapse |
| Designation |
PhD guide |
| Affiliation |
R.A Podar Ayurved Medical College, Worli |
| Address |
Department of Shalya Tantra,
RA Podar Ayurved Medical College,
Dr Annie Besant Rd, B Wing, BDD Chawls Worli, Worli, Mumbai, Maharashtra 400018
Mumbai
MAHARASHTRA
400018
India |
| Phone |
9930939867 |
| Fax |
|
| Email |
rasrajk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradnya Rajesh Kapse |
| Designation |
PhD guide |
| Affiliation |
R.A Podar Ayurved Medical College, Worli |
| Address |
Department of Shalya Tantra,
RA Podar Ayurved Medical College,
Dr Annie Besant Rd, B Wing, BDD Chawls Worli, Worli, Mumbai, Maharashtra 400018
Mumbai
MAHARASHTRA
400018
India |
| Phone |
9930939867 |
| Fax |
|
| Email |
rasrajk@gmail.com |
|
|
Source of Monetary or Material Support
|
| R.A Podar Ayurveda Medical College, Worli, Mumbai. |
|
|
Primary Sponsor
|
| Name |
Dr. Gaurav Prakash Londhe |
| Address |
31, Sharnam Bungalows, Jitodiya, Anand-388001 |
| Type of Sponsor |
Other [Self] |
|
|
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 Pradnya Rajesh Kapse |
R.A Podar Ayurveda College |
Department of Shalya Tantra, Hospital wing,
Dr Annie Besant Rd, B Wing, BDD Chawls Worli, Worli, Mumbai, Maharashtra 400018
Mumbai
MAHARASHTRA |
9930939867
rasrajk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| R.A Podar Ayurved College, Worli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M658||Other synovitis and tenosynovitis. Ayurveda Condition: AVABAHUKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Dry Cupping Therapy | (Procedure Reference: Wood S, Fryer G, Tan LLF, Cleary C. Dry cupping for musculoskeletal pain and range of motion: A systematic review and meta-analysis. J Bodyw Mov Ther. 2020 Oct, pg 503, Procedure details: Duration of Treatment: 30 days.
Frequency of procedure: 2 interventions at day 1 & day 15.
Data Values collected at baseline, Day1 1 hour after procedure, Day 15 1 hour after procedure & at day 30 which is the final day of study.
Procedure details:
The point of maximum tenderness is identified over the selected shoulder joint & vacuum is created using the cupping set.
The cups are kept over the site until the skin develops erythema & subsequent ecchymosis.
The cups are removed after the desired level of ecchymosis is achieved.)
| | 2 | Comparator Arm | Procedure | - | Wet Cupping Therapy | (Procedure Reference: Sushrut Samhita Sharir Sthana Chapter 8 verse 17, Procedure details: Duration of Treatment: 30 days.
Frequency of procedure: 2 interventions at day 1 & day 15.
Data Values collected at baseline, Day1 1 hour after procedure, Day 15 1 hour after procedure & at day 30 which is the final day of study.
Procedure details:
The selected shoulder joint will be painted with Povidone Iodine Solution ensuring aseptic environment.
The part will be prepared for cupping by using surgical drapes.
Vacuum will be created over the desired point of maximum tenderness using the cupping apparatus till ecchymosis is achieved.
Superficial incision will be taken over the site using Surgical Blade no.15. Incision is to be taken 0.1mm length & 0.1mm distance parallel to one another to fill the complete area under the cup.
Approximately 25-30 small incisions are made. Vacuum will be reapplied for up to a time period till desired amount of blood (around 20ml) is collected in the cups.
The superficial incised wound will be later on dressed using betadine ointment & closed using gauze dressing.
)
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed as Avabahuka. (Rotator Cuff tendinopathy and Adhesive
capsulitis).
2. Patients of any sex.
3. Patients of age group 20-60 years.
4. Patients irrespective of caste, religion, economical status. |
|
| ExclusionCriteria |
| Details |
1.Patient suffering from major trauma having dislocation or fracture at shoulder region.
2.Patient suffering from any major systemic disorders excluding well controlled
Diabetes Mellitus-type 2 (BSL-PP less than 200 mg per dl)
3. Those patients who need other emergency interventions like surgery and other means
are excluded.
4. HIV, HBsAg positive patients are also excluded.
5. Patient suffering from Haematological disorders like thrombocytopenia, Von
Willebrand’s disease, thalassemia etc.
6. Patient suffering from severe Anaemia (Hb less than 8 gm percent) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Change in SPADI
(Shoulder Pain and Disability Index) total
score from baseline to day 30.
2.Shoulder ROM (abduction, flexion, external
rotation) using goniometer.
3.VAS (Visual Analogue Scale) for pain at rest
and on movement. |
1. Baseline (Day 0), Week 6 (end of treatment
plus or minus 3 days).
2.Baseline, Week 2, Week 4, Week 6, Week
12.
3.Baseline, Week 2, Week 4, Week 6, Week
12
chronologically. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
01/10/2025 |
| 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="3"
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
|
|
Brief Summary
|
Shoulder joint is the most mobile joint of human body with wide range of movements facilitating day to day work ranging from simple jobs like wearing clothes to complex ones like lifting objects. Imagine cessation of movement of our shoulder joint, attributed further by pain and stiffness. Routine life will be partially handicapped in this scenario. The clinical vignette described above goes by the name of Frozen Shoulder or Adhesive Capsulitis. It is most commonly associated with patients with Diabetes Mellitus. The prevalence of frozen shoulder is estimated to be 2 to 5 percent of the general population. Such patients have a lifetime risk of 10-20 percent of developing frozen shoulder. Alternatively Supraspinatus Tendinitis also brings similar picture in front of us.Treatment of the above disease in early stage is with analgesics, intraextra capsular corticosteroid injections, which are hepatotoxic, nephrotoxic; produce gastric irritation. It also requires regular ‘pendulum’ exercises of the arm to prevent the capsule from over tightening. So, the patient has to go to physiotherapist for regular follow ups, which is too costly and time consuming. Acharya Sushruta has mentioned the symptom complex analogous to frozen shoulder/supraspinatus tendinitis in Avabahuka. He opines the use of Raktamokshana in the management of Avabahuka. Raktamokshana has been described as “Ardha Chikitisa” by Acharya Sushruta. It provides quick relief in conditions of shoola (pain) and Shoth (Inflammation). There are various techniques of performing Raktamokshana out of which the technique of choice for the management of Avabahuka is Cupping Therapy. Shringa Therapy can be considered analogous to cupping therapy since vacuum created by suction to draw out blood is mainstay of the modus operandi of both the techniques. This is similar to Wet Cupping therapy. Similarly, Dry cupping can also be performed on the grounds that the ecchymosis thus created by negative pressure can be compared to Raktamokshana. Cupping Therapy has now 4 4 become a mainstay of Sports medicine and being utilized by even top Athletes like Michael Phelps. Chronic conditions like Avabahuka usually do not respond positively to standard protocol of management. Physiotherapy requires additional resources viz. time, money and patience. Raktamokshana is unchartered territory in the arena of Avabahuka management which require to be tapped in and researched upon to give low cost, safe and time bound remedy to its hold on our society.
Study plan:
Two groups, interventional involves dry cupping and control involves wet cupping therapy.
45 patients sample size per group.
Follow up on day 15 and day 30.
objective criteria involves range of motion and VAS. |